COMPARISON OF INTRA AND POST OPERATIVE

COMPLICATIONS BETWEEN IN SITU AND

EXTRA ABDOMINAL UTERINE REPAIR AT

CESAREAN DELIVERY

INTRODUCTION:

Cesarean section has been a mode of delivery since ages. It is the most significant

obstetric intervention that has saved countless number of mothers and infants. Numerous

references to cesarean section have been made in ancient Indian, Egyptian, Roman, and

European literature. Cesarean section has evolved very drastically and dramatically in

respect to the purpose, technique, post operative care, cost effectiveness and other aspects

to reduce the morbidity.

Historical background:

The origin of the word cesarean is unclear. It is likely that the term comes from

lex regia or royal law legislated from by one of the early kings of Rome, Numa

Pomphilius in 715 BC1. This law proclaimed that women who died before delivering

their infant had to have the infant removed through the abdomen before burial. This law

continued under the ruling of Caesar when it was called lex caesarea2.

During the 15th and 16th century caesarean section was carried out after the

mother’s death primarily to fulfill the religious beliefs that prevailed. The first witnessed

and documented caesarean section was performed by Jeremias Trautmann inWittenberg,

Germany in 16103.

During the 19th century classical cesarean section was widely adopted in Britain

and it gained enormous popularity and very good results. But it was Munro Kerr in 1911,

who performed the first transverse lower segment caesarean operation. Though initially

met with resistance, it was slowly accepted because of the strong reasons given by him.

He cited that lower segment was less vascular, thinned and easily approximated making

suturing easier and stronger. He also claimed that lower segment incision also had

minimal risk of rupture during subsequent pregnancies.

During caesarean section done in earlier days, patients generally died due to

hemorrhage or sepsis. After the advent of antibiotics, clean surgical practices and

improved surgical techniques these deaths were radically brought down. Introduction of

anesthesia and its massive advancement has improved maternal as well fetal outcomes

and provided pain relief for the laboring women.

Definition:

Cesarean delivery is defined as the birth of a fetus via laparotomy and then

hysterotomy4 . It can also be defined as an operative procedure whereby the fetus or

fetuses after the period of viability are delivered through an incision on the abdominal

and uterine walls5.

Statistics:

International health care community has considered the ideal rate for cesarean

sections to be between 10-15%6 . In the latest National Family Health Survey-4 (2015-16)

it is shown that the births delivered by Cesarean Section accounts to 17.2% in India as

compared to 8.5% in NFHS-3(2005-2006)7. In Tamil Nadu, births delivered by Cesarean

section during the same period have been shown to be as high as 34.1 %. In the previous

NFHS – 3 (2005-2006) births delivered by caesarean section was 20.3%. In Chennai

during the period of 2015-2016 percentage of births by caesarean section was 28.8%.

Since the last two decades, a progressive increase in caesarean delivery rates has been

observed worldwide. Maternal, obstetric, fetal, medicolegal, and social factors are pivotal

in this increment. It can be said that Cesarean section has become one of the commonly

performed surgical procedure in day to day obstetrics practice.

Classification of urgency of cesarean section:

A new classification developed based on the urgency of cesarean section was

proposed in 2000 by Lucas et al8 Prior to this classification all non elective cases posted

for cesarean section, were by default labeled as “emergency”. This led to a lot of

confusion because some cases were to be dealt with more urgency than the others. Based

on the new system, clinically significant decisions like decision – delivery interval,

choice of anesthesia etc can be made by the obstetricians and their team.

Fig Classification relating the degree of urgency to the presence or absence of fetal or maternal compromise

In category 1, decision to delivery interval can range from as soon as possible to

maximum of 30 minutes. Here there is immediate threat to the woman or the fetus when

delivery is not done. The clinical situations include prolonged fetal bradycardia, fetal

scalp pH <7.2, cord prolapse, abruptio placenta with fetal heart changes and suspected

uterine rupture.

In category 2, delivery is intended to be done within 30-45 minutes. Situations

like antepartum hemorrhage with reactive fetal heart tracing, non- progress of labor with

maternal and fetal compromise not as severe as category 1 are included in this category.

Category 3 in this classification requires early delivery but currently there is no

immediate risk to both the fetus and the mother. Non progress of labor without maternal

or fetal compromise, women scheduled for elective cesarean but presenting with ruptured

membranes or in labor non willing for trial of labor, worsening pre-eclampsia, are some

of the day to day scenarios which can be classified as category 3. It is recommended that

these women be delivered by at least 75 minutes to avoid adverse events.

Category 4 - Elective planned caesarean section that can be timed to suit the

woman and the obstetrics staff fall under this category. All cesarean section under this

category should be preferentially done after 39 completed weeks to have better neonatal

outcome in the absence of any other risk factors.

Anesthesia for caesarean section:

All women who are pregnant are potential candidates for emergency

administration of anesthesia. Those admitted for safe confinement have a great

probability for the need of anesthesia. Considering this fact, it is wise to send all high risk

pregnant women for pre anesthetic evaluation in their late second or early third trimester.

The anesthesiologist can take a focused history and physical examination that evaluates

the lungs, airway, and heart in a much more composed environment because during labor

it is very difficult to do the same. Risk and benefits of anesthetic management decisions

should be discussed on case to case basis. During the event of a caesarean delivery it is

always important to get an elaborate informed written consent for the surgery as well as

anesthesia, stating all the potential complications including aspiration, hemorrhage and

thrombo-embolism. Caesarean section carries a risk for short term postoperative

morbidity like fever, pain, hemorrhage, damage to bladder, bowel or ureters, and

thromboembolism. Long term clinical and obstetric problems include chronic pain,

infertility, bowel obstruction, abnormal placentation and its consequence.

Aspiration prophylaxis in the form of providing clear liquids after the onset of

labor, pharmacological drugs like non particulate antacids, H2 receptor antagonist,

metaclopramide, proton pump inhibitors can be used. Proper administration of the drugs

at least 30 minutes prior to cesarean section can reduce the intra operative complications

like nausea, vomiting and help in the women to have a better recovery.

It is ideal that the delivery unit and the operating room are adjacent to help in

prompt transfer of the patient during adverse events. The operating room should be well

equipped with monitors and checked regularly. Drugs used for general and neuraxial

anesthesia should be made promptly available.

Any day regional anesthesia is found to be better than general anesthesia for

obstetric patients unless there are special situations like thrombocytopenia, infections etc.

But there are certain drawbacks like inadequate blockade leading on to perception of

pain, failure to take up, multiple punctures, post Dural headache, hematoma etc.

Adequate sensory blockade up to sensory level of T4 and motor level up to T6 is

desirable to perform caesarean section9. All this being said, there are reports of cesarean

section being performed under local anesthesia; patients still doing well.

Surgical technique:

Cesarean section is delivery of the baby though an abdominal incision from an

intact uterus after the period of viability. Low transverse Pfannenstiel or Joel –Cohen

incision in made over the abdomen. Lower midline incision may be used when speed of

entry is paramount. The abdominal wall is entered in layers to reach the peritoneum,

which is opened as high as possible. Some surgeons prefer finger or blunt dissection of

the peritoneum while some prefer sharp. The uterus is checked for dextro- or laevo-

rotation. The uterovesical fold of peritoneum is identified and incision is made 2 cm

below this reflection over the lower uterine segment avoiding the bladder. The thickness

of the lower uterine segment varies depending on the gestational age, the stage and

duration of labor. When the patient is in well established labor, the lower segment is very

thin and simple nick of 1 cm will be enough to open the uterus. But when the patient is

remote from labor, this segment can be as thick as the upper segment and deeper incision

might be needed to open the uterus. The incision is then extended in cephalocaudal

direction.

The baby is extracted, umbilical cord is clamped and cut and the baby is handed

over to the pediatrician. Here again, latest consensus emphasis on the need for delayed

cord clamping when the fetus is not in distress to reduce the incidences of anemia.

In active management of third stage of labor, uterotonics are administered within

one minute following delivery. Commonly, during caesarean section Oxytocin 5 U can be

given as slow intravenous injection followed by Oxytocin 40 U in intravenous solution of

Ringer Lactate as a drip that can be left to run over three to four hours. Placenta is

spontaneously expelled. The uterus is then closed in layers, hemostasis is achieved and

abdomen is closed in layers. Single layer or double layer closure with continuous or

interlocking sutures of the uterine wound are also under dispute. Transient removal of the

uterus from the abdomen and exteriorizing it to facilitate repair of uterine incision has

been used as technique in many institutes. This has been shown to be of immense help

when the exposure of the uterine angles is difficult or with extension of the uterine

incision due to difficult delivery or thinned out lower uterine segment. Many

obstetricians prefer this method and claim that blood loss has also been shown to be

minimal due to reduction in blood flow as a result to kinking of the uterine veins.

However, opposition to this technique when the patient is under regional anesthesia has

been put forth as it leads to intra and post operative events like nausea, vomiting,

hypotension, trauma to the adnexal structures and pain which are undesirable.

Exteriorization of the uterus also has a potential risk of infections.

“There is more than one way to skin the cat” -Like for any surgical procedure, the

techniques and steps followed during cesarean section varies from one gynecologist to

the other. Though the basic principles of the surgery are the same, subtle differences in

the techniques adopted are done for the comfort of the surgeon and for the benefit of the

patient. These technical variations have been aimed at reducing the operative blood loss,

easier surgical access, length of the procedure, febrile or infectious morbidity, reducing

the days of hospital stay, decreasing adverse effects, and other events like nausea,

vomiting, pain, hypotension etc. Many surgical techniques have not been rigorously

assessed in randomized controlled trials and so whether any them are associated with

better outcome for the women and babies is not known, or rather proven scientifically.

Owing to volume of caesarean deliveries done globally, even a small difference in

morbidity between the techniques could cause huge impact on the improvement of

women’s health and their quality of life.

After observing these techniques which are practiced routinely, question arises to

which technique is superior with respect to reduced morbidity, patient’s safety, comfort

and surgeon’s preference. Hence, this study was done to identify these differences and

give the best possible care for the patient.

AIMS AND OBJECTIVES:

Primary objectives:

1. To compare intra operative pain morbidity between in situ and extra abdominal

repair in women undergoing caesarean delivery using verbal analogue scoring

scale.

2. To compare post operative fall in hemoglobin among the women undergoing

caesarean section by in situ and extra abdominal uterine repair.

Secondary objectives:

1. To compare the incidence of nausea and vomiting between the two groups during

intra operative period.

2. To compare the incidence of post operative febrile morbidity among the two

groups.

3. To compare the time taken for return of bowel functions between the two groups.

REVIEW OF LITERATURE:

Chauhan S et al10

This study was published in January 2018. It was a randomized controlled trial

done at Kerala Institute of Medical Sciences, Trivandrum. 200 pregnant patients were

randomized into two groups of 100 each. Statistical analysis of various events and

variables like mean time taken for uterine incision closure, intra operative blood loss and

post operative morbidities were done. They concluded that lesser mean time for uterine

wound repair ( P value = 0.05) was seen in exteriorized group. Post operative pain (P

value 0.025) and need for additional analgesic dose (P value = 0.034) was more in

exteriorized group. They found no significant difference in incidence of intra operative

nausea, vomiting, incidence of endomyometritis, febrile morbidity, wound infections,

time taken for return of bowel functions and length of hospital stay.

They concluded by saying that surgeon’s experience and

preference should determine the choice of uterine repair. There was no

evidence to suggest that exteriorizing the uterus has a more harmful

influence on maternal morbidity than in situ repair.

Priya L et al11

This study was published in April 2017. It was a prospective

comparative study performed at Mahatma Gandhi Medical College and

Research Institute, Pondicherry. 200 women undergoing cesarean

delivery were assigned as two groups with 100 patients in each group.

They included patients undergoing both emergency and elective

cesarean section with a term live singleton pregnancy in cephalic

presentation. They showed significant difference in blood loss P value

<0.001 and increased rate of blood transfusion P value of 0.038 in in-

situ repair group. Post operative complications like febrile morbidity

was also significant in in-situ group (P value 0.046). there were no

significance in other variables like urinary tract infection,SSI,

Endometritis and hospital stay.

V. Zaphiratos et al12

In 2015, systematic review and meta-analysis was published in Canadian Journal

of Anesthesia which included 16 randomized controlled trials and results were discussed.

In total, 9,736 subjects underwent extra abdominal and 9,703 had in situ uterine repair.

The primary outcomes and the results are as follows:

S.No Primary outcome Results

1 Reduction in haemoglobin

Six studies including 7,585 patients reported

a reduction in haemoglobin data. Pooled

results showed statistically significant drop

in haemoglobin higher in in-situ group.

(Mean difference,-0.14 g_dL-1; 95%

CI, -0.22 to -0.07).

2 Blood transfusion

Ten studies including 17,568 patients did not

show any significant difference.

3 Estimated blood loss Pooled data from six studies (908 patients)

showed no statistically significant difference

between the two repair techniques. (mean

difference [MD], -61.03 mL; 95%

confidence interval [CI], -127.34 to

5.28);

4 Intra operative nausea and

vomiting

Five studies were analysed and no

significant difference was identified. (odds

ratio [OR], 0.99; 95% CI, 0.74 to

1.34)

5 Intra operative pain Three studies( 439 patient)s pooled results

were analysed and showed no difference.

(OR, 1.52; 95%

CI, 0.86 to 2.71)

The secondary and additional outcomes studied were:

S.No Outcomes Results

1 Return of bowel function Four studies including 6,473 patients were

analysed and three out of the four studies

strongly favoured in situ repair. (MD, 3.09

hr; 95% CI, 2.21 to 3.97)

2 Endometritis (sensitivity

analysis)

17,600 patients over a span of eight studies

were compared and in situ repair was found

to be slightly advantageous over the extra

abdominal repair of uterus. (OR, 1.25;

95% CI, 0.96 to 1.62)

3 Wound infection (sensitivity

analysis)

Nine studies including 17,188 patients

showed no significant difference between

the two groups.

4 Operative time Thirteen studies were analysed and no

statistically significant results were arrived.

5 Hospital stay Nine studied showing 17,161 patients were

compared and found to have no statistically

significant difference between the two

techniques

6 Fever No significant difference was noted in five

studies that included 10,610 patients.

The studies included are as follows :

I. El-Khayat et al13

This study was published in June 2014. It was a double

blinded randomized controlled trial conducted in Egypt. During the

year of 2012-2013, 1000 participants undergoing cesarean section

were recruited. They clearly concluded that in situ repair of the uterine

wound is better than it’s extra abdominal counterpart in terms of

lesser duration of surgery(49.9 ± 2.3 minutes vs 39.9 ± 1.8 minutes; P < 0.001),

reduced pain morbidity(165 [33.0%] vs 115 [23.0%]; P = 0.001) and faster return of

bowel functions(17.0 ± 2.7 hours vs 14.0 ± 1.9 hours; P < 0.001).

II. Abalos et al14

Popularly called as the CORONIS (caesarean section surgical techniques)

collaborative group, Abalos et al published their 2X2X2X2X2 fractional, factorial

randomized controlled trial in Lancet 2013.It was international study done in 19 sites

including India. Each site was assigned three of the five intervention pairs: blunt versus

sharp abdominal entry; exteriorization versus in-situ repair of the uterus; single versus

double layer closure of the uterus, closure versus non—closure of the peritoneum,

chromic catgut versus polyglactin-910 for uterine repair. Total of 15,935 women were

recruited for the study. Eligibility criteria were any women undergoing caesarean section

through a transverse incision irrespective of fever, gestational age, or multiple

pregnancies. The primary outcome was the composite of death (<0.1% in in situ and

0.1% in exteriorized RR 0.25%), maternal infectious morbidity(1% in in situ and 1% in

exteriorized RR 1.06), further operative procedures(2%in in situ and 2% in exteriorized

RR 1.04)or blood transfusion( 1.5% in in situ and 1.5% in exteriorized RR1.04) . There

was no statistically significant difference in any of the primary outcomes they measured.

They suggested that any of these techniques were acceptable, but whether absence of

short term adverse effects will translate into absence of long term consequences need to

be studied.

III. Ozbay et al15

A total of 338 patients who were randomized as 171 in extra

abdominal group and 167 as in-situ repair group were included in this

study. It was published in 2011. They compared variables like blood

loss, febrile morbidity, postoperative analgesic dosage, and incidence

of post operative nausea and vomiting. They concluded that both the

techniques were valid options during cesarean section but the surgery took a lesser time

and shorter length of hospital stay when the uterine repair was done in-situ (30.64 +/-

8.65 vs 33.02 +/- 9.54 min., p = 0.011 and 2.23 +/- 0.49 vs 2.45 +/- 0.94 days, p = 0.045).

IV. Dog˘anay et al16

In 2010, a large prospective randomized controlled trial done by

Dog˘anay et al. Objective of this study was comparing the rates of

intra and post operative complications of uterine repair when

performed extra abdominally or in-situ. 4925 participated in the study

and variables like drop in hemoglobin concentration, operative time,

return of bowel sound, duration of hospitalization, rates of uterine

atony, need for blood transfusion, intra operative complications,

endometritis, wound infection were analyzed. They concluded that with

in-situ repair there were fewer instances of uterine atony(3.8% in situ

group and 9.1% in extra abdominal group; p=0.001) , faster return of

bowel functions, lesser need for analgesia and reduced incidence of

wound infections( p =0.001,p=0.002,p=0.003,respectively).

V. Coutinho et al17

This study was conducted in Brazil and published in Obstetrics and Gynecology

(Green journal) in 2008. It was a randomized controlled trial with 637 participants.

Variables analyzed were nausea, vomiting, mean operative time, intra operative blood

loss, number of surgical sutures for uterine repair, postoperative pain, number of post

operative analgesic doses, surgical site infections, and endometritis. A significant

difference was noted in the operative time 44% with exteriorized uterus compared with

35.3% with in situ uterus) which was found to be shorter in exteriorized group and less

suture material (18.2% requiring one suture in the exteriorized group compared with

11.9% in the in situ group, P=.03) was needed for uterine repair. However, moderate to

severe pain after 6 hours was noted in the same group (23.1%) when compared to those

who had in-situ(32.6%) repair. There were no other noteworthy differences in relation to

the other variables compared.

VI. Orji et al18

This study was published in 2008 in the Australian and New

Zealand Journal of Obstetrics and Gynecology. It was done to assess

the intra operative and postoperative morbidity following extra

abdominal repair of the uterus at caesarean section as compared to

those with non- exteriorization. 210 participants were recruited. Their

results showed significant reduction in intra operative blood loss

(p<0.05), number of analgesic dose(p<0.05), and duration of hospital

stay(p<0.05) in uterine exteriorized group but return of bowel function

was slightly longer.

VII. Siddiqui et al19

In 2007, a randomized single blinded controlled trial was published

in the Green Journal, where 80 women undergoing elective cesarean

section under spinal anesthesia were studied. In this study assisted

delivery of placenta, spinal anesthesia and oxytocin management

protocols were standardized. The primary outcome observed was post

operative nausea or vomiting. They concluded that exteriorization of

uterus was associated with significant increase in the incidence of

nausea or vomiting (18% compared with 38%; P=0.04) and

tachycardia (3% compared to 18%; P=0.03) during cesarean delivery

under spinal anesthesia. They further went on to say that wherever

possible in-situ repair of the uterus must tried.

VIII. Nafisi et al20

This study was done to compare post cesarean pain associated with

routine exteriorization of the uterus and in situ repair. It was a

prospective randomized control trial published in 2007 including 206

women who underwent cesarean delivery under general anesthesia.

They concluded that exteriorization was associated with increased post

operative pain in the first and second post operative day (66.7 vs. 43.5 (P < 

0.001); 44.6 vs. 23.9 (P < 0.001 respectively).

IX. Baksu et al21

This randomized controlled trial was published in February 2005 in Acta

Obstetrcia et Gynecologica Scandinavica. The purpose of the study was to determine

whether method of placental removal and site of uterine repair made any significant

difference in post operative endometritis and blood loss. 840 women who underwent

caesarean section were recruited into 4 groups. Patients who received intra partum

antibiotics, had chorioamnionitis, required emergency hysterectomy , rupture of

membranes more than 12 hours, abnormal placentation, prior postpartum hemorrhage,

bleeding diathesis were excluded. The study concluded that manual removal of placenta

at caesarean delivery resulted in more significant blood loss and occurrence of

endometritis( 15.2% in manual removal and 5.7% in spontaneous with p<0.05). The site

of uterine repair did not show any statistically significant discrepancy.

X. Ezechi et al22

They compared 136 women undergoing primary caesarean section at Nigeria

and published their findings in 2005. They concluded that operative time, estimated blood

loss, transfusion rate and postoperative anemia rate were significantly less in the

exteriorized group than the intra peritoneal group (p= 0.000, 0.009,0.048 0.038and 0.028

respectively). Exteriorization of the uterus is a preferred technique of uterine

wound closure except where it is not impossible because of adhesions

or surgeons inexperience.

XI. Wahab et al23

This prospective randomized controlled trial was published in 1999 in British

Journal of Obstetrics and Gynecology. 316 women were randomized. They gave an

important conclusion that with effective anesthesia, exteriorization of the uterus for repair

was not associated with significant blood loss or increased pain (P< 0.05). Hence, during

an emergency, surgeons need not be reluctant in exteriorizing the uterus for repair.

XII. Edi-Osagie et al24

This was also a randomized controlled trial published in 1998.

194 participants were randomized as 100 in extra abdominal group

and 94 in in-situ group. The variables compared were intra operative

pulse rate, mean arterial blood pressure and oxygen saturation,

hemoglobin concentration, incidence of intra operative vomiting, pain,

intra- and postoperative complications, febrile and infectious morbidity,

immediate and late puerperal pain, satisfaction post surgery. 57% of all pain complaints

occurred at the initial skin incision, 14% at incision of the rectus sheath, and 29% on

uterine exteriorization. These data suggest the occurrence of pain depended more on the

adequacy of anesthesia utilized for surgery, than the individual techniques of the

operation. They found no evidence that exteriorization of the uterus at cesarean had a

harmful influence on maternal morbidity than in situ repair. Providing

adequate anesthesia for women undergoing cesarean section are

paramount and universal anti-emetics policy needs to be advised to

reduce risk of vomiting, thereby reducing the risk of aspiration.

XIII. Magann et al25

The same set of investigators published a larger trial in 1995 with

284 participants to compare the infectious morbidity. They concluded

that manual removal of placenta and exteriorization of the uterus for

repair increase the infectious morbidity when the women received

prophylactic antibiotics.

XIV. Magann et al26

In 1993, Magann et al conducted a randomized controlled trial to

compare the blood loss with two methods of placental removal and site

of uterine repair. They concluded that it was the method of placental

removal and not the position of the uterus at the time of repair had a

significant role in blood loss during cesarean section.

XV. Magann et al27

In the same year, Magann et al published another study in

Infectious diseases in obstetrics and Gynecology were they compared

the infectious morbidity arising due to the different techniques of

uterine repair and type of placental removal. They concluded that

endometritis was more in manual removal of placenta with

exteriorization of the uterus when all the other known causes of

infectious morbidity was constant.

XVI. Hershey et al28

This study was done in 1978 at Los Angeles – University of Southern

California Medical center were 386 consecutive cesarean sections were

randomized and analyzed. Their results favored exteriorization of the

uterus except for vomiting (3.4%) which was lesser in in-situ repair

group.

Thus, this systematic review and meta-analysis computed various

outcomes that were studied and gave a comprehensive report. But

there are certain limitations like no study in this analysis had all the

primary outcomes defined in the review, nausea, vomiting, pain and

hemodynamic instability with exteriorization was reported in only few

studies and different post operative analgesia regimens were used in

different studies. Blood loss estimation was not standardized in many

studies. Finally, several outcomes discussed here can be influenced by

many confounding variables like emergency or elective cesarean

section, length of labor, rupture of membranes, type of anesthesia, use

and timing of antibiotics, use of vasopressor agents, and post

operative analgesia regimen.

They concluded by saying that ideal technique of uterine repair for

cesarean delivery is still under debate. Variables like blood loss, intra

operative nausea, vomiting, or pain showed no statistically significant

difference. In situ repair may be associated with faster return of bowel

function. Well conducted randomized control trials are need to focus on

intra operative events like nausea, vomiting or pain.

Shuja et al29

This was a randomized control trial done during the period of 2012-2013 at

Combined Military Hospital, Quetta. It was published in 2015. Here 780 patients (390 in

each group) were recruited for the study and many significant conclusions were made.

Inclusion criteria: elective cesarean deliveries, parity 2 or more with singleton pregnancy

at term assessed by dating scan. They showed results reinforcing the concept of in-situ

repair stating that exteriorization of the uterus was accompanied with increase in pain and

vomiting (18%in in situ repair group and 38% in exteriorization group ;p< 0.001) and

also increased operative time. The only advantage of exteriorization of uterus was found

to be good surgical exposure and access to uterine angles better.

4. Uzma Yaqub et al30

This was a randomized control trial done and published in 2012 at Lahore,

Pakistan. 100 patients were randomized. Only Primi gravidas were included in the study.

Exclusion criteria- previous cesarean section, chorioamnionitis, antepartum hemorrhage,

and pregnancy induced hypertension and diabetes, previous abdominal surgeries.

Different variables analyzed were fever, vomiting, mean operative time, intra operative

blood loss, post operative blood loss, postoperative pain, number of post operative

analgesic doses and surgical site infections. They concluded that the operative time and

need for lesser suture material was seen in the exteriorized group. But here the post

operative pain was found to be more severe. They concluded that the other variables like

vomiting and return of bowel function and febrile morbidity had no significant difference

between the two groups.

5. Jacobs-Jokhan et al31

This review was published in Cochrane library in 2004 by Jacobs-

Jokhan et al. It was edited in 2011 without any changes made in the

conclusion. The objective was to evaluate the effects of extra

abdominal repair of the uterine incision compared to the intra

abdominal repair. Six randomized controlled trials which have been

discussed previously(Edi – Osagie et al, Hershey et al(4) , Magann et al(7) ,Wahab et

al, Magann et al, magann et al) were used for data analysis. 1294 patients were

randomized overall and 1221 women were included for analysis. The primary outcomes

measured were blood loss and puerperal sepsis. Secondary outcomes included length of

Hospital stay, febrile morbidity, hemorrhage/blood transfusion, deep

vein thrombosis, hematuria, pain and vomiting - intra/postoperative,

late puerperal pain. They said that the quality of the trials were not high overall. The

existing data do not provide clinicians adequate answers regarding the benefits or risks of

either of the methods. 3 of the six trials reviewed, had women randomized based on

methods of placental removal as well. Meta analysis showed that except for febrile

morbidity(relative risk 0.41, 95%confidence interval (CI) 0.17to 0.97) and length of

hospital stay (weighted mean difference 0.24 days, 95% CI 0.08 to 0.39) there were no

significant difference in any of the outcomes which favored exteriorization . These results

are based on too few and too small studies to detect differences in rare, but severe,

complications. Possibility of rare complications like tearing of the ovarian veins should

also be borne in mind while interpreting the trial data.

MATERIALS AND METHODS:

Study design: Prospective interventional randomized controlled study

Study period: June 2016-May 2018

Study area : Department of Obstetrics and Gynecology,

Southern Railway Headquarters Hospital

Ayanavaram, Perambur , Chennai

Study population: all pregnant women in who undergo category 3 and 4 cesarean

section at Southern Railway Headquarters Hospital, Chennai.

INCLUSION CRITERIA:

All women undergoing lower segment cesarean delivery (category 3 and category

4 ) at Southern Railway HQ hospital, Chennai under regional anesthesia with singleton

fetus of gestational age 37 completed weeks or more.

EXCLUSION CRITERIA:

1. Cesarean section category 1 and category 2 (due to suboptimal time for action of

anti emetics prophylaxis)

2. Cesarean section done under general anesthesia( intra operative pain, NV cannot

be assessed while the patient is in general anaesthesia)

3. Previous 2 or more cesarean sections, prior abdominal or pelvic surgeries

( anticipation of adhesions which can interfere with duration of the operation)

4. Preterm cesarean section( due to increase blood loss through a thicker lower

uterine segment)

5. Classical, Inverted T shaped or J shaped incision on the uterus

6. Women with placenta previa, placental abruption( increased blood loss )

7. Concurrent procedures like Cesarean hysterectomy, cesarean mymectomy

(increased blood loss, duration) , surgical procedures for management of PPH

8. Dense Adhesions intraoperatively (can interfere with return of bowel functions,

diffuclty in exteriorization if needed)

9. Maternal fever or chorioamnionitis( increased risk for infectious morbidity)

10. Morbid obesity ( increased risk for infections, need for closure of subcutaneous

tissue which might increase the time required for completion of surgery)

11. Morbidly Adherent placenta( increased blood loss, operating time, concurrent

procedures)

SAMPLE SIZE ESTIMATION:

Average number of deliveries per year is approximately 1000 in Southern

Railway HQ Hospital. During the year 2016-2017, percentage of cesarean section done

was approximately 40%.

Sample size:

Sample size was calculated assuming the proportion of complications in in-situ

group to be 18% and in the exteriorization group to be 38% as per the study by Shuja, A.,

et al..(1) Other parameters considered for sample size calculation were 80% power of

study and 5% alpha error. The following formula was used for sample size calculation.

(2) According to the above mentioned formula, the required ample size would be 78

subjects in each group. To account for a non-participation rate of 5%, a total of 82

subjects will be sampled into each study group. Hence the total sample size would be 164

women.

Formula used for sample calculation: (Comparison of two proportions)

(Sample size of each group)

N=\{u √ [ π1 (1−π1) + π0(1−π0 )] + v √ [2 π ( 1−π )]}2

(π0− π1 )2

N Sample Size

1 ,0 Proportion (1 = 38% ,0=18%)

U one-sided percentage point of the normal distribution corresponding to 100

% – the power (For 80% power u =0.84 )

V Percentage point of the normal distribution corresponding to the (two-sided)

significance level (for significance level = 5%, v = 1.96)

In my study 170 participants were recruited and met the criteria. Informed

consent was obtained from all.

METHODOLOGY:

The study will be Randomized single blind controlled trial

Randomization:

Participants will be allocated to each of the study groups using random number

tables from a standard statistical text book. Numerical sequence for each of the

intervention will be laid down before random sequence generation ( For example: odd

numbers from 1-9 for intervention A and Even numbers for intervention B)

Allocation concealment:

Random sequence generated will be kept in serially numbered opaque sealed

envelope in the custody of an independent statistician or faculty, who is not part of the

primary research team. After recruiting each participant, the corresponding numbered

envelop will be opened and the participant will be allotted to the particular intervention

Blinding:

The investigator blinding is not possible, considering the nature of intervention.

The participants and the statistician analyzing the data will be blinded for the

intervention.

STATISTICAL METHODS:

Intra and post operative pain and fall in hemoglobin levels were considered as primary

outcome variables.

Secondary outcome variables: Nausea or vomiting, return of bowel function, and febrile

morbidity

Technique of LSCS was considered as primary explanatory variable.

Normality tests for quantitative variables:

A shapiro- wilk’s test (p>0.05) and a visual inspection of their histograms, normal

Q-Q plots and box plots showed that the duration of surgery, fall in haemoglobin, Verbal

analog score for pain, return of bowel function parameters were non-normally distributed

for technique of LSCS.

Descriptive analysis of quantitative variables was carried out by mean and

standard deviation for normally distributed variables and median, inter quartile range for

non-normally distributed variables. Categorical variables were summarized by frequency

and proportion.

The comparison between technique of LSCS and duration of surgery, fall in

haemoglobin, Verbal analog score, return of bowel function parameters were assessed by

comparing the median values. Mann Whitney U test was used to assess statistical

significance. Data was also represented using appropriate diagram like comparative box

plots.

The association between technique of LSCS, PPH and type of cesarean delivery,

intra operative and post operative pain, intra and post operative NV, post-operative

febrile morbidity were assessed by cross tabulation and comparison of percentages. Chi

square test was used to test statistical significance. Data was also represented using

appropriate diagram like clustered bar chart.

P value < 0.05 was considered statistically significant. IBM SPSS version 22 was

used for statistical analysis.

All pregnant women undergoing lower segment cesarean delivery (category 3

and 4) at Southern Railway HQ hospital, Chennai who had given a written informed

consent for participating in the study are listed. In our institution, both extra abdominal

and in-situ repair of the uterine incision has been done by the consultants depending on

the their level of comfort. In the event of a cesarean delivery, type of repair, operative

time from the start of skin incision to the closure of the skin wound and the intra and post

operative complications was observed and recorded in the operative notes and the same

was used to complete the proforma of every participant.

All patients received metoclopramide injection (0.25mg/kg body weight) and

ranitidine injection (2mg/kg maximum of 50mg) intravenously 30 minutes prior to the

surgery. The baseline readings of noninvasive blood pressure, heart rate, and SpO2 were

taken two times, 5 minutes apart, in the preoperative holding area, where an large bore

intravenous line (16 or 18 gauge) was established and lactated Ringer’s solution started to

keep the vein open.

Patients were randomly assigned by means of a computer-generated

randomization scheme into one of the two study groups: extra abdominal repair or in situ

repair in the maternity unit prior to their arrival to the operating theatre . Spinal

anesthesia by “single shot” technique was performed in the sitting position or lateral

position, using a 25,26 or 27-gauge Quincke needle depending on the patient, with 7.5

mg – 15 mg of 0.5%hyperbaric bupivacaine, depending on the height of the patient. E

technique was performed at the L3 to L4 interspace or lower. After the spinal injection,

patients were immediately placed in the supine position with slight left tilt. Supplemental

oxygen via nasal oxygen mask was administered at a rate of 4 L/min until delivery of the

infant. A sensory block to T4 is checked by pin prick prior to incision. Motor blockade up

to T6 is achieved. Patients were informed that they may be aware of surgical

manipulations during the procedure but perception of pain will not be present. Any

concerns were encouraged to be informed immediately. Two gram of cefazolin injection

diluted in 10 mL of normal saline was given as the first choice antibiotic given 15

minutes prior to incision.

Pfannelsteil incision was the skin incision used and abdomen was entered either

bluntly or by sharp dissection of the peritoneum. Uterovesical fold of peritoneum was

identified and Kerr’s incision was given over the lower uterine segment and baby was

delivered. After the delivery of the infant, all patients received a bolus of 5 Units of

oxytocin injection intravenously, followed by an infusion of 40 Units diluted in 500 mL

of lactated Ringer’s at a rate of 200ml/hr . Incremental bolus doses of 5 units can be

given at the surgeons’ request. If the surgeon demands extra uterotonics, they were given

and made a special mention in the operative notes. Spontaneous delivery of the placenta

was done and appropriate contraction of the uterus was achieved before exteriorization,

incase patients were randomly assigned to do so. Blood pressure was assessed every

minute throughout the cesarean delivery. Any drop in blood pressure was treated with an

intravenous bolus dose of 6mg of Ephedrine, repeated as necessary, to maintain systolic

blood pressure within 10% of the baseline values. Phenylephrine was used as a second

choice as per institution protocol. Hypotension was defined as a decrease in systolic

blood pressure greater than 20% of the baseline value, despite the use of prophylactic

ephedrine. In the event of discomfort requiring analgesic supplementation, the patients

can be given up to 50-100 mcg of Fentanyl intravenously. Intraoperative notes were used

to fill the detailed proforma available for each patient regarding other significant events

like Adhesiolysis, Postpartum hemorrhage etc.

The patients were questioned intra operatively at specific intervals and records

kept of any nausea, vomiting, or pain. Pain was quantified with a verbal numerical rating

scale of 0 to 10 (0 being no pain and10 being worst pain imaginable). Uterus exteriorized

was to be placed over a clean wet mop to prevent desiccation. Uterine repair in our

institution is done in two layers with No 1 polyglactin suture material. Sterilization (if the

patient has given consent) was done using chromic catgut by modified Pomeroy’s

technique. Peritoneum is routinely closed using No 2-0 polyglactin suture material.

Rectus sheath is then closed with continuous sutures of No 1-0 monofilament nylon

sutures. Skin is closed with 4-5 mattress sutures using No 2-0 monofilament nylon. The

total duration of surgery (skin incision to skin suture) was noted. Immediately before and

after surgery, the level of anesthetic block was checked bilaterally by pinprick and

recorded. Diclofenac Sodium suppositories were administered rectally at the end of the

surgery as an adjunct to postoperative analgesia. If patients requested for additional

analgesia injection tramadol 50-100 mg was given intramuscularly. Need for additional

analgesia was noted in the proforma. Patients were observed for 24 hours in the post

operative care unit. The oxytocin infusion was continued at the rate of 40 milli-Units/min

for 4 hours. Hemoglobin was recorded before surgery and within 24- 72 hours after

surgery. Postoperatively after 3-6 hours following the surgery once again patients were

enquired regarding nausea, vomiting, uneasiness, pain etc. Return of bowel function was

checked every three hours by auscultation for bowel sounds and patients were also

enquired regarding passage of flatus. Liquid diet on the return of bowel sounds was

started.

Postoperative wound dressings were changed on post operative day 3.

Temperature, BP chart was maintained and wound was checked for induration, discharge

and pain. Suture removal was done generally 7 days post operative or depending of the

wound. Patients are to be followed up for 6 weeks in the post natal clinic for wound

infections.

Febrile morbidity is defined as temperature of 38.C(100.4.F)or greater recorded

on two separate occasions, atleast 6 hours apart, more than 24 hours after the surgical

procedure. It is important to recognize that all febrile morbidity is not infectious

morbidity. It is important to treat the infection and not just the fever. In case of post

operative fever, patients were examined for lung infections, UTI, thrombophebitis or

wound infections. Category 3 and 4 Cesarean section wounds are generally clean or clean

contaminated wounds. There can be development of organ/space surgical site infections

or superficial/deep incision infections. These are characterized by presence of erythema,

warmth, tendernesss, swelling, seroma or purulent discharge from the wound site (wound

cellulitis) or presence of necrosis (deep wound infections).

Puerperal infections are associated with fevers spiking within the first 24 hours

after giving birth. These may be caused by preexisting genital tract infections. Other

causes of puerperal fever includes breast engorgement, urinary tract infections,

episiotomy and abdominal infections, perineal lacerations, hematoma, respiratory

complications.* Postpartum uterine infections are variedly called as endometritis,

endomyometritis and endoparametritis. Route of delivery is the single most significant

risk factor for development of uterine infections. Puerperal infections following cesarean

delivery is most commonly due to primarily infected surgical site. Microorganisms that

colonise the cervix and vagina gain access to the amniotic fluid and invade the

devitalized uterine tissue leading to infection. Clinical features include fever, abdominal

pain, parametrial tenderness, leucocytosis, foul smelling lochia, sub involution of uterus.

Due to overlapping definitions, in my study both surgical site infections as well as

puerperal sepsis has been included under variable as febrile morbidity. Patients are

followed up to six weeks for any of the above mentioned clinical features and treated

with appropriate antibiotics for the same.

OBSERVATION AND RESULTS:

A total of 174 subjects were recruited for the study but 4 patients intraoperatively had complications like dense adhesions, need for surgical management for PPH and hence excluded. Finally, the study was conducted with 170 subjects and the following analysis were done.

AGE DISTRIBUTION:

Table 1: Descriptive analysis of age (in years) in study population (N=170)

Parameter Mean ± SD Median Min Max 95% C.ILower Upper

Age (in years) 26.49 ± 4.11 26.00 19.00 39.00 25.87 27.12

The mean age was 26.49 ± 4.11in the study population. Ranged between was 19 years to

39 years(95% CI 25.87to 27.12). (Table 1)

GESTATIONAL AGE:

Table 2: Descriptive analysis of Gestational age (in weeks) in study population (N=170)

Parameter Mean ± SD Median Min Max 95% C.ILower Upper

Gestational age (in weeks) 38.63 ± 0.91 38.43 37.14 41.00 38.49 38.76

The mean gestational age (in weeks) was 38.63 ± 0.91in the study population. Ranged

between was 37.14 weeks to 41 weeks (95% CI 38.49to 38.76). (Table 2)

TYPE OF CAESAREAN:

Table 3: Descriptive analysis of type of Caesarean in study population (N=170)

Type of Caesarean Frequency PercentagesRepeat Caesarean 105 61.80%

Primary 65 38.20%

Among the study population, 105 (61.80%) women had repeat cesarean and 65 (38.20%)

women had primary cesarean. (Table 3 & Figure 1)

Figure 1: Pie chart of type of cesarean in study population (N=170)

61.80%

38.20%Repeat CesareanPrimary

Table 23: Comparison of technique of LSCS with type of Caesarean (N=170)

Type of Caesarean

Technique of LSCSChi square

 P-value

 Insitu (N=87) Extra abdominal (N=83)

Repeat Caesarean 54 (62.1%) 51 (61.4%)

0.007 0.933Primary 33 (37.9%) 32 (38.6%)

In in situ group, 54 (62.1%) women had repeat caesarean and 33 (37.9%) women had

primary caesarean. In extra abdominal group, 51 (61.4%) women participants repeat

caesarean and 32 (38.6%) women participants had primary caesarean. The difference in

the proportion of type of caesarean between technique of LSCS was statistically not

significant (P value 0.933) (Table 23)

TECHNIQUE OF UTERINE WOUND CLOSURE:

Table 4: Descriptive analysis of Technique of LSCS in study population (N=170)

Technique of LSCS Frequency PercentagesInsitu 87 51.20%Extra abdominal 83 48.80%

Among the study population, 87 (51.20%) women had in situ of LSCS and 83 (48.80%)

women had extra abdominal of LSCS. (Table 4& Figure 2)

Figure 2: Bar chart of technique of LSCS in study population (N=170)

In situ Extra abdominal 47.50%

48.00%

48.50%

49.00%

49.50%

50.00%

50.50%

51.00%

51.50% 51.20%

48.80%

Technique of LSCS

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INTRAOPERATIVE COMPLICATIONS:

Table 5: Descriptive analysis of extension of uterine wound in study population (N=170)

Extension of uterine wound Frequency Percentages

Yes 20 11.80%No 150 88.20%

Among the study population, 20 (11.80%) participants had extension of uterine wound. (Table 5)

Table 6: Descriptive analysis of adhesions in study population (N=170)

Adhesions Frequency PercentagesYes 18 10.60%No 152 89.40%

Among the study population, 18 (10.60%) participants had adhesions. (Table 6)

Both extension of uterine incision and presence of adhesion are significant

challenges encounter during caesarean section.

Table 7: Descriptive analysis of intra operative pain in study population (N=170)

Intra operative pain Frequency PercentagesYes 36 21.20%No 134 78.80%

Among the study population, 36 (21.20%) participants had intra operative pain. (Table 7)

Table 8: Descriptive analysis of intra operative Nausea or Vomiting in study population (N=170)

Intra operative Nausea or Vomiting Frequency Percentages

Yes 38 22.40%No 132 77.60%

Among the study population, 38 (22.40%) participants had intra operative Nausea or vomiting. (Table 8)

Since, C sections done in this study were under regional (i.e) spinal anesthesia, all

our participants are fully conscious during the procedure. Adequency of sensory blockade

up to T4 level and motor blockade of T6 were checked before and after the procedure and

patients were given universal anti emetics prophylaxis.

Table 9: Descriptive analysis of PPH in study population (N=170)

PPH Frequency PercentagesYes 22 12.90%No 148 87.10%

Among the study population, 22 (12.90%) participants had PPH. (Table 9)

Post partum haemorrhage is a dreaded complication in obstetrics. During

caesarean section an average of 1000ml of blood loss is expected. But current definition

of PPH according to ACOG is cumulative blood loss greater than or equal to 1000ml or

any amount of blood loss accompanied by signs or symptoms of hypovolemia within 24

hours after birth process including intra partum loss regardless of route of delivery. In

this study PPH was made by subjective assumption of the surgeon and their team.

Though objective assessment of hemorrhage is more scientific, it is more labourious,

difficult and not cost effective. Measurement of blood loss through assessment of mops,

suction apparatus, surgical drapes always tends to under estimate the amount of loss. For

our study we could not procure standardised mops, drapes due to budget constraints.

Most of morbidity and mortality due to PPH is “too little done too late”.

Commonest causes for PPH can be classified as 4T’s: Tone, Trauma,

Tissue,Thrombosis. Atonicity is the single most important cause for PPH. Drugs like

Prostaglandin E1, F2alpha, Ergometerine are now available which should be used wisely

during PPH management to tackle atonicity. But these drugs have side effects like

nausea, vomiting, loose stools, intra operative and post operative changes in

hemodynamics which can alter the findings of this study.

Table 10: Comparison of PPH with intra operative nausea or vomiting (N=170)

Intra operative Nausea or vomiting

PPHChi square  P-value 

Yes (N=22) No (N=148)Yes 7 (31.8%) 31 (20.9%)

1.304 0.253No 15 (68.2%) 117 (79.1%)

Out of 22 people with PPH, 7 (31.8%) people had intra operative nausea or

vomiting. The difference in the proportion of intra operative nausea or vomiting between

PPH was statistically not significant (P value 0.253) (Table 10& Figure 3)

Figure 3: Clustered bar chart of comparison of PPH with intra operative nausea or vomiting (N=170)

PPH Yes PPH No 0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

31.80%

20.90%

68.20%

79.10%

Intra operative NV Yes Intra operative NV No

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Table 19: Descriptive analysis of Duration of Surgery in study population (N=170)

Parameter Median Interquartile rangeDuration of Surgery 45.00 (35,45)

The median duration of surgery was 45 minutes (IQR 35 to 45 minutes).(Table 19)

POST OPERATIVE COMPLICATIONS:

Table 12: Descriptive analysis of haemoglobin status (%)in study population (N=170)

Parameter Mean ± SD Median Min Max 95% C.ILower Upper

Pre-operative Hb (%) 11.86 ± 1.32 12.00 9.30 14.80 11.66 12.06Post-operative Hb (%) 10.25 ± 1.18 10.20 7.00 13.50 10.07 10.43Fall in haemoglobin

(%) 1.61 ± 0.85 1.40 0.30 6.00 1.48 1.74

The mean pre-operative haemoglobin was 11.86 ± 1.32in the study population. Ranged

between was 9.30% to 14.80%(95% CI 11.66 to 12.06).The mean post-operative was

10.25 ± 1.18in the study population. Ranged between 7%to 13.50%(95% CI 10.07 to

10.43).The mean fall in haemoglobin was 1.61 ± 0.85 in the study population. Ranged

between 0.30% to 6% (95% CI 1.48 to 1.74). (Table 12)

Table 11: Descriptive analysis of need blood transfusion in study population (N=170)

Need blood transfusion Frequency PercentagesYes 4 2.40%No 166 97.60%

Among the study population, 4 (2.40%) participants had need blood transfusion. (Table 11)

Table 13: Descriptive analysis of Verbal Analog Scale for pain in study population (N=170)

Parameter Median Inter quartile range VA scale for pain 6.00 (6,8)

The median VA score for pain was 6 (IQR 6 to 8).(Table 13)

Table 18: Descriptive analysis of return of bowel function in study population (N=170)

Parameter Median Interquartile range Return of bowel function 6.00 (6,6)

The median return of bowel function was 6 hours (IQR 6 to 6).(Table 18)

Table 15: Descriptive analysis of endometritis in study population (N=170)

Endometritis Frequency PercentagesYes 4 2.40%No 166 97.60%

Among the study population, 4 (2.40%) participants had endometritis. (Table 15)

Table 16: Descriptive analysis of cystitis in study population (N=170)

Cystitis Frequency PercentagesYes 1 0.60%No 169 99.40%

Among the study population, only one (0.60%) people had cystitis. (Table 16)

Table 17: Descriptive analysis of fever in study population (N=170)

Fever Frequency PercentagesYes 8 4.70%No 162 95.30%

Among the study population, 8 (4.70%) people had fever. (Table 17)

Table 21: Descriptive analysis of period of hospitalisation (in days) in study population (N=170)

Parameter Mean ± SD Median Min Max 95% C.I

Lower UpperPeriod of hospitalisation

(in days) 4.11 ± 1.58 4.00 3.00 14.00 3.87 4.35

The mean suture removal was 7.92 ± 0.49in the study population. Ranged between 6 to

10 (95% CI 7.85 to 8). (Table 21)

Table 24: Comparison of median value in fall in haemoglobin (%) between techniques of LSCS

Technique of LSCS fall in haemoglobin (%)Median (IQR)

Mann Whitney U test (P value)

In situ 1.30 (1.10, 1.90) 0.971

Extra abdominal 1.40 (1.00, 2.00)

Among the people with in situ, the median fall in haemoglobin was 1.30 (IQR 1.10 to

1.90) and it was 1.40 (IQR 1 to 2) in people with extra abdominal. The difference in the

fall in haemoglobin between techniques of LCSC groups was statistically not significant

(P Value 0.971). (Table 24& Figure 4)

Figure 4: Comparative box plots of median value in fall in haemoglobin (%) between techniques of LSCS

Table 25: Comparison of technique of LSCS with intra operative NV (N=170)

Intra operative Nausea or Vomiting

Technique of LSCS Chi square P-value

In situ (N=87) Extra abdominal (N=83)    

Yes 14 (16.1%) 24 (28.9%)4.025 0.045

No 73 (83.9%) 59 (71.1%)

In in-situ group, 14 (16.1%) women had intra operative nausea or vomiting. Extra

abdominal group, 24 (28.9%) women had intra operative nausea or vomiting. The

difference in the proportion of intra operative nausea or vomiting between technique of

LSCS was statistically significant (P value 0.045) (Table 25 & Figure 5)

Figure 5: Clustered bar chart of comparison of technique of LSCS with intra operative NV (N=170)

In situ Extra abdominal0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

16.10%

28.90%

83.90%

71.10%

Intra op NV Yes Intra op NV No

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Table 26: Comparison of technique of LSCS with intra operative pain (N=170)

Intra op pain

Technique of LSCSChi

square P-value In-situ (N=87) Exteriorisation

(N=83)Yes 11 (12.6%) 25 (30.1%)

7.773 0.005No 76 (87.4%) 58 (69.9%)

In in-situ group, 11 (12.6%) women had intra operative pain. Extra abdominal group, 25

(30.1%) women had intra operative pain. The difference in the proportion of intra

operative pain between technique of LSCS was statistically significant (P value 0.005)

(Table 2 & Figure 6)

Figure 6: Clustered bar chart of comparison of technique of LSCS with intra op pain (N=170)

In situ Extra abdominal 0.00%

10.00%

20.00%

30.00%

40.00%

50.00%

60.00%

70.00%

80.00%

90.00%

100.00%

12.60%

30.10%

87.40%

69.90%

Intra op pain Yes Intra op pain No

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Table 27: Comparison of median value in duration of surgery between techniques of LSCS

Technique of LSCS Duration of surgeryMedian (IQR)

Mann Whitney U test (P value)

Insitu 45 (35, 45)0.385

Extra abdominal 45 (35, 45)

Among the people with in situ, the median duration of surgery was 45 mints (IQR 35 to

45) and it was 45 mints (IQR 35 to 45) in people with extra abdominal. The difference in

the duration of surgery between techniques of LCSC groups was statistically not

significant (P Value 0.385). (Table 27)

Table 28: Comparison of median value in Verbal analog score for post operative pain between techniques of LSCS

Technique of LSCS VA scoreMedian (IQR)

Mann Whitney U test (P value)

In-situ 6 (6, 8)0.561

Extra abdominal 6 (6, 8)

Among the people with in situ, the median VA score was 6 (IQR 6 to 8) and it was 6

(IQR 6 to 8) in people with extra abdominal. The difference in the VA score between

techniques of LCSC groups was statistically not significant (P Value 0.561). (Table 28)

Table 29: Comparison of median value in Return of bowel function between techniques of LSCS

Technique of LSCS Return of bowel functionMedian (IQR)

Mann Whitney U test (P value)

Insitu 6 (6,6)0.088

Extra abdominal 6 (6, 6)

Among the people with in situ, the median return of bowel function was 6 (IQR 6 to 6)

and it was 6 mints (IQR 6 to 6) in people with extra abdominal. The difference in the

return of bowel function between techniques of LCSC groups was statistically not

significant (P Value 0.088). (Table 29)

Table 30: Descriptive analysis of post-operative febrile morbidity in study population (N=170)

Post-operative febrile morbidity

Frequency Percentages

Yes 8 4.70%No 162 95.30%

Among the study population, 8 (4.70%) participants had post-operative febrile morbidity. (Table 30)

Table 31: Comparison of technique of LSCS with post-operative febrile morbidity (N=170)

Post-operative febrile morbidity

Technique of LSCSChi square  P-value 

In-situ (N=87) Extra abdominal (N=83)

Yes 1 (1.1%) 7 (8.4%)5.026 0.025

No 86 (98.9%) 76 (91.6%)

In in-situ group, 1 (1.1%) women had post-operative febrile morbidity. Extra abdominal

group, 7 (8.4%) women had post-operative febrile morbidity. The difference in the

proportion of post-operative febrile morbidity between technique of LSCS was

statistically significant (P value 0.025) (Table 31& Figure 7)

Figure 7: Clustered bar chart of Comparison of technique of LSCS with post-operative febrile morbidity (N=170)

In situ Extra abdominal0.00%

20.00%

40.00%

60.00%

80.00%

100.00%

120.00%

1.10%8.40%

98.90%91.60%

Post op febrile morbidity Yes Post op febrile morbidity No

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DISCUSSION:

INTRA OPERATIVE PAIN

In in-situ group, 11 out of 87 women (12.6%) had intra operative pain while in extra

abdominal group, 25 out of 83 women (30.1%) had intra operative pain. The difference in

the proportion of intra operative pain between techniques of LSCS was statistically

significant (P= 0.005). Wahab et al, Siddiqui et al, Edi- Osagi et al, Lakshmi P et

al,Jacobs- Jokhan et al concluded that with adequate anesthesia, incidence of intra

operative pain was not statistically significant. Bringing out the uterus outside the

abdominal cavity, intra abdominal exploration , peritoneal traction and repositioning can

cause pain and discomfort. Pulling out and repositioning the uterus through a relatively

smaller incision can cause pain. Hence, surgeons must ensure adequate size of the

incision before mobilizing the uterus. Visceral pain is carried through unmyelinated C

fibres are poorly localized. Despite the use of adequate anesthesia and level of

blockade(sensory level T4 motore level T6), some of these fibres may not be blocked

leading to the perception of pain. Patchy blockade causes difficulty for the surgeon as

well as the muscles are all taut and don’t give way. Some times intraoperative pain can

also be due to wearing off of spinal anesthesia due to substandard drugs, inadequate

dosage or prolonged surgery.

FALL IN HEMOGLOBIN

Among the people with in situ group, the median fall in hemoglobin was 1.30 (IQR 1.10

to 1.90) and it was 1.40 (IQR 1 to 2) in people with extra abdominal group. The

difference in the fall in haemoglobin between techniques of LCSC groups was

statistically not significant (P= 0.971). Studies done by Baksu et al (P=0.83; P=0.91),

Dog˘anay et al (in situ 1.2±0.4; extra abdominal 1.1±0.7 P=0.21), Chauhan S et al (in situ

0.37±0.101; extra abdominal 0.52±0.182 P=0.752), Lakshmi P et al , Nafisi et al, Jacobs-

Jokhan et al showed similar results. Randomized controlled trials done by Orji et al (P

=0.001but packed cell volume was compared), Wahab et al (95% CI 0.03-0.51 for mean

haemoglobin reduction), Ezechi et al (P 0.028) have concluded that exteriorization of the

uterus was associated with reduction in fall in hemoglobin levels. They proposed that

exteriorization of the uterus led to kinking of the uterine veins, better visualization of the

uterine angle, prompt management of atony, faster closure of the wound. But one may

argue that exteriorization may help in maintaining a relatively bloodless surgical field but

blood may flow away through drapes, mops etc. Metanalysis by Zaphiratos et al have

concluded that though there may be reduction in hemoglobin fall following

exteriorization, the finding may not be clinically significant. Need for active management

of third stage of labor cannot be over emphasized. Many studies have emphasized that it

is the mode of placental delivery either spontaneous or manual that has an impact over

the blood loss during cesarean section. In my study placenta was allowed for spontaneous

expulsion. Hence, when all the other parameters were standardized, both these techniques

showed no difference with respect to fall in hemoglobin.

INTRA OPERATIVE NAUSEA OR VOMITING

16.1% of women had intra operative nausea or vomiting in in-situ group and 28.9%

women had intra operative nausea or vomiting in extra abdominal group. The difference

in the proportion of intra operative nausea or vomiting between technique of LSCS was

statistically significant (P value 0.045) in our study. Trials conducted by Siddiqui et al ( P

value = 0.04), Shuja et al concluded that exteriorization of uterus led to increase in intra

operative nausea and vomiting. Pooled results of the two repair techniques in

the metaanalysis conducted by Zaphiratos et al did not show a

statistically significant difference in Intra operative nausea for 2,071

patients (OR, 0.99; 95%CI, 0.74 to 1.34; I2 = 36%) or in Intra operative

vomiting for 2,075 patients (OR, 0.94; 95%CI, 0.66 to 1.35; I2 = 22%).

Chauhan et al, El Khayat et al, Coutinho et al, Lakshmi P et al, Edi-

Osagie et al, Jacobs-Jokhan et al concluded no significant difference in

intra operative nausea and vomiting between the two techniques.

Intraoperative nausea or vomiting can be triggered by different factors

like inadequate level of blockade in spinal anesthesia, hypotension,

visceral pain, drugs used in anesthesia, Postpartum hemorrhage

prophylaxis , opioids etc. In our study, pre-anesthetic preparation of

our patients like pre loading of intravenous fluids, anti emetics

prophylaxis and the protocol for administration of spinal anesthesia

was standardized. Even when there is a seeming dense sympathetic

blockade following spinal anesthesia, vigourous manipulation of tissues

can trigger emesis. We had also taken meticulously taken efforts to

standardize the use of uterotonics judiciously. Oxytocin when given as

fast bolus can cause hypotension; drugs used for PPH like

prostagladins like F2alpha, ergot alkaloids can cause nausea or

vomiting. Hence, we have taken judicious steps in the use of these

drugs and to prevent hypotension intra operatively and we found

significant difference with these two techniques of uterine repair.

Neuraxial opiods have well known side effects of which most are more

annoying than life threatening. These side effects are pruritus, nausea,

vomiting, delayed gastric emptying, urinary retention, sedation and

respiratory depression. Hypotension is the most common side effect of

spinal anaesthesia because of the profound sympathectomy produced. Prophylaxis and

treatment of hypotension is a combination of proper positioning, fluid resuscitation and

vasopressor support.

FEBRILE MORBIDITY

In in-situ group, 1.1% women had post-operative febrile morbidity. Extra abdominal

group, 8.4% women had post-operative febrile morbidity. The difference in the

proportion of post-operative febrile morbidity between techniques of LSCS was

statistically significant (P value 0.025). This includes endometritis, cystitis, post operative

fever, wound infection. Dog˘anay et al, Abalos et al, Khayat et al, Chauhan

S et al, Lakshmi P et al, Coutinho et al, Baksu et al, Edi-Osagie et al

showed no differences in the incidence of endometritis comparing the

two techniques. Wahab et al, Ezechi et al, Nafisi et al showed similar

incidence of post operative fever between the two groups of cesarean

deliveries. Wound infection was compared in Nafisi et al, Orji et al,

Abalos et al, El Khayat et al no significant difference was brought out.

Magann et al said that when all the other factors causing infections

were constant, manual removal of placenta with uterine exteriorization

led to increase in postcesarean endometritis. But Cochrane review

shows significant increase in the incidence of post operative febrile

morbidity, sepsis and endometritis to be more in in situ group. Febrile

morbidty is influenced by various other factors like prolonged pre

operative hospital stay, premature rupture of membranes, increased

number of per vaginal examinations, chorio amnionitis, poor socio

economic status, unhygienic practices or taboos in the society.

TIME TAKEN FOR RETURN OF BOWEL FUNCTIONS

Among the people with in-situ, the median time taken for return of bowel function was 6

hours (IQR 6 to 6) and it was 6 hours (IQR 6 to 6) in people with exteriorization. The

difference in the return of bowel function between techniques of LCSC groups was

statistically not significant (P Value 0.088). Chauhan S et al showed similar conclusion in

their study (in 6-8 hours, 96%of in-situ group and 92% in exteriorization group) . But

Zaphiratus et al( mean difference of at least three hours), Shuja et al, El khayat et al,

Dog˘anay et al showed faster return of bowel functions with in-situ repair than extra

abdominal repair. They postulated that with in-situ repair manipulation of bowel and

peritoneum was comparatively lesser. Usage of opioid drugs can also cause ileus. These

drugs cause ineffective non propulsive activity of the small and large bowel leading to

increase in bowel transit time. Hence, bowel functions resumed sooner.

SUMMARY:

CONCLUSION:

In-situ repair of the uterine wound at cesarean delivery is associated with lesser incidence

of intra operative pain and intra operative nausea or vomiting than compared to extra

abdominal repair technique. Post operative febrile morbidity was also found to be lesser

in in-situ group. There is no significant difference in the post operative fall in hemoglobin

levels or time taken for return of bowel functions between the two techniques.

RECOMMENDATIONS:

1. Studies with primary outcome that focus on intra operative hemodynamic changes

while exteriorizing the uterus must be done.

2. During their training in Obstetrics, residents must be trained and exposed to both

these techniques and their pros and cons, so that during an emergency they will be

in a better equipped to handle them.

3. Though there are a considerable number of trial on post operative events, none of

these trials have shown to have provided us with data regarding the long term

sequelae like chronic pain, adhesions etc.

4. Intra operative events like nausea, vomiting, pain should be studied as a primary

outcome in future.

5. Subgroup analysis for infectious morbidity needs to be done as it has many

confounding factors like stage of labor, number of per vaginal examinations done,

antibiotic prophylaxis, duration of rupture of membranes etc.

LIMITATIONS:

1. Only category 3 and 4 cesarean deliveries were included in the trial.

2. Sample size of the study is relatively small to obtain meaningful conclusions to

form guidelines.

3. Hemodynamic changes have not been included as a variable.

4. Subgroup analysis of febrile morbidity has not been done.

5. Fall in hemoglobin levels may not be a reflection of blood loss during surgery.

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