midtrimester preterm prelabour rupture of membranes (pprom) english

8/12/2019 Midtrimester Preterm Prelabour Rupture of Membranes (PPROM) English

1/20

Expectant management oramnioinfusion for improving

perinatal outcomes


2/20

backgroundPPROM before 26 weeks can delay lung development

and can cause pulmonary hypoplasia .

Pulmonary hypoplasia is a term to describe an alteredpulmonary development-a reduction in the number of pulmonary alveoli or inbronchial branching.

In fetal lung development a critical interval, thecanalicular phase , (16 and 28 weeks gestation)


3/20

Aims

The primary aim of this study is to evaluate theeffectiveness of amnioinfusion compared to expectantmanagement

for relieving oligohydramnios in womenmidtrimester PPROM < 24 weeks gestational in reducing perinatal mortality and neonatal

morbidities.


4/20

PPROM? Amnioinfusion

ExpectantManagement


5/20

Participants/eligibility criteria

A singleton pregnancy who are first diagnosedbetween 16 - 24 weeks gestational age

Oligohydramnios secondary to PPROM, at least 72hours OR < 21 days Women with oligohydramnios secondary to

iatrogenic PPROM


6/20

Exclude categories:1. Signs of uterine contractions,

(8x uterine contractions/ h)2. Intrauterine infection

(temperature > 38C plus fetal tachycardia

uterine tenderness foul/purulent amniotic fluid)

3. A pregnancy complication (hypertension, HELLP syndrome,preeclampsia etc

4. placental or major structural fetal anomalies5. signs of cervical incompetence (visible cervical dilatation/ cervical length of


7/20

Procedures, recruitment, randomisation andcollection of data

sterile speculum examination for visible fluid loss nitrazine test ( Litmus ) ferning test

to exclude signs of cervical incompetence(visible dilatation)

ultrasound examination single deepest pocket (SDP)

Olihohidromnion SDP < 2 cm to exclude placental and or fetal structural anomalies.

pulmonary hypoplasia - TC/AC or TC/FL


8/20

Transabdominal Amnioinfusion

RL


9/20


10/20

Use of co-intervention

1. Corticosteroids ie Dexamethasone

2. Antibiotics (Erythromycinorally 250 mg 4 x per day for 10 days).


11/20

Study parameters/endpoints

We will compare two groups:

1) Amnioinfusion for midtrimester PPROM withOligohydramnios

2) Expectant management for midtrimester PPROM with oligohydramnios.


12/20

primary outcome-> measure will be perinatal mortality,

intrauterine death

intrapartum deathneonatal death in the first 28 days of life.


13/20

Secondary outcomes Gestational age at delivery

Time from membrane rupture to deliverySuccessful amnioinfusion ie SDP > 2cmPlacental abruption Cord prolapse

Chorioamnionitis- (fever before or during > 37.5C on 2 occasion > 1h apart />38.0C- uterine tenderness (or contractions)- leucocytosis, maternal/ fetal Tachycardia

- foul-smelling vaginal discharge

Fetal trauma due to puncture. Maternal length of stay in hospital.


14/20

Neonatal endpointsLethal pulmonary hypoplasia

Non-lethal pulmonary hypoplasia Survival till discharge from NICU.Chronic lung disease (CLD) oxygen dependency at 28days of life Number of days on ventilatory support. Length of stay in hospital. Necrotising enterocolitis (NEC) (infant bowel disorder)

Periventricular leukomalacia (PVL) > gradeI Severe intraventricular hemorrhage (IVH) >grade II Proven neonatal sepsis + blood culture taken at birth within 72 hours >2 symptoms of infection


15/20

An adverse event (AE)an event afterwhich the intervention has to bestopped.

Reasons for discontinuation ;-placental abruption- cord prolapse,chorioamnionitis- -fetal loss, fetal trauma due to puncture- -premature labour and delivery.


16/20

Sample size calculation A sample size calculation was based on an expected rate ofperinatal mortality of 70% with expectant management tobe reduced to 35% with amnioinfusion.

0

10

20

30

40

50

60

70

80


17/20


18/20

DiscussionInsufficient evidence to recommend this procedure

Small sample sizeThe benefits might be increased neonatal survival anddecreased pulmonary complications esp pulmonaryhypoplasia.

Potential harms include-placental abruption, premature-labour and delivery- cord prolapse- -chorioamnionitis,- fetal loss, fetal trauma due to puncture.

Expectant management indeed carries these same risks


19/20

Conclusion At present, there is no evidence on which a rational choice betweenexpectant management or therapeuticamnioifusion can be based.


20/20

midtrimester preterm prelabour rupture of membranes (pprom) english

Documents