Original research article

Comparison of efficacy and complications of IUD insertion inimmediate postplacental/early postpartum period with interval period:

1 year follow-upB

Kafiye Eroglua,4, Gqlcihan Akkuzub, GulYen Vuralc, Berna Dilbazd,AyYe AkVne, Lale TaYkVna, Ali Haberald

aDepartment of Obstetrics and Women’s Health Nursing, School of Nursing, Hacettepe, University, 06100 Ankara, TurkeybDepartment of Nursing and Health Services, Faculty of Health Sciences, Baskent University, 06810 Ankara, TurkeycDepartment of Obstetrics and Women’s Health Nursing, School of Nursing, Gazi University, 06330 Ankara, Turkey

dMinistry of Health Ankara Etlik Maternity and Women’s Health Teaching Hospital, 06010 Ankara, TurkeyeDepartment of Community Health, School of Medicine, Hacettepe University, 06100 Ankara, Turkey

Received 10 November 2004; revised 5 July 2006; accepted 5 July 2006

Abstract

Objective: This study aimed to compare immediate postplacental (IPP) and early postpartum (EP) intrauterine device (IUD) insertions withinterval (INT) IUD insertions with respect to efficacy and complications.

Methods: The study group consisted of 268 women in whom the following TCu 380A IUD insertions were performed: 84 IPP (less than10 min), 46 EP (10 min to 72 h) and 138 INT (more than 6 weeks). The women were followed up 8 weeks, 6 months and 12 months afterinsertion. Complications and pregnancies encountered at the end of 1 year following IPP, EP and INT insertions were compared. The chi-

square test and Fisher’s Exact Test were used for the evaluation of the data.Results: Complications developed in 40.4% of the women in the IPP group, in 74.4% of the women in the EP group and in 19.2% of thewomen in the INT group (pb .001). Although no statistically significant difference was found between the groups for uterine perforation and

infection (pN .001), there was a statistically significant difference between the groups in the incidence of complete and partial expulsionaccording to the time of IUD insertion. The overall cumulative pregnancy rate and frequency of pregnancy were found to be higher (pN .05for both), which are both insignificant for the EP group (2 of 43 women), as compared with the INT (4 of 130 women) and IPP groups (2 of

84 women), and pregnancy rates at 1 year for all groups was 3.1% (8 of 257 women).Conclusion: IPP and EP insertion of the TCu 380A IUD is an effective and convenient procedure, and expulsion rates in these groups arehigher than in the INT group. Further studies are necessary to determine the cause of the higher expulsion rates and to find ways to reducesuch rates.

D 2006 Elsevier Inc. All rights reserved.

Keywords: IUD; Postpartum insertion; IUD complications; Efficacy; Contraception

1. Introduction

Women are highly motivated to use contraception in thepostpartum period. For this reason, the postpartum period isthe ideal time to commence contraception [1]. Althoughhealth care institutions in Turkey have ample facilities forpre- and postnatal care, abortion and contraceptive services,

postpartum family planning (FP) services are relativelylacking [2,3]. A Turkish study conducted in the early 1990sfound that 95% of postpartum and 88% of postabortalwomen were willing to use a contraceptive methodimmediately after termination of pregnancy; more than70% of the women who were admitted for delivery ortermination of pregnancy leave the institution withoutreceiving a contraceptive method [4]. This study impliesthat there is an unmet demand in the field of postpartumcontraceptive services. Still, postpartum intrauterine device(IUD) insertions are restricted to a limited number of centersin Turkey.

0010-7824/$ – see front matter D 2006 Elsevier Inc. All rights reserved.

doi:10.1016/j.contraception.2006.07.003

B This study was sponsored by the Hacettepe University Scientific

Research Center.

4 Corresponding author.

E-mail address: keroglu@hacettepe.edu.tr (K. Eroglu).

Contraception 74 (2006) 376–381

In the postpartum period, mothers encounter somedifficulty in reaching the FP clinics once they leave thefacility where the delivery was performed because they haveto take care of their children; this is true especially in the ruralareas and in families where the mother does not get supportfrom her family. For this reason, it is important to ensure thatwomen are counseled regarding FP, that is, including choos-ing what method to use, while they are still in the hospital.

The IUD has been the most frequently chosen contra-ceptive method in Turkey since 1988 [5,6]. Introduction of apostpartum IUD insertion program could address women’sneed for contraception and contribute to a decrease in healthcare expenses [7]. The concerns about an increased risk ofcomplications with postpartum IUD insertion, specificallyexpulsion and failure, need to be addressed carefully [8–11].Randomized controlled trials that directly compare imme-diate postplacental (IPP) IUD insertion with delayedpostpartum or interval (INT) insertion are lacking in theliterature [12]. This prospective study aimed to compare IPP,

early postpartum (EP) and INT IUD insertions with respectto efficacy and complications.

2. Material and methods

This study was conducted at the Ankara Social SecurityHospital FP and Maternity units between June 1, 2000, andSeptember 30, 2000. This time frame was chosen because theresearchers felt that they could work full-time and that theywould be able to reach most of the population during this timeframe. The study was approved by the local ethics committeeof the hospital where the study was carried out. The inclusioncriteria for recruitment into the study were the following:between 15 and 49 years of age, no contraindications for IUDinsertion [13], living in Ankara municipality and planning ahospital delivery. All the women signed an informed consentform at the time of recruitment. Women who came forantenatal outpatient care with gestational age of z32 weekswho met the inclusion criteria were counseled by specially

Table 1

Distribution of demographic and obstetric characteristicsa

Characteristics IPP (n =84) EP (n =46) INT (n =138) Total (N =268) p

n % n % n % n %

Age group

15–19 8 9.5 6 13.0 14 10.1 28 10.4 .104

20–24 37 44.0 18 39.1 47 34.1 102 38.1

25–29 26 31.0 12 26.1 32 23.2 70 26.1

30–34 12 14.3 6 13.0 26 18.8 44 16.4

V35 1 1.2 4 8.7 19 13.8 24 9.0

Educational level

Without schooling or only literate 2 2.4 0 0 3 2.2 5 1.9 .751

Primary school 44 52.4 29 63.0 78 56.5 151 56.3

Secondary school 8 9.5 5 10.9 14 10.1 27 10.1

Higher graduates 30 35.7 12 26.1 43 31.2 85 31.7

Occupation

Working 8 9.5 3 6.5 14 10.1 25 9.3 .763

Not working 76 90.5 43 93.5 124 89.9 243 90.7

Number of pregnancies

1 30 35.7 16 34.8 48 34.8 94 35.1 .648

2 29 34.5 14 30.4 36 26.1 79 29.5

3 14 16.7 8 17.4 22 15.9 44 16.4

z4 11 13.1 8 17.4 32 23.2 51 19.0

Number of living children

1 40 47.6 17 37.0 61 44.2 118 44.0 .684

2 26 31.0 20 43.5 51 37.0 97 36.2

z3 18 21.4 9 19.5 26 18.8 53 19.8

Spontaneous abortion

Without experience 71 84.5 41 89.1 121 87.7 233 86.9 .707

With experience 13 15.5 5 10.9 17 12.3 35 13.1

Number of induced abortion

0 78 92.9 38 82.7 107 77.5 223 83.2 .058

1 4 4.8 6 13.0 20 14.5 30 11.2

z2 2 2.4 2 4.3 11 8.0 15 5.6

Stillbirth

Without experience 76 90.5 42 91.3 129 93.5 247 92.2 .702

With experience 8 9.5 4 8.7 9 6.5 21 7.8

Desires a child in the future

Yes 23 27.4 8 17.4 19 16.0 50 20.1 .119

No 61 72.6 38 82.6 100 84.0 199 79.9

a Column percentage calculation.

K. Eroglu et al. / Contraception 74 (2006) 376–381 377

trained FP nurses about all the contraceptive methodsavailable. Women who desired IUD as their contraceptivemethod were given the option of IPP, EP or INT IUD insertion[10]. Women chose the timing for IUD insertion aftercounseling and, thus, were not randomized. IPP is definedas insertion within 10 min after removal of the placenta aftervaginal delivery or cesarean section. EP insertion includedinsertions later than 10 min after placental removal but within72 h of delivery. All other insertions performed anytime after6 weeks following vaginal delivery or 8 weeks after cesareansection were defined as INT insertions. There were noinsertions between 72 h and 6 weeks.

All women underwent a TCu 380A IUD insertion usingstandardized techniques as described by the Association forVoluntary Surgical Contraception [14]. Postplacental inser-tions were performed by an assistant physician or aspecialist physician. The technique for IPP includes theuse of ring forceps for fundal placement of the device.Routine gynecological examination was performed to allwomen at 4 weeks following insertion. During thisexamination, complications of excessive bleeding, partialand complete expulsion and perforation were diagnosed viapelvic examination, ultrasound and laboratory tests. Womenwho complained of pain were referred to the FP andMaternity units. Perforations or expulsion was diagnosedand confirmed via ultrasound. Ultrasonographic examina-tion and required laboratory tests were performed when thestrings of the IUD were not seen; during pelvic examination,it was determined that there was discharge, that women hada history of amenorrhea and that they felt severe pain.Follow-up at 8 weeks and 6 months following insertion wasconducted via home visits made by a research nurse; follow-up 12 months after the insertion was conducted in thehospital. At each follow-up visit, women were questionedabout excessive bleeding, severe pain, vaginal discharge andamenorrhea. In addition, women were instructed to contactthe research nurse between visits if they recognized any ofthese problems; women with any of these findings werereferred to the FP and Maternity units where a study doctorevaluated the women. Vaginal swabs were performed at the4th-week and 12th-month follow-up visits and for anyinterim visits for a complaint of vaginal discharge. Theseswabs were processed to evaluate for the presence oftrichomonas, chlamydia and other infectious agents.

The parameters studied were efficacy, incidence andspectrum of the complications related with IUD use andcontinuation rate. Excessive bleeding (double the amount ofprevious menstrual cycles) during menstruation was desig-nated as heavy bleeding. Statistical analysis was carried outusing the chi-square test and Fisher’s Exact Test with the useof SPSS 11.0.

3. Results

The study group consisted of 268 women in whom thefollowing insertions were performed: 84 IPP, 46 EP and 138T

able

2

Distributionofcomplicationsandcontinuationsat

thetimeoffollow-up

Resultsoffollow-ups

8weeks

6months

12months

IPP(n

=82)

EP(n

=46)

INT(n

=138)

pIPP(n

=61)

EP(n

=24)

INT(n

=120)

pIPP(n

=52)

EP(n

=14)

INT(n

=111)

p

n%

n%

n%

n%

n%

N%

n%

n%

n%

No.ofthose

whoattended

82

100.0

43

93.5

137

99.3

61

100.0

24

100.0

119

99.1

51

98.0

1178.5

104

93.6

No.ofcomplicationsa

23

28.0

23

50.0

15

10.9

.000

58.2

729.2

119.2

.033

10

18.3

321.4

10

9.0

.140

Complete

expulsion

911.0

614.0

53.6

.033

11.6

28.3

00

.026

23.9

00

00

Partial

expulsion

13

15.9

16

37.2

21.5

.000

34.9

520.8

10.8

.001

35.9

19.1

11.0

.130

Uterineperforation

00

00

21.5

00

00

10.8

00

00

00

Excessivebleeding

11.2

12.3

32.2

.858

00

00

21.6

.338

12.0

19.1

32.9

.565

Genital

infection

00

00

32.2

11.6

00

21.6

.685

00

00

00

No.ofpatientswho

continued

themethod

59

72.0

21

48.8

121

88.3

.000

585.2

1145.8

109

91.5

.000

42b

80.7

763.6

94c

90.4

.033

Missingstringwith

IUD

inplace

11.2

24.7

32.2

.512

23.3

14.2

54.2

.052

47.8

19.1

65.8

.843

Pregnancy

00

24.7

21.5

.114

11.6

00

21.6

.685

12.0

00

00

aThreewomen

intheIPPgroupandtwowomen

intheEPgrouphad

more

than

onecomplication.

bThreepatientswithoutanycomplicationsdecided

todiscontinuethemethodforother

reasons(desires

tobepregnant,etc.).

cNinety-onewomen

had

nocomplications,andthreewomen

whowerediagnosedwithgenital

infectionweretreatedandcontinued

themethod.

K. Eroglu et al. / Contraception 74 (2006) 376–381378

INT. Two women could not be reached for their first follow-up visit, three for their second follow-up and 11 for theirthird follow-up.

The sociodemographic and obstetric characteristics of thestudy groups are shown in Table 1. The significance testapplied to the three groups regarding the descriptive andobstetrics characteristics of the women showed no statisti-cally significant difference between the three groups(pb .05; Table 1).

The number of women who attended follow-up visits andcomplications encountered during each visit were recordedfor the three groups (Table 2). Complications in the EPgroup had the highest rate of occurrence at the 8th-week and6th-month follow-up visits (50% and 29.2% vs. 28% and8.2% in the IPP and 10.9% and 9.2% in the INT groups,respectively). The differences between the EP, IPP and INTgroups with regard to complication rates were statisticallysignificant (pb .05) at the 8th-week and 6th-month follow-up visits and insignificant at the 12th-month follow-up visit.During the initial follow-up, the complete expulsion ratewas higher in the EP (14%) and IPP (11%) groups than inthe INT (3.6%) group. At the 8th-week follow-up visit,partial expulsion occurred in 37.2% of the women in the EPgroup, in 15.9% of the women in the IPP group and in 1.5%of the women in the INT group, and the difference betweenthe EP, IPP and INT groups was statistically significant(pb .05) at the 8th-week and 6th-month follow-up visits.Uterine perforation occurred only in three women in theINT group (2.3%). At the 8th-week follow-up visit, 88.3%of the women in the INT group, 72.0% of the women in theIPP group and 48.8% of the women in the EP groupcontinued the method, and the continuation rates were lowerin the EP group in comparison to the other groups on allvisits. Overall complications developed in 40.4% of thewomen in the IPP group, in 74.4% of the women in the EPgroup and in 19.2% of the women in the INT group, and thedifference between the EP, IPP and INT groups wasstatistically significant (pb .001), as seen in Table 3.

Pregnancy with IUD in place occurred in two women inthe EP group (4.7%) and in two women in the INT group(1.5%) at the 8th-week follow-up visit; no such pregnancyoccurred in the IPP group in the same follow-up period.Pregnancy with IUD in place occurred in one woman in the

IPP group and in two women in the INT group at the 6th-month follow-up visit and in one woman in the IPP group atthe 12th-month follow-up visit. The total pregnancy ratewas 2.4% in the IPP group, 4.7% in the EP group and 3.1%in the INT group at the end of the follow-up (1 year), andthe difference between the groups in terms of method failurewas not statistically significant (pN .05). Total pregnancyrate per 100 women at 1 year was 3.1% (Table 3).

The distribution of complications at the end of 1 year isshown in Table 3. Complete expulsion occurred in 14.3% ofthe women in the IPP group, in 18.6% of the women in theEP group and in 3.8% of the women in the INT group.Partial expulsion was encountered in 22.6% of the womenin the IPP group, in 51.2% of the women in the EP groupand in 3.1% of the women in the INT group. There was astatistically significant difference between the EP, IPP andINT groups regarding the occurrence of complete or partialexpulsion according to the time of IUD insertion (pb .001).

Although uterine perforation did not occur in the IPP andEP groups, it was found in 2.3% of the women in the INTgroup. Excessive bleeding occurred in 2.4% of the womenin the IPP group, in 4.7% of the women in the EP group andin 6.2% of the women in the INT group. Genital infectionsdid not occur in the EP group, but they occurred in 1.3% ofthe women in the IPP group and in 3.8% of the women inthe INT group.

4. Discussion

There is no study in the literature that compares all of thepostnatal copper T (Cu-T) IUD insertions in regard tocomplication and failure rates [12]. In the present study,IUD-related complications developed more often in the EPgroup as compared with the IPP and INT groups, and thisdifference was related to the higher incidence of expulsion(partial and complete) encountered in the EP group. Inprevious studies, there are controversial results in terms ofexpulsion rates following postpartum IUD insertions. Thereis debate whether differences in the expulsion rates arerelated to the time of insertion, type of IUD used, techniqueof insertion and skill and experience of the service providers[1,10,15–20]. A recent study from Turkey reported acumulative expulsion rate of 12.3% in the first year

Table 3

Cumulative distribution of complications seen within 1 year

Complications IPP (n =84) EP (n =43) INT (n =130) Total (n =257) p

n % n % n % n %

Complete expulsion 12 14.3 8 18.6 5 3.8 25 9.7 .003

Partial expulsiona 19 22.6 22 51.2 4 3.1 45 17.5 .000

Uterine perforation 0 0 0 0 3 2.3 3 1.1

Excessive bleedinga 2 2.4 2 4.7 8 6.2 12 4.6

Genital infectionsa 1 1.3 0 0 5 3.8 6 2.3

Overall 34 40.4 32 74.4 25 19.2 91 35.4

Pregnancy 2 2.4 2 4.7 4 3.1 8 3.1 .784

a Genital infection plus partial expulsion was found in two women from the IPP group; intrauterine missing string plus bleeding was found in one woman

from the IPP group and in one woman from the EPP group; partial expulsion plus bleeding was found in one woman from the IPP group.

K. Eroglu et al. / Contraception 74 (2006) 376–381 379

following early postplacental insertion [21]. In the presentstudy, expulsion was found to be high in the EP and IPPgroups at the 6th-month follow-up visit as compared withsome other studies [10,18,22]. The results of a studyperformed by Morrison et al. [20] are similar to ours. Astudy from China that examined complications 6 monthsafter postplacental Cu 380A insertion reported the rate ofexpulsion as 12.7–13.3% [23]. In our study in the EP group,expulsion rate (complete or partial) of IUD was found to behigher than in the IPP and INT groups in the first 6 months.This result can be related to postpartum insertion of IUD asnot being part of routine hospital services. It is thought thatphysicians’ skill of insertion of IUDs into the upper fundalarea may not be sufficient. In a study that compares manualand ring forceps use for IPP insertion, the cumulativeexpulsion rates at the end of 1 year were found to be similarto those in the present study [24].

The study setting was a teaching hospital with anongoing residency program, and the high expulsion ratemight be related to the possibility that the insertions werecarried out by the staff who were still on the learning curve.When partial expulsion (presence of the IUD in the cervicalcanal) was investigated, INT insertions had the lowestpartial expulsion rates [25]. In our study, the incidence ofpartial expulsion at 8 weeks, at 6 months and at the end of1 year was found to be higher in the EP group than in theIPP and INT groups. IPP insertion had a lower partialexpulsion rate than EP insertion, and this result can berelated to the higher fundal placement of IUD during IPPinsertion. Postpuerperal insertions in breast-feeding womenwere described to have a high rate of continuation [24]. Ourresults show that the lowest expulsion rates occurred in theINT group. At the end of the study, apart from the caseswith partial or complete expulsion, there was a smallnumber of patients who had missing IUD strings onexamination, although the IUD was still within the uterinecavity. There are limited studies that deal with IUD missingstrings in the literature. Turan et al. [25] determined the IUDmissing strings rate in INT insertion to be 15.6%. In ourstudy, at the 8th-week, 6th-month and 12th-month follow-upvisits, data regarding missing strings with IUD in place werefound to be lower than those reported by Turan et al. [25]following INT insertion. There were lower rates in both theIPP and INT groups in our study. This result can be relatedto insertion techniques (insertion of IUD in the upper fundalarea), but there is insufficient evidence in the literature tomake a definite statement.

Some studies have found that the use of postpartum IUDinsertion does not increase the risk of infection, perforationor bleeding, and in large clinical trials, perforation rarelyoccurs, reportedly with rates of 1.3–2.2 per 1000 inser-tions [8,9,11,26]. However, IUD insertions 0–3 monthspostpartum compared with 3–6 months postpartum werefound to increase the risk of uterine perforation [odds ratio(OR)=11.7, 95% confidence interval (CI)=2.8–49.2 vs.OR=13.2, 95% CI=2.8–62, respectively] [27]. In the present

study, there were three perforations, which were diagnosed inthe INT group at the 8th-week (two women) and 6th-month(one woman) follow-up visits. The uterine wall is thick afterdelivery; thus, uterine perforation during IPP insertion isunlikely to occur, but during the puerperium, the uterus issmall and the uterine wall is thin, leading to an increased riskof uterine perforation during insertion. Lactating womenappear to be a high-risk group for perforation [9,27]. In ourstudy, the three women with perforation had insertion duringthe puerperal period (minimum, 28 days; maximum, 130days; mean, 62.62 days of insertion following delivery). It isthought that perforation could be a complication risk in theINT group.

Copper IUDs are associated with an increase in the amountof menstrual bleeding. Parikh and Gandhi [28] reported anexcessive bleeding rate of 6.6% in the group who had Cu-TIUD insertion after cesarean section. In another study, therewere other complaints following IUD insertions such asbleeding and pain in 1.0–2.1% of patients; however, nouterine perforation, infection or pregnancy was encountered[1]. At the 6th-month follow-up, the incidence of excessivebleeding was found to be 1.6% in the INT group and did notoccur in the IPP and EP groups. The incidence of excessivebleeding in the EP group was found to be the highest at the12th-month follow-up (pN .05). At the end of 1 year, ourstudy found excessive bleeding to be lower than that reportedby others [28]. Lactational amenorrhea might have led to adecrease in the incidence of bleeding related to the presenceof the IUD, but the lactational status of the women was notanalyzed in the present study.

According to a study carried out in 12 developingcountries by the World Health Organization, mild pelvicinfection was diagnosed in 10% of the women who hadpostpuerperal Cu-T insertion at 6 weeks and in 18% of thewomen who had postpuerperal Cu-T insertion at 6 months[11]. In our study, genital infection was found in threewomen in the INT group at the 8th-week follow-up and inone woman in the IPP group and in two women in the INTgroup at the 6th-month follow-up. At the end of 1 year, nogenital infection was encountered in EP insertions, but therewas a low incidence (1.3%) in IPP insertion, and a higherincidence of genital infection was noted in INT insertions(3.8%) in comparison to IPP insertions.

In our study, two of the pregnancies occurred in womenwho had unrecognized complete expulsion of the IUD. In astudy from China, at the end of 2 years of follow-up afterpostpartum IUD insertion (after vaginal delivery or cesareansection), the pregnancy rate was found to be 5.4% [19].Another study from China showed the absence of pregnancyafter 6 months follow-up in women who had postplacentalIUD insertion [29]. In the present study, a small number ofpregnancies occurred in the IPP, EP and INT groups at the6th-month follow-up. Cumulative pregnancy rate 24 monthsafter postplacental IUD insertion was found to be 2.0–2.8[10]. When compared to the results of this study, our overallcumulative pregnancy rate and frequency of pregnancy were

K. Eroglu et al. / Contraception 74 (2006) 376–381380

found to be higher (pN .05 for both), which are bothinsignificant for the EP group, as compared with the INTand IPP groups.

5. Conclusions

This study showed that there were more complications inthe IPP and EP groups than in the INT group. Expulsionwas higher in the IPP and EP insertion groups than in theINT insertion group. In addition, there were significantdifferences in complications following postpartum inser-tions than INT insertion, especially in the EP group.Reassessment of the IPP and EP IUD insertion techniquesand improvement in the skill of health personnel arerequired to decrease the expulsion rate that was found tobe high in the present study.

Acknowledgments

Wewould like to thank the Hacettepe University ScientificResearch Center, the women who volunteered for the study,the nurses and doctors at the research hospital and the nurseswho carried out home visits.

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