Contraception 74 (2006) 376 381

Original research article

Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-upB
lua,4, Gqlcihan Akkuzub, Gu Kafiye Erog lYen Vuralc, Berna Dilbazd, AyYe AkVne, Lale TaYkVna, Ali Haberald
a

Department of Obstetrics and Womens Health Nursing, School of Nursing, Hacettepe, University, 06100 Ankara, Turkey b Department of Nursing and Health Services, Faculty of Health Sciences, Baskent University, 06810 Ankara, Turkey c Department of Obstetrics and Womens Health Nursing, School of Nursing, Gazi University, 06330 Ankara, Turkey d Ministry of Health Ankara Etlik Maternity and Womens Health Teaching Hospital, 06010 Ankara, Turkey e Department 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 with interval (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 than 10 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 after insertion. Complications and pregnancies encountered at the end of 1 year following IPP, EP and INT insertions were compared. The chisquare test and Fishers 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 the women in the INT group (p b .001). Although no statistically significant difference was found between the groups for uterine perforation and infection (p N .001), there was a statistically significant difference between the groups in the incidence of complete and partial expulsion according to the time of IUD insertion. The overall cumulative pregnancy rate and frequency of pregnancy were found to be higher (p N .05 for 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 are higher than in the INT group. Further studies are necessary to determine the cause of the higher expulsion rates and to find ways to reduce such 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 the postpartum period. For this reason, the postpartum period is the ideal time to commence contraception [1]. Although health care institutions in Turkey have ample facilities for pre- and postnatal care, abortion and contraceptive services,
B This study was sponsored by the Hacettepe University Scientific Research Center. 4 Corresponding author. lu). E-mail address: keroglu@hacettepe.edu.tr (K. Erog

postpartum family planning (FP) services are relatively lacking [2,3]. A Turkish study conducted in the early 1990s found that 95% of postpartum and 88% of postabortal women were willing to use a contraceptive method immediately after termination of pregnancy; more than 70% of the women who were admitted for delivery or termination of pregnancy leave the institution without receiving a contraceptive method [4]. This study implies that there is an unmet demand in the field of postpartum contraceptive services. Still, postpartum intrauterine device (IUD) insertions are restricted to a limited number of centers in Turkey.

0010-7824/$ see front matter D 2006 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2006.07.003

K. Erog lu et al. / Contraception 74 (2006) 376 381 Table 1 Distribution of demographic and obstetric characteristicsa Characteristics IPP (n = 84) n Age group 1519 2024 2529 3034 V 35 Educational level Without schooling or only literate Primary school Secondary school Higher graduates Occupation Working Not working Number of pregnancies 1 2 3 z4 Number of living children 1 2 z3 Spontaneous abortion Without experience With experience Number of induced abortion 0 1 z2 Stillbirth Without experience With experience Desires a child in the future Yes No
a

377

EP (n = 46) % 9.5 44.0 31.0 14.3 1.2 2.4 52.4 9.5 35.7 9.5 90.5 35.7 34.5 16.7 13.1 47.6 31.0 21.4 84.5 15.5 92.9 4.8 2.4 90.5 9.5 27.4 72.6 n 6 18 12 6 4 0 29 5 12 3 43 16 14 8 8 17 20 9 41 5 38 6 2 42 4 8 38 % 13.0 39.1 26.1 13.0 8.7 0 63.0 10.9 26.1 6.5 93.5 34.8 30.4 17.4 17.4 37.0 43.5 19.5 89.1 10.9 82.7 13.0 4.3 91.3 8.7 17.4 82.6

INT (n = 138) n 14 47 32 26 19 3 78 14 43 14 124 48 36 22 32 61 51 26 121 17 107 20 11 129 9 19 100 % 10.1 34.1 23.2 18.8 13.8 2.2 56.5 10.1 31.2 10.1 89.9 34.8 26.1 15.9 23.2 44.2 37.0 18.8 87.7 12.3 77.5 14.5 8.0 93.5 6.5 16.0 84.0

Total (N = 268) n 28 102 70 44 24 5 151 27 85 25 243 94 79 44 51 118 97 53 233 35 223 30 15 247 21 50 199 % 10.4 38.1 26.1 16.4 9.0 1.9 56.3 10.1 31.7 9.3 90.7 35.1 29.5 16.4 19.0 44.0 36.2 19.8 86.9 13.1 83.2 11.2 5.6 92.2 7.8 20.1 79.9

8 37 26 12 1 2 44 8 30 8 76 30 29 14 11 40 26 18 71 13 78 4 2 76 8 23 61

.104

.751

.763

.648

.684

.707

.058

.702

.119

Column percentage calculation.

In the postpartum period, mothers encounter some difficulty in reaching the FP clinics once they leave the facility where the delivery was performed because they have to take care of their children; this is true especially in the rural areas and in families where the mother does not get support from her family. For this reason, it is important to ensure that women are counseled regarding FP, that is, including choosing what method to use, while they are still in the hospital. The IUD has been the most frequently chosen contraceptive method in Turkey since 1988 [5,6]. Introduction of a postpartum IUD insertion program could address womens need for contraception and contribute to a decrease in health care expenses [7]. The concerns about an increased risk of complications with postpartum IUD insertion, specifically expulsion and failure, need to be addressed carefully [811]. Randomized controlled trials that directly compare immediate postplacental (IPP) IUD insertion with delayed postpartum or interval (INT) insertion are lacking in the literature [12]. This prospective study aimed to compare IPP,

early postpartum (EP) and INT IUD insertions with respect to efficacy and complications. 2. Material and methods This study was conducted at the Ankara Social Security Hospital FP and Maternity units between June 1, 2000, and September 30, 2000. This time frame was chosen because the researchers felt that they could work full-time and that they would be able to reach most of the population during this time frame. The study was approved by the local ethics committee of the hospital where the study was carried out. The inclusion criteria for recruitment into the study were the following: between 15 and 49 years of age, no contraindications for IUD insertion [13], living in Ankara municipality and planning a hospital delivery. All the women signed an informed consent form at the time of recruitment. Women who came for antenatal outpatient care with gestational age of z 32 weeks who met the inclusion criteria were counseled by specially

378 .565 .033 .140 .130 .843

K. Erog lu et al. / Contraception 74 (2006) 376 381

Table 2 Distribution of complications and continuations at the time of follow-up

No. of those who attended No. of complicationsa Complete expulsion Partial expulsion Uterine perforation Excessive bleeding Genital infection No. of patients who continued the method Missing string with IUD in place Pregnancy

Results of follow-ups

Three women in the IPP group and two women in the EP group had more than one complication. Three patients without any complications decided to discontinue the method for other reasons (desires to be pregnant, etc.). Ninety-one women had no complications, and three women who were diagnosed with genital infection were treated and continued the method.

trained FP nurses about all the contraceptive methods available. Women who desired IUD as their contraceptive method were given the option of IPP, EP or INT IUD insertion [10]. Women chose the timing for IUD insertion after counseling and, thus, were not randomized. IPP is defined as insertion within 10 min after removal of the placenta after vaginal delivery or cesarean section. EP insertion included insertions later than 10 min after placental removal but within 72 h of delivery. All other insertions performed anytime after 6 weeks following vaginal delivery or 8 weeks after cesarean section were defined as INT insertions. There were no insertions between 72 h and 6 weeks. All women underwent a TCu 380A IUD insertion using standardized techniques as described by the Association for Voluntary Surgical Contraception [14]. Postplacental insertions were performed by an assistant physician or a specialist physician. The technique for IPP includes the use of ring forceps for fundal placement of the device. Routine gynecological examination was performed to all women at 4 weeks following insertion. During this examination, complications of excessive bleeding, partial and complete expulsion and perforation were diagnosed via pelvic examination, ultrasound and laboratory tests. Women who complained of pain were referred to the FP and Maternity units. Perforations or expulsion was diagnosed and confirmed via ultrasound. Ultrasonographic examination and required laboratory tests were performed when the strings of the IUD were not seen; during pelvic examination, it was determined that there was discharge, that women had a history of amenorrhea and that they felt severe pain. Follow-up at 8 weeks and 6 months following insertion was conducted via home visits made by a research nurse; followup 12 months after the insertion was conducted in the hospital. At each follow-up visit, women were questioned about excessive bleeding, severe pain, vaginal discharge and amenorrhea. In addition, women were instructed to contact the research nurse between visits if they recognized any of these problems; women with any of these findings were referred to the FP and Maternity units where a study doctor evaluated the women. Vaginal swabs were performed at the 4th-week and 12th-month follow-up visits and for any interim visits for a complaint of vaginal discharge. These swabs were processed to evaluate for the presence of trichomonas, chlamydia and other infectious agents. The parameters studied were efficacy, incidence and spectrum of the complications related with IUD use and continuation rate. Excessive bleeding (double the amount of previous menstrual cycles) during menstruation was designated as heavy bleeding. Statistical analysis was carried out using the chi-square test and Fishers Exact Test with the use of SPSS 11.0. 3. Results The study group consisted of 268 women in whom the following insertions were performed: 84 IPP, 46 EP and 138

93.6 9.0 0 1.0 0 2.9 0 90.4

INT (n = 111)

5.8 9.1 1 7.8 4 .052 4.2 4.2 1 3.3 2 .512 2.2 3 4.7 2 1.2 1 5 6

104 10 0 1 0 3 0 94c

EP (n = 14)

78.5 21.4 0 9.1 0 9.1 0 63.6

11 3 0 1 0 1 0 7

98.0 18.3 3.9 5.9 0 2.0 0 80.7

12 months

IPP (n = 52)

51 10 2 3 0 1 0 42b

.338 .685 .000

.033 .026 .001

99.1 9.2 0 0.8 0.8 1.6 1.6 91.5

INT (n = 120)

119 11 0 1 1 2 2 109

EP (n = 24)

100.0 29.2 8.3 20.8 0 0 0 45.8

24 7 2 5 0 0 0 11

100.0 8.2 1.6 4.9 0 0 1.6 85.2

6 months

IPP (n = 61)

61 5 1 3 0 0 1 5

.000 .033 .000

.858

.000

99.3 10.9 3.6 1.5 1.5 2.2 2.2 88.3

INT (n = 138)

137 15 5 2 2 3 3 121

93.5 50.0 14.0 37.2 0 2.3 0 48.8

EP (n = 46)

43 23 6 16 0 1 0 21

IPP (n = 82)

100.0 28.0 11.0 15.9 0 1.2 0 72.0

8 weeks

82 23 9 13 0 1 0 59

4.7

1.5

.114

1.6

1.6

.685

1
b a

2.0

K. Erog lu et al. / Contraception 74 (2006) 376 381 Table 3 Cumulative distribution of complications seen within 1 year Complications IPP (n = 84) n Complete expulsion Partial expulsiona Uterine perforation Excessive bleedinga Genital infectionsa Overall Pregnancy
a

379

EP (n = 43) % 14.3 22.6 0 2.4 1.3 40.4 2.4 n 8 22 0 2 0 32 2 % 18.6 51.2 0 4.7 0 74.4 4.7

INT (n = 130) n 5 4 3 8 5 25 4 % 3.8 3.1 2.3 6.2 3.8 19.2 3.1

Total (n = 257) n 25 45 3 12 6 91 8 % 9.7 17.5 1.1 4.6 2.3 35.4 3.1

12 19 0 2 1 34 2

.003 .000

.784

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.

INT. Two women could not be reached for their first followup visit, three for their second follow-up and 11 for their third follow-up. The sociodemographic and obstetric characteristics of the study groups are shown in Table 1. The significance test applied to the three groups regarding the descriptive and obstetrics characteristics of the women showed no statistically significant difference between the three groups (p b .05; Table 1). The number of women who attended follow-up visits and complications encountered during each visit were recorded for the three groups (Table 2). Complications in the EP group had the highest rate of occurrence at the 8th-week and 6th-month follow-up visits (50% and 29.2% vs. 28% and 8.2% in the IPP and 10.9% and 9.2% in the INT groups, respectively). The differences between the EP, IPP and INT groups with regard to complication rates were statistically significant (p b .05) at the 8th-week and 6th-month followup visits and insignificant at the 12th-month follow-up visit. During the initial follow-up, the complete expulsion rate was higher in the EP (14%) and IPP (11%) groups than in the INT (3.6%) group. At the 8th-week follow-up visit, partial expulsion occurred in 37.2% of the women in the EP group, in 15.9% of the women in the IPP group and in 1.5% of the women in the INT group, and the difference between the EP, IPP and INT groups was statistically significant (p b .05) at the 8th-week and 6th-month follow-up visits. Uterine perforation occurred only in three women in the INT 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 the IPP group and 48.8% of the women in the EP group continued the method, and the continuation rates were lower in the EP group in comparison to the other groups on all visits. Overall 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 the women in the INT group, and the difference between the EP, IPP and INT groups was statistically significant (p b .001), as seen in Table 3. Pregnancy with IUD in place occurred in two women in the EP group (4.7%) and in two women in the INT group (1.5%) at the 8th-week follow-up visit; no such pregnancy occurred 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 6thmonth follow-up visit and in one woman in the IPP group at the 12th-month follow-up visit. The total pregnancy rate was 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), and the difference between the groups in terms of method failure was not statistically significant (p N .05). Total pregnancy rate per 100 women at 1 year was 3.1% (Table 3). The distribution of complications at the end of 1 year is shown in Table 3. Complete expulsion occurred in 14.3% of the women in the IPP group, in 18.6% of the women in the EP group and in 3.8% of the women in the INT group. Partial expulsion was encountered in 22.6% of the women in the IPP group, in 51.2% of the women in the EP group and in 3.1% of the women in the INT group. There was a statistically significant difference between the EP, IPP and INT groups regarding the occurrence of complete or partial expulsion according to the time of IUD insertion (p b .001). Although uterine perforation did not occur in the IPP and EP groups, it was found in 2.3% of the women in the INT group. Excessive bleeding occurred in 2.4% of the women in the IPP group, in 4.7% of the women in the EP group and in 6.2% of the women in the INT group. Genital infections did not occur in the EP group, but they occurred in 1.3% of the women in the IPP group and in 3.8% of the women in the INT group. 4. Discussion There is no study in the literature that compares all of the postnatal copper T (Cu-T) IUD insertions in regard to complication and failure rates [12]. In the present study, IUD-related complications developed more often in the EP group as compared with the IPP and INT groups, and this difference was related to the higher incidence of expulsion (partial and complete) encountered in the EP group. In previous studies, there are controversial results in terms of expulsion rates following postpartum IUD insertions. There is debate whether differences in the expulsion rates are related to the time of insertion, type of IUD used, technique of insertion and skill and experience of the service providers [1,10,1520]. A recent study from Turkey reported a cumulative expulsion rate of 12.3% in the first year

380

K. Erog lu et al. / Contraception 74 (2006) 376 381

following early postplacental insertion [21]. In the present study, expulsion was found to be high in the EP and IPP groups at the 6th-month follow-up visit as compared with some other studies [10,18,22]. The results of a study performed by Morrison et al. [20] are similar to ours. A study from China that examined complications 6 months after postplacental Cu 380A insertion reported the rate of expulsion as 12.713.3% [23]. In our study in the EP group, expulsion rate (complete or partial) of IUD was found to be higher than in the IPP and INT groups in the first 6 months. This result can be related to postpartum insertion of IUD as not being part of routine hospital services. It is thought that physicians skill of insertion of IUDs into the upper fundal area may not be sufficient. In a study that compares manual and ring forceps use for IPP insertion, the cumulative expulsion rates at the end of 1 year were found to be similar to those in the present study [24]. The study setting was a teaching hospital with an ongoing residency program, and the high expulsion rate might be related to the possibility that the insertions were carried out by the staff who were still on the learning curve. When partial expulsion (presence of the IUD in the cervical canal) was investigated, INT insertions had the lowest partial expulsion rates [25]. In our study, the incidence of partial expulsion at 8 weeks, at 6 months and at the end of 1 year was found to be higher in the EP group than in the IPP and INT groups. IPP insertion had a lower partial expulsion rate than EP insertion, and this result can be related to the higher fundal placement of IUD during IPP insertion. Postpuerperal insertions in breast-feeding women were described to have a high rate of continuation [24]. Our results show that the lowest expulsion rates occurred in the INT group. At the end of the study, apart from the cases with partial or complete expulsion, there was a small number of patients who had missing IUD strings on examination, although the IUD was still within the uterine cavity. There are limited studies that deal with IUD missing strings in the literature. Turan et al. [25] determined the IUD missing strings rate in INT insertion to be 15.6%. In our study, at the 8th-week, 6th-month and 12th-month follow-up visits, data regarding missing strings with IUD in place were found to be lower than those reported by Turan et al. [25] following INT insertion. There were lower rates in both the IPP and INT groups in our study. This result can be related to insertion techniques (insertion of IUD in the upper fundal area), but there is insufficient evidence in the literature to make a definite statement. Some studies have found that the use of postpartum IUD insertion does not increase the risk of infection, perforation or bleeding, and in large clinical trials, perforation rarely occurs, reportedly with rates of 1.32.2 per 1000 insertions [8,9,11,26]. However, IUD insertions 03 months postpartum compared with 36 months postpartum were found to increase the risk of uterine perforation [odds ratio (OR) = 11.7, 95% confidence interval (CI) = 2.849.2 vs. OR =13.2, 95% CI= 2.862, respectively] [27]. In the present

study, there were three perforations, which were diagnosed in the INT group at the 8th-week (two women) and 6th-month (one woman) follow-up visits. The uterine wall is thick after delivery; thus, uterine perforation during IPP insertion is unlikely to occur, but during the puerperium, the uterus is small and the uterine wall is thin, leading to an increased risk of uterine perforation during insertion. Lactating women appear to be a high-risk group for perforation [9,27]. In our study, the three women with perforation had insertion during the puerperal period (minimum, 28 days; maximum, 130 days; mean, 62.62 days of insertion following delivery). It is thought that perforation could be a complication risk in the INT group. Copper IUDs are associated with an increase in the amount of menstrual bleeding. Parikh and Gandhi [28] reported an excessive bleeding rate of 6.6% in the group who had Cu-T IUD insertion after cesarean section. In another study, there were other complaints following IUD insertions such as bleeding and pain in 1.02.1% of patients; however, no uterine perforation, infection or pregnancy was encountered [1]. At the 6th-month follow-up, the incidence of excessive bleeding was found to be 1.6% in the INT group and did not occur in the IPP and EP groups. The incidence of excessive bleeding in the EP group was found to be the highest at the 12th-month follow-up (p N .05). At the end of 1 year, our study found excessive bleeding to be lower than that reported by others [28]. Lactational amenorrhea might have led to a decrease in the incidence of bleeding related to the presence of the IUD, but the lactational status of the women was not analyzed in the present study. According to a study carried out in 12 developing countries by the World Health Organization, mild pelvic infection was diagnosed in 10% of the women who had postpuerperal Cu-T insertion at 6 weeks and in 18% of the women who had postpuerperal Cu-T insertion at 6 months [11]. In our study, genital infection was found in three women in the INT group at the 8th-week follow-up and in one woman in the IPP group and in two women in the INT group at the 6th-month follow-up. At the end of 1 year, no genital infection was encountered in EP insertions, but there was a low incidence (1.3%) in IPP insertion, and a higher incidence of genital infection was noted in INT insertions (3.8%) in comparison to IPP insertions. In our study, two of the pregnancies occurred in women who had unrecognized complete expulsion of the IUD. In a study from China, at the end of 2 years of follow-up after postpartum IUD insertion (after vaginal delivery or cesarean section), the pregnancy rate was found to be 5.4% [19]. Another study from China showed the absence of pregnancy after 6 months follow-up in women who had postplacental IUD insertion [29]. In the present study, a small number of pregnancies occurred in the IPP, EP and INT groups at the 6th-month follow-up. Cumulative pregnancy rate 24 months after postplacental IUD insertion was found to be 2.02.8 [10]. When compared to the results of this study, our overall cumulative pregnancy rate and frequency of pregnancy were

K. Erog lu et al. / Contraception 74 (2006) 376 381

381

found to be higher (p N .05 for both), which are both insignificant for the EP group, as compared with the INT and IPP groups. 5. Conclusions This study showed that there were more complications in the IPP and EP groups than in the INT group. Expulsion was higher in the IPP and EP insertion groups than in the INT insertion group. In addition, there were significant differences in complications following postpartum insertions than INT insertion, especially in the EP group. Reassessment of the IPP and EP IUD insertion techniques and improvement in the skill of health personnel are required to decrease the expulsion rate that was found to be high in the present study. Acknowledgments We would like to thank the Hacettepe University Scientific Research Center, the women who volunteered for the study, the nurses and doctors at the research hospital and the nurses who carried out home visits.

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