Contraception 69 (2004) 279 282

Original research article

Clinical outcomes of early postplacental insertion of intrauterine contraceptive devices

S evki C elen*, Perran Mo ro y, Ayhan Sucak, Ayla Aktulay, Nuri Dans man
Zekai Tahir Burak Women Health Education and Research Hospital, Ankara, Turkey Received 9 July 2003; received in revised form 11 November 2003; accepted 3 December 2003

Abstract Objectives: To assess the efcacy, safety and, thus, advantages and disadvantages, of early postplacental intrauterine device (IUD) insertion. Methods: IUDs were inserted within 10 min after postplacental expulsion in term pregnancy both in vaginal and cesarean deliveries via a ring forceps. Of the 276 patients enrolled, 235 were included in the study. Recipients were scheduled for examination before hospital discharge and at 6 weeks, 6 months and 12 months after postplacental insertion. Results: The percentages of women returning for a follow-up visit were 221 (94%), 210 (89%) and 183 (78%) at 6 weeks, 6 months and 12 months, respectively. Among IUD acceptors, 74% of the cases had vaginal deliveries and 26% had cesarean deliveries. Continuation rates were relatively high, 87.6% and 76.3%, at 6 and 12 months, respectively, after postplacental insertion of IUD. In this study, the 1-year cumulative expulsion rate with TCu 380A device was 12.3%, which may be regarded as a standard expulsion rate for immediate postplacental insertion of similar models of IUDs. Conclusion: The evidence from this study suggests that immediate postplacental insertion of CuT 380 models is an effective, useful, safe, convenient and low-cost procedure for early postpartum contraception. 2004 Elsevier Inc. All rights reserved.
Keywords: Intrauterine device; Postplacental insertion

1. Introduction The concept of early postpartum intrauterine device (IUD) insertion has been investigated since the 1960s and has become accepted worldwide. For women with limited access to medical care, term delivery provides an important opportunity to address the need for contraception [1]. Compared with other contraceptive methods, early postpartum IUD insertion has several advantages. It provides protection against pregnancy without interfering with breastfeeding [2,3]. Moreover, early insertion of an IUD may avoid discomfort related to insertion. However, in spite of these advantages, insertion of IUD after delivery is associated with high expulsion rates in several studies [4]. The present study was conducted to assess the efcacy and safety of early postplacental IUD insertion.

2. Materials and methods This experimental study was carried on healthy volunteers recruited from the parturients admitted at Zekai Tahir Burak women health education and research hospital maternity unit. Upon admission, the women were informed of the possibility of having an IUD inserted immediately after delivery. Study staff gave information about the study verbally during the recruitment period. The advantages and disadvantages of all available methods were explained. All of the IUD acceptors gave their informed consent. Women who requested an immediate postplacental IUD insertion, met medical criteria for an IUD insertion and had no contraindications, were included in the study. IUDs were inserted within 10 min after postplacental expulsion in a term pregnancy both in vaginal and cesarean deliveries via a ring forceps. Cefazolin sodium was used for prophylaxis at cesarean deliveries. Women were excluded from the study if they had cervical dilatation 6 cm at admission, more than 12 h of

* Corresponding author. Tel.: 00903122406637. E-mail address: sevkicelen@hotmail.com (S evki C elen). 0010-7824/04/$ see front matter 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.contraception.2003.12.004

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S . C elen et al. / Contraception 69 (2004) 279 282 Table 1 Clinical characteristics of immediate postplacental IUD insertion acceptors IUD acceptors (n 235) Mean age SD (y) Parity 1 1 Mean no. of living children SD Education (any) Elementary High school University Previous IUD use Wants more children Mean time until desired pregnancy (y) Prenatal care Family-planning counseling during prenatal care Values in parentheses are percentages. 24.7 1.12 79 (34) 156 (76) 1.62 0.8 213 (91) 129 (55) 68 (29) 16 (7) 61 (26) 99 (42) 3.21 0.5 89 (38) 49 (21)

ruptured membranes, any hemorrhagic disorder, prolonged labor (12 h), history of fever or of clinical symptoms of infection, history of pelvic inammatory disease or of ectopic pregnancy. Of the 276 patients enrolled, 235 were included in the study. Clinically obvious pelvic inammatory disease (PID) was dened as the presence of chills, fever greater than 38C, lochia with foul odor, associated or not with spontaneous pain or tenderness of the uterus and/or delayed uterine involution. It was also diagnosed when the white cells ratio showed deviation to the left. The model TCu 380A postpartum IUD (Pregna; Pregna International, Chakan, India) was inserted by one of the authors after the delivery of placenta via a ring forceps. At the time of insertion, the strings of the IUDs were trimmed to extend just beyond the external cervical os. The IUD was placed through the hysterotomy incision and then the strings passed through the cervix, via ring forceps during cesarean section. In the case of cesarean section insertion, the strings were trimmed immediately after the operation. Data were collected on sociodemographic characteristics, antenatal care, previous contraceptive usage and family-planning counseling at admission. Recipients were scheduled for examination before hospital discharge and at 6 weeks, 6 months and 12 months after postplacental insertion. At each visit the volunteers were interviewed by one of the project staff. Physical and pelvic examinations were performed to verify the presence of the IUD, to check for signs of infection and excessive bleeding. IUD expulsions were veried both clinically and sonographically. The subjects were directed to return at any time if they experienced pelvic pain, fever, excessive bleeding or unusual vaginal discharge. An IUD acceptor was terminated from the study if the IUD was expelled or if a pregnancy occurred. Data were validated and entered into a computer. Statistical analysis was carried out using SPSS-PC (11.0 version). Life-table analysis was performed to provide cumulative rates. Principal outcome measures include pregnancy and removal rates, cumulative expulsion and continuation rates.

3. Results In this study, the loss to follow-up at 12 months after insertion was 25%. The number of women returning for a follow-up visit were 221 (94%), 210 (89%) and 183 (78%) at 6 weeks, 6 months and 12 months, respectively. Demographic characteristics of the study participants are shown in Table 1. Mean age of the subjects was 24.7 years (range, 19 31 years), 76% of the cases were multiparous and 91% had formal education. Only 26% of the subjects had used an IUD previously and half of them wanted more children. Of 235 subjects, 89 (38%) cases had prenatal care and about half of them received family-planning counseling during prenatal care.

Among IUD acceptors, 74% of the cases had vaginal deliveries and 26% had cesarean section deliveries. All of the participants had live births and in only 1% of the cases were complications at delivery observed. It should be noted that very low infection and unplanned pregnancy rates were found during the course of this study. Suspected PID occurred in cases 1 and 2, at 6 weeks and 6 months postinsertion, respectively. In these cases, the IUD was removed and antibiotic therapy was administered. There were no other serious complications, such as perforations, associated with immediate postplacental IUD insertion. The incidence of minimal complications, such as irregular spotting, menorrhagia and uterine cramping, was negligible. Gross cumulative event rates per 100 users are shown in Table 2. Rates of removals for bleeding and/or pain were 3.1% in the year after insertion. Terminations for other medical reasons were minimal (2 for per 100 users). Unplanned intrauterine pregnancies were observed in only 0.7% of study participants during the course of the study. Continuation rates were relatively high, 87.6% and 76.3% at 6 and 12 months, respectively, after postplacental insertion of TCu 380A IUD.
Table 2 Immediate postplacental insertion of CuT 380 model (n 235) 6 Weeks (n 221) Removals for Bleeding/pain Other medical reasons Planned pregnancy Personal reasons Unplanned pregnancy Expulsion rate Continuation rate 0.3 0.1 0.1 0.5 0.0 5.1 94.3 6 Months (n 210) 2.8 0.8 1.1 0.8 0.2 7.0 87.6 12 Months (n 183) 3.1 1.1 4.8 2.1 0.3 12.3 76.3

Values are gross cumulative event rates per 100 users up to 12 months.

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In this study, the 1-year cumulative expulsion rate with TCu 380A postplacental device was observed to be 12.3 per 100 users, which may be regarded as a standard expulsion rate for immediate postplacental insertion of similar models of IUDs.

4. Discussion Postpartum IUD insertion has been recommended since 1967. For many women, it would be convenient to leave the hospital after delivery already protected against unplanned pregnancy. Immediate insertion of an IUD after the delivery of placenta satises the basic requirements of any contraceptive methods [5,6]. The results of this study indicate that immediate postplacental insertion of an IUD neither increases the amount of bleeding and/or pain nor increases the risk of infection. These ndings and the low rates of termination for other medical reasons support the conclusions of other studies [7]. In this study, no serious complications, such as uterine perforations or clinically obvious PID, were observed. Recent reports suggesting a greater risk of uterine perforation when IUDs are inserted in the puerperium period is a further reason to give preference to immediate postplacental insertion [8,9]. The immediate postplacental insertion of IUD lost acceptance after a World Health Organization-sponsored multicenter trial reported unacceptably high pregnancy and expulsion rates [10]. However, recent reviews found better clinical performance with immediate postplacental insertion of IUD. The present study indicates a very low incidence of pregnancy, in accordance with the latter reports. These ndings may be reported to be due to the high efcacy of the CuT 380 IUD and the fact that almost all women were breastfeeding [10 12]. In the present study, both cesarean section and vaginal deliveries were included. Although there are no randomized controlled trials that evaluated IUD insertion at the time of cesarean section delivery, one cohort study found signicantly lower expulsion rate with IUD insertion at the time of cesarean delivery than with insertion immediately after birth [1,13]. In several reports, it was stated that the Cu IUD devices had higher expulsion rates when inserted immediately after the delivery of placenta, than with delayed postplacental insertions. The reasons for the divergence in expulsion rates according to timing are still poorly understood. Moreover, there are controversial data in the literature about the cumulative expulsion rates of immediate postplacental insertion Cu IUD models. In our series, it was observed after 1 year that the cumulative expulsion rate may be regarded as a standard expulsion rate for immediate postplacental insertion of Cu IUDs [2,3,14]. The experience of the clinician performing the insertion

may inuence expulsion rates. The observational data of several reports suggest that the rate of expulsion after postplacental insertion may be governed more by the insertion techniques than by the shape and size and/or the use of suspension technique [12]. Continuation rates observed in our series, 75 per 100 users for CuT 380 devices, indicate the acceptability of postplacental insertion [3,6,15]. 5. Conclusion In fact, the safety of immediate postplacental insertion has never been questioned seriously and, according to consensus, this procedure does not enhance the hazard of infection or the rate of uterine perforation. Studies to date have not shown that IUDs interfere with lactation. In conclusion, the evidence from this study suggests that immediate postplacental insertion of CuT 380 models is an effective, useful, safe, convenient and low-cost procedure for early postpartum contraception. Trials of adequate power are needed to compare immediate postplacental insertion with delayed postplacental and interval insertion. References
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