The present study was conducted in the context of increasing utilisation of TCu380A for immediate postpartum contraception as a result of the FIGO program to institutionalize PPIUD in Tanzania but with scanty data available to demonstrate method effectiveness and safety in a long term. Tanzania is among countries with low modern contraceptive prevalence rate of only 35% for the married women among whom less than 1% are using any form of IUD[17].
This study has demonstrated that TCu380A when inserted within 48 hours of delivery is effective since among the 511 women who were followed upto one year, only one became pregnant which represents a slim failure rate of about 0.2%. Moreover, for this case the IUD was not found in the uterus following an early ultrasound scan during pregnancy indicating that probably the IUD had been expelled unnoticed some time before conception. The copper IUD has long been reported to be safe and effective for contraception with failure rates of less than 1%[18, 19] although few others have reported higher failure rates particularly among the youth[4, 20].
TCu380A in current study was found to be safe, except for common minor problems reported by about a third (34%) of the women within one year. Our previous comperative analyses of women with the use of PPIUD and those without use of any method under the same FIGO program, reported comperable incidences of such complaints (data not yet published). For the current study, these complaints were predominantly in form of abdominal cramps and irregularities of menses. None of these women was hospitalized, but among them a third (31.8%) discontinued the method indicating the need to mitigate these complaints. Across literature on PPIUD it is difficult to compare the complication rates due the lack of standardized definition. If expulsion and menstrual problems were combined in current study, the complication rate would have been around 7% which is much lower than the 32.5% in a study that assessed these complications by Mishra et al[9]. Notwithstanding how PPIUD complications are defined, many studies generally report almost similar or higher rates of complications following PPIUD[4].
Our earlier report of 2.4% expulsion rate after a 6-week followup for exclusively vaginally delivered women [21] and the current expulsion rate of 2.1% at one year follow up of a mixed sample by mode of delivery are generally better than reports by most earlier studies that often quote higher expulsion rates of up to about 40% even on shorter follow up intervals[8-10, 18, 22-25]. Although previous systematic review indicated no association of the insertion technique and expulsion rates[5, 26], the reviewed studies mostly used ring forceps, hands or other types of IUD inserters to place the IUD into the uterine cavity unlike the FIGO initiative that uses long curved Kelly’s forceps that places the IUD higher up into the uterine fundus[11, 12]. Moreover, the previous systematic reviews for the subject did not restrict the IUD type to TCu380A IUD which is considered to be superior to other types of IUD[18, 26].
Method continuation in the current study was found to be high (86%) at one year of follow-up which is comparable or better than the 55-82% commonly reported by many other published studies[3, 20, 27-31]. Moreover, the most vulnerable period for PPIUD discontinuation was that period after the puerperium to six months of delivery (i.e., 43-180 days) contrary to the period of up to 6 weeks post-delivery that is reported to be critical for IUD related complications and removal in some earlier studies [32, 33]. In connection to this, over two thirds of the women who discontinued PPIUD method and gave reasons for discontinuation, attributed it to husband influence and menstrual irregularities which could explain this timing that coincides with resumption of menstruation and coitus. Other influences of discontinuation were abdominal pain, IUD expulsion, and voluntary IUD removal in order to allow pregnancy. Generally, the overall spectrum of complications attributable to PPIUD discontinuation in current study is similar to what is commonly reported by others[20, 30].
The use of an equally effective method of contraception after the discontinuation of TCu380A was rare. Three quarters of the women who discontinued the IUD resorted to Calendar and condom methods which are among the least effective compared to other available modern methods of contraception. Non-use of an effective method after PPIUD discontinuation has been reported by others where up to half of clients did not use an alternative method[30]. This phenomenon could be a reflection of negative attitude towards modern contraception in general rather than being specific to the IUD, thus, calling for the need to intensify education on postpartum contraception and family planning in general.
Apart from the experienced problems or complications, two other important factors were identified to be independently related to method continuation including the mode of delivery and the woman’s age group. The finding that delivery by cesarean section increased the likelihood for method continuation independent of other factors supports what was observed by previous studies of reduced rate of method discontinuation when IUD is inserted at Cesarean section as compared to vaginal delivery[22, 34, 35]. This could be at least partially explained by women who have had Cesarean section being more concerned about getting pregnant again given the scarred uterus and so more likely to continue with effective contraception even in the event of side effects or the women may have been advised by health care workers that if they wish to have another pregnancy after a Cesarean section they should wait at least 24 months as uterine rupture may be less likely than after shortened periods of birth spacing. The finding that youths (16-24years) are likely to continue with the method than older age groups (ages 35years and above) has not been documented due to paucity of published literature comparing the continuation rates of TCu380A across age groups. Nevertheless, it is reported that youths have highest unmet need for postpartum contraception[1].
A great majority (93.4%) of women who continued with the method after one year, would recommend it to people in their close social networks. This an important step towards demand creation for postpartum family planning, especially in a setting where the rate for IUD use is less than 1%[17]. The few women who would not recommend the method to their close social networks gave several reasons for not recommending including; irregularities of menses, abdominal pain, and uncertainty about the long term outcome. This is an important feedback to the health care providers to strengthen pre and post IUD insertion counselling and education to the clients.
Although the women in this study were followed prospectively, the phone calls reported on events that occurred retrospectively, thus subjecting it to the risks of recall bias as one of its limitation. In order to mitigate this, the women had baseline data collected face to face on their first interviews and during a 6-week follow-up that could be accessed from our database and inform on some missing information. Another important limitation is a large proportion of women that dropped out of the study leaving about 46% who could be analyzed at end of one year. However, such a low yield at one year follow-up is commonly reported in case of PPIUD in developing countries[2, 31]. The long term follow-up, the use of a sample of women who underwent IUD placement using same protocol for insertion under the FIGO PPIUD initiative constitute the strength of this study and its suitability for comparison with other similar studies elsewhere in developing countries.