Comparative multicentre trial of three IUDs inserted immediately following delivery of the placenta. Immediate postpartum insertion: performance of the Nova-T-PP and randomized comparison with the Nova-T. Postpartum IUD insertions in Manila, Philippines. A study of delta intrauterine devices in Ankara, Turkey. A comparative study of two techniques used in immediate postplacental insertion (IPPI) of the Copper T-380A IUD in Shanghai, People's Republic of China. Postpartum insertion of modified intrauterine devices. Comparison of T Cu 200 and Progestasert IUDs. Comparative performance of two copper-wired IUDs (ML Cu 250 and T Cu 200: immediate postpartum and interval insertion.
A multinational comparative trial of three IUDs (Copper 7, Lippes loop size D and the Postpartum T) randomly inserted immediately following delivery of the placenta was conducted in six centres. A total of 841 women entered the study. As the predetermined termination indices for expulsions were exceeded at six months the trial was prematurely closed. An excess of expulsions during the first 48 hours following insertion was observed for the Lippes loop compared to the other devices. At six months the expulsion rate for the Lippes loop was significantly higher than that for the Copper 7. In addition, the discontinuation rate for the Lippes loop at 12 months was significantly higher than that for the Copper 7. There were no significant differences in either the expulsion rates or the discontinuation rate at six or twelve months between the postpartum T and the other devices. At 12 months the pregnancy rates with all three devices was high; there were no ectopic pregnancies. Considerable between-centre differences were observed, particularly for expulsion rates. Possible reasons for this are discussed and future research lines are suggested. Clinical evaluation of the Postpartum Nova-T or Nova-T-PP (a Nova-T IUD adapted for postpartum insertion) was based on 412 insertions and showed that this model--besides being effective and safe--had a low expulsion rate (7.2% at 1 year). To prove that the Nova-T-PP's low expulsion rate is indeed the result of its special design, a randomized trial was conducted to compare the Nova-T-PP with the parent model (Nova-T) when inserted within 10 minutes of delivery of the placenta. The result of this study (408 insertions, 203 of them Nova-T) indicate that there is no significant difference in expulsion rate between the two IUD models, suggesting that the addition of two extra arms to the original Nova-T model does not improve the retention of the adapted IUD model. In comparative IUD trials conducted in the Philippines, IUDs were inserted immediately postpartum (within ten minutes postplacenta). The first study was designed to compare the IPCS-52 mg (Intrauterine Progestasert Contraceptive System) IUD with the TCu200 when inserted either by hand or with an inserter. Follow-up continued for three years because the IPCS model was designed to release progesterone for this length of time. There was one suspected pregnancy for which the IUD was removed during the study period. The expulsion rates were higher in the IPCS groups than in the TCu groups (p less than or equal to 0.05) and they were higher in the hand insertion groups than in the inserter groups (p less than or equal to 0.05). The second study was a comparison of the Lippes Loop D and a Delta Loop, modified by the addition of three biodegradable suture projections (made of Ethicon #2 chromic material) on the upper arms of the device. The purpose of this modification was to lower the expulsion rates associated with postpartum insertions. The expulsion rates for these two devices were comparable. There were no difficulties during insertion in either study, and few complaints were reported at follow-up. These two studies demonstrated that immediate postpartum IUD insertion proved a safe, effective means of postpartum contraception. Delta devices, modifications of standard Lippes Loop D and TCu 220C IUDs, were designed for postpartum insertion. A study of the Delta T and the Delta Loop was conducted at Hacettepe University School of Medicine in Ankara, Turkey. The IUDs were randomly allocated to 246 immediately postpartum women (less than 10 min postplacenta). Twelve-month expulsion rates were low for both devices; 3.7 for Delta Loop users and 7.6 for Delta T users. Chinese women in Shanghai who delivered vaginally and who chose to use an IUD for contraception received a Copper T-380A IUD inserted vaginally within 10 minutes after delivery of the placenta (i.e., immediate postplacental insertion, IPPI). Among them, 97.7% were primipara. The women were randomly divided into two groups: IUD inserted by hand and IUD via ring forceps. The follow-up rate of six months was 95.2%. Using Tietze's life table method and log rank test, the expulsion and other discontinuation rates were compared at three and six months postinsertion between these two different insertion techniques. Expulsions were the main reason for discontinuation. The six-month gross cumulative expulsion rates were 13.3 and 12.7 per 100 women in the hand-insertion group and ring forceps-insertion group, respectively. Discontinuation rates for medical removals (bleeding/pain) were 2.1 and 1.0 in these two groups, respectively. Neither of the differences was statistically significant (p > 0.05). No uterine perforation, infection or pregnancy occurred. The results suggest that these two different insertion techniques do not significantly affect discontinuation rates in vaginal IPPI using the TCu 380A, and the TCu 380A appears to be suitable for postpartum insertion in Chinese women. Other relevant issues, such as breastfeeding and IUD placement in uterine cavity, are also analyzed and discussed in this report. The immediate postpartum insertion of standard intrauterine devices (IUDs) and those specially modified for postpartum use was evaluated in a multicenter clinical trial. The immediate postpartum insertion of IUDs was not associated with any increased risk of perforation or infection, although expulsion rates were higher than with interval insertions. The expulsion rate varied widely between centers using similar devices, suggesting that training in insertion is essential. Postpartum IUD insertions can be a practical contraceptive option for patients and providers of medical services. Insertions of the T Cu 200 and the Progestasert IUDs in a total of 400 postpartum women were compared. Insertions were carried out within 10 minutes of delivery, either manually or with an inserter. There was a significant difference in the 6 and 12 month expulsion rates (P0.05) between the 2 groups, but no differences were found related to type of insertion. 12 month expulsion rates for the T Cu hand and inserter groups were 9.0 and 8.1, respectively, and 35.8 and 35.2 for the Progestasert hand and inserted groups, respectively. Overall, significantly fewer Progestasert users reported dysmenorrhea at follow-up and the specific 12 month dysmenorrhea rate was significantly lower for the Progestasert users than for the T Cu users. More women in the Progestasert groups reported intermenstrual spotting and bleeding, but specific 12 month rates of intermenstrual pain, spotting, and bleeding showed no differences between the groups. nan
Immediate post-partum insertion of IUDs appeared safe and effective, though direct comparisons with other insertion times were limited. Expulsion rates appear to be higher than with interval insertion. Advantages of immediate post-partum insertion include high motivation, assurance that the woman is not pregnant, and convenience. The popularity of immediate post-partum IUD insertion in countries as diverse as China, Mexico, and Egypt support the feasibility of this approach. Early follow up may be important in identifying spontaneous IUD expulsions.