Importance of the delivery-to-insertion interval in immediate postpartum intrauterine device insertion: A secondary analysis.

OBJECTIVE: To evaluate the delivery-to-insertion interval for copper postpartum intrauterine devices (PPIUDs). METHODS: Secondary analysis of two related studies at five academic sites in India from March 2015 to July 2016. IUDs were inserted within 48 hours of vaginal delivery. Women (n=560) were grouped by whether they underwent postplacental (≤10 minutes) or immediate (>10 minutes) insertion. Outcomes were complete expulsion at the 6-8-week follow-up (primary), and IUD-to-fundus distance, as assessed by postinsertion ultrasound (secondary). RESULTS: Overall, 93 (16.6%) women received a postplacental PPIUD and 467 (83.4%) received an immediate PPIUD. Complete expulsion at follow-up was 3.2% (n=3) in the postplacental and 7.5% (n=35) in the immediate postpartum group (P=0.176; difference in proportions, 4.3%; 95% confidence interval, -2.0 to 8.1). Distance from the fundus did not differ between the two groups (P=0.107); high fundal placement (≤10 mm from the internal endometrial verge) was achieved for most women. CONCLUSION: The present data challenge previous guidance on the timing of PPIUD insertion. The 10-minute insertion window is a barrier to uptake and should be reassessed for inclusion in service delivery guidelines. A flexible interval would accommodate the multiple post-delivery tasks of providers and increase access to PPIUD.

Comparative safety and efficacy of a dedicated postpartum IUD inserter versus forceps for immediate postpartum IUD insertion: a randomized trial.

OBJECTIVE: To compare postpartum intrauterine device (PPIUD) insertion using a newly developed dedicated PPIUD inserter (inserter) to insertion with modified Kelly placental forceps (forceps). STUDY DESIGN: We randomized 500 women at five Indian academic centers to PPIUD insertion of a Copper T380A with either the inserter or forceps. The primary outcomes were fundal placement (assessed by postinsertion ultrasound), ease of insertion on a 5-point Likert scale and safety (infection/perforation). Secondary outcomes included IUD status at 6-8 weeks postpartum, assessed by string check, ultrasound or x-ray. RESULTS: Between September 2015 and July 2016, 241 women in the inserter group and 239 women in the forceps group completed the study, with 20 women excluded due to consent withdrawal (n=4), lost to follow-up (n=10) and protocol deviation (n=6). Median distance from the fundus was similar (p=.36): 5.2 mm (0-130) and 5.8 mm (0-120) in the inserter and forceps groups, respectively. Most providers reported insertion to be easy or very easy with inserter (n=195, 81%) and forceps (n=206, 86%; p=.51). There were no perforations or insertion-related infections. Complete expulsion occurred in 19 (7.9%) in the inserter and 13 (5.4%) forceps groups (p=.28). The inserter group had more partial expulsions (n=26, 10.8% versus n=12, 5.0%,) and self-removals (n=4, 1.7% versus n=0); however, most retained their IUD [174 (72.2%) and 200 (83.7%), respectively] (p=.01). Strings were not visible at follow-up in 23 (13.1%) participants in the inserter group and 45 (22.4%) in the forceps group (p=.04). CONCLUSIONS: High fundal placement was similar between groups, with strings subsequently seen more frequently in the inserter group. The inserter's increased partial expulsions and self-removals are likely associated with the longer string. IMPLICATIONS: The easily performed technique of Cu-T380A PPIUD insertion with the inserter may make immediate PPIUD insertions more convenient for patients and providers. The technique, involving less IUD manipulation and reduced dependence on extra instruments, could combine to make PPIUD a more popular option. Since this study has a short follow-up period, further study is needed to better understand comparative outcomes with longer follow-up. Additional research on string management for IUDs inserted with the inserter could help explain the increased number of partial expulsions.

A Dedicated Postpartum Intrauterine Device Inserter: Pilot Experience and Proof of Concept.

OBJECTIVE: To assess the feasibility, acceptability, and safety of a dedicated postpartum intrauterine device (PPIUD) inserter specifically designed for the post-delivery setting. Primary objectives of fundal placement and expulsion rates were assessed. Secondary objectives were participant satisfaction and IUD retention. METHODS: In this pilot proof of concept, we enrolled 80 women who presented for PPIUD insertion at 2 government hospitals in Delhi and Lucknow, India, between March and July 2015. PPIUD insertion was completed with the dedicated inserter in all cases, by trained providers with no prior experience in PPIUD insertion, followed immediately by ultrasound to assess location and fundal placement of the IUD. Follow-up took place at 6 to 8 weeks post-insertion, and ultrasound was used to assess IUD location. Providers and participants also completed satisfaction surveys. RESULTS: High fundal placement (≤10 mm from uterine fundus) was achieved with the dedicated PPIUD inserter in 82% of cases (n = 65). There were no perforations or infections among the participants and no other complications associated with use of the dedicated inserter. The mean distance between the IUD and the endometrial verge immediately post-insertion was 5.8 mm (range, 0-31; N = 80); this distance at follow-up was also 5.8 mm (range, 0-25; n = 50). Complete expulsion was observed in 6 cases (7.5%), and asymptomatic partial expulsion in 8 cases (10%). Providers reported the majority (93%, n = 74) of insertions to be easy. The majority (74%, n = 59) of participants reported the same level of pain before and after insertion. CONCLUSIONS: This dedicated PPIUD inserter performed as intended and was found to be safe, with high acceptability among the participants and providers. Further study and use of the dedicated inserter may reveal reduced risk of infection among PPIUD users as well as increased convenience compared with standard PPIUD insertion techniques, and could improve acceptability of postpartum IUD provision among providers. The success of this study has led to the initiation of a formal randomized controlled trial in India to further investigate the acceptability of the dedicated inserter.