Paul D Blumenthal1, Klaira Lerma2, Renita Bhamrah3, Sharad Singh3. 1. Stanford Program for International Reproductive Education and Services (SPIRES), Division of Family Planning Services and Research, Department of Obstetrics and Gynecology, School of Medicine, Stanford University, 300 Pasteur Drive, HG 332, Stanford, CA, 94305, USA; Population Services International, 1120 19th Street, NW Suite 600, Washington, DC 20036, USA. Electronic address: pblumen@stanford.edu. 2. Stanford Program for International Reproductive Education and Services (SPIRES), Division of Family Planning Services and Research, Department of Obstetrics and Gynecology, School of Medicine, Stanford University, 300 Pasteur Drive, HG 332, Stanford, CA, 94305, USA; Population Services International, 1120 19th Street, NW Suite 600, Washington, DC 20036, USA. 3. Population Services International, C-445, Chittaranjan Park, New Delhi-110019, India.
Abstract
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.
RCT Entities:
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 CopperT380A 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.
Authors: Sarah H Averbach; Yokabed Ermias; Gary Jeng; Kathryn M Curtis; Maura K Whiteman; Erin Berry-Bibee; Denise J Jamieson; Polly A Marchbanks; Naomi K Tepper; Tara C Jatlaoui Journal: Am J Obstet Gynecol Date: 2020-03-03 Impact factor: 8.661