Bryant Amy G, Kamanga Gift, Stuart Gretchen S, Haddad Lisa B, Meguid Tarek, Mhango Chisale
Department of Obstetrics and Gynecology, Division of Women's Primary Healthcare, University of North Carolina, USA.
Afr J Reprod Health. 2013 Jun;17(2):72-9.
This study aimed to evaluate the feasibility of conducting a randomized controlled trial of postpartum intrauterine device insertion and to demonstrate that the postpartum intrauterine device is acceptable to women. Women attending prenatal care at a maternity hospital in Lilongwe, Malawi were recruited into a trial comparing immediate (10 minutes to 48 hours) to 6 week postpartum insertion. Feasibility of recruiting and consenting 140 women and randomizing 70% of them was evaluated. Satisfaction with the intrauterine device was also assessed. One hundred fifteen women consented and 49 (61%) were randomized. Twenty-six women were assigned to immediate insertion, and 23 to insertion at 6 weeks postpartum. Thirty (24%) women received the device as part of the study protocol, and 28 (93%) had the device in place at 12 weeks postpartum. The intrauterine device is acceptable to some postpartum women in Malawi, but conducting a randomized clinical trial may not be feasible.
本研究旨在评估开展产后宫内节育器放置随机对照试验的可行性,并证明产后宫内节育器为女性所接受。在马拉维利隆圭一家妇产医院接受产前护理的女性被纳入一项试验,该试验比较产后立即(10分钟至48小时)放置与产后6周放置宫内节育器的情况。评估了招募140名女性并使其同意参与试验以及将其中70%随机分组的可行性。还评估了对宫内节育器的满意度。115名女性同意参与试验,其中49名(61%)被随机分组。26名女性被分配至立即放置组,23名被分配至产后6周放置组。30名(24%)女性按照研究方案接受了宫内节育器,28名(93%)女性在产后12周时宫内节育器在位。宫内节育器为马拉维一些产后女性所接受,但开展随机临床试验可能不可行。