Canning David, Shah Iqbal H, Pearson Erin, Pradhan Elina, Karra Mahesh, Senderowicz Leigh, Bärnighausen Till, Spiegelman Donna, Langer Ana
Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, USA.
BMC Pregnancy Childbirth. 2016 Nov 21;16(1):362. doi: 10.1186/s12884-016-1160-0.
During the year following the birth of a child, 40% of women are estimated to have an unmet need for contraception. The copper IUD provides safe, effective, convenient, and long-term contraceptive protection that does not interfere with breastfeeding during the postpartum period. Postpartum IUD (PPIUD) insertion should be performed by a trained provider in the early postpartum period to reduce expulsion rates and complications, but these services are not widely available. The International Federation of Obstetricians and Gynecologists (FIGO) will implement an intervention that aims to institutionalize PPIUD training as a regular part of the OB/GYN training program and to integrate it as part of the standard practice at the time of delivery in intervention hospitals.
This trial uses a cluster-randomized stepped wedge design to assess the causal effect of the FIGO intervention on the uptake and continued use of PPIUD and of the effect on subsequent pregnancy and birth. This trial also seeks to measure institutionalization of PPIUD services in study hospitals and diffusion of these services to other providers and health facilities. This study will also include a nested mixed-methods performance evaluation to describe intervention implementation.
This study will provide critical evidence on the causal effects of hospital-based PPIUD provision on contraceptive choices and reproductive health outcomes, as well as on the feasibility, acceptability and longer run institutional impacts in three low- and middle-income countries.
Trial registered on March 11, 2016 with ClinicalTrials.gov, NCT02718222 .
据估计,在孩子出生后的一年内,40%的女性存在未满足的避孕需求。铜宫内节育器提供安全、有效、便捷且长期的避孕保护,在产后不会干扰母乳喂养。产后宫内节育器(PPIUD)应由经过培训的医护人员在产后早期放置,以降低排出率和并发症,但这些服务并未广泛提供。国际妇产科联合会(FIGO)将实施一项干预措施,旨在将PPIUD培训制度化,作为妇产科培训计划的常规组成部分,并将其纳入干预医院分娩时的标准操作流程。
本试验采用整群随机阶梯楔形设计,以评估FIGO干预措施对PPIUD的采用和持续使用的因果效应,以及对后续妊娠和分娩的影响。本试验还旨在衡量研究医院中PPIUD服务的制度化情况,以及这些服务向其他医护人员和卫生机构的推广情况。本研究还将包括一项嵌套的混合方法绩效评估,以描述干预措施的实施情况。
本研究将为在三个低收入和中等收入国家基于医院提供PPIUD对避孕选择和生殖健康结局的因果效应,以及对可行性、可接受性和长期机构影响提供关键证据。
该试验于2016年3月11日在ClinicalTrials.gov注册,注册号为NCT02718222。