Postpartum Family Planning

产后计划生育

• 批准号: 10649405
• 负责人: Maria F Gallo
• 金额: $ 29.2万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-27 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10649405
• 关键词: 5 year old; Adult; Air; Birth; Birth Intervals; Blinded; Body Composition; Breast Feeding; Centers for Disease Control and Prevention (U.S.); Cessation of life; Child; Child Development; Child Mortality; Clinical; Contraception Behavior; Contraceptive Agents; Contraceptive Usage; Contraceptive methods; Counseling; Data; Depo Provera; Disputes; Enrollment; Ensure; Exclusion; Family Planning; Fertility; Growth; Guidelines; Hour; Human; Impairment; Infant; Infant Mortality; Inferior; Injectable; Injections; Intention; International; Intervention; Intramuscular; Lactation; Maternal Mortality; Measures; Medroxyprogesterone 17-Acetate; Methods; Milk; Mothers; Obesity; Outcome; Patients; Pilot Projects; Placebos; Plethysmography; Policies; Postpartum Period; Postpartum Women; Pregnancy; Prevalence; Progestins; Race; Randomized; Randomized, Controlled Trials; Recommendation; Risk; Science; Shapes; Site; Standardization; Supplementation; Target Populations; Technology Assessment; Testing; Time; University Hospitals; Woman; World Health Organization; arm; avoid pregnancy; condoms; design; evidence base; feeding; follow-up; infant morbidity/mortality; innovation; lactational amenorrhea; lactogenesis; maternal morbidity; milk production; milk secretion; postpartum contraception; prevent; primary outcome; public health relevance; randomized trial; secondary outcome; standard care; treatment arm

PROJECT SUMMARY / ABSTRACT Postpartum women often are inadequately protected against rapid repeat pregnancy. Ensuring adequate inter- birth intervals could prevent an estimated 9% of deaths worldwide among children less than 5 years of age. Intramuscular injectable depot medroxyprogesterone acetate (DMPA) is rapidly becoming the method of choice in some settings, including regions where high maternal and child mortality make birth spacing critical. DMPA possesses many advantages for postpartum contraception as compared to other methods. However, the World Health Organization (WHO) advises against use of progestin-only injectables during the first six weeks postpartum among breastfeeding women. In contrast, the Centers for Disease Control and Prevention (CDC) recommends that progestin-only injectables generally can be started immediately postpartum on the grounds that their known advantages, as a whole, outweigh their unknown risks. This inconsistency in guidance reflects the lack of high-quality data for making evidence-based decisions. Studies conducted, to date, have important limitations: short follow-up intervals, low power, lack of consistency in using sensitive and standardized assessments, and lack of randomized trials evaluating DMPA administration specifically in the immediate postpartum period. We propose to evaluate the effects of immediate postpartum initiation of DMPA on breastfeeding and on child development. We will conduct a randomized controlled trial of 429 adult women who have delivered a healthy, full-term infant, intend to breastfeed for ≥6 months, and want to use DMPA. Women will be randomized to receive within 48 hours of delivery: 1) DMPA (“intervention” arm), 2) placebo injection (“placebo” arm) or 3) no injection (“open control” arm). The first two arms will be blinded while the open control arm will be unblinded. We will determine the effect of immediate postpartum initiation of DMPA on breastfeeding (Aim 1) and on contraception use (Aim 2). The proposed trial is innovative in use of 1) a randomized, partially-blinded design with sufficient power and follow up; 2) standardized, validated measures on lactation as well as breastfeeding and contraception behaviors; and 3) whole-body air displacement plethysmography to identify differences between arms in infant body composition. The findings of a pilot study in the target population support the feasibility of the proposed trial. We expect the trial findings will permit the harmonization of the WHO and CDC guidance on the timing of DMPA initiation among breastfeeding women. This would have important implications for shaping global policy and practice worldwide, especially in settings where inadequate birth spacing contributes to high maternal and infant morbidity and mortality.

项目总结/摘要 产后妇女往往得不到充分的保护，无法迅速避免再次怀孕。确保充分的内部- 据估计，生育间隔可以防止全世界5岁以下儿童9%的死亡。 肌内注射贮库型醋酸甲羟孕酮（DMPA）正迅速成为 在某些情况下，包括在孕产妇和儿童死亡率高，生育间隔至关重要的地区，生育间隔是一种选择。 DMPA在产后避孕方面具有许多其他方法无法比拟的优势。然而，在这方面， 世界卫生组织（WHO）建议在前六个月内不要使用仅含孕激素的注射剂， 哺乳期妇女产后10周。相比之下，疾病控制和预防中心 (CDC)建议仅孕激素注射剂通常可以在产后立即开始， 理由是，它们的已知优势，作为一个整体，超过了它们未知的风险。这种不一致性， 指导意见反映出缺乏高质量的数据，无法作出循证决策。研究 迄今为止，进行的研究有重要的局限性：随访间隔短，功率低，缺乏一致性， 使用敏感和标准化的评估，缺乏评估DMPA给药的随机试验 特别是在产后期间。我们建议评估产后立即 启动关于母乳喂养和儿童发展的DMPA。我们将进行一项随机对照试验 429名已分娩健康足月婴儿、打算母乳喂养≥6个月且希望 使用DMPA。女性将在分娩后48小时内随机接受：1）DMPA （“干预”组），2）安慰剂注射（“安慰剂”组）或3）无注射（“开放对照”组）。的 前两组将设盲，而开放对照组将揭盲。我们将确定 产后立即开始DMPA母乳喂养（目标1）和避孕（目标2）。 拟议试验创新性地使用了1）具有足够把握度的随机化、部分设盲设计， 随访; 2）标准化、有效的哺乳、母乳喂养和避孕措施 行为; 3）全身空气置换体积描记法，以确定婴儿手臂之间的差异 身体成分在目标人群中进行的一项试点研究的结果支持拟议的 审判我们预计，试验结果将使世卫组织和疾病预防控制中心关于 在哺乳期妇女中启动DMPA。这将对制定全球政策产生重要影响 特别是在生育间隔不足导致孕产妇死亡率高的情况下， 婴儿发病率和死亡率。