Measuring Lactation Initiation After Early Postpartum Injectable Progestin (DMPA) Use Among Women in Dhanusha District of Nepal: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Enrollment feasibility
研究概览
简要总结
This is a pilot study of early postpartum initiation of the injectable progestin contraception, depo medroxyprogesterone acetate (DMPA), among 40 postpartum people. The study aims to assess the feasibility to conduct a larger trial evaluating the effects of early postpartum initiation DMPA on lactation and infant growth outcomes in Nepal.
详细描述
The primary objective of this study is to pilot the procedures necessary to demonstrate feasibility for a larger randomized trial evaluating the effects of early postpartum initiation of DMPA on time to lactogenesis (transition to mature milk), lactation continuation, and infant growth and development.
The investigators will conduct a pilot study among 40 birthing people who deliver a singleton, healthy, term infant; intend to feed their infant human milk (breastfeed) exclusively for at least 6 months; and plan to use DMPA for postpartum contraception. Participants will be administered DMPA within 48 hours after birth and will be followed for 12 weeks postpartum. Time to lactogenesis, the proportion of participants exclusive feed their infant human milk at 12 weeks, any lactation and infant growth through 12 weeks will be measured. We will analyze time to onset of lactogenesis the proportion of participants exclusively feeding human milk at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently live in Nepal
- •Had a vaginal or cesarean delivery of a singleton full-term infant within the past 48 hours
- •Not yet undergone lactogenesis
- •Desire to use DMPA as a method of postpartum contraception
排除标准
- •Desire a repeat pregnancy in less than 6 months
- •Do not intend to exclusively feed infant own human milk for 6 months
- •Do not have access to a telephone
- •Any medical contraindication to DMPA
- •Any contraindication to human milk feeding for their infant
- •History of breast surgery (augmentation or reduction)
- •Infant with a major congenital anomaly (will be excluded due to unique challenges with feeding in these populations)
研究组 & 干预措施
Intervention
Initiation of injectable depo medroxyprogesterone acetate (DMPA) within 48 hours of birth
干预措施: Depo Medroxyprogesterone acetate (Drug)
结局指标
主要结局
Enrollment feasibility
时间窗: 12 weeks
The ability of project staff to consent and enroll 40 individuals who are willing to participate in this pilot study within 12 weeks.
次要结局
- Time to lactogensis(148 hours)
- Change in infant length(Birth to 4 weeks)
- Change in infant head circumference(Birth to 4 weeks)
- Change in infant weight(Birth to 4 weeks)
- Exclusive lactation(12 weeks)
- DMPA Continuation(12 weeks)
研究者
Sarah Averbach, MD MAS
Associate Professor
University of California, San Diego