Labor and Delivery Implant Insertion: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Time to Lactogenesis Stage II [Questionnaire]
研究概览
简要总结
A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis. In this trial, the investigators aim to describe the effects of immediate insertion of the contraceptive implant on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82 consenting women will be randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room or insertion of the implant following delivery in postpartum room and prior to medical discharge (24-48 hours following delivery).
Participants complete a questionnaire that asks questions about breastfeeding continuation, supplementation, duration, and exclusivity. This questionnaire also includes questions about contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women who are patients of the Stanford University Obstetrics service
- •Pregnant women who delivery a healthy infant, regardless of gestational age.
- •Intend to breastfeed
- •Desire the contraceptive implant as their method of contraception
- •Agree to be randomized to delivery room vs. postpartum ward insertion
排除标准
- •Not English or Spanish speaking
- •Allergy or Contraindication to contraceptive implant.
研究组 & 干预措施
Delivery Room Insertion
Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery).
干预措施: Etonogestrel-Immediate (Drug)
Postpartum Insertion
Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery).
干预措施: Etonogestrel-Delayed (Drug)
结局指标
主要结局
Time to Lactogenesis Stage II [Questionnaire]
时间窗: Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II.
Lactogenesis Stage II: The initiation of copious milk secretion as documented by maternal perception. To obtain measurement of time to lactogenesis, we will document time at which participants perceive initiation of copious milk secretion using a set of specific validated questions and subtract this by the documented time of delivery.
次要结局
- Number of of Participants Actively Breastfeeding(2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery)
- Number of Participants Reporting a Pregnancy Within 12 Months(12 months)
- Number of Participants Attending a Postpartum Care Visit by Month 3(month 3)
- Number of Participants Still With the Contraceptive Implant at Month 12.(month 12)
- Number of Participants Satisfied or Very Satisfied With Implant Contraceptive(month 12)
研究者
Kate Ayers Shaw
Clinical Associate Professor
Stanford University