Effect of Immediate Versus Standard Postpartum Insertion of the Contraceptive Implant on Breastfeeding Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum
研究概览
简要总结
The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the implant placed in the first 24 hours after delivery of the baby and placenta or 4-6 weeks later. The investigators do not believe there will be a difference in breastfeeding 8 weeks after delivery or time to lactogenesis between those who get the implant placed early or later.
详细描述
Counseling and provision of postpartum contraception is an integral component of comprehensive reproductive healthcare. A woman's preference for contraception is paramount; early initiation of postpartum contraception may assist in optimal birth spacing promoting the wellbeing of mother and baby. Equally important is the provision of appropriate support for breastfeeding. Exclusive breastfeeding for six months with continuation beyond one year of age is recommended by the American Academy of Pediatrics (AAP), American Academy of Family Physicians, American College of Obstetricians and Gynecologists (ACOG), and the World Health Organization (WHO).
The utilization of Long Acting Reversible Contraception (LARC's) has increased in the last decade. The etonogestrel (ENG) implant is one of the most effective LARC's and has become one of the methods used by many women in the postpartum period to prevent an unplanned pregnancy. The major advantage of immediate ENG implant insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with breastfeeding and the life changes and demands of motherhood.
Our long-term goal is to understand the impact of the ENG implant hormonal contraceptive, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that breastfeeding continuation at eight weeks postpartum is not inferior in women in the immediate insertion group of the ENG implant than in those with standard insertion and that time to lactogenesis stage II is not more than 8 hours difference between the immediate insertion and standard insertion groups.
Primary:
Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women or women who have delivered vaginally and by cesarean section within 22 hours (2-hour window will allow for implant insertion by 24 hours postpartum)
- •Aged 13 and older
- •English or Spanish speakers
- •Deliver an infant at UNM Hospital at > 37 weeks gestational age
- •Intend to breastfeed
- •Desire the implant as a method for contraception
- •Agree to randomization
- •Must have a working phone (study questions to be answered through phone calls or accessed electronically by a link sent through email or text message)
排除标准
- •Under age 13
- •History of breast cancer (screen by past medical history)
- •History of undiagnosed vaginal bleeding (screen by past medical history)
- •Head trauma that affected pituitary function (screen by past medical history)
- •Prolactin insufficiency (screen by past medical history)
- •Previous lactation failure (defined as no lactation within 5 days postpartum)
- •Any contraindication to lactation/implant use including diseases transmittable by breast milk (screen by past medical history)
- •Liver dysfunction (screen by past medical history)
- •Use of drugs that inhibit lactation (screen by medical history)
- •Sensitivity to the components of the ENG implant (screen by past medical history)
- •Contraindications to use the implant by the (US MEC) (screen by past medical history)
- •Active labor
- •Delivery at < 37 weeks gestational age
研究组 & 干预措施
Immediate insertion group
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
干预措施: Etonogestrel (Drug)
Immediate insertion group
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
干预措施: Nexplanon (Device)
Standard Postpartum Insertion Group
Insertion of the Etonogestrel implant 4-6 weeks postpartum Intervention.
干预措施: Etonogestrel (Drug)
Standard Postpartum Insertion Group
Insertion of the Etonogestrel implant 4-6 weeks postpartum Intervention.
干预措施: Nexplanon (Device)
结局指标
主要结局
Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum
时间窗: For the primary outcome will be the first eight weeks after delivery.
Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.
次要结局
- Exclusive Breastfeeding(Up to 24 weeks postpartum.)
- Factors Associated With Breastfeeding Discontinuation.(Up to 24 weeks postpartum.)
- Satisfaction With Postpartum Contraception Counseling(At enrollment.)
- Postpartum Mood(At 2, 4, and 8 weeks postpartum.)
- Sexual Function(At 4, 8, and 12 weeks postpartum)
- Postpartum Bleeding Days(At 2, 4, and 8 weeks postpartum.)
- Satisfaction With the ENG Implant(At 8 weeks postpartum)
- Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups.(Up to 24 weeks postpartum)