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临床试验/NCT02866279
NCT02866279已完成不适用

Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial

Montefiore Medical Center2 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
155
试验地点
2
主要终点
Number of Participants Breastfeeding at 6 Months

研究概览

简要总结

The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time period

详细描述

Immediate postpartum initiation of the etonogestrel contraceptive implant has been proven to decrease rates of rapid, repeat pregnancies. Evidence supports that in healthy women with term infants initiation of the contraceptive implant 1-3 days postpartum does not appear to have any adverse effects on lactogenesis or breastfeeding continuation. However, no high quality study to date has examined the effects of progestin-only contraception in women known to be at risk for low milk supply, including women with a premature delivery, obesity, polycystic ovarian syndrome, diabetes, or a prior history of low milk supply.

The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration. This will be a three-armed randomized non-inferiority study of women who plan to breastfeed, have known risk factors for low milk supply, and who intend to use the contraceptive implant postpartum. Women will be randomized to one of three groups for the timing of contraceptive implant placement: within 30 minutes of placental delivery, 24-72 hours postpartum, or 6 or more weeks postpartum. Women will be assessed at 6 weeks, 3 months and 6 months postpartum. Outcomes will include time to Lactogenesis Stage II, duration and exclusivity of breastfeeding, continuation of and satisfaction with the contraceptive implant, and side effects, including bleeding patterns, associated with the implant.

Findings from this trial will be used by clinicians, hospital systems, and policy makers working to expand access to immediate postpartum implants while supporting women in meeting their breastfeeding goals.

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

年龄范围
17 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Live pregnancy of at least 24 weeks gestation
  • Intention to use a contraceptive implant postpartum
  • 17 years of age or older
  • English or Spanish speaking
  • Admission to Labor and Delivery with a plan for delivery (women in both latent and active labor will be eligible)
  • The presence of at least one of the following conditions known to be a risk factor for low milk supply:
  • Expected delivery prior to 34 weeks
  • Obesity (pre-pregnancy BMI >35)
  • Polycystic Ovarian Syndrome
  • Diabetes (gestational or pre-gestational)
  • Self-reported difficulty with low milk supply in past

排除标准

  • Not English or Spanish speaking
  • Allergy or Contraindication to contraceptive implant

结局指标

主要结局

Number of Participants Breastfeeding at 6 Months

时间窗: 6 months postpartum

Exclusive Breastfeeding at 6 months

Time to Lactogenesis Stage II

时间窗: 1-5 days postpartum

Difference in time to Lactogenesis Stage II

次要结局

  • Satisfaction With Contraceptive Implant(0-6 months postpartum)
  • Vaginal Bleeding(0-6 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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