Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Levonorgestrel IUD to Assess Breast Feeding Outcomes (BLIS - Breastfeeding Levonorgestrel IUD Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 2
- 主要终点
- Breastfeeding Continuation Rates at 8 Weeks Postpartum
研究概览
简要总结
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.
详细描述
Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women initiate use of this method in the post partum period. The major advantage of immediate postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with the intense demands of newborn care, but any contraceptive method initiated in the postpartum period must not interfere with breastfeeding.
Our long-term goal is to understand the impact of hormonal contraceptives, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that quality of breastfeeding is not negatively affected by progestin-only hormonal contraceptives.
We will pursue three specific aims comparing women randomized to immediate post-placental vs. delayed (4-6 week) postpartum LNG IUD insertion:
Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation, exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26 weeks postpartum in both groups
This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD.
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
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, 18-40 year old pregnant women
- •Intend to breastfeed
- •Desire the LNG IUD as their method of contraception
- •Agree to be randomized to early versus standard postpartum insertion
- •Have delivered a healthy term infant (37 weeks gestation)
- •Willing to complete all study related procedures, visits and questionnaires
排除标准
- •Chorioamnionitis
- •Obstetric complications including transfusion
- •Severe pregnancy induced hypertension
- •Prolonged hospitalization
- •Coagulopathy
- •Liver disease
- •Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).
研究组 & 干预措施
Early IUD Insertion Group
Immediate post-placental placement of the levonorgestrel IUD
干预措施: Levonorgestrel IUD (Drug)
Standard Postpartum Insertion Group
Placement of the levonorgestrel IUD 4-6 weeks postpartum
干预措施: Levonorgestrel IUD (Drug)
结局指标
主要结局
Breastfeeding Continuation Rates at 8 Weeks Postpartum
时间窗: 8 weeks postpartum
To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.
次要结局
- Time to Lactogenesis Stage 2(First 5 days after birth)