Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- IUD Use
研究概览
简要总结
This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 18-45
- •Pregnant and greater than or equal to 24 weeks of estimated gestational age
- •Live Pregnancy
- •States a plan to use an Intrauterine Device (IUD) postpartum for contraception
- •Plan for cesarean delivery
- •Intend to stay in the Chapel Hill area for at least 6 months after birth
- •Fluent in English or Spanish
排除标准
- •known uterine anomalies
- •allergies to any component of the IUD of their choosing
- •known or suspected carcinoma of the breast
- •known acute liver disease or liver tumor (benign or malignant)
- •known or suspected uterine or cervical neoplasia
- •active pelvic inflammatory disease
- •genital bleeding of unknown etiology
- •history of solid organ transplantation
- •positive test for gonorrhea or chlamydia during this pregnancy
研究组 & 干预措施
Interval IUD Placement
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
Immediate Postplacental IUD placement
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
干预措施: Immediate Postplacental Placement of an IUD during cesarean delivery (Device)
结局指标
主要结局
IUD Use
时间窗: 6 months postpartum
The use of an IUD at 6 months postpartum is the primary outcome measure
次要结局
- Women's Satisfaction With IUDs(0-6 months postpartum)
- IUD Expulsion(0-6 months postpartum)
研究者
Erika Levi, MD, MPH
Principal Investigator
University of North Carolina, Chapel Hill