Early Versus Standard Interval Postpartum Intrauterine Device (IUD) Placement at 3 Weeks or 6 Weeks Following Delivery: A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Subjects With an IUD at 3 Months Postpartum
研究概览
简要总结
Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement
详细描述
The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit. We will investigate whether they are more likely to return and to receive an IUD if the follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability, safety and efficacy will also be examined. This prospective, randomized, controlled trial will enroll approximately 240 women at our academic tertiary care hospital in the United States. Participants will be recruited from women who deliver a live-born singleton infant at greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine contraception. Subjects will choose to receive either a levonorgestrel-containing IUS (Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date. Women will be followed by phone contacts at 3 months and 4 months and will have a clinic visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the uterine size will be assessed at 6 months.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception
- •Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment
- •English or Spanish speaking
- •Able to give consent and agree to terms of the study
- •No contraindications to use of either intrauterine device
排除标准
- •Preterm delivery prior to 32 weeks gestation
- •Recent pregnancy with multiple gestation
- •Current incarceration
- •Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
- •Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion)
- •Suspected hypersensitivity or contraindication to the chosen IUD
- •No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM)
研究组 & 干预措施
Levonorgestrel IUS insertion at 3 weeks
IUD placement at 3 weeks after delivery.
干预措施: Levonorgestrel IUS (Drug)
Levonorgestrel IUS insertion at 6 weeks
IUD placement at 6 weeks after delivery.
干预措施: Levonorgestrel IUS (Drug)
结局指标
主要结局
Subjects With an IUD at 3 Months Postpartum
时间窗: Three months after delivery
Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .
次要结局
- Satisfaction With the Timing of IUD Placement.(Immediately following IUD placement.)
- Uterine Thickness at the Fundus(At IUD placement)
- Subjects With an IUD at 6 Months Postpartum(Six months after delivery)
- Pain With IUD Placement(At the time of IUD placement.)
- Number of Subjects With Adverse Events(Six months after delivery)
研究者
Maureen Baldwin
Instructor, Ob/Gyn, Fellow in Family Planning
Oregon Health and Science University