Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 4
- 主要终点
- Proportion of Participants With an IUD Expulsion (Complete) at 6 Months
研究概览
简要总结
Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women who desire intrauterine contraception after delivery. A two-week postpartum visit could be a convenient time for women to receive contraception, including IUDs. Offering women IUDs at two-weeks postpartum may decrease the risk of undesired pregnancy and rapid repeat pregnancy. This study will compare IUD insertion at two different times after delivery: two-weeks and six-weeks postpartum. This will allow researchers to assess whether the timing of IUD placement affects whether an IUD is expelled, or pushed out of it's ideal location.
详细描述
The purpose of this study is to determine the proportion of IUDs inserted in the Early Postpartum (EPP) period that are expelled at 6 months postpartum. This prospective, multi-site randomized trial will enroll approximately 404 women at three large academic hospitals in the United States.
Women will be recruited who are interested in receiving a levonorgestrel-IUD or a copper-IUD after delivery. Postpartum women who desire an IUD will be randomized to EPP IUD insertion (between 14-28 days PP) or interval postpartum IUD insertion (42-56 days PP) and the proportion of IUDs expelled will be compared between groups at 6 months postpartum. All women will be seen in clinic at 6-8 weeks and 6 months postpartum. Women randomized to EPP IUD placement will be seen at 2-3 weeks postpartum.
Provider perspectives of EPP IUD placement will also be evaluated, as will whether these attitudes change after 6 to 9 months of providing early postpartum IUDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Gave birth less than or equal to 10 days ago
- •Desires to use an IUD for Contraception (either copper or levonorgestrel)
- •Willing and able to sign an informed consent
- •Willing to comply with the study protocol
- •Age greater than or equal to 18 years
- •English or Spanish speaking
排除标准
- •Uterine anomaly or leiomyomata which would not allow placement of an IUD
- •Desire for repeat pregnancy in less than 6 months
- •Evidence of intrauterine infection (chorioamnionitis or postpartum endometritis) treated with antibiotics
- •Ruptured uterus at the time of delivery
- •Received a postpartum tubal ligation or immediate postpartum IUD or implant at delivery
- •Incarcerated women or women with significant cognitive impairment
- •4th degree perineal laceration sustained at delivery
- •Any medical contraindication to IUD per the US Centers for Disease Control (CDC) Medical Eligibility Criteria
- •Suspicion for new pregnancy
研究组 & 干预措施
Control Group
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
干预措施: IUD (Device)
Intervention Group
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
干预措施: IUD (Device)
结局指标
主要结局
Proportion of Participants With an IUD Expulsion (Complete) at 6 Months
时间窗: 6 months postpartum
Complete IUD expulsion will be defined as an IUD which no longer in the uterus on speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use
次要结局
- Proportion of Participants Using an IUD at 6 Months(6 months postpartum)
- Proportion of Participants With an IUD Expulsion (Partial) at 6 Months(6 months)
- Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement(6 months)
- Proportion of Participants With a Pelvic Infection Within 6 Months(6 months)
- Proportion of Participants With an IUD Perforation at 6 Months(6 months)
研究者
Sarah Averbach, MD MAS
Associate Professor
University of California, San Diego