A Comparison of Short Interval vs. Routine Postpartum Visit on Contraceptive Initiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Initiation of LARC by time of standard postpartum visit
研究概览
简要总结
The current postpartum care model of a single visit 4-6 weeks after delivery does not optimally address contraceptive needs. By this visit, many women have resumed sexual activity, potentially putting them at risk for unintended and rapid repeat pregnancy. In addition, many women with pregnancy-related Medicaid lose insurance coverage at this time, making it difficult to obtain long-acting reversible contraception (LARC) if desired. Therefore, an earlier postpartum visit may remove barriers to improve access to LARC thereby, reducing unintended and rapid repeat pregnancy. Our primary objective is to determine whether an additional 3-week postpartum visit, compared to usual postpartum care, will affect the initiation of LARC by 6 weeks postpartum.
详细描述
Our primary objective is to determine whether an additional 3-week postpartum visit, compared to usual postpartum care, will affect the initiation of LARC by 6 weeks postpartum. Our secondary outcomes include: 1) desired method of postpartum contraception; 2) continuation and satisfaction with contraception; and 3) incidence of rapid repeat and unintended pregnancy at 12 months. We will also measure attendance and satisfaction with 3- compared to 6-week postpartum visits.We will perform a two-arm randomized controlled trial (RCT). Women will be randomized to routine postpartum follow-up compared to two postpartum visits; one at 3 weeks and one at 6 weeks, with initiation of contraception at the 3-week visit as indicated. Women will be recruited from the postpartum service of Barnes-Jewish Hospital and all women will receive structured comprehensive counseling (adapted from the CHOICE Project Model) prior to discharge from the hospital. Postpartum visits will occur at our outpatient ambulatory clinic sites. Participants will complete in-person surveys at baseline and at each visit, and telephone surveys at 6- and 12-months postpartum. Planned recruitment will be 200 women based on a 2-fold increase in LARC initiation in the intervention group compared to control group (40% vs. 20% initiation rate).
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
- 14 Years 至 45 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Delivered at Barnes-Jewish Hospital
- •Receiving postpartum care at resident clinic
排除标准
- •Received LARC, sterilization, or hysterectomy
- •Abortion, stillbirth, or neonatal death
- •Non-English speaking
- •Unable to comply with follow-up
研究组 & 干预措施
3-week visit
Participants randomized to this arm will receive an additional visit at 3-weeks postpartum
干预措施: 3-week visit (Other)
usual care
Participants randomized to this arm will receive usual postpartum care, including the standard timing for a postpartum visit.
干预措施: usual care (Other)
结局指标
主要结局
Initiation of LARC by time of standard postpartum visit
时间窗: 4-8 weeks postpartum
Initiation of LARC method
次要结局
- Contraceptive use at 6 & 12 months(6 & 12 months postpartum)
- Unintended rapid-repeat pregnancy(12 months postpartum)
