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临床试验/NCT02769676
NCT02769676已完成不适用

A Comparison of Short Interval vs. Routine Postpartum Visit on Contraceptive Initiation

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

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

Experimental

Participants randomized to this arm will receive an additional visit at 3-weeks postpartum

干预措施: 3-week visit (Other)

usual care

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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