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

Not Applicable

Completed

• Conditions: Contraception
• Interventions: Other: usual care; Other: 3-week visit

• Registration Number: NCT02769676
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-04
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Delivered at Barnes-Jewish Hospital
• Receiving postpartum care at resident clinic

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Exclusion Criteria

• Received LARC, sterilization, or hysterectomy
• Abortion, stillbirth, or neonatal death
• Non-English speaking
• Unable to comply with follow-up

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care	usual care	Participants randomized to this arm will receive usual postpartum care, including the standard timing for a postpartum visit.
3-week visit	3-week visit	Participants randomized to this arm will receive an additional visit at 3-weeks postpartum

Primary Outcome Measures

Name	Time	Method
Initiation of LARC by time of standard postpartum visit	4-8 weeks postpartum	Initiation of LARC method

Secondary Outcome Measures

Name	Time	Method
Contraceptive use at 6 & 12 months	6 & 12 months postpartum	Use of contraception
Unintended rapid-repeat pregnancy	12 months postpartum	Incidence of an unintended rapid-repeat pregnancy

Trial Locations

Locations (1)

Washington University in St Louis; 🇺🇸 Saint Louis, Missouri, United States