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

NCT02769676 | Completed DMC

• 1 other identifier: 201512058
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Initiation of LARC by time of standard postpartum visit

  Initiation of LARC method

  4-8 weeks postpartum

Secondary Outcomes (2)

• Contraceptive use at 6 & 12 months

  6 & 12 months postpartum

• Unintended rapid-repeat pregnancy

  12 months postpartum

Study Arms (2)

3-week visit

EXPERIMENTAL

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

Other: 3-week visit

usual care

ACTIVE COMPARATOR

Participants randomized to this arm will receive usual postpartum care, including the standard timing for a postpartum visit.

Other: usual care

Interventions

3-week visit OTHER

The intervention will be an additional visit to the usual postpartum care provider at 3-weeks postpartum.

3-week visit

usual care OTHER

Participants in the usual care arm will receive no additional interventions.

usual care

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Society of Family Planning: collaborator

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.

  PMID: 34286512 DERIVED

• Bernard C, Wan L, Peipert JF, Madden T. Comparison of an additional early visit to routine postpartum care on initiation of long-acting reversible contraception: A randomized trial. Contraception. 2018 Sep;98(3):223-227. doi: 10.1016/j.contraception.2018.05.010. Epub 2018 May 18.

  PMID: 29778586 DERIVED

Study Officials

• Caitlin Bernard, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 8, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)