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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Other: 3-week visit; Other: usual care

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3-week visit; Participants randomized to this arm will receive an additional visit at 3-weeks postpartum	Other: 3-week visit; The intervention will be an additional visit to the usual postpartum care provider at 3-weeks postpartum.
Active Comparator: usual care; Participants randomized to this arm will receive usual postpartum care, including the standard timing for a postpartum visit.	Other: usual care; Participants in the usual care arm will receive no additional interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of LARC by time of standard postpartum visit	Initiation of LARC method	4-8 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraceptive use at 6 & 12 months	Use of contraception	6 & 12 months postpartum
Unintended rapid-repeat pregnancy	Incidence of an unintended rapid-repeat pregnancy	12 months postpartum

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Caitlin Bernard, MD, Washington University School Of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 201512058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO