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

NCT ID: NCT02769676

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-05-31

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).

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3-week visit

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

Group Type: EXPERIMENTAL

3-week visit

Intervention Type: OTHER

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

usual care

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

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: OTHER

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

Interventions

3-week visit

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

Intervention Type: OTHER

usual care

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caitlin Bernard, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University in St Louis

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34286512 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29778586 (View on PubMed)

Other Identifiers

201512058

Identifier Type: -

Identifier Source: org_study_id