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Clinical Trials/NCT02769676
NCT02769676
Completed
Not Applicable

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

Washington University School of Medicine1 site in 1 country200 target enrollmentMay 2016
ConditionsContraception

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contraception
Sponsor
Washington University School of Medicine
Enrollment
200
Locations
1
Primary Endpoint
Initiation of LARC by time of standard postpartum visit
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
May 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Initiation of LARC by time of standard postpartum visit

Time Frame: 4-8 weeks postpartum

Initiation of LARC method

Secondary Outcomes

  • Contraceptive use at 6 & 12 months(6 & 12 months postpartum)
  • Unintended rapid-repeat pregnancy(12 months postpartum)

Study Sites (1)

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