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OpenTrials
Completed

NCT Number: NCT02769676

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.

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Key information

Conditions

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in St Louis

St Louis, Missouri, 63110, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3-week visit

Other

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

Usual Care

Other

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

Primary outcomes

  1. Initiation of LARC by time of standard postpartum visit

    Time frame: 4-8 weeks postpartum

    Initiation of LARC method

Secondary outcomes

  1. Contraceptive use at 6 & 12 months

    Time frame: 6 & 12 months postpartum

    Use of contraception

  2. Unintended rapid-repeat pregnancy

    Time frame: 12 months postpartum

    Incidence of an unintended rapid-repeat pregnancy

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Society of Family Planning

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 11, 2016
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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