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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02769676
Enrollment
200
Registered
2016-05-11
Start date
2016-05-31
Completion date
2018-05-31
Last updated
2019-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

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).

Interventions

OTHER3-week visit

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

OTHERusual care

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

Sponsors

Society of Family Planning
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Initiation of LARC by time of standard postpartum visit4-8 weeks postpartumInitiation of LARC method

Secondary

MeasureTime frameDescription
Contraceptive use at 6 & 12 months6 & 12 months postpartumUse of contraception
Unintended rapid-repeat pregnancy12 months postpartumIncidence of an unintended rapid-repeat pregnancy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026