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

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The Washington University

Status

Completed

Conditions

Contraception

Treatments

Other: usual care
Other: 3-week visit

Study type

Interventional

Funder types

Other

Identifiers

NCT02769676
201512058

Details and patient eligibility

About

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.

Full 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).

Enrollment

200 patients

Sex

Female

Ages

14 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

3-week visit
Experimental group
Description:
Participants randomized to this arm will receive an additional visit at 3-weeks postpartum
Treatment:
Other: 3-week visit
usual care
Active Comparator group
Description:
Participants randomized to this arm will receive usual postpartum care, including the standard timing for a postpartum visit.
Treatment:
Other: usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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