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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769676
• Other study ID #: 201512058
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: January 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Other:
• 3-week visit
The intervention will be an additional visit to the usual postpartum care provider at 3-weeks postpartum.
• usual care
Participants in the usual care arm will receive no additional interventions.

Locations

Country	Name	City	State
United States	Washington University in St Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of LARC by time of standard postpartum visit	Initiation of LARC method	4-8 weeks postpartum
Secondary	Contraceptive use at 6 & 12 months	Use of contraception	6 & 12 months postpartum
Secondary	Unintended rapid-repeat pregnancy	Incidence of an unintended rapid-repeat pregnancy	12 months postpartum