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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Contraception

Intervention / Treatment
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* Other: 3-week visit
* Other: usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-week visit<br>Participants randomized to this arm will receive an additional visit at 3-weeks postpartum | Other: 3-week visit<br>* The intervention will be an additional visit to the usual postpartum care provider at 3-weeks postpartum.<br>|
| Active Comparator: usual care<br>Participants randomized to this arm will receive usual postpartum care, including the standard timing for a postpartum visit. | Other: usual care<br>* Participants in the usual care arm will receive no additional interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of LARC by time of standard postpartum visit | Initiation of LARC method | 4-8 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraceptive use at 6 & 12 months | Use of contraception | 6 & 12 months postpartum | 
| Unintended rapid-repeat pregnancy | Incidence of an unintended rapid-repeat pregnancy | 12 months postpartum |