Care After Pregnancy Study (CAPS): Engaging Women in Postpartum Care

NCT04257552 | Completed Results

• 2 other identifiers: STUDY190403121R56NR017933-01A1
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching hypothesis of our research agenda is that an intervention that engages economically disadvantaged women in personalized postpartum care will promote equality in maternal child health. As a first step to test our hypothesis the investigators propose the following aims: Specific Aim 1: Measure the impact of Healthy Beyond Pregnancy on key components of postpartum care, including use of effective contraception at three and six months postpartum and breastfeeding duration at three and six months. Specific Aim 2: Determine if Healthy Beyond Pregnancy improves adherence to health screening and linkage to follow-up care for women with cardio-metabolic complications of pregnancy.

Conditions

Postpartum Care

Keywords

contraception; postpartum care; breast feeding; interconception care

Outcome Measures

Primary Outcomes (3)

• Number of Participants Using a Non-barrier Method of Contraception

  Effective contraception (non-barrier method)

  3 months after delivery

• Number of Participants Using a Non-barrier Method of Contraception

  Effective contraception (non-barrier method)

  6 months after delivery

• Adherence of Postpartum Visit

  Attendance at postpartum visit (yes/no)

  12 weeks after deliery

Secondary Outcomes (4)

• The Number of Participants Who Given Their Infant Breast Milk

  1 week after delivery

• The Number of Participants Who Given Their Infant Breast Milk

  1 month after delivery

• The Number of Participants Who Given Their Infant Breast Milk

  3 months after delivery

• The Number of Participants Who Given Their Infant Breast Milk

  6 months after delivery

Study Arms (3)

Attention Control Group

ACTIVE COMPARATOR

If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.

Other: Attention Control

Pre-Scheduled Postpartum Visit:

ACTIVE COMPARATOR

If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.

Behavioral: Pre-Scheduled Postpartum Visit

Healthy Beyond Pregnancy

EXPERIMENTAL

Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.

Behavioral: Healthy Beyond Pregnancy

Interventions

Healthy Beyond Pregnancy BEHAVIORAL

Web-based application grounded in tenants of behavioral economics.

Healthy Beyond Pregnancy

Pre-Scheduled Postpartum Visit BEHAVIORAL

Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.

Pre-Scheduled Postpartum Visit:

Attention Control OTHER

Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.

Attention Control Group

Eligibility Criteria

• Age: 12 Years - 50 Years
• Gender Eligibility Details: This is a study of postpartum women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Insured by a PA Medicaid insurance
• Pregnancy care in the Magee Womens Hospital Outpatient Clinic

You may not qualify if:

• Delivery less than 24 weeks
• Fetal or neonatal demise
• Women who had a postpartum tubal ligation
• Women less than 18 year of age

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr. Katherine Himes
• Organization: University of Pittsburgh, Magee Womens Research Institute

himekp@upmc.edu

(412) 641-1805

Study Officials

• Francesca Facco, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators are unaware of study arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 6, 2020
• Study Start: February 3, 2020
• Primary Completion: June 2, 2021
• Study Completion: September 2, 2021
• Last Updated: October 21, 2022
• Results First Posted: October 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately upon publication of the trial. They will be available indefinitely.
• Access Criteria: Anyone who wished to access the data.

Locations

US (1)