Impact of Earlier Postpartum Contact on Postpartum Visit Compliance and Maternal Wellbeing

NCT04226807 | Terminated DMC

• 1 other identifier: 2019-10372
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The American College of Obstetricians and Gynecologists has recommended a paradigm shift in how postpartum care is instituted. They recommend that in addition to the normal 4-12 week postpartum visit, women receive contact with a provider within the first 3 weeks after giving birth. This RCT will randomize patients to routine care- 6-12 week postpartum visit alone- or enhanced care- routine care plus a phone call within the first 3 weeks postpartum. The patients will then be asked to complete a follow up survey at 6 months postpartum. The primary outcome measure would be rates of compliance with the 6-12 week postpartum visit. Secondary outcome measures will include breastfeeding rates, rates of postpartum depression, hospital readmission rates and met desire for contraception.

Conditions

Postpartum Care

Keywords

Postpartum Care; Visit Attendance

Outcome Measures

Primary Outcomes (1)

• Attendance at comprehensive postpartum care visit

  Percentage of women attending comprehensive postpartum visit

  12 weeks postpartum

Secondary Outcomes (6)

• Breastfeeding rates at 6 months

  6 months postpartum

• Need for family planning met

  6 months postpartum

• Social work referral

  6 months postpartum

• Repeat pregnancy within 6 months of delivery

  6 months postpartum

• Readmission to the hospital

  6 months postpartum

Study Arms (2)

Early Postpartum Contact

EXPERIMENTAL

Patient receive a phone call from research staff 2-3 weeks after giving birth in addition to routine postpartum visit

Other: Early Postpartum Phone Call

Routine Postpartum Care

NO INTERVENTION

Patient receives routine postpartum visit only

Interventions

Early Postpartum Phone Call OTHER

Participants receive a phone call 2-3 weeks after birth asking about overall wellbeing, screening for complications and postpartum depression and referring to lactation or WIC as needed.

Early Postpartum Contact

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had a vaginal or cesarean delivery at the Jack D. Weiler Hospital
• Gestational age greater than or equal to 36 weeks
• Received prenatal care at the Comprehensive Family Care Center (CFCC) clinic

You may not qualify if:

• \- Fetal or neonatal death or demise

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (7)

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  PMID: 24797575 BACKGROUND

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• Chen MJ, Hsia JK, Hou MY, Wilson MD, Creinin MD. Comparing Postpartum Visit Attendance with a Scheduled 2- to 3-Week or 6-Week Visit after Delivery. Am J Perinatol. 2019 Jul;36(9):936-942. doi: 10.1055/s-0038-1675623. Epub 2018 Nov 10.

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Related Links

• Healthcare Effectiveness Data and Information Set: Prenatal and Postpartum Care

Study Officials

• Talitha Bruney, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology and Women's Health

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: January 31, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)