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

Not Applicable

Terminated

• Conditions: Postpartum Care
• Interventions: Other: Early Postpartum Phone Call

• Registration Number: NCT04226807
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2021-01-31
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

• 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

Exclusion Criteria

• Fetal or neonatal death or demise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Postpartum Contact	Early Postpartum Phone Call	Patient receive a phone call from research staff 2-3 weeks after giving birth in addition to routine postpartum visit

Primary Outcome Measures

Name	Time	Method
Attendance at comprehensive postpartum care visit	12 weeks postpartum	Percentage of women attending comprehensive postpartum visit

Secondary Outcome Measures

Name	Time	Method
Breastfeeding rates at 6 months	6 months postpartum	Percentage of women exclusively breastfeeding, using combined breastfeeding and formula feeding or exclusively using formula.
Need for family planning met	6 months postpartum	Percentage of women who want to be using a birth control method who are using one
Social work referral	6 months postpartum	Percentage of women who attend a social work appointment
Repeat pregnancy within 6 months of delivery	6 months postpartum	Percentage of women with a positive pregnancy test since delivery
Readmission to the hospital	6 months postpartum	Percentage of women admitted to any Montefiore hospital
Acceptability of early visit	6 months postpartum	Percentage of women who were "Very Satisfied" or "Satisfied" with the early phone call

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States