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.
Brief Title
Impact of Earlier Postpartum Contact on Postpartum Visit Compliance and Maternal Wellbeing
Completion Date
Completion Date Type
Actual
Conditions
Postpartum Care
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
Female
Gender Based
false
Keywords
Postpartum Care
Visit Attendance
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04226807
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10372
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Re-imagining the Postpartum Process: The Impact of Earlier Postpartum Contact on Attendance at Postpartum Visits and Maternal Wellbeing
Primary Outcomes
Outcome Description
Percentage of women attending comprehensive postpartum visit
Outcome Measure
Attendance at comprehensive postpartum care visit
Outcome Time Frame
12 weeks postpartum
Secondary Outcomes
Outcome Description
Percentage of women exclusively breastfeeding, using combined breastfeeding and formula feeding or exclusively using formula.
Outcome Time Frame
6 months postpartum
Outcome Measure
Breastfeeding rates at 6 months
Outcome Description
Percentage of women who want to be using a birth control method who are using one
Outcome Time Frame
6 months postpartum
Outcome Measure
Need for family planning met
Outcome Description
Percentage of women who attend a social work appointment
Outcome Time Frame
6 months postpartum
Outcome Measure
Social work referral
Outcome Description
Percentage of women with a positive pregnancy test since delivery
Outcome Time Frame
6 months postpartum
Outcome Measure
Repeat pregnancy within 6 months of delivery
Outcome Description
Percentage of women admitted to any Montefiore hospital
Outcome Time Frame
6 months postpartum
Outcome Measure
Readmission to the hospital
Outcome Description
Percentage of women who were "Very Satisfied" or "Satisfied" with the early phone call
Outcome Time Frame
6 months postpartum
Outcome Measure
Acceptability of early visit
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Talitha Lisa-Marie Bruney
Investigator Email
talmarti@montefiore.org
Investigator Phone
718-405-8376