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

NCT ID: NCT04226807

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-01-31

Brief Summary

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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

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Conditions

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Postpartum Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Early Postpartum Contact

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

Group Type EXPERIMENTAL

Early Postpartum Phone Call

Intervention Type 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.

Routine Postpartum Care

Patient receives routine postpartum visit only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early Postpartum Phone Call

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Talitha Bruney, MD

Assistant Professor of Obstetrics and Gynecology and Women's Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Talitha Bruney, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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Reference Type BACKGROUND
PMID: 24797575 (View on PubMed)

ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.

Reference Type BACKGROUND
PMID: 29683911 (View on PubMed)

Wilcox A, Levi EE, Garrett JM. Predictors of Non-Attendance to the Postpartum Follow-up Visit. Matern Child Health J. 2016 Nov;20(Suppl 1):22-27. doi: 10.1007/s10995-016-2184-9.

Reference Type BACKGROUND
PMID: 27562797 (View on PubMed)

Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018 Sep;98(3):228-231. doi: 10.1016/j.contraception.2018.04.016. Epub 2018 May 8.

Reference Type BACKGROUND
PMID: 29750924 (View on PubMed)

Tsai PJ, Nakashima L, Yamamoto J, Ngo L, Kaneshiro B. Postpartum follow-up rates before and after the postpartum follow-up initiative at Queen Emma Clinic. Hawaii Med J. 2011 Mar;70(3):56-9.

Reference Type BACKGROUND
PMID: 21365543 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30414598 (View on PubMed)

Goulet L, D'Amour D, Pineault R. Type and timing of services following postnatal discharge: do they make a difference? Women Health. 2007;45(4):19-39. doi: 10.1300/J013v45n04_02.

Reference Type BACKGROUND
PMID: 18032166 (View on PubMed)

Related Links

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https://www.ncqa.org/hedis/measures/prenatal-and-postpartum-care-ppc/

Healthcare Effectiveness Data and Information Set: Prenatal and Postpartum Care

Other Identifiers

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2019-10372

Identifier Type: -

Identifier Source: org_study_id

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