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Postpartum Care Timing: A Randomized Trial

NCT ID: NCT03733405

Last Updated: 2020-11-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2020-07-01

Brief Summary

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The purpose of this study is to determine if shortening the time to initial postpartum visit from six weeks to two weeks can improve clinic visit attendance and decrease usage of the emergency department.

Detailed Description

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Postpartum care is an integral component to completing the maternal peripartum experience and transitioning the patient to well-women care. The American Congress of Obstetrics and Gynecology has recently highlighted the importance of this "fourth stage" of pregnancy suggesting earlier and more comprehensive visits compared to the standard 6-week postpartum visit. Specifically they describe that "all women should ideally have contact with a maternal care provider within the first three weeks postpartum" however this is largely derived from expect opinion and retrospective data. The current rate of postpartum visit attendance is as low as 66%, especially in women with scant prenatal care. In the investigators government-funded clinic, the postpartum clinic attendance in 2017 was 69% and many of the patients have co-morbidities, notably a 25% rate of psychiatric illness. Additionally, in this population, the investigators have identified a high rate of Emergency Department (ED) usage (8.7%) within 30 days of delivery suggesting that perhaps an earlier routine visit is ideal and can prevent the use of the ED. The aim therefore is to evaluate the utility of an early postpartum visit at two weeks in addition to a standard six-week visit with a randomized control trial.

Conditions

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Postpartum Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Postpartum Visit 6 Weeks

Participants will have a postpartum visit scheduled 6 weeks after birth

Group Type EXPERIMENTAL

Postpartum Visit at 6 Weeks

Intervention Type BEHAVIORAL

The patient will be scheduled for a routine postpartum visit at the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.

Postpartum Visit 2 and 6 Weeks

Participants will have postpartum visits scheduled 2 and 6 weeks after birth

Group Type EXPERIMENTAL

Postpartum Visit at 6 Weeks

Intervention Type BEHAVIORAL

The patient will be scheduled for a routine postpartum visit at the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.

Postpartum Visit at 2 Weeks

Intervention Type BEHAVIORAL

The patient will be scheduled for an earlier postpartum visit in addition to the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.

Interventions

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Postpartum Visit at 6 Weeks

The patient will be scheduled for a routine postpartum visit at the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.

Intervention Type BEHAVIORAL

Postpartum Visit at 2 Weeks

The patient will be scheduled for an earlier postpartum visit in addition to the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Receives antepartum, intrapartum and postpartum care at UCLA
* Speaks English or Spanish
* Provides informed consent for study participation
* Vaginal, cesarean delivery or operative vaginal delivery

Exclusion Criteria

* Cognitive impairment, psychiatric instability, or language barriers that limit her ability to provide informed consent
* Plans to received postpartum care at other institution
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Ilina Datkhaeva

Co-principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilina Datkhaeva, MD

Role: STUDY_DIRECTOR

University of California, Los Angeles

Locations

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University of California Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Pluym ID, Tandel MD, Kwan L, Mok T, Holliman K, Afshar Y, Rao R. Randomized control trial of postpartum visits at 2 and 6 weeks. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100363. doi: 10.1016/j.ajogmf.2021.100363. Epub 2021 Mar 27.

Reference Type DERIVED
PMID: 33785465 (View on PubMed)

Other Identifiers

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18-001453

Identifier Type: -

Identifier Source: org_study_id