NCT03733405

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

November 5, 2018

Last Update Submit

November 2, 2020

Conditions

Keywords

BreastfeedingContraceptionEmergencyDepartment

Outcome Measures

Primary Outcomes (1)

  • Attendance at one or more routine postpartum visits

    The primary outcome will be the attendance at one or more scheduled postpartum visits at the clinic where the patient received her prenatal care.

    8 weeks postpartum

Secondary Outcomes (1)

  • Rate of Emergency Department usage within 30 days of delivery

    30 days postpartum

Study Arms (2)

Postpartum Visit 6 Weeks

EXPERIMENTAL

Participants will have a postpartum visit scheduled 6 weeks after birth

Behavioral: Postpartum Visit at 6 Weeks

Postpartum Visit 2 and 6 Weeks

EXPERIMENTAL

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

Behavioral: Postpartum Visit at 6 WeeksBehavioral: Postpartum Visit at 2 Weeks

Interventions

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 WeeksPostpartum Visit 6 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.

Postpartum Visit 2 and 6 Weeks

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast FeedingEmergencies

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ilina Datkhaeva, MD

    University of California, Los Angeles

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-principal investigator

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

October 31, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations