Postpartum Care Timing: A Randomized Trial
PUnCTuAL
Randomized Control Trial of Postpartum Visits at Two or Six Weeks to Evaluate Clinic Attendance and Emergency Department Usage
1 other identifier
interventional
256
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2018
CompletedFirst Submitted
Initial submission to the registry
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedNovember 4, 2020
November 1, 2020
1.7 years
November 5, 2018
November 2, 2020
Conditions
Keywords
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
EXPERIMENTALParticipants will have a postpartum visit scheduled 6 weeks after birth
Postpartum Visit 2 and 6 Weeks
EXPERIMENTALParticipants will have postpartum visits scheduled 2 and 6 weeks after birth
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.
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.
Eligibility Criteria
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
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.
PMID: 33785465DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ilina Datkhaeva, MD
University of California, Los Angeles
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