PUnCTuAL: Postpartum Care Timing: A Randomized Trial

Sponsor

University of California, Los Angeles (Other)

Overall Status

Completed

CT.gov ID

NCT03733405

Collaborator

(none)

256

Enrollment

Location

Arms

Actual Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Pregnancy Related	Behavioral: Postpartum Visit at 6 Weeks Behavioral: Postpartum Visit at 2 Weeks	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

256 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Randomized Control Trial of Postpartum Visits at Two or Six Weeks to Evaluate Clinic Attendance and Emergency Department Usage

Actual Study Start Date :

Oct 31, 2018

Actual Primary Completion Date :

Jul 1, 2020

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Postpartum Visit 6 Weeks Participants will have a postpartum visit scheduled 6 weeks after birth	Behavioral: 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.
Experimental: Postpartum Visit 2 and 6 Weeks Participants will have postpartum visits scheduled 2 and 6 weeks after birth	Behavioral: 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. 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.

Arm

Intervention/Treatment

Experimental: Postpartum Visit 6 Weeks

Participants will have a postpartum visit scheduled 6 weeks after birth

Behavioral: 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.

Experimental: Postpartum Visit 2 and 6 Weeks

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

Behavioral: Postpartum Visit at 6 Weeks

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.

Outcome Measures

Primary Outcome Measures

Attendance at one or more routine postpartum visits [8 weeks postpartum]
The primary outcome will be the attendance at one or more scheduled postpartum visits at the clinic where the patient received her prenatal care.

Secondary Outcome Measures

Rate of Emergency Department usage within 30 days of delivery [30 days postpartum]
The secondary outcome will be the presentation and usage of an Emergency Department during the 30 days since delivery of the baby.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Los Angeles	Los Angeles	California	United States	90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

Study Director: Ilina Datkhaeva, MD, University of California, Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ilina Datkhaeva, Co-principal investigator, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT03733405

Other Study ID Numbers:

18-001453

First Posted:

Nov 7, 2018

Last Update Posted:

Nov 4, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ilina Datkhaeva, Co-principal investigator, University of California, Los Angeles

Study Results

No Results Posted as of Nov 4, 2020