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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Postpartum
• Intervention / Treatment: Behavioral: Postpartum Visit at 6 Weeks; Behavioral: Postpartum Visit at 2 Weeks

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 Type: Interventional
• Enrollment (Actual): 256
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Emergency Department usage within 30 days of delivery	The secondary outcome will be the presentation and usage of an Emergency Department during the 30 days since delivery of the baby.	30 days postpartum

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Contraception; Emergency; Breastfeeding; Department
• Other Study ID Numbers: 18-001453

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No