Postpartum Care Timing: A Randomized Trial

Pregnancy Related Clinical Trial

— PUnCTuAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733405
• Other study ID #: 18-001453
• Status: Completed
• Phase: N/A
• Start date: October 31, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Postpartum
• Pregnancy Related

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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