Clinical trial NCT03733405: Postpartum Care Timing: A Randomized Trial
Official title: Randomized Control Trial of Postpartum Visits at Two or Six Weeks to Evaluate Clinic Attendance and Emergency Department Usage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum
Pregnancy Related
Keywords: Breastfeeding
Contraception
Emergency
Department
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Attendance at one or more routine postpartum visits
timeFrame: 8 weeks postpartum
Secondary outcomes:
measure: Rate of Emergency Department usage within 30 days of delivery
timeFrame: 30 days postpartum
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Ilina Datkhaeva, MD
role: STUDY_DIRECTOR
References:
citation: 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.