Postpartum Care Timing: A Randomized Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postpartum, Pregnancy Related

Intervention / Treatment
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* Behavioral: Postpartum Visit at 6 Weeks
* Behavioral: Postpartum Visit at 2 Weeks


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postpartum Visit 6 Weeks<br>Participants will have a postpartum visit scheduled 6 weeks after birth | Behavioral: Postpartum Visit at 6 Weeks<br>* 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.<br>|
| Experimental: Postpartum Visit 2 and 6 Weeks<br>Participants will have postpartum visits scheduled 2 and 6 weeks after birth | Behavioral: Postpartum Visit at 6 Weeks<br>* 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.<br>Behavioral: Postpartum Visit at 2 Weeks<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Contraception, Emergency, Department