Postpartum Visit Timing and the Effect on Visit Attendance

NCT ID: NCT05399784

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-06-01

Brief Summary

The objective of this study is to assess if the addition of an early postpartum visit improves attendance at postpartum visits. We seek to evaluate if an additional early postpartum visit improves patient education, satisfaction, or trust in the clinicians during the postpartum period; all of which may ultimately facilitate improved outcomes. Additionally, we seek to explore patient preferences for postpartum care delivery.

Detailed Description

Maternal mortality in the United States is currently at a record high of 17 deaths per 100,000 live births and the majority of pregnancy related deaths occur in the postpartum period due to complications from chronic disease exacerbation, pregnancy-related hypertension, or psychiatric conditions that lead to suicide. Optimal postpartum care would reduce mortality risk, but numerous studies have demonstrated current care is inadequate. Up to 40% of women do not attend their postpartum visit at 4-6 weeks after delivery and the 15-minute visit is too short to achieve the comprehensive goals that the American College of Obstetricians and Gynecologists (ACOG) sets for this visit: a full assessment of physical, social, and psychological well-being. In addressing the current gap between optimal and actual care, ACOG recently recommended that practitioners shift from the standard, single six-week postpartum visit to two postpartum visits, the first within three weeks of delivery. While this change is intended to address current sub-optimal outcomes, the effects of this change are entirely unknown.

The long term goal of our program is to improve postpartum care for women in Rhode Island. The primary objective of this project is to determine if the ACOG proposed additional postpartum visit within three weeks of delivery improves attendance to postpartum appointments compared to routine postpartum care. Additionally, we intend to examine whether having two scheduled postpartum visits (one within three weeks and the other at the standard 4-6 week postpartum time point) which we describe as "early and often" postpartum care-improves patient knowledge, satisfaction and trust in clinicians compared to routine care as well as explore patient preferences for postpartum care. Our central hypothesis is that early and often postpartum care will lead to improved patient visit attendance compared to routine care.

Conditions

Postpartum Disorder; Postpartum Depression; Postpartum Weight Retention; Breastfeeding; Satisfaction, Patient; Trust

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Early & Often Postpartum Care

Visit at 2-3 and 6 weeks postpartum.

Group Type: EXPERIMENTAL

Early postpartum visit

Intervention Type: BEHAVIORAL

The early postpartum visit will be an in-person visit with a medical provider at 14-21 days postpartum.

Standard postpartum visit

Intervention Type: BEHAVIORAL

The standard postpartum visit will occur at 35 to 56 days postpartum.

Standard Postpartum Care

Visit at 6 weeks postpartum.

Group Type: PLACEBO_COMPARATOR

Standard postpartum visit

Intervention Type: BEHAVIORAL

The standard postpartum visit will occur at 35 to 56 days postpartum.

Interventions

Early postpartum visit

The early postpartum visit will be an in-person visit with a medical provider at 14-21 days postpartum.

Intervention Type: BEHAVIORAL

Standard postpartum visit

The standard postpartum visit will occur at 35 to 56 days postpartum.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• age 13 to 50 years old
• literacy in English or Spanish
• receipt of prenatal care at the Obstetrics and Gynecology Care Center of Women & Infants Hospital
• delivery at Women & Infants Hospital during the study time period

Exclusion Criteria

High risk pregnancy defined as one or more of the following:

• chronic hypertension
• gestational hypertension
• preeclampsia
• eclampsia
• third degree perineal laceration
• fourth degree perineal laceration
• blood product transfusion
• intensive care unit admission
• who were prescribed anxiolytic or antidepressant medications in the antepartum period

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martha B Kole-White, MD

Role: PRINCIPAL_INVESTIGATOR

Women & Infants Hospital

Locations

Women & Infants Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

Kole_ConstanceHowesGrant_2020

Identifier Type: -

Identifier Source: org_study_id