Postpartum Visit Timing and the Effect on Visit Attendance

NCT05399784 | Completed

• 1 other identifier: Kole_ConstanceHowesGrant_2020
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of postpartum visits attended

  The number of times a patient attends a postpartum visit in the first 12 weeks postpartum will be counted

  3 months

Secondary Outcomes (4)

• Number of recommended items covered during postpartum care

  3 months

• Trust in physician scale

  3 months

• Short Assessment of Patient Satisfaction

  3 months

• Number of emergency room visits

  3 months

Study Arms (2)

Early & Often Postpartum Care

EXPERIMENTAL

Visit at 2-3 and 6 weeks postpartum.

Behavioral: Early postpartum visit; Behavioral: Standard postpartum visit

Standard Postpartum Care

PLACEBO COMPARATOR

Visit at 6 weeks postpartum.

Behavioral: Standard postpartum visit

Interventions

Early postpartum visit BEHAVIORAL

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

Early & Often Postpartum Care

Standard postpartum visit BEHAVIORAL

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

Early & Often Postpartum Care; Standard Postpartum Care

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Puerperal Disorders; Depression, Postpartum; Gestational Weight Gain; Breast Feeding; Patient Satisfaction

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Martha B Kole-White, MD

  Women & Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: June 1, 2022
• Study Start: February 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)