Reshaping Postpartum Follow-up

Reshaping Postpartum Follow-up in Women With High Risk Pregnancies

The aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. Participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge.

The primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. The secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes; Hypertension in Pregnancy; Cervical Dysplasia
• Intervention / Treatment: Behavioral: Postpartum follow up card; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rosanna Sobota; Phone Number: 2028778035; Email: rosanna.sobota@medstar.net
• Study Contact Backup: Name: Victoria Greenberg, MD; Phone Number: 202-295-0544; Email: Victoria.R.Greenberg@medstar.net

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Washington Hospital Center
      • Contact: Rosanna Sobota, MD; Phone Number: 202-877-8305; Email: rosanna.sobota@medstar.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects >=18 years of age
• Ability to read English or Spanish
• Delivered via vaginal delivery or c-section within the past 48 hours
• Able to consent for themselves

Exclusion Criteria:

• Received antepartum care at a facility outside of the Medstar system or plans to continue care with a facility outside of the Medstar system

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Follow up cards; Subjects will receive a personalized postpartum health card with recommendations for follow up based on their comorbid conditions in pregnancy. They will receive education about these comorbid conditions when they receive their cards.	Behavioral: Postpartum follow up card; The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. The back of the card will list relevant phone numbers to assist patients with scheduling.
Placebo Comparator: Standard education; Subjects will receive standard postpartum education as it is routinely performed by nurses prior to discharge.	Other: Control; No deviation from standard discharge education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure check	Rate of attendance at a blood pressure check one week postpartum	6 months
Two hour glucose tolerance test	Rate of completion of two hour glucose tolerance test at six weeks postpartum	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical cancer screening	Rate of completion of postpartum pap smear or colposcopy as indication	6 months
Primary care	Rate of attendance at visit with primary care provider for annual exam	6 months

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: gestational diabetes; pre-eclampsia; eclampsia; pap smear; hypertensive disorders of pregnancy; Postpartum followup
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Precancerous Conditions; Hypertension; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Dysplasia; Diabetes, Gestational; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: STUDY00006037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No