NCT06054841

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 22, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

May 22, 2023

Last Update Submit

June 25, 2025

Conditions

Keywords

Postpartum followuphypertensive disorders of pregnancyeclampsiapre-eclampsiapap smeargestational diabetes

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Cervical cancer screening

    6 months

  • Primary care

    6 months

Study Arms (2)

Follow up cards

EXPERIMENTAL

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

Standard education

PLACEBO COMPARATOR

Subjects will receive standard postpartum education as it is routinely performed by nurses prior to discharge.

Other: Control

Interventions

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.

Follow up cards
ControlOTHER

No deviation from standard discharge education

Standard education

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedDiabetes, GestationalUterine Cervical DysplasiaEclampsiaPre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPrecancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesGenital Diseases

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

May 22, 2023

First Posted

September 26, 2023

Study Start

May 22, 2023

Primary Completion

August 1, 2024

Study Completion

March 1, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations