search
Back to results

Reshaping Postpartum Follow-up

Primary Purpose

Hypertension in Pregnancy, Gestational Diabetes, Cervical Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Postpartum follow up card
Control
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension in Pregnancy focused on measuring Postpartum followup, hypertensive disorders of pregnancy, eclampsia, pre-eclampsia, pap smear, gestational diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Washington Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Follow up cards

Standard education

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Blood pressure check
Rate of attendance at a blood pressure check one week postpartum
Two hour glucose tolerance test
Rate of completion of two hour glucose tolerance test at six weeks postpartum

Secondary Outcome Measures

Cervical cancer screening
Rate of completion of postpartum pap smear or colposcopy as indication
Primary care
Rate of attendance at visit with primary care provider for annual exam

Full Information

First Posted
May 22, 2023
Last Updated
September 19, 2023
Sponsor
Medstar Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT06054841
Brief Title
Reshaping Postpartum Follow-up
Official Title
Reshaping Postpartum Follow-up in Women With High Risk Pregnancies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medstar Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy, Gestational Diabetes, Cervical Dysplasia
Keywords
Postpartum followup, hypertensive disorders of pregnancy, eclampsia, pre-eclampsia, pap smear, gestational diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Follow up cards
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard education
Arm Type
Placebo Comparator
Arm Description
Subjects will receive standard postpartum education as it is routinely performed by nurses prior to discharge.
Intervention Type
Behavioral
Intervention Name(s)
Postpartum follow up card
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No deviation from standard discharge education
Primary Outcome Measure Information:
Title
Blood pressure check
Description
Rate of attendance at a blood pressure check one week postpartum
Time Frame
6 months
Title
Two hour glucose tolerance test
Description
Rate of completion of two hour glucose tolerance test at six weeks postpartum
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cervical cancer screening
Description
Rate of completion of postpartum pap smear or colposcopy as indication
Time Frame
6 months
Title
Primary care
Description
Rate of attendance at visit with primary care provider for annual exam
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosanna Sobota
Phone
2028778035
Email
rosanna.sobota@medstar.net
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Greenberg, MD
Phone
202-295-0544
Email
Victoria.R.Greenberg@medstar.net
Facility Information:
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosanna Sobota, MD
Phone
202-877-8305
Email
rosanna.sobota@medstar.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reshaping Postpartum Follow-up

We'll reach out to this number within 24 hrs