Reshaping Postpartum Follow-up

Gestational Diabetes Clinical Trial

Official title:

Reshaping Postpartum Follow-up in Women With High Risk Pregnancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054841
• Other study ID #: STUDY00006037
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: September 2023
• Source: Medstar Health Research Institute
• Contact: Rosanna Sobota
• Phone: 2028778035
• Email: rosanna.sobota[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Diabetes, Gestational
• Gestational Diabetes
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced
• Uterine Cervical Dysplasia

Intervention

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.

Other:
• Control
No deviation from standard discharge education

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure check	Rate of attendance at a blood pressure check one week postpartum	6 months
Primary	Two hour glucose tolerance test	Rate of completion of two hour glucose tolerance test at six weeks postpartum	6 months
Secondary	Cervical cancer screening	Rate of completion of postpartum pap smear or colposcopy as indication	6 months
Secondary	Primary care	Rate of attendance at visit with primary care provider for annual exam	6 months