Reshaping Postpartum Follow-up

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT06054841

Collaborator

(none)

240

Enrollment

Location

Arms

21.3

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension in Pregnancy Gestational Diabetes Cervical Dysplasia	Behavioral: Postpartum follow up card Other: Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Reshaping Postpartum Follow-up in Women With High Risk Pregnancies

Actual Study Start Date :

May 22, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Blood pressure check [6 months]
Rate of attendance at a blood pressure check one week postpartum
Two hour glucose tolerance test [6 months]
Rate of completion of two hour glucose tolerance test at six weeks postpartum

Secondary Outcome Measures

Cervical cancer screening [6 months]
Rate of completion of postpartum pap smear or colposcopy as indication
Primary care [6 months]
Rate of attendance at visit with primary care provider for annual exam