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Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan

NCT04149002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-02

Study results available
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Summary

The purpose of this study is to pilot an intervention that was developed to improve uptake and adhere to an Individualized Prematurity Prevention Plan (IP3) for preterm birth prevention. Non-Hispanic Black (NHB) women are at higher risk for preterm birth compared to other racial and ethnic groups. Building on qualitative data from NHB women with input from a multidisciplinary stakeholder group, a patient-centered intervention was developed to improve uptake and adherence to an IP3 in NHB women.

Conditions

Interventions

BEHAVIORAL

Intervention Arm Weekly IP3 text messages

Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.

OTHER

Active Control Arm General pregnancy text messages

Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.

Sponsors & Collaborators

Principal Investigators

  • Sarahn Wheeler, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-04-01
Completion
2021-04-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04149002 on ClinicalTrials.gov