MedTrace Logo

University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid

NCT04053413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-21

No results posted yet for this study

Summary

This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean delivery can improve the birth options decision-making process for patients.

Participants are screened for eligibility through electronic health records. Once an individual is screened eligible, and email invite is sent providing information about the study and assessing the interest in participation. An on-line consent is completed and women are entered sequentially into the usual care group and then through further recruitment, another sample of women are entered into the decision aid group. The primary outcome is satisfaction with the shared decision-making process with their provider.

Conditions

  • Scar; Previous Cesarean Section
  • Vaginal Birth After Cesarean
  • Decision Making, Shared

Interventions

OTHER

Decision Aid

The decision aid is a series of web pages that includes videos, questions, and evidence-based information. The decision aid is designed to help women think about what matters to them and what questions they may have for their doctor or midwife. At the end, they receive a summary of which way they are leaning and what matters most to them.

Sponsors & Collaborators

  • Healthwise

    collaborator UNKNOWN

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Wanda K Nicholson, MD · Univerisity of North Carolina - Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT04053413 on ClinicalTrials.gov