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

NCT04053413 | Completed

• 1 other identifier: 17-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Shared Decision Making (SDM) Process score

  This is a measure of the patient's involvement in the decision. 1 point is assigned for discussing the pros 'a lot' or 'some'; 1 point is assigned for discussing the cons 'a lot' or 'some'; 1 point is assigned for responding 'yes' if the provider explained the options; and 1 point is assigned for responding 'yes' that the provider asked the patient what treatment she wanted. The tool's score range is 0-4. A higher score indicates more involvement in the decision.

  Up to 6 months prior to delivery

Secondary Outcomes (4)

• Number of Participants (by category) With the Intent to Deliver by Repeat Cesarean Section or by Vaginal Delivery

  Date of Admission

• Number of Participants (by category) who Delivered by Repeat Cesarean or Vaginal Delivery

  Up to 72 hours after delivery

• Maternal or Fetal Complications at Delivery

  Up to 72 hours after delivery

• Number of Participants (by Category) who desired Repeat Cesarean, Vaginal Delivery or Are Undecided after completion of the study survey

  Up to 6 months prior to delivery

Study Arms (2)

Usual care

NO INTERVENTION

Women in this group will undergo usual care and the complete the survey questions on knowledge and involvement in the decision for trial of labor after cesarean (TOLAC) or repeat cesarean.

Decision Aid

ACTIVE COMPARATOR

Women in this group will receive a decision aid prior to undergoing counseling by their physician. Following completion of the decision aid and physician counseling, they will complete a series of survey questions to assess their perceptions of their knowledge and involvement in the decision for trial of labor after cesarean (TOLAC) or repeat cesarean delivery.

Other: Decision Aid

Interventions

Decision Aid OTHER

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.

Decision Aid

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gestational age between 19/0 and 36/6 weeks
• History of 1 or 2 prior cesarean deliveries

You may not qualify if:

• No contraindications to trial of labor after cesarean (TOLAC)
• No history of prior TOLAC

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Healthwise: collaborator

Study Sites (1)

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (1)

• Venkatesh KK, Brodney S, Barry MJ, Jackson J, Lyons KM, Talati AN, Ivester TS, Munoz MC, Thorp JM, Nicholson WK. Patient decision aid for trial of labor after cesarean (TOLAC) versus planned repeat cesarean delivery: a quasi-experimental pre-post study. BMC Pregnancy Childbirth. 2021 Sep 23;21(1):650. doi: 10.1186/s12884-021-04119-3.

  PMID: 34556061 DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Wanda K Nicholson, MD

  Univerisity of North Carolina - Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 12, 2019
• Study Start: April 16, 2018
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available 9 to 36 months following publication of the data as indicated in the section on Plan Description outlined above.
• Access Criteria: Researchers will respond to letter or email requests from researchers with the plan description outlined in this section.

Locations

US (1)