University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid (B-READY)

University of North Carolina (UNC)

Status: Completed

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

Treatments: Other: Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04053413

17-2023

Details and patient eligibility

About

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.

Full description

Once a potential participant is screened eligible, completes the on-line informed consent, they are officially enrolled in the study and sent a link confirming their enrollment and the study group in which they have been assigned. Participants are sequentially enrolled in the study with enrollment first into the usual care group. Once enrollment in the usual care group is complete, enrollment into the decision aid group will occur.

The study includes two non-randomized groups:

Arm 1 (Usual care group): Women in this group will undergo usual care and complete the survey questions on knowledge of risks and benefits of TOLAC (also referred to as VBAC) and planned repeat cesarean (PRCS), certainty of their decision, and involvement in the decision for trial of labor (TOLAC) or repeat cesarean delivery.

Arm 2: (Decision aid group- group receiving the decision tool): 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 knowledge of the risks and benefits of TOLAC and PRCS, certainty of their decision, and involvement in the decision for repeat cesarean or TOLAC.

The decision aid group will be compared with women who do not receive the decision aid (usual care group).

Enrollment: 100 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Usual care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Decision Aid