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

NCT ID: NCT04053413

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2019-12-31

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.

Detailed 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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Decision Aid

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.

Group Type: ACTIVE_COMPARATOR

Decision Aid

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Healthwise

UNKNOWN

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wanda K Nicholson, MD

Role: PRINCIPAL_INVESTIGATOR

Univerisity of North Carolina - Chapel Hill

Locations

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34556061 (View on PubMed)

Other Identifiers

17-2023

Identifier Type: -

Identifier Source: org_study_id