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

Not Applicable

Completed

• Conditions: Vaginal Birth After Cesarean; Scar; Previous Cesarean Section; Decision Making, Shared
• Interventions: Other: Decision Aid

• Registration Number: NCT04053413
• Lead Sponsor: University of North Carolina, Chapel Hill

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).

Study Timeline

• Study Start: 2018-04-16
• Primary Completion: 2019-07-31
• Study First Submitted: 2019-08-05
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-12
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Decision Aid	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.

Primary Outcome Measures

Name	Time	Method
Shared Decision Making (SDM) Process score	Up to 6 months prior to delivery	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants (by category) With the Intent to Deliver by Repeat Cesarean Section or by Vaginal Delivery	Date of Admission	Intended mode of delivery (repeat cesarean or vaginal) prior to actual delivery
Maternal or Fetal Complications at Delivery	Up to 72 hours after delivery	Number of complication events: maternal postpartum hemorrhage, infection, fetal admission to neonatal intensive care unit.
Number of Participants (by category) who Delivered by Repeat Cesarean or Vaginal Delivery	Up to 72 hours after delivery	Actual method of delivery (repeat cesarean or vaginal 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	Participant responses are: 1) repeat cesarean delivery, 2) vaginal delivery and 3) undecided

Trial Locations

Locations (1)

University of North Carolina - Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States