Clinical trial NCT04053413: University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid
Official title: Pilot Study to Assess the Effectiveness of a Decision Tool for Cesarean Delivery vs. Trial of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar; Previous Cesarean Section
Vaginal Birth After Cesarean
Decision Making, Shared
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Healthwise
First posted: 2019-08-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Shared Decision Making (SDM) Process score
timeFrame: Up to 6 months prior to delivery
Secondary outcomes:
measure: Number of Participants (by category) With the Intent to Deliver by Repeat Cesarean Section or by Vaginal Delivery
timeFrame: Date of Admission
measure: Number of Participants (by category) who Delivered by Repeat Cesarean or Vaginal Delivery
timeFrame: Up to 72 hours after delivery
measure: Maternal or Fetal Complications at Delivery
timeFrame: Up to 72 hours after delivery
measure: Number of Participants (by Category) who desired Repeat Cesarean, Vaginal Delivery or Are Undecided after completion of the study survey
timeFrame: Up to 6 months prior to delivery
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina - Chapel Hill
state: North Carolina
Study officials:
affiliation: Univerisity of North Carolina - Chapel Hill
name: Wanda K Nicholson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.