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Completed

NCT Number: NCT04053413

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

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.

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Key information

Conditions

Scar; Previous Cesarean Section Cicatrix Decision Making, Shared Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vaginal Birth After Cesarean

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27517, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Shared Decision Making (SDM) Process score

    Time frame: 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 outcomes

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

    Time frame: Date of Admission

    Intended mode of delivery (repeat cesarean or vaginal) prior to actual delivery

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

    Time frame: Up to 72 hours after delivery

    Actual method of delivery (repeat cesarean or vaginal delivery)

  3. Maternal or Fetal Complications at Delivery

    Time frame: Up to 72 hours after delivery

    Number of complication events: maternal postpartum hemorrhage, infection, fetal admission to neonatal intensive care unit.

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

    Time frame: Up to 6 months prior to delivery

    Participant responses are: 1) repeat cesarean delivery, 2) vaginal delivery and 3) undecided

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Healthwise

Registry information

Official study title

Pilot Study to Assess the Effectiveness of a Decision Tool for Cesarean Delivery vs. Trial of Labor

Acronym: B-READY

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 12, 2019
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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