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NCT Number: NCT07117708

Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

Nationally, 32.1% of pregnant patients deliver via cesarean delivery, including both patients who undergo a planned cesarean delivery and patients who intend to undergo vaginal delivery and are recommended to deliver via cesarean delivery. The investigators aim to understand how to optimize the patient experience for patients who present to the hospital intending to deliver vaginally but are recommended to deliver via cesarean delivery (an unplanned cesarean delivery). Practices regarding timing of informed consent for possible cesarean delivery vary widely across hospitals in the United States; some institutions will consent every patient on admission to the hospital for possible cesarean delivery, whereas some institutions consent patients for possible cesarean delivery only if a patient's clinical course suggests cesarean delivery may be indicated.

This study aims to determine optimal timing for consent for possible cesarean delivery by randomizing patients to either be consented for possible cesarean delivery on admission to the hospital or if it appears to be clinically indicated. This study will only assess altered timing of a surgical consent process and will not impact the clinical care participants receive. After delivery, participants will share their experiences with the consent process and with their overall childbirth experience.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Sarahn Wheeler

CONTACT

[email protected]

9196815220

About this study

This study is a randomized-controlled trial in which patients presenting to Labor and Delivery for their scheduled induction of labor will be randomized to either be consented for possible cesarean delivery on admission to Labor and Delivery or be consented for possible cesarean delivery if it appears to be clinically indicated (as is current standard of care). The purpose of this study is to understand whether earlier cesarean delivery consent could be one strategy to improve the delivery experience of patients recommended to undergo unplanned cesarean delivery and enhance education for all birthing patients. The proposed study will fill this gap in the literature by determining whether early informed surgical consent reduces negative patient delivery experiences and address concerns about the mechanism of obtaining informed consent for cesarean delivery.

Duke Perinatal Durham or Duke Women's Health Associates patients will be approached to be consented for the research study between 34-41 weeks of pregnancy. Those who agree to participate will be randomized to either an early surgical consent for possible cesarean delivery at the time of admission to Labor and Delivery or, as per our current standard of care, will be surgically consented for cesarean delivery if it is clinically indicated. On postpartum day 1, patients will be texted a link to a survey about their experience with the surgical consent process and their overall childbirth experience. The investigators will collect additional patient information via chart review, including a patient's medical history and information about their labor, delivery, and postpartum courses.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age or older
  • Receiving prenatal care at Duke Perinatal Durham or Duke Women's Health Associates
  • Between 34 weeks 0 days and 41 weeks 0 days of gestation
  • Scheduled for induction of labor OR are eligible/intend to be scheduled for an induction of labor

Exclusion criteria

  • Trial of labor after cesarean delivery
  • Multiple gestation
  • Major fetal anomalies
  • Presenting for induction of labor as a transfer from the antepartum inpatient service
  • Non-English speaking
  • Those who do not intend to labor
  • Patients who are ineligible for vaginal delivery for other reasons, including fetal malpresentation or abnormal placentation

Treatment and study plan

Early Surgical Consent

Other

Surgical consent for possible cesarean delivery will be completed upon arrival to labor and delivery before induction of labor begins

Surgical Consent if Clinically Indicated

Other

Surgical consent for possible cesarean delivery will be completed if it appears clinically indicated during a participant's induction of labor.

Primary outcomes

  1. Patient Perception of Informed Consent Process

    Time frame: From day 1 postpartum to 6 weeks postpartum

    As measured by survey.

Secondary outcomes

  1. Patient Childbirth Experience

    Time frame: From day 1 postpartum to 6 weeks postpartum

    As measured by survey.

Study contacts

Contact information is provided by the study sponsor or research team.

Kelsey McNew, MD, PhD

CONTACT

[email protected]

Sarahn Wheeler, MD, MHSc

CONTACT

[email protected]

919-681-5220

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Apr 23, 2026

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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