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Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

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

Who can join

Ages 18 and older · Women

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

About the study

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.

What is being tested

• Early Surgical Consent (other)
• Surgical Consent if Clinically Indicated (other)

Sponsor: Duke University · Participants: 200 · Started: Aug 27, 2025

Contact the study team

• Sarahn Wheeler, MD, MHSc · Phone: 919-681-5220

Official record on ClinicalTrials.gov — NCT07117708

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.