When to get consent for a possible cesarean during labor
Official title: The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery
Run by Duke University · NCT07117708 · Data updated 2026-11-12
This trial tests whether asking patients to sign consent for a possible cesarean when they are admitted to Labor and Delivery, versus only consenting if it becomes clinically likely, improves the childbirth experience for people who plan a vaginal birth but later need an unplanned cesarean.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | August 27, 2025 |
| Main results expected | December 2026 |
| Study ends | May 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07117708 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older who receive prenatal care at Duke Perinatal Durham or Duke Women's Health Associates, are between 34+0 and 41+0 weeks gestation, are scheduled for or intend to be scheduled for induction of labor, have a singleton pregnancy, and are eligible for vaginal delivery.
✕Probably not a fit
Patients who plan a repeat cesarean or trial of labor after cesarean, have multiple gestation, major fetal anomalies, are not eligible for vaginal delivery (for example fetal malpresentation or abnormal placentation), do not intend to labor, or are non–English speaking are excluded and unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized controlled trial enrolling patients scheduled for induction of labor who receive prenatal care at Duke Perinatal Durham or Duke Women's Health Associates. Participants are consented for the research between 34 and 41 weeks and randomized to either sign surgical consent for a possible cesarean on admission to Labor and Delivery or to be consented only if cesarean appears clinically indicated (current standard). On postpartum day 1 participants will receive a text link to a survey about their surgical consent experience and overall childbirth experience. The study will compare reported negative delivery experiences and measures of preparedness and education between the two groups.
Why it matters
Potential benefit: If successful, earlier consent could reduce distress and improve preparedness and education for patients who unexpectedly need a cesarean delivery.
How similar studies have gone: Practices vary widely and this specific randomized comparison of consent timing is novel, with limited prior evidence showing whether earlier consent improves patient experience.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Sarahn Wheeler, MD, MHSc
- Email: Sarahn.wheeler@duke.edu
- Phone: 919-681-5220
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.