When to get consent for a possible cesarean during labor
The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07117708 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Practices vary widely and this specific randomized comparison of consent timing is novel, with limited prior evidence showing whether earlier consent improves patient experience.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.