NCT07117708 Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery
| NCT ID | NCT07117708 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-08-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07117708 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07117708 currently recruiting?
Yes, NCT07117708 is actively recruiting participants. Visit ClinicalTrials.gov or contact Duke University to inquire about joining.
Where is the NCT07117708 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT07117708 clinical trial?
NCT07117708 is sponsored by Duke University. The trial plans to enroll 200 participants.