Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

Recruiting now · Not applicable

Conditions studied: Pregnancy, Informed Consent

In brief

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.

Key facts

Study ID

NCT07117708

Run by

Duke University

People needed

200

Starts

2025-08-27

Expected to finish

2027-05-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Duke University — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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