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Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery
Sponsor: Duke University
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.
Official title: The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2025-08-27
Completion Date
2027-05
Last Updated
2025-10-23
Healthy Volunteers
No
Conditions
Interventions
Early Surgical Consent
Surgical consent for possible cesarean delivery will be completed upon arrival to labor and delivery before induction of labor begins
Surgical Consent if Clinically Indicated
Surgical consent for possible cesarean delivery will be completed if it appears clinically indicated during a participant's induction of labor.
Locations (1)
Duke University
Durham, North Carolina, United States