The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery
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.
Description
This study is a randomized-controlled trial in which patients presenting to Labor and Delivery for their scheduled induction of labor will be randomized to either be consented for possible cesarean delivery on admission to Labor and Delivery or be consented for possible cesarean delivery if it appears to be clinically indicated (as is current standard of care). The purpose of this study is to understand whether earlier cesarean delivery consent could be one strategy to improve the delivery experience of patients recommended to undergo unplanned cesarean delivery and enhance education for all b…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- OtherEarly Surgical Consent
Surgical consent for possible cesarean delivery will be completed upon arrival to labor and delivery before induction of labor begins
- OtherSurgical 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.
Location
- Duke UniversityDurham, North Carolina