Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorDuke University

About this trial

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

Qualifiers

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

Disqualifiers

Trial of labor after cesarean delivery

Multiple gestation

Major fetal anomalies

Presenting for induction of labor as a transfer from the antepartum inpatient service

Trial design

Treatments tested in this trial

  • Early Surgical Consent
  • Surgical Consent if Clinically Indicated

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators