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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Early Surgical Consent
Other interventionSurgical consent for possible cesarean delivery will be completed upon arrival to labor and delivery before induction of labor begins
Surgical Consent if Clinically Indicated
Other interventionSurgical consent for possible cesarean delivery will be completed if it appears clinically indicated during a participant's induction of labor.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Early Consent for Possible Cesarean DeliveryExperimental treatment 1 intervention
Group B: Indicated Consent for Possible Cesarean DeliveryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Perception of Informed Consent Process
As measured by survey.
Time frame
From day 1 postpartum to 6 weeks postpartumSecondary outcomes
1
Patient Childbirth Experience
As measured by survey.
Time frame
From day 1 postpartum to 6 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov