Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07117708
Status
Recruiting
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Conditions

  • Informed Consent
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Early Surgical Consent — OTHER
    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 — OTHER
    Surgical consent for possible cesarean delivery will be completed if it appears clinically indicated during a participant's induction of labor.

Study Details

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 Dates

Start date
Aug 27, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Early Consent for Possible Cesarean Delivery
    Patients randomized to this arm of the study will undergo surgical consent for possible cesarean delivery upon arrival to labor and delivery for the start of their induction of labor.
  • Active Comparator: Indicated Consent for Possible Cesarean Delivery
    Patients randomized to this arm of the study will undergo surgical consent for possible cesarean delivery only if it appears to be clinically indicated throughout their induction of labor.

Primary Outcome Measure

Patient Perception of Informed Consent Process [ Time Frame: From day 1 postpartum to 6 weeks postpartum ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Sarahn Wheeler
[email protected]
9196815220

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