Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07117708

Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

Led by Duke University · Updated on 2026-04-23

200

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 other reasons, including fetal malpresentation or abnormal placentation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

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Research Team

S

Sarahn Wheeler, MD, MHSc

CONTACT

K

Kelsey McNew, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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