Recruiting

Cesarean Consent

Sponsor:

Duke University

Code:

NCT07117708

Conditions

Pregnancy

Informed Consent

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early Surgical Consent

Surgical Consent if Clinically Indicated

Study Details

Brief 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.

Conditions

Pregnancy

Informed Consent

Study ID

NCT07117708

Start date

Aug 27, 2025

Status verified date

Aug, 2025

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 other reasons, including fetal malpresentation or abnormal placentation

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Early Surgical Consent

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

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sarahn Wheeler, MD, MHSc

919-681-5220Sarahn.wheeler@duke.edu

Kelsey McNew, MD, PhD

kelsey.mcnew@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

More Information

Sponsor

Duke University

Last update posted

Apr 23, 2026

Last verified

Aug, 2025

Keywords

  • pregnancy
  • informed consent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-23.