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Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

NCT07117708 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

OTHER

Early Surgical Consent

Surgical consent for possible cesarean delivery will be completed upon arrival to labor and delivery before induction of labor begins

OTHER

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.

Sponsors & Collaborators

Principal Investigators

  • Kristin Weaver · Duke University

  • Rebecca Beal · Duke University Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07117708 on ClinicalTrials.gov