RecruitingNot ApplicableNCT07117708

Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery


Sponsor

Duke University

Enrollment

200 participants

Start Date

Aug 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Early Surgical Consent and Surgical Consent if Clinically Indicated for people with informed consent and pregnancy. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREarly Surgical Consent

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

OTHERSurgical 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.


Locations(1)

Duke University

Durham, North Carolina, United States

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NCT07117708


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