Trial Information
Current as of August 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The Optimize Trial is a study looking at the best time to talk with pregnant patients about the possibility of having a cesarean delivery (C-section) if it becomes necessary during labor. Right now, hospitals handle this in different ways—some ask for consent for a C-section when patients first arrive at the hospital, while others wait until it seems likely a C-section will be needed. This study wants to find out which approach makes patients feel more comfortable and informed, especially for those who plan to have a vaginal delivery but end up needing a C-section unexpectedly.
Women who are 18 or older, receiving prenatal care at Duke, and between 34 and 41 weeks pregnant may be eligible to join if they are scheduled for labor induction (when labor is started artificially). The study will not change any medical care; it only looks at when consent for possible C-section is obtained. After delivery, participants will be asked about their experience with the consent process and their overall childbirth experience. This trial is not yet recruiting participants and excludes women with certain medical conditions or who do not plan to labor.
Gender
FEMALE
Eligibility criteria
- 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
About Duke University
Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Rebecca Beal
Study Director
Duke University Department of Obstetrics and Gynecology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported