NCT07076368 Ropivacaine and Fentanyl for Labor Epidural Initiation
| NCT ID | NCT07076368 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, San Francisco |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 50 participants in total. It began in 2025-10-24 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is being done to determine the most effective dose of medicine to use to initially provide effective pain relief within the first 30 minutes of receiving an epidural for pain labor during labor. The study team will also study any side effects related to the epidural medication and patients' satisfaction with the quality of pain relief after receiving the epidural.
Eligibility Criteria
Inclusion Criteria: * Patients with singleton vertex pregnancies in active labor (latent or spontaneous labor or after induction of labor) * Cervical dilatation between 2 and 7 cm * Requesting neuraxial labor analgesia * Age 18 or older Exclusion Criteria: * Significant obstetric disease (e.g., pre-eclampsia, major cardiac disease) * Chronic pain or chronic opioid use * BMI ≥ 50 * Multiple gestations * Allergy or anaphylaxis to local anesthetic * Fetal compromise or non-reassuring fetal trace * Age under 18 * Inability to speak and understand English or Spanish
Contact & Investigator
Alexander Butwick, MBBS, FRCA, MS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07076368 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07076368 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 50 participants.
Is NCT07076368 currently recruiting?
Yes, NCT07076368 is actively recruiting participants. Contact the research team at alexander.butwick@ucsf.edu for enrollment information.
Where is the NCT07076368 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07076368 clinical trial?
NCT07076368 is sponsored by University of California, San Francisco. The principal investigator is Alexander Butwick, MBBS, FRCA, MS at University of California, San Francisco. The trial plans to enroll 50 participants.