Diphenhydramine for cervical edema during active labor
Official title: Anticholinergics for Cervical Edema in Labor (ACCEL)
Run by The University of Texas Health Science Center, Houston · NCT06702670 · Data updated 2026-11-12
This will test whether a single IV dose of diphenhydramine given during active labor can prevent labor arrest and lower cesarean delivery rates in first-time (primiparous) women.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | March 25, 2025 |
| Main results expected | March 25, 2027 |
| Study ends | April 9, 2027 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT06702670 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
First-time pregnant women (primiparous) at or beyond 34 weeks with a ruptured membrane, a viable singleton fetus, active labor (≥6 cm dilation), and a reassuring (Category I) fetal heart tracing.
✕Probably not a fit
Women with nonreassuring fetal tracings (Category II/III), a known allergy to diphenhydramine, multiple gestation, or those not in active labor are unlikely to receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2/3 interventional study gives a single intravenous dose of diphenhydramine to primiparous women in active labor and compares outcomes to usual care. Eligible participants are ≥34 weeks with a viable singleton pregnancy, ruptured membranes, a Category I fetal tracing, and cervical dilation ≥6 cm; those with Category II/III tracings or an allergy to diphenhydramine are excluded. The primary goal is to see if treating presumed cervical edema with an anticholinergic reduces labor arrest and cesarean deliveries. Treatment is administered in the hospital labor ward at UTHealth Houston and delivery outcomes are followed through birth.
Why it matters
Potential benefit: If effective, a single inexpensive IV dose could reduce the chance of labor arrest and decrease cesarean deliveries for first-time mothers.
How similar studies have gone: Using anticholinergic or antihistamine drugs for cervical edema in labor is a relatively novel approach with limited prior clinical evidence supporting its effectiveness.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primiparous * Viable single intrauterine pregnancy -≥ 34 weeks of gestation * Ruptured membranes * Category I tracing at time of inclusion * Active phase of labor (\>=6 cm of cervix dilation) Exclusion Criteria: * Category II or III tracing * Allergy to the study medication (IV Diphenhydramine)
Where it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Samantha Antonioli, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Samantha Antonioli, MD
- Email: Samantha.Hentosh@uth.tmc.edu
- Phone: (713) 566-5735
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.