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Anticholinergics for Cervical Edema in Labor
RecruitingPhase 2/3
Anticholinergics for Cervical Edema in Labor (ACCEL)
Who can join
Ages 18 and older · Women
Full eligibility 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)
About the study
The purpose of this study is to is to determine the clinical effectiveness of a single dose of intravenous (IV) medication for the prevention of labor arrest and cesarean delivery in primiparous women undergoing trial of labor.
What is being tested
- Treatment with Diphenhydramine (drug)
- Usual Care (combination product)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 200 · Started: Mar 25, 2025
Contact the study team
- Samantha Antonioli, MD · Phone: (713) 566-5735
- Aaron Roberts · Phone: (713) 500-6412
Official record on ClinicalTrials.gov — NCT06702670
Locations in the U.S.
| Texas | The University of Texas Health Science Center at Houston, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.