Your session is about to expire
← Back to Search
Anticholinergic
Diphenhydramine for Labor Dystocia (ACCEL Trial)
Phase 2 & 3
Waitlist Available
Led By Samantha Antonioli, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Viable single intrauterine pregnancy at ≥34 weeks of gestation
Be older than 18 years old
Must not have
Allergy to the study medication (IV Diphenhydramine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from birth up to 6 weeks post-delivery
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if giving a single dose of IV medication can help first-time mothers in labor progress smoothly and reduce the need for a cesarean delivery."
Who is the study for?
This trial is for first-time mothers undergoing labor who may be at risk of labor stopping and needing a cesarean delivery. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not provided.
What is being tested?
The study is testing the effectiveness of an IV medication, Diphenhydramine, against usual care in preventing labor from stopping and reducing the need for cesarean deliveries in new mothers.
What are the potential side effects?
While specific side effects are not listed, common side effects of Diphenhydramine can include drowsiness, dry mouth, dizziness, or blurred vision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently pregnant with one baby, who is at least 34 weeks along.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to IV Diphenhydramine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from birth up to 6 weeks post-delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth up to 6 weeks post-delivery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of neonates that had adverse events
Number of participants who have Postpartum complications captured as composite maternal morbidity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment with DiphenhydramineExperimental Treatment2 Interventions
Group II: Usual CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,660 Total Patients Enrolled
Samantha Antonioli, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston