NCT06702670

Anticholinergics for Cervical Edema in Labor

Anticholinergics for Cervical Edema in Labor (ACCEL)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Labor Dystocia

Interventions

Type	Name	Description
DRUG	Treatment with Diphenhydramine	Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor
COMBINATION_PRODUCT	Usual Care	Participants will receive cervical exams every 2 hours in active labor, placement of intrauterine pressure catheter, up titration of Pitocin if contractions are inadequate, maternal repositioning, and use of adjunct devices such as a peanut ball.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-14
• First posted: 2024-11-25
• Last updated: 2024-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study