Anticholinergics for Cervical Edema in Labor (ACCEL)

The University of Texas System (UT)

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Labor Dystocia

Treatments: Drug: Treatment with Diphenhydramine; Combination Product: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06702670

HSC-MS-24-0841

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Treatment with Diphenhydramine

Experimental group

Treatment:

Combination Product: Usual Care

Drug: Treatment with Diphenhydramine

Usual Care

Active Comparator group

Treatment:

Combination Product: Usual Care