Anticholinergics for Cervical Edema in Labor (ACCEL)

What this Trial Is About

Researchers are evaluating the clinical effectiveness of a single intravenous dose of medication to prevent labor arrest and cesarean delivery in first-time mothers experiencing labor dystocia. The focus is on primiparous women with viable single pregnancies who are in the active phase of labor, aiming to improve labor outcomes. This phase 2 and 3 interventional trial is sponsored by The University of Texas Health Science Center, Houston. Participants receive either an experimental treatment of 50 mg IV Diphenhydramine within one hour of a cervical exam diagnosing prolonged active labor or usual care. Usual care includes cervical exams every two hours, use of an intrauterine pressure catheter, adjustment of Pitocin if contractions are insufficient, maternal repositioning, and adjunct devices like a peanut ball. The study compares these two approaches in a randomized design without masking. During the study, researchers monitor cervical dilation up to 4 and 6 hours after treatment start to assess complete dilation. They also track vaginal delivery rates after protracted labor, postpartum complications up to six weeks, and any adverse events in newborns up to six weeks after birth. Participant involvement includes regular cervical exams, labor monitoring, and follow-up for maternal and neonatal outcomes lasting through postpartum hospitalization and six weeks thereafter.

Anticholinergics for Cervical Edema in Labor