Anticholinergics for Cervical Edema in Labor (ACCEL)

Anticholinergics for Cervical Edema in Labor (ACCEL)

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.

Study Overview

• Status: Recruiting
• Conditions: Labor Dystocia
• Intervention / Treatment: Drug: Treatment with Diphenhydramine; Combination product: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Samantha Antonioli, MD; Phone Number: (713) 566-5735; Email: Samantha.Hentosh@uth.tmc.edu
• Study Contact Backup: Name: Aaron Roberts; Phone Number: (713) 500-6412; Email: Aaron.W.Roberts@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Aaron Roberts; Phone Number: (713) 500-6412; Email: Aaron.W.Roberts@uth.tmc.edu
      • Contact: Samantha Antonioli, MD; Phone Number: 713-566-5735; Email: Samantha.Hentosh@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	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.
Experimental: Treatment with Diphenhydramine	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants that achieve complete dilation of cervix (10cm)	from start of treatment upto 4 hours
Number of participants that achieve complete dilation of cervix (10cm)	from start of treatment upto 6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who have vaginal delivery after protracted labor		End of delivery (an average of upto 6 hours after start of treatment)
Number of participants who have Postpartum complications captured as composite maternal morbidity	This includes postpartum hemorrhage, cervical lacerations or intraamniotic infection	from hospitalization up to 6 weeks postpartum
Number of neonates that had adverse events	Adverse events include 5 minute APGAR SCORES less than 7, Respiratory Support with intubation in the delivery room , Neonatal intensive acre unit (NICU) admission, Fetal Anomalies, Infection, Intraventricular Hemorrhage, Hypoglycemia, Retinopathy of prematurity, Injuries, Fractures	from birth up to 6 weeks post-delivery

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Samantha Antonioli, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): April 9, 2027

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: labor; dilation
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Pathological Conditions, Signs and Symptoms; Dilatation, Pathologic; Dystocia; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Benzene Derivatives; Ethylamines; Benzhydryl Compounds; Diphenhydramine; Therapeutics
• Other Study ID Numbers: HSC-MS-24-0841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No