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NCT Number: NCT06702670

Anticholinergics for Cervical Edema in Labor

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.

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Key information

Conditions

Labor Dystocia Dilatation, Pathologic Dystocia Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Treatment with Diphenhydramine

Drug

Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor

Usual Care

Combination Product

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.

Primary outcomes

  1. Number of participants that achieve complete dilation of cervix (10cm)

    Time frame: from start of treatment upto 4 hours

  2. Number of participants that achieve complete dilation of cervix (10cm)

    Time frame: from start of treatment upto 6 hours

Secondary outcomes

  1. Number of participants who have vaginal delivery after protracted labor

    Time frame: End of delivery (an average of upto 6 hours after start of treatment)

  2. Number of participants who have Postpartum complications captured as composite maternal morbidity

    Time frame: from hospitalization up to 6 weeks postpartum

    This includes postpartum hemorrhage, cervical lacerations or intraamniotic infection

  3. Number of neonates that had adverse events

    Time frame: from birth up to 6 weeks post-delivery

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Roberts

CONTACT

[email protected]

(713) 500-6412

Samantha Antonioli, MD

CONTACT

[email protected]

(713) 566-5735

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Anticholinergics for Cervical Edema in Labor (ACCEL)

Acronym: ACCEL

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 25, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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