Anticholinergics for Cervical Edema in Labor

NCT06702670 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HSC-MS-24-0841
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dilation; labor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

  from hospitalization up to 6 weeks postpartum

• Number of neonates that had adverse events

  from birth up to 6 weeks post-delivery

Study Arms (2)

Treatment with Diphenhydramine

EXPERIMENTAL

Drug: Treatment with Diphenhydramine; Combination Product: Usual Care

Usual Care

ACTIVE COMPARATOR

Combination Product: Usual Care

Interventions

Treatment with Diphenhydramine DRUG

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

Treatment with Diphenhydramine

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.

Treatment with Diphenhydramine; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primiparous
• Viable single intrauterine pregnancy
• ≥ 34 weeks of gestation
• Ruptured membranes
• Active phase of labor (\>=6 cm of cervix dilation)

You may not qualify if:

• Category II or III tracing
• Allergy to the study medication (IV Diphenhydramine)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Dystocia; Dilatation, Pathologic

Interventions

Therapeutics; Diphenhydramine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Samantha Antonioli, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Antonioli, MD

CONTACT

(713) 566-5735; Samantha.Hentosh@uth.tmc.edu

Aaron Roberts

CONTACT

(713) 500-6412; Aaron.W.Roberts@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: March 25, 2025
• Primary Completion (Estimated): March 25, 2027
• Study Completion (Estimated): April 9, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)