Anticholinergics for Cervical Edema in Labor

Purpose

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.

Condition

  • Labor Dystocia

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Samantha Antonioli, MD
713-566-5735
Samantha.Hentosh@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Samantha Antonioli, MD
(713) 566-5735
Samantha.Hentosh@uth.tmc.edu