Anticholinergics for Cervical Edema in Labor

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06702670
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Labor Dystocia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • 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.

Study Details

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.

Key Dates

Start date
Mar 25, 2025
Status verified
May 2026
Primary completion
Mar 25, 2027
Completion
Apr 9, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with Diphenhydramine
  • Active Comparator: Usual Care

Primary Outcome Measure

Number of participants that achieve complete dilation of cervix (10cm) [ Time Frame: from start of treatment upto 4 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Samantha Antonioli, MD
[email protected]
713-566-5735
Aaron Roberts
[email protected]
(713) 500-6412

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The University of Texas Health Science Center at Houston· Houston, TX

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