RecruitingPhase 2Phase 3NCT06702670

Anticholinergics for Cervical Edema in Labor

Anticholinergics for Cervical Edema in Labor (ACCEL)


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

200 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria2

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

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Interventions

DRUGTreatment with Diphenhydramine

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

COMBINATION_PRODUCTUsual 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.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT06702670


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