Recruiting
Phase 2
Phase 3

IV Medication

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06702670

Conditions

Labor Dystocia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Treatment with Diphenhydramine

Usual Care

Study Details

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

Study ID

NCT06702670

Start date

Mar 25, 2025

Status verified date

May, 2026

Completion date

Apr 9, 2027

Anticipated

Primary completion date

Mar 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with Diphenhydramine

active comparator: Usual Care

Interventions

Treatment with Diphenhydramine

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

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.

Primary outcome measure

  • Number of participants that achieve complete dilation of cervix (10cm) [ Time Frame: from start of treatment upto 4 hours ]
  • Number of participants that achieve complete dilation of cervix (10cm) [ Time Frame: from start of treatment upto 6 hours ]

Central Contacts and Locations

Central contacts

Samantha Antonioli, MD

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

Aaron Roberts

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Samantha Antonioli, MD

713-566-5735Samantha.Hentosh@uth.tmc.edu

Aaron Roberts

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • dilation
  • labor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-05-06.