A Phase 2/3 interventional study of Treatment with Diphenhydramine and Usual Care in Labor Dystocia, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by The University of Texas Health Science Center, Houston · Phase 2/3, Interventional, and Treatment
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Viable single intrauterine pregnancy
-≥ 34 weeks of gestation
Exclusion Criteria:
Drug: Treatment with Diphenhydramine · Combination Product: Usual Care
Combination Product: Usual Care
Drug page: Diphenhydramine
Diphenhydramine 50mg IV will be administered within 1 hour of the cervical exam which diagnosed prolonged active phase of labor
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.
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
Number of participants who have vaginal delivery after protracted labor
Time frame: 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
This includes postpartum hemorrhage, cervical lacerations or intraamniotic infection
Time frame: from hospitalization up to 6 weeks postpartum
Number of neonates that had adverse events
Adverse events include 5 minute APGAR SCORES less than 7, Respiratory Support with intubation in the delivery room , Neonatal intensive acre unit (NICU) admission, Fetal Anomalies, Infection, Intraventricular Hemorrhage, Hypoglycemia, Retinopathy of prematurity, Injuries, Fractures
Time frame: from birth up to 6 weeks post-delivery
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Mar 2027, 24 months after the start.
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Studies of the drug tested here: Diphenhydramine
The University of Texas Health Science Center, Houston →