Anticholinergics for Cervical Edema in Labor

Phase 2

Not yet recruiting

• Conditions: Labor Dystocia
• Interventions: Drug: Treatment with Diphenhydramine; Combination Product: Usual Care

• Registration Number: NCT06702670
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Study Start: 2024-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Diphenhydramine	Treatment with Diphenhydramine	-
Treatment with Diphenhydramine	Usual Care	-
Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
Number of participants that achieve complete dilation of cervix (10cm)	from start of treatment upto 6 hours

Secondary Outcome Measures

Name	Time	Method
Number of participants who have vaginal delivery after protracted labor	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	from hospitalization up to 6 weeks postpartum	This includes postpartum hemorrhage, cervical lacerations or intraamniotic infection
Number of neonates that had adverse events	from birth up to 6 weeks post-delivery	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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States