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NCT06702670·Phase 2 / Phase 3·INTERVENTIONAL

Anticholinergics for Cervical Edema in Labor

OxytocinOtherRecruiting

Status

Recruiting

Phase

Phase 2 / Phase 3

Enrollment

200

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Treatment with Diphenhydramine

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

COMBINATION_PRODUCT

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.

Timeline

From registration to results.

  1. First posted

    Nov 25, 2024

  2. Study start

    Mar 25, 2025

  3. Primary completion

    Mar 25, 2027

  4. Study completion

    Apr 9, 2027

  5. Results posted

    Not reported

  6. Registry updated

    May 6, 2026

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

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

Time frame · from hospitalization up to 6 weeks postpartum

This includes postpartum hemorrhage, cervical lacerations or intraamniotic infection

Number of neonates that had adverse events

Time frame · 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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

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