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Recruiting NCT06702670

Anticholinergics for Cervical Edema in Labor

Phase II / Phase III Interventional Labor Dystocia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Treatment with Diphenhydramine, Usual Care.
Who it may be relevant to
Registry conditions: Labor Dystocia. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Anticholinergics for Cervical Edema in Labor (ACCEL)

Overview

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

  • 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.

Primary outcome measures

  • 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 outcome measures (3)
  • 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]
  • Number of neonates that had adverse events [Time frame: from birth up to 6 weeks post-delivery]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT06702670 · HSC-MS-24-0841

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗