Anticholinergics for Cervical Edema in Labor

This study is looking at whether a single dose of intravenous (IV) Diphenhydramine (an antihistamine) can help prevent labor from stopping and reduce the need for a C-section in women having their first baby. You might be able to join if you are at least 18 years old, pregnant with one baby at 34 weeks or more, your water has broken, and you are in active labor (cervix dilated at least 6 cm). The researchers want to see if Diphenhydramine helps your cervix fully dilate (reach 10 cm) within 4 to 6 hours of treatment. The study is currently unclear on its recruitment status and plans to enroll 200 participants.

Study design
This is an interventional study comparing Diphenhydramine treatment to usual care during labor. It plans to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track how long it takes for your cervix to fully dilate, up to 6 hours after treatment begins.

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NCT06702670

Anticholinergics for Cervical Edema in Labor

Recruiting
PHASE2Ages 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~200 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Treatment with DiphenhydramineUsual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants that achieve complete dilation of cervix (10cm)
Measured over from start of treatment upto 4 hours
+1 more outcome measured
Labor Dystocia
1 sites across 1 states
Texas1
  • Samantha Antonioli, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

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

Category II or III tracing
Allergy to the study medication (IV Diphenhydramine)
  • Number of participants that achieve complete dilation of cervix (10cm)from start of treatment upto 4 hours
  • Number of participants that achieve complete dilation of cervix (10cm)from start of treatment upto 6 hours