Anticholinergics for Cervical Edema in Labor
Recruiting
Phase 2
Phase 3
Interventional Study
Labor Dystocia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- The University of Texas Health Science Center, Houston · Other
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About This Trial
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.
Trial Locations
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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 medicati…
Contacts