Status:
COMPLETED
ED90 of 3% Chloroprocaine for Cervical Cerclage
Lead Sponsor:
Duke University
Collaborating Sponsors:
University of Arkansas
Conditions:
Cerclage, Cervical
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to identify the dose of intrathecal (IT) chloroprocaine that provides effective anesthesia in 90% of patients undergoing elective cerclage placement (intraoperative analgesic ...
Detailed Description
Cervical cerclage is a procedure performed on pregnant women with cervical incompetence to reduce the risk of second trimester spontaneous abortion and preterm labor. This outpatient procedure is perf...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Singleton pregnancy
- ASA class II or III
- Cervical cerclage 1st or 2nd trimester of pregnancy
- Simple prophylactic cervical cerclage
Exclusion
- Patient refusal
- Abdominal and complex cervical cerclage (e.g. bulging bag)
- BMI ≥ 50 kg/m2
- ASA class IV or above
- Contraindication to neuraxial anesthesia
- Allergy to chloroprocaine
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03805438
Start Date
February 7 2019
End Date
October 23 2020
Last Update
October 12 2021
Active Locations (2)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Duke University Hospital
Durham, North Carolina, United States, 27710