Status:
RECRUITING
Hyperbaric Prilocaine Compared With Hyperbaric Bupivacaine in Cervical Cerclage?
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
Obstetric Anaesthetists' Association United Kingdom
Conditions:
Cervical Incompetence in Pregnancy as Antepartum Condition
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Patients that have a "cervical stitch" (cervical cerclage) require an anaesthetic. The most common choice is a spinal block. This is an injection in the back that makes the lower half of the body beco...
Detailed Description
Cervical incompetence is defined as the inability to sustain a pregnancy to full term. It is characterized by recurrent second-trimester pregnancy losses. Cervical cerclage is a procedure that is comm...
Eligibility Criteria
Inclusion
- Healthy (ASA score 2 or 3) pregnant women presenting for elective cervical cerclage under SAB.
- Age \> 18 years
Exclusion
- Inability to read or understand the patient information sheet (PIS)
- Age \< 18 years
- Unable or unwilling to consent to participation
- non-elective procedure
- serious co-morbidities (ASA score 4 or above)
- any contraindication to SAB, e.g. local or generalised infection, active central nervous system disease, coagulation disorders or anti-coagulant medication
- any history of allergic reaction to any of the medications in the protocol
- concomitant use of class III anti-arrhythmics (sulfonamides, antimalarials, sodium nitroprussate, nitroglycerin, other local anaesthetics)
- any contraindication to the use of bupivacaine or prilocaine as listed in the SmPCs.
Key Trial Info
Start Date :
August 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04394533
Start Date
August 27 2021
End Date
August 31 2024
Last Update
March 18 2024
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7RT