Status:
WITHDRAWN
Investigating the Novel Observation of Right-left Difference in Uterine Artery Vascular Resistance in Pre-eclampsia
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Pre-eclampsia
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
The investigators previously demonstrated that epidural ropivacaine reduces uterine artery vascular resistance in a dose dependent manner in pre-eclampsia. The investigators also noted a marked right-...
Eligibility Criteria
Inclusion
- Pre-eclampsia patients and normal pregnancy controls scheduled to receive epidural catheterization for induction of labor or Cesarean delivery. Non-pregnant controls receiving epidural catheterization for elective surgery. Pre-eclampsia group:
- gestational age between 35 to 40 completed weeks
- uterine artery notching OR evidence of reduced uterine artery blood flow
- resting systolic pressure \> 140mmHg or diastolic pressure \> 90mmHg measured twice at least 6 hours apart
- proteinuria (at least 0•1 g/l in two random samples at least 6 hours apart or at least 0•3g in a 24 hour collection).
- Normal pregnancy control group:
- gestational age between 35 to 40 completed weeks
- absence of other inclusion factors for the pre-eclampsia group. Non-pregnant control group: Non-pregnant women of reproductive age.
Exclusion
- Active labor, resting blood pressure ≥ 160/110 (recorded on at least two occasions 6 hours apart), coagulopathy or other contraindications for epidural catheterization, abnormal fetal heart tracing, known fetal anomaly, intrauterine infection, placental anomalies, twins, and refusal of consent.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00848679
Start Date
March 1 2009
End Date
October 1 2009
Last Update
September 12 2019
Active Locations (1)
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1
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 91120