Status:
COMPLETED
Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Preeclampsia Severe
Preeclampsia Postpartum
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
The objective of the study is to determine whether administration of vitamin C (1.5g/6 hours) in the first three days post-partum reduces the amount of extravascular lung water assessed by lung ultras...
Detailed Description
Risk of fluid over-resuscitation is high in preeclampsia due to endothelial dysfunction and resulting increased vascular permeability. The Confidential Enquiry into Maternal Deaths in the UK reported ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Singleton pregnancy with severe featutes of preeclampsia (any of the following):
- Systolic blood pressure of 160 mm Hg or higher, or diastolic blood pressure of 110 mm Hg or higher on two occasions at least 4 hours apart while the patient is on bed rest (unless antihypertensive therapy is initiated before this time)
- Thrombocytopenia (platelet count less than 100x109/L)
- Impaired liver function as indicated by abnormally elevated blood concentrations of liver enzymes (to twice normal concentration), severe persistent right upper quadrant or epigastric pain unresponsive to medication and not accounted for by alternative diagnoses, or both
- Progressive renal insufficiency (serum creatinine concentration greater 97 µmol/L or a doubling of the serum creatinine concentration in the absence of other renal disease)
- Pulmonary edema
- New-onset cerebral or visual disturbances
Exclusion
Key Trial Info
Start Date :
April 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03451266
Start Date
April 7 2018
End Date
June 27 2019
Last Update
June 28 2019
Active Locations (1)
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1
UMC Ljubljana
Ljubljana, Slovenia, 1000