Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03451266
• Date of registration: 17/02/2018
• Prospective Registration: Yes
• Primary sponsor: University Medical Centre Ljubljana
• Public title: Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia
• Scientific title: Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia: a Randomized, Placebo-controlled Trial
• Date of first enrolment: April 7, 2018
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03451266
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Slovenia

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Preeclampsia Severe

Preeclampsia Postpartum

Intervention(s)

Drug: Vitamin C

Drug: placebo

Primary Outcome(s)

Echo Comet Score at day 1 post-delivery [Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 1 following delivery]

Secondary Outcome(s)

Echo Comet Score at day 2 post-delivery [Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 2 following delivery]

Echo Comet Score at day 3 post-delivery [Time Frame: Echo Comet Score (ECS) will be assessed by lung ultrasound at day 3 following delivery]

Secondary ID(s)

2017 0031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors