Effect of Folic Acid supplementation in pregnancy on preeclampsia
- Conditions
- pre-eclampsiaMedDRA version: 20.0Level: PTClassification code 10036485Term: Pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2012-001918-42-GB
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 3656
The patient has the mental capacity to understand the trial procedures and to be recruited into the the trial.
18 years or older at the time of consent
Patient is taking less than or equal to 1.1 mg of folic acid daily at the time of randomisation.
Live fetus(documented positive fetal heart beat) prior to randomisation
Gestational Age between 8 0/7 and 16 6/7 at time of randomisation.
Subject plans to give birth in the participating hospital site.
Patient must fulfil at least one of the following risk factors for Preeclampsia;
Pre-existing hypertension
Pre-pregnancy diabetes
Twin pregnancy
Documented evidence of history of PE in a previous pregnancy
BMI = 35 kg/m2 within 3 months prior to this pregnancy or during 1st trimester.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 750
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Indication for high dose folic acid (5 mg) during pregnancy e.g. to reduce risk of fetal central nervous system anomaly (e.g. neural tube defect) based on family or personal history.
Known history or presence of any clinically significant disease or condition which would be a contraindicaiton to folic acid supplemenation of up to 5.1 mg daily for the duration of the pregnancy.
Known major fetal anomaly or fetal demise
History of medical complications, including: -
a) renal disease with altered renal function
b) epilepsy
c) cancer
d) user of folic acid antagonists such as valproic acid
Patient who is taking part in another clinical trial, or has participated in another clinical trial, or received investigational drug within 3 months of the date of randomisation (unless approved by the Trial Coordinating Centre)
Known presence of alcohol abuse or alcohol dependance.
Drug substance use and/or dependance.
Known hypersensitivity to folic acid.
Multiple Pregnancy (triplets or more)
Participation in this study in a previous pregnancy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method