Prevention of pre-eclampsia Pregnancy and Childbirth Gestational [pregnancy-induced] hypertension with significant proteinuria
Conditions
Interventions
Current interventions as of 13/03/2012:
Drug name: Folic Acid /Placebo
Dosage form: Tablet
Dosage: 4 mg
Frequency: 4 tablets of 1 mg folic acid daily
Study Treatment will be administered from ran
Sponsors
Ottawa Hospital Research Institute (OHRI) (Canada)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 28/04/2014: 1. Capability of subject to comprehend and comply with study requirements 2. At least 18 years of age at time of consent 3. Subject is taking less than or equal to 1.1 mg of folic acid daily at the time of randomization 4. Live fetus (documented positive fetal heart prior to randomization) 5. Gestational Age between 8 0/7 and 16 6/7 weeks of pregnancy 6. Subject plans to give birth in a participating hospital site 7. Pregnant subjects must fulfill at least one of the following identified risk factors for pre-eclampsia (PE): 7.1 Pre-existing hypertension (documented evidence of diastolic blood pressure =90 mmHg on two separate occasions or at least 4 hours apart prior to randomization, or use of antihypertensive medication during this pregnancy specifically for the treatment of hypertension prior to randomization) 7.2 Pre-pregnancy diabetes (documented evidence of Type I or Type II DM) 7.3 Twin pregnancy 7.4 Documented evidence of history of PE in a previous pregnancy 7.5 BMI > 35 kg/m2 within 3 months prior to this pregnancy or up to randomization of this pregnancy (documented evidence of height and weight to calculate BMI is required) Inclusion criteria from 13/03/2012 to 28/04/2014: 1. Capability of subject to comprehend and comply with study requirements 2. At least 18 years of age at time of consent 3. Subject is taking less than or equal to 1.1 mg of folic acid daily at the time of randomization 4. Live fetus (documented positive fetal heart prior to randomization) 5. Gestational Age between 8 0/7 and 16 6/7 weeks of pregnancy 6. Subject plans to give birth in a participating hospital site 7. Pregnant subjects must fulfill at least one of the following identified risk factors for pre-eclampsia (PE): 7.1 Pre-existing hypertension (documented evidence of diastolic blood pressure =90 mmHg on two separate occasions or at least 4 hours apart prior to randomization, or use of antihypertensive medication during this pregnancy specifically for the treatment of hypertension prior to randomization) 7.2 Pre-pregnancy diabetes (documented evidence of Type I or Type II DM) 7.3 Twin pregnancy 7.4 Documented evidence of history of PE in a previous pregnancy 7.5 BMI > 35 kg/m2 within 3 months prior to this pregnancy or during the first trimester of this pregnancy (documented evidence of height and weight to calculate BMI is required) Inclusion criteria from 14/07/2011 to 13/03/2012: 1. Capability of subject to comprehend and comply with study requirements 2. At least 18 years of age at time of consent 3. Subject is taking less than or equal to 1 mg of folic acid daily at the time of randomization 4. Live fetus (documented positive fetal heart prior to randomization) 5. Gestational Age between 8 0/7 and 16 6/7 weeks of pregnancy 6. Subject plans to give birth in a participating hospital site 7. Pregnant subjects must fulfill at least one of the following identified risk factors for pre-eclampsia (PE): 7.1 Pre-existing hypertension (documented evidence of diastolic blood pressure =90 mmHg on two separate occasions or at least 4 hours apart prior to randomization, or use of antihypertensive medication during this pregnancy specifically for the treatment of hypertension prior to randomization) 7.2 Pre-pregnancy diabetes (documented evidence of Type I or Type II DM) 7.3 Twin pregnancy 7.4 Documented evidence of history of PE in a previous pregnancy 7.5 BMI > 35 kg/m2 within 3 months pri
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/07/2011: 1. Known history or presence of any clinically significant disease or condition which would be a contraindication to folic acid supplementation of up to 5.1 mg daily for the duration of pregnancy 2. Known major fetal anomaly or fetal demise 3. History of medical complications, including: 3.1 Renal disease with altered renal function 3.2 Epilepsy 3.3 Cancer, or 3.4 Use of folic acid antagonists such as valproic acid 4. Individual who is currently enrolled or has participated in another clinical trial or who received an investigational drug within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre) 5. Known history or presence of: 5.1 Alcohol abuse (= 2 drinks per day) or alcohol dependence 5.2 Illicit drug/substance use and/or dependence 6. Known hypersensitivity to folic acid 7. Multiple Pregnancy (triplets or more) 8. Participation in this study in a previous pregnancy Previous exclusion criteria: 1. Known history or presence of any clinically significant disease or condition, as determine by the Principal Investigator which he/she believes would be a contraindication to folic acid supplementation of up to 5 mg daily for the pregnancy duration 2. Women who have known abnormalities (e.g. hydatidiform mole) or known foetal chromosomal or major malformations in the current pregnancy 3. Women who have a history of medical complications, including: 3.1. Untreated hypo/hyper thyroidism 3.2. Renal disease with altered renal function 3.3. Epilepsy 3.4. Any collagen disease such as lupus erythromatosus and scleroderma 3.5. Active and chronic liver disease (hepatitis) 3.6. Cancer 3.7. Use of folic acid antagonists such as valproic acid 4. Threatened abortion. Women with a previous bleeding in the first trimester, can be included if the site documents a viable foetus at the time of recruitment through ultrasound. 5. Women who are using illicit drug or alcohol abuse (greater than or equal to 2 drinks per day) during current pregnancy 6. Known history or presence of: 6.1. Alcoholism 6.2. Drug dependence and/or substance abuse 6.3. Hypersensitivity or idiosyncratic reaction to folic acid 7. Previously been enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preeclampsia is measured by chart reviews (medical tests) in women greater than 20+0 weeks of gestation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures: 1. Maternal death is measured by chart reviews from randomization until 42 days postpartum (after delivery) 2. Severe preeclampsia is measured by chart reviews (medical tests) from 20+0 weeks of gestation until delivery 3. Placenta abruption is measured by chart reviews (medical tests) from 20+0 weeks of gestation until delivery 4. Preterm birth is measured by chart reviews from 20+0 weeks to 36+6 weeks of gestation 5. Premature rupture of membranes. is measured by chart reviews (medical tests) from randomization until the onset of labor 6. Antenatal inpatient length of stay is measured by chart reviews from randomization until admission for delivery 7. Intrauterine growth restriction is measured by chart reviews (medical tests) from 20+0 weeks of gestation until delivery 8. Spontaneous abortion is measured by chart reviews from randomization until 20+0 weeks of gestation 9. Perinatal mortality is measured by chart reviews from 20+0 weeks of gestation until 28 days of life 10. Stillbirth is measured by chart reviews from a birth of infant to 20+0 weeks of gestation 11. Neonatal death is measured by chart reviews from birth of infant until 28 days of life Neonatal Morbidity: 12. Retinopathy of prematurity is measured by chart reviews (medical tests) for the duration of the hospital stay, or up to 6 weeks 13. Intraventricular hemorrhage (IVH) is measured by chart reviews (medical tests) for the duration of the hospital stay, or up to 6 weeks 14. Early onset sepsis is measured by chart reviews (medical tests) from birth to 48 hours of life. 15. Necrotising enterocolitis is measured by chart reviews (medical tests) for the duration of the hospital stay, or up to 6 weeks 16. Ventilation is measured by chart reviews (medical tests) for the duration of the hospital stay, or up to 6 weeks 17. Need for oxygen at 28 days is measured by chart reviews (medical tests) from birth of infant until 28 days of life. 18. Length of stay in 'high | — |
Countries
Argentina, Australia, Canada, Jamaica, United Kingdom
Outcome results
None listed