Comparison · NCT01355159-d35bbd4c
Folic Acid 4 mg vs Placebo: Preeclampsia
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Folic Acid 4 mg vs Placebo: Preeclampsia. Trial comparisons, record NCT01355159-d35bbd4c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01355159-d35bbd4c
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.148 | 0.128 | 0.169 | wilson | |
| Risk in group 2 | 0.135 | 0.116 | 0.156 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0129 | -0.0156 | 0.0414 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.896 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.879 | 1.41 | log | |
| Number needed to treat, for one more participant with the outcome on Folic Acid 4 mg than on Placebo | 77.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Folic Acid 4 mg | Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid~Folic Acid 4 mg: Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid | 169 | 1,144 | OG000 |
| Group 2 | Placebo | Women will be randomised in a 1:1 ratio to folic acid 4.0 mg or placebo~Placebo: Placebo x 4 tablets will be taken daily by oral administration. | 156 | 1,157 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Preeclampsia
- Description
PE is defined as diastolic blood pressure ≥90 mmHg on two occasions ≥4 hours apart and proteinuria developed in women greater than 20+0 weeks of gestation. Proteinuria is defined as: urinary protein ≥300mg in 24 hour urine collection OR in the absence of 24 hour collection, ≥2+ dipstick proteinuria, OR random protein-creatinine ratio ≥30mg protein/mmol.~OR HELLP (Haemolysis, Elevated, Liver Enzymes, Low Platelets) syndrome defined as: Haemolysis (characteristic peripheral blood smear), Serum LDH ≥ 600U/L, Serum AST ≥ 70U/L, and Platelet count \<100 x109/L~OR Superimposed pre-eclampsia, defined as history of pre-existing hypertension (diagnosed pre-pregnancy or before 20+0 weeks' gestation) with new proteinuria.
- Time frame
- Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery)
- Population
Source ClinicalTrials.gov
Trial
- Title
- High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention
- NCT number
- NCT01355159
- Phases
- PHASE3
- Conditions
- Pregnancy Complications, Preeclampsia
- Interventions
- Folic Acid 4 mg, Placebo
- Lead sponsor
- Ottawa Hospital Research Institute
- Results first posted
- 2020-07-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01355159?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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