Comparison · NCT01355159-52c9d2d1
Folic Acid 4 mg vs Placebo: HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count)
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: HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count). Trial comparisons, record NCT01355159-52c9d2d1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01355159-52c9d2d1
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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 | 0.00524 | 0.00241 | 0.0114 | wilson | |
| Risk in group 2 | 0.00433 | 0.00185 | 0.0101 | wilson | |
| Risk difference, group 1 minus group 2 | 0.000919 | -0.0055 | 0.00755 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.21 | 0.371 | 3.96 | log | |
| Odds ratio, group 1 over group 2 | 1.21 | 0.369 | 3.99 | log | |
| Number needed to treat, for one more participant with the outcome on Folic Acid 4 mg than on Placebo | 1,090 | 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 | 6 | 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. | 5 | 1,156 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count)
- Description
- Haemolysis (characteristic peripheral blood smear), Serum LDH \>=600U/L, Serum AST \>=70U/L, Platelet count \<100 x109/L
- Time frame
- Participants will be followed from 20+0 weeks of gestation until delivery
- Population
- Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome.
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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