Comparison · NCT01355159-052dc8a8
Folic Acid 4 mg vs Placebo: Maternal Death
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: Maternal Death. Trial comparisons, record NCT01355159-052dc8a8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01355159-052dc8a8
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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 | 0 | 0.00335 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00331 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.00331 | 0.00335 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | 0 | 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. | 0 | 1,157 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Maternal Death
- Description
According to the World Health Organization, A maternal death is defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes.
- Time frame
- Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery)
- Population
- Participants who completed study and were analyzed for primary 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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