Trial · NCT01355159
High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention
NCT01355159, Phase 3, Completed, Ottawa Hospital Research Institute; results first posted 2020-07-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention. Trials, record NCT01355159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01355159
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High Dose Folic Acid Supplementation Throughout Pregnancy for Preeclampsia Prevention
- NCT number
- NCT01355159
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,464 participants, actual
- Lead sponsor
- Ottawa Hospital Research Institute
- Conditions
- Pregnancy Complications, Preeclampsia
- Interventions
- Folic Acid 4 mg, Placebo
- First posted
- 2011-05-17
- Last updated
- 2020-07-07
- Other registries' IDs
- isrctn:ISRCTN23781770
- Results first posted
- 2020-07-07
- Limitations and caveats
The diagnosis of PE is complex due to its heterogenous aetiology. The criteria for PE have remained consistent with NICE guidelines, but there have been revisions in other settings. Therefore additional women in the study might have had PE.
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Preeclampsia | Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery) | 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. |
| Secondary | Maternal Death | Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery) | 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. |
| Secondary | Spontaneous Abortion | Participants will be followed from randomization until 20+0 weeks of gestation | Spontaneous abortion or miscarriage defined as death of a fetus \<500g or \<20 weeks of gestation |
| Secondary | Placenta Abruption | Participants will be followed from 20+0 weeks of gestation until delivery | Placental abruption (abruptio placentae) is the premature detachment of a normally positioned placenta from the wall of the uterus. |
| Secondary | Premature Rupture of Membranes | Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor | Rupture of the membranes (rupture of the amniotic sac) before the onset of labor. |
| Secondary | Preterm Birth | Participants will be followed from 20+0 weeks to 36+6 weeks of gestation | Birth that occur earlier than 37+0 weeks of gestational age. |
| Secondary | HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count) | Participants will be followed from 20+0 weeks of gestation until delivery | Haemolysis (characteristic peripheral blood smear), Serum LDH \>=600U/L, Serum AST \>=70U/L, Platelet count \<100 x109/L |
| Secondary | Severe Preeclampsia | Participants will be followed from 20+0 weeks of gestation until delivery. | Severe PE: Defined as PE with convulsion or HELLP or delivery \<34 weeks. |
| Secondary | Antenatal Inpatient Length of Stay | Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery | Length of inpatient stay before admission for delivery in days |
| Secondary | Stillbirth | Participants will be followed from 20+0 weeks of gestation up to delivery. | Fetal death defined as death of fetus of at least 500 grams birth weight or, if birth weight is unavailable, a gestational age of at least 20+0 weeks of gestation. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Preeclampsia | Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Maternal Death | Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery) | Participants who completed study and were analyzed for primary outcome | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Spontaneous Abortion | Participants will be followed from randomization until 20+0 weeks of gestation | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Placenta Abruption | Participants will be followed from 20+0 weeks of gestation until delivery | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Premature Rupture of Membranes | Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Preterm Birth | Participants will be followed from 20+0 weeks to 36+6 weeks of gestation | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count) | Participants will be followed from 20+0 weeks of gestation until delivery | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Severe Preeclampsia | Participants will be followed from 20+0 weeks of gestation until delivery. | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antenatal Inpatient Length of Stay | Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | days | MEAN |
| SECONDARY | Stillbirth | Participants will be followed from 20+0 weeks of gestation up to delivery. | A total of 2738 infants were born to women recruited into the trial (1364 in folic acid group and 1374 in placebo group). This is an infant outcome. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Preeclampsia | Folic Acid 4 mg | 169 | Participants | ||
| Preeclampsia | Placebo | 156 | Participants | ||
| Maternal Death | Folic Acid 4 mg | 0 | Participants | ||
| Maternal Death | Placebo | 0 | Participants | ||
| Spontaneous Abortion | Folic Acid 4 mg | 27 | Participants | ||
| Spontaneous Abortion | Placebo | 21 | Participants | ||
| Placenta Abruption | Folic Acid 4 mg | 12 | Participants | ||
| Placenta Abruption | Placebo | 19 | Participants | ||
| Premature Rupture of Membranes | Folic Acid 4 mg | 215 | Participants | ||
| Premature Rupture of Membranes | Placebo | 224 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Folic Acid 4 mg | 1,228 | |
| Overall Study | STARTED | Placebo | 1,236 | |
| Overall Study | COMPLETED | Folic Acid 4 mg | 1,144 | |
| Overall Study | COMPLETED | Placebo | 1,157 | |
| Overall Study | NOT COMPLETED | Folic Acid 4 mg | 84 | |
| Overall Study | NOT COMPLETED | Placebo | 79 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Other AE | Pregnancy, puerperium and perinatal conditions | Folic Acid 4 mg | 961 | 1,227 | |
| other | Other AE | Pregnancy, puerperium and perinatal conditions | Placebo | 968 | 1,236 | |
| serious | Prematurity | Pregnancy, puerperium and perinatal conditions | Folic Acid 4 mg | 29 | 1,227 | |
| serious | Prematurity | Pregnancy, puerperium and perinatal conditions | Placebo | 20 | 1,236 | |
| serious | Hypertension | Pregnancy, puerperium and perinatal conditions | Folic Acid 4 mg | 31 | 1,227 | |
| serious | Hypertension | Pregnancy, puerperium and perinatal conditions | Placebo | 25 | 1,236 | |
| serious | Other SAE | Pregnancy, puerperium and perinatal conditions | Folic Acid 4 mg | 167 | 1,227 | |
| serious | Other SAE | Pregnancy, puerperium and perinatal conditions | Placebo | 150 | 1,236 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Folic Acid 4 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Folic Acid 4 mg | 961 | 1,227 |
| Total, other adverse events | Placebo | 968 | 1,236 |
| Total, serious adverse events | Folic Acid 4 mg | 227 | 1,227 |
| Total, serious adverse events | Placebo | 195 | 1,236 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons24
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Folic Acid 4 mg vs Placebo: Maternal Death | Trial comparisons |
| Folic Acid 4 mg vs Placebo: Neonatal Intensive Care Unit (NICU) Admission | Trial comparisons |
| Folic Acid 4 mg vs Placebo: Intrauterine Growth Restriction (<10th Percentile) | Trial comparisons |
| Folic Acid 4 mg vs Placebo: Necrotising Enterocolitis | Trial comparisons |
| Folic Acid 4 mg vs Placebo: Retinopathy of Prematurity | Trial comparisons |
| Folic Acid 4 mg vs Placebo: Severe Preeclampsia | Trial comparisons |
| Folic Acid 4 mg vs Placebo: Neonatal Death | Trial comparisons |
| Folic Acid 4 mg vs Placebo: HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count) | Trial comparisons |
| Folic Acid 4 mg vs Placebo: Composite Severe Adverse Fetal/Neonatal Outcome | Trial comparisons |
| Folic Acid 4 mg vs Placebo: Premature Rupture of Membranes | Trial comparisons |
1 to 10 of 24
See all 24 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01355159
GET https://conductscience.org/api/trials/v1/NCT01355159/registered?page=2