| Primary | Preeclampsia | 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. | | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks of gestational age until 42 days postpartum (after delivery) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Chi-squared | | 0.37 | | Risk Ratio (RR) | 1.10 | | | 2-Sided | 95 | 0.90 | 1.34 | | | | | Superiority | | |
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| Secondary | Maternal Death | 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. | Participants who completed study and were analyzed for primary outcome | Posted | | Count of Participants | | Participants | | Time Frame: Participants will be followed from 20+0 weeks of gestation until 42 days postpartum (after delivery) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Spontaneous Abortion | Spontaneous abortion or miscarriage defined as death of a fetus <500g or <20 weeks of gestation | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Posted | | Count of Participants | | Participants | | Participants will be followed from randomization until 20+0 weeks of gestation | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Placenta Abruption | Placental abruption (abruptio placentae) is the premature detachment of a normally positioned placenta from the wall of the uterus. | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks of gestation until delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Premature Rupture of Membranes | Rupture of the membranes (rupture of the amniotic sac) before the onset of labor. | | Posted | | Count of Participants | | Participants | | Participants will be followed from randomization (8-16 weeks' completed gestation) until the onset of labor | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
| |
| Secondary | Preterm Birth | Birth that occur earlier than 37+0 weeks of gestational age. | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks to 36+6 weeks of gestation | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
| |
| Secondary | HELLP (Hemolysis, Elevated Liver Enzyme Levels & Low Platelet Count) | Haemolysis (characteristic peripheral blood smear), Serum LDH >=600U/L, Serum AST >=70U/L, Platelet count <100 x109/L | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks of gestation until delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Severe Preeclampsia | Severe PE: Defined as PE with convulsion or HELLP or delivery <34 weeks. | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks of gestation until delivery. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
| |
| Secondary | Antenatal Inpatient Length of Stay | Length of inpatient stay before admission for delivery in days | Not all participants had secondary outcome data. Numbers above reflect those that had information available for this secondary outcome. | Posted | | Mean | Standard Deviation | days | | Participants will be followed from date of randomization (8-16 weeks' completed gestation) until admission for delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Stillbirth | 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. | 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. | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks of gestation up to delivery. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Intrauterine Growth Restriction (<3rd Percentile) | Intrauterine growth restriction is defined as a birth weight less than the 3rd percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks of gestation until delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Placebo | |
|
| Secondary | Intrauterine Growth Restriction (<10th Percentile) | Intrauterine growth restriction is defined as a birth weight less than the 10th percentile of the population, adjusted for sex and gestational age, based on the current population-based Canadian reference standard. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks of gestation until delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Placebo | |
|
| Secondary | Neonatal Death | Neonatal death defined as death of a baby that occurred during first 28 days of life. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Participants will be followed from birth until 28 days of life | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Perinatal Mortality | The perinatal mortality is defined as the number of deaths (fetal deaths and neonatal deaths) of babies ≥ 500 grams birth weight or, if birth weight is unavailable, a gestational age ≥ 20+0 weeks, up to 28 completed days after birth. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Participants will be followed from 20+0 weeks of gestation until 28 days of life. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Placebo | |
|
| Secondary | Retinopathy of Prematurity | Retinopathy of prematurity a retinopathy typically occurring in premature infants treated with high concentrations of oxygen, characterized by vascular dilatation, proliferation, tortuosity, edema, retinal detachment, and fibrous tissue behind the lens confirmed by retinal examination according to an International Committee for the Classification of Retinopathy of Prematurity. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Infants born to the participant will be followed for the duration of hospital stay, or up to 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 |
|
| Secondary | Early Onset Sepsis | Within first 48hr of life, confirmed by positive blood or cerebrospinal fluid cultures | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Infants born to the participants will be followed first 48 hours of life. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Necrotising Enterocolitis | Necrotizing enterocolitis (NEC) according to modified Bell's criteria stage 2 or higher (grossly bloody stool, plus absent bowel sounds with or without abdominal tenderness and radiographic findings such as intestinal dilation, ileus, pneumatosis intestinalis), excluding isolated spontaneous intestinal perforations. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Infants borm to the participants will be followed for the duration of hospital stay, or up to 6 weeks. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| Secondary | Intraventricular Hemorrhage (IVH) |
- IVH Grade 1(Blood in germinal matrix)
- IVH Grade 2 (Blood in germinal matrix and extending into the ventricles)
- IVH Grade 3 (Ventricular enlargement)
- IVH Grade 4 (Intraparenchymal lesion)
| 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Time Frame: Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Placebo | |
|
| Secondary | Ventilation | Ventilatory support after initial resuscitation, with/without intubation. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Infants born to the participants will be followed for the duration of hospital stay, or up to 6 weeks. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
|
| Secondary | Need for Oxygen at 28 Days | | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Infants to the participants will be followed for 28 days after birth. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
| |
| Secondary | Composite Severe Adverse Fetal/Neonatal Outcome | Composite outcome included any of retinopathy of prematurity, periventricular leukomacia, early onset sepsis, necrotizing enterocolitis, intraventricular haemorrhage, ventilation. Need for O2at 28 days, NICU admission | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Outcomes included in the composite outcome were measured for each of their respective time frames, up to 6-weeks after birth | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Placebo |
|
| Secondary | Length of Stay in 'High Level' Neonatal Care Unit | | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Mean | Standard Deviation | days | | Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks. | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
| |
| Secondary | Neonatal Death | Neonatal death defined as death of the infant occurred before 28 days of life | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Infants to the participants will be followed for 28 days after birth. | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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| Secondary | Periventricular Leukomalacia | One of the two outcomes used to measure neonatal morbidity. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Infants to the participants were followed for 28 days after birth. | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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| Secondary | Neonatal Intensive Care Unit (NICU) Admission | This outcome measured whether or not the infant was admitted into the NICU. | 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. Some participants had missing data for this outcome and therefore were excluded from this analysis. | Posted | | Count of Participants | | Participants | | Infants to the participants will be followed for the duration of hospital stay, or up to 6 weeks. | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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