Trial Outcomes & Findings for Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS) (NCT NCT00135707)
NCT ID: NCT00135707
Last Updated: 2019-02-21
Results Overview
Severe hypertension (blood pressure \[BP\]\>= 160/110) or mild hypertension (BP\>= 140/90) \>= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10154 participants
Primary outcome timeframe
20 weeks through discharge following delivery
Results posted on
2019-02-21
Participant Flow
The trial was conducted from July 2003 through February 2008 at the 16 clinical centers and the independent data coordinating center of the MFMU Network. Gestational age at randomization was between 9 weeks 0 days and 16 weeks 6 days. Women were eligible for inclusion if they had not had a previous pregnancy that lasted beyond 19 weeks 6 days.
Women who were no more than 15 weeks pregnant and who consented to participate in the study were given a supply of placebo and asked to return within 2 weeks. Those who returned, who had taken at least 50% of the placebo they were supposed to have taken, and who still met the eligibility criteria were randomly assigned to receive study drug.
Participant milestones
| Measure |
Vitamins
Vitamins C \& E
|
Placebo
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Overall Study
STARTED
|
5088
|
5066
|
|
Overall Study
COMPLETED
|
4993
|
4976
|
|
Overall Study
NOT COMPLETED
|
95
|
90
|
Reasons for withdrawal
| Measure |
Vitamins
Vitamins C \& E
|
Placebo
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
94
|
89
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Institutional review board request
|
1
|
0
|
Baseline Characteristics
Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
Baseline characteristics by cohort
| Measure |
Daily Vitamin Supplements
n=5087 Participants
1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery.
|
Placebo for Vitamins C and E
n=5065 Participants
Placebo capsules consisting of Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell, twice daily between randomization (at 9 to 16 weks) up to delivery.
|
Total
n=10152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.5 years
STANDARD_DEVIATION 5.2 • n=39 Participants
|
23.5 years
STANDARD_DEVIATION 5.2 • n=41 Participants
|
23.5 years
STANDARD_DEVIATION 5.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
5087 Participants
n=39 Participants
|
5065 Participants
n=41 Participants
|
10152 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black
|
1268 Participants
n=39 Participants
|
1295 Participants
n=41 Participants
|
2563 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1602 Participants
n=39 Participants
|
1566 Participants
n=41 Participants
|
3168 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
2217 Participants
n=39 Participants
|
2204 Participants
n=41 Participants
|
4421 Participants
n=35 Participants
|
|
Week of pregnancy at randomization
|
13.4 weeks
STANDARD_DEVIATION 2.1 • n=39 Participants
|
13.4 weeks
STANDARD_DEVIATION 2.1 • n=41 Participants
|
13.4 weeks
STANDARD_DEVIATION 2.1 • n=35 Participants
|
|
<13th week of pregnancy at randomization
|
2227 Participants
n=39 Participants
|
2203 Participants
n=41 Participants
|
4430 Participants
n=35 Participants
|
|
Prepregnancy body-mass index
|
25.4 kg/m2
STANDARD_DEVIATION 6.0 • n=39 Participants
|
25.4 kg/m2
STANDARD_DEVIATION 5.9 • n=41 Participants
|
25.4 kg/m2
STANDARD_DEVIATION 6.0 • n=35 Participants
|
|
Smoker
|
812 Participants
n=39 Participants
|
781 Participants
n=41 Participants
|
1593 Participants
n=35 Participants
|
|
Educational level
|
12.8 year
STANDARD_DEVIATION 2.7 • n=39 Participants
|
12.8 year
STANDARD_DEVIATION 2.7 • n=41 Participants
|
12.8 year
STANDARD_DEVIATION 2.7 • n=35 Participants
|
|
Use of prenatal vitamins or multivitamins
|
3903 Participants
n=39 Participants
|
3889 Participants
n=41 Participants
|
7792 Participants
n=35 Participants
|
|
Daily dose of vitamin C
|
120 mg
n=39 Participants
|
100 mg
n=41 Participants
|
100 mg
n=35 Participants
|
|
Daily dose of vitamin E
|
22 IU
n=39 Participants
|
22 IU
n=41 Participants
|
22 IU
n=35 Participants
|
|
Previous pregnancy
|
1161 Participants
n=39 Participants
|
1170 Participants
n=41 Participants
|
2331 Participants
n=35 Participants
|
|
Family history of preeclampsia
|
650 Participants
n=39 Participants
|
674 Participants
n=41 Participants
|
1324 Participants
n=35 Participants
|
|
Blood pressure
Systolic
|
109 mm Hg
STANDARD_DEVIATION 10 • n=39 Participants
|
109 mm Hg
STANDARD_DEVIATION 10 • n=41 Participants
|
109 mm Hg
STANDARD_DEVIATION 9.1 • n=35 Participants
|
|
Blood pressure
Diastolic
|
66 mm Hg
STANDARD_DEVIATION 8 • n=39 Participants
|
65 mm Hg
STANDARD_DEVIATION 8 • n=41 Participants
|
65 mm Hg
STANDARD_DEVIATION 6.6 • n=35 Participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge following deliveryPopulation: The analysis was intent to treat.
Severe hypertension (blood pressure \[BP\]\>= 160/110) or mild hypertension (BP\>= 140/90) \>= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate
|
305 Participants
|
285 Participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge following deliveryIncluded here are women who had severe hypertension only and those who had severe hypertension with elevated liver enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or fetal death after 20 weeks of gestation, or neonatal death.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Severe Hypertension
|
210 Participants
|
204 Participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge following deliveryElevated liver enzyme levels are specified as an aspartate aminotransferase level of \>= 100 U per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels
|
26 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge following deliveryThrombocytopenia defined as a platelet count of \<100,000 per cubic millimeter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia
|
21 participants
|
31 participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge following deliveryElevated serum creatinine defined as ≥1.5 mg per deciliter or 132.6 μmol per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level
|
7 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge following deliveryWomen who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure
|
10 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge following deliveryWomen who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders
|
13 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge following deliveryWomen who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the 3rd Percentile) Adjusted for Sex and Race or Ethnic Group
|
60 Participants
|
46 Participants
|
PRIMARY outcome
Timeframe: 20 weeks through discharge or prior to discharge following delivery admissionWomen who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 20 weeks through discharge following deliveryHELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)
Total Preeclampsia
|
358 Participants
|
332 Participants
|
|
Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)
Mild Preeclampsia
|
212 Participants
|
191 Participants
|
|
Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)
Severe Preeclampsia
|
134 Participants
|
129 Participants
|
|
Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)
HELLP Syndrome
|
2 Participants
|
8 Participants
|
|
Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)
Eclampsia
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 20 weeks through discharge following deliveryOutcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Pregnancy Associated Hypertension
|
1457 Participants
|
1322 Participants
|
SECONDARY outcome
Timeframe: 20 weeks through discharge following deliveryOutcome measures
| Measure |
Vitamins
n=4952 Participants
Vitamins C \& E
|
Placebo
n=4934 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Medically Indicated Delivery Because of Hypertension
|
509 Participants
|
473 Participants
|
SECONDARY outcome
Timeframe: 20 weeks through dischargeOutcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Aspartate Aminotransferase ≥100 U/Liter
|
35 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: 20 weeks through dischargeOutcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Creatinine ≥1.5 mg/dl (133 μmol/Liter)
|
9 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: During pregnancyOutcome measures
| Measure |
Vitamins
n=4956 Participants
Vitamins C \& E
|
Placebo
n=4937 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Antepartum Bleeding
|
56 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: During pregnancyOutcome measures
| Measure |
Vitamins
n=4934 Participants
Vitamins C \& E
|
Placebo
n=4923 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Premature Rupture of Membranes
|
124 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: During pregnancyOutcome measures
| Measure |
Vitamins
n=4957 Participants
Vitamins C \& E
|
Placebo
n=4938 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Placental Abruption
|
24 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: DeliveryOutcome measures
| Measure |
Vitamins
n=4958 Participants
Vitamins C \& E
|
Placebo
n=4940 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Cesarean Delivery
|
1269 Participants
|
1224 Participants
|
SECONDARY outcome
Timeframe: Delivery through hospital dischargePopulation: One maternal death in each group due to peripartum cardiomyopathy.
Outcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Maternal Death
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: After delivery through dischargeOutcome measures
| Measure |
Vitamins
n=4951 Participants
Vitamins C \& E
|
Placebo
n=4926 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Postpartum Pulmonary Edema
|
3 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Delivery admission to dischargeOutcome measures
| Measure |
Vitamins
n=4954 Participants
Vitamins C \& E
|
Placebo
n=4927 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Hematocrit ≤24% With Transfusion
|
40 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Delivery through dischargeOutcome measures
| Measure |
Vitamins
n=4952 Participants
Vitamins C \& E
|
Placebo
n=4935 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Maternal Hospital Stay
|
2.0 days
Interval 2.0 to 3.0
|
2.0 days
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: DeliveryOutcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Gestational Age at Delivery
|
38.9 weeks
Standard Deviation 3.5
|
38.8 weeks
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: DeliveryOutcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Preterm Birth
<37 weeks' gestation
|
513 Participants
|
526 Participants
|
|
Preterm Birth
<32 weeks' gestation
|
149 Participants
|
173 Participants
|
SECONDARY outcome
Timeframe: During pregnancy or thorugh dischargeOutcome measures
| Measure |
Vitamins
n=4993 Participants
Vitamins C \& E
|
Placebo
n=4976 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Fetal or Neonatal Death
All Fetal or Neonatal Deaths
|
113 Participants
|
122 Participants
|
|
Fetal or Neonatal Death
Fetal loss at < 20 weeks
|
55 Participants
|
59 Participants
|
|
Fetal or Neonatal Death
Fetal death at ≥20 weeks
|
38 Participants
|
36 Participants
|
|
Fetal or Neonatal Death
Neonatal death
|
20 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: Liveborn infants
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Birth Weight
|
3247 grams
Standard Deviation 575
|
3244 grams
Standard Deviation 581
|
SECONDARY outcome
Timeframe: At birthPopulation: Live born infants
A baby whose birth weight is less than the 3rd percentile is considered to be small for gestational age (adjusted for sex and race or ethnic group)
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Small for Gestational Age
|
133 Participants
|
132 Participants
|
SECONDARY outcome
Timeframe: At birthPopulation: Live born infants
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Birth Weight <2500 Grams
|
345 Participants
|
369 Participants
|
SECONDARY outcome
Timeframe: Delivery through dischargePopulation: Live born infants
NICU denotes neonatal intensive care unit.
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Admission to NICU
|
577 Participants
|
557 Participants
|
SECONDARY outcome
Timeframe: Delivery through dischargePopulation: Live born infants
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Respiratory Distress Syndrome
|
150 Participants
|
144 Participants
|
SECONDARY outcome
Timeframe: Delivery through dischargePopulation: Live born infants
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Intraventricular Hemorrhage, Grade III or IV
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Delivery through dischargePopulation: Live born infants
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Sepsis
|
30 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Delivery through dischargePopulation: Live born infants
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Necrotizing Enterocolitis
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Within 1 month of birthPopulation: Live born infants
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Retinopathy of Prematurity
|
19 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: At birthOutcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Apgar Score <=3 at 5 Minutes
|
23 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Birth through discharge from hospitalPopulation: Live born infants
Outcome measures
| Measure |
Vitamins
n=4900 Participants
Vitamins C \& E
|
Placebo
n=4881 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Neonatal Hospital Stay
|
2.0 days
Interval 2.0 to 3.0
|
2.0 days
Interval 2.0 to 3.0
|
POST_HOC outcome
Timeframe: During pregnancySubgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized on or after the 13th week of pregnancy.
Outcome measures
| Measure |
Vitamins
n=2812 Participants
Vitamins C \& E
|
Placebo
n=2814 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Analysis of Primary Composite Outcome in Participants Randomized on or After the 13th Week of Pregnancy
|
161 Participants
|
158 Participants
|
POST_HOC outcome
Timeframe: During pregnancySubgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized before the 13th week of pregnancy.
Outcome measures
| Measure |
Vitamins
n=2181 Participants
Vitamins C \& E
|
Placebo
n=2162 Participants
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Analysis of Primary Composite Outcome in Participants Randomized Before the 13th Week of Pregnancy
|
144 Participants
|
127 Participants
|
Adverse Events
Vitamins
Serious events: 108 serious events
Other events: 0 other events
Deaths: 1 deaths
Placebo
Serious events: 173 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vitamins
n=5087 participants at risk
Vitamins C \& E
|
Placebo
n=5065 participants at risk
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
|
|---|---|---|
|
Cardiac disorders
Peripartum Cardiomyopathy
|
0.02%
1/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.02%
1/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal Death
|
0.88%
45/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
1.9%
95/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Pregnancy, puerperium and perinatal conditions
Bleeding
|
0.18%
9/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.14%
7/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Renal and urinary disorders
Renal and Urinary disorders
|
0.08%
4/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.18%
9/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Pregnancy, puerperium and perinatal conditions
Hemorrhage
|
0.08%
4/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.10%
5/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Infections and infestations
Infection
|
0.10%
5/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.04%
2/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress/pneumonia
|
0.02%
1/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.02%
1/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Respiratory, thoracic and mediastinal disorders
DVT/PE
|
0.04%
2/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.02%
1/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Surgical and medical procedures
Colon resection
|
0.02%
1/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.00%
0/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Blood and lymphatic system disorders
Hodgkin's disease
|
0.02%
1/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.00%
0/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.02%
1/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Congenital, familial and genetic disorders
Fetal birth defects
|
0.12%
6/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.41%
21/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Congenital, familial and genetic disorders
Fetal atrial flutter/arrythmia/bradycardia
|
0.04%
2/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.02%
1/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
General disorders
Neonatal death
|
0.39%
20/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.53%
27/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Nervous system disorders
Infant Seizures
|
0.04%
2/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.00%
0/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Injury, poisoning and procedural complications
Birth injury
|
0.02%
1/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.02%
1/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Blood and lymphatic system disorders
Infant low platelet count
|
0.02%
1/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.00%
0/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infant - Soft Tissue Mass
|
0.02%
1/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.00%
0/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Musculoskeletal and connective tissue disorders
Umbilical hernia
|
0.00%
0/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.02%
1/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
|
Nervous system disorders
Hypoxic Events
|
0.04%
2/5087 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
0.00%
0/5065 • Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. James Roberts
Dept of Obstetrics and Gynecology, University of Pittsburgh
Phone: 412-641-1427
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60