CClinicalTrials.gg
Sign In
CompletedNCT00135707CAPPSUpdated Feb 21, 2019Results posted

Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)

A Phase 3 interventional study of Dietary Supplement/Vitamins and Placebo for Vitamin C and Vitamin E in Preeclampsia, sponsored by The George Washington University Biostatistics Center. Completed at 16 sites in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-21.

Sponsored by The George Washington University Biostatistics Center · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
10,154
Allocation
Randomized
Sex
Female
01

Study summary

Preeclampsia is one of the most common complications of pregnancy and is characterized by high blood pressure and protein in the urine. This can cause problems in the second half of pregnancy for both the mother and fetus. This study of preeclampsia consists of two parts: 1) a randomized, placebo controlled, multicenter clinical trial of 10,000 low-risk nulliparous women between 9 and 16 weeks gestation and 2) an observational, cohort study of 4,000 patients between 9 and 12 weeks gestation who are also enrolled in the trial.

Subjects in both parts will receive either 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo daily. The purpose of the randomized, clinical trial is to find out if high doses of vitamin C and E will reduce the risk of preeclampsia and other problems associated with the disease. The study will also evaluate the safety of antioxidant therapy for mother and infant. Patients will be seen monthly to receive their supply of study drug, to have weight and blood pressure recorded, to have urine protein measured, and to assess any side effects. At two visits, blood and urine will be collected.

The observational, cohort study will prospectively measure potential biochemical and biophysical markers that might predict preeclampsia. These patients will have additional procedures including uterine artery Doppler and blood drawn for a complete blood count (CBC).

Read the detailed description

A Randomized, Clinical Trial of Antioxidants to Prevent Preeclampsia:

Preeclampsia is the leading cause of maternal morbidity, as well as perinatal morbidity and mortality. Once the diagnosis has been established, therapy other than delivery has not been successful except to prolong pregnancy minimally (at some risk to mother and infant). Prevention efforts to reduce or eliminate preeclampsia are directed at the pathophysiology of the disorder prior to clinically evident preeclampsia and before irreversible changes have occurred.

This double-masked, placebo-controlled trial of 10,000 subjects is designed to evaluate the effects of antioxidant therapy in preventing serious complications associated with pregnancy-related hypertension in low risk, nulliparous women who begin treatment at 9-16 weeks gestation. The hypothesis being tested is that antioxidant therapy initiated prior to 16 weeks gestation will reduce the frequency of serious maternal and infant complications associated with pregnancy-related hypertension.

After randomization, subjects will receive either 1000 mg of vitamin C and 400 IU of vitamin E or matching placebo daily. They will be seen for monthly pill counts and to assess side effects, weight, blood pressure, and urine for protein. Blood and urine are collected at 24 and 32 weeks' gestation.

An Observational Cohort Study to Predict Preeclampsia:

A prospective, cohort study has been designed to complement the randomized, controlled, trial (RCT) and will test various biochemical and biophysical markers for ability to predict preeclampsia in 4,000 of the women who are enrolled in the RCT and are between 9 and 12 weeks gestation. These subjects will have additional procedures including a CBC and uterine artery Doppler.

02

Conditions studied

  • Preeclampsia

Browse trials for

Keywords

  • Antioxidants
  • Preeclampsia
  • Pregnancy
  • Hypertension
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 10,154 is above the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

The George Washington University Biostatistics Center is the lead sponsor of 25 studies on the registry; 3 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

RCT Inclusion Criteria:

  • Gestational age 9 -16 weeks
  • Singleton pregnancy
  • Nulliparous

Observational Inclusion Criteria:

  • Women randomized to the RCT
  • Gestational age 9 - 12 wks

Exclusion Criteria RCT and Observational:

  • BP >= 135/85
  • Proteinuria
  • History or current use of anti-hypertensive medication or diuretics
  • Use of vitamins C > 150 mg and/or E > 75 IU per day
  • Pregestational diabetes
  • Current pregnancy is a result of in vitro fertilization
  • Regular use of platelet active drugs or non-steroidal anti-inflammatory drugs (NSAIDS)
  • Known fetal abnormalities
  • Documented uterine bleeding within a week of screening
  • Uterine malformations
  • History of medical complications
  • Illicit drug or alcohol abuse during current pregnancy
  • Intent to deliver elsewhere
  • Participating in another interventional study
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
10,154 participants (actual)

Study arms

  • Experimental
    Dietary Supplement/Vitamins

    1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery.

    Drug: Dietary Supplement/Vitamins

  • Placebo comparator
    Placebo for Vitamin C and Vitamin E

    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.

    Drug: Placebo for Vitamin C and Vitamin E

Interventions

  • DrugDietary Supplement/Vitamins

    Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

    Also known as: Ascorbic Acid and d-alpha-Tocopheryl Acetate

  • DrugPlacebo for Vitamin C and Vitamin E

    Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

06

What researchers measure

Primary outcomes

  1. Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate

    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

    Time frame: 20 weeks through discharge following delivery

  2. Severe Hypertension

    Included 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.

    Time frame: 20 weeks through discharge following delivery

  3. Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels

    Elevated 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.

    Time frame: 20 weeks through discharge following delivery

  4. Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia

    Thrombocytopenia 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.

    Time frame: 20 weeks through discharge following delivery

  5. Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level

    Elevated 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.

    Time frame: 20 weeks through discharge following delivery

  6. Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure

    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.

    Time frame: 20 weeks through discharge following delivery

  7. Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders

    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.

    Time frame: 20 weeks through discharge following delivery

  8. 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

    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.

    Time frame: 20 weeks through discharge following delivery

  9. Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death

    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.

    Time frame: 20 weeks through discharge or prior to discharge following delivery admission

Secondary outcomes

  1. Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)

    HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.

    Time frame: 20 weeks through discharge following delivery

  2. Pregnancy Associated Hypertension

    Time frame: 20 weeks through discharge following delivery

  3. Medically Indicated Delivery Because of Hypertension

    Time frame: 20 weeks through discharge following delivery

  4. Aspartate Aminotransferase ≥100 U/Liter

    Time frame: 20 weeks through discharge

  5. Creatinine ≥1.5 mg/dl (133 μmol/Liter)

    Time frame: 20 weeks through discharge

  6. Antepartum Bleeding

    Time frame: During pregnancy

  7. Premature Rupture of Membranes

    Time frame: During pregnancy

  8. Placental Abruption

    Time frame: During pregnancy

  9. Cesarean Delivery

    Time frame: Delivery

  10. Maternal Death

    Time frame: Delivery through hospital discharge

  11. Postpartum Pulmonary Edema

    Time frame: After delivery through discharge

  12. Hematocrit ≤24% With Transfusion

    Time frame: Delivery admission to discharge

  13. Maternal Hospital Stay

    Time frame: Delivery through discharge

  14. Gestational Age at Delivery

    Time frame: Delivery

  15. Preterm Birth

    Time frame: Delivery

  16. Fetal or Neonatal Death

    Time frame: During pregnancy or thorugh discharge

  17. Birth Weight

    Time frame: At birth

  18. Small for Gestational Age

    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)

    Time frame: At birth

  19. Birth Weight <2500 Grams

    Time frame: At birth

  20. Admission to NICU

    NICU denotes neonatal intensive care unit.

    Time frame: Delivery through discharge

  21. Respiratory Distress Syndrome

    Time frame: Delivery through discharge

  22. Intraventricular Hemorrhage, Grade III or IV

    Time frame: Delivery through discharge

  23. Sepsis

    Time frame: Delivery through discharge

  24. Necrotizing Enterocolitis

    Time frame: Delivery through discharge

  25. Retinopathy of Prematurity

    Time frame: Within 1 month of birth

  26. Apgar Score <=3 at 5 Minutes

    Time frame: At birth

  27. Neonatal Hospital Stay

    Time frame: Birth through discharge from hospital

07

Results

Posted Nov 20, 2018

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.

Participant flow — Overall Study
MilestoneVitaminsPlacebo
Started50885066
Completed49934976
Not completed9590
Withdrew: Lost to follow-up9489
Withdrew: Withdrawal by subject01
Withdrew: Institutional review board request10

Outcome measures

PrimaryComposite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate

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

Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate
ParticipantsVitaminsPlacebo
Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate305285
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.42 · Risk ratio (rr): 1.07 · 95% CI 0.91 to 1.25
PrimarySevere Hypertension

Included 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.

Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Severe Hypertension
ParticipantsVitaminsPlacebo
Severe Hypertension210204
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.79 · Risk ratio (rr): 1.03 · 95% CI 0.85 to 1.24
PrimarySevere or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels

Elevated 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.

Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels
ParticipantsVitaminsPlacebo
Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels2633
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.35 · Risk ratio (rr): 0.79 · 95% CI 0.47 to 1.31
PrimarySevere or Mild Pregnancy-associated Hypertension With Thrombocytopenia

Thrombocytopenia 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.

Time frame:
20 weeks through discharge following delivery
Reported as:
Number · participants
Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia
participantsVitaminsPlacebo
Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia2131
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.16 · Risk ratio (rr): 0.68 · 95% CI 0.39 to 1.17
PrimarySevere or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level

Elevated 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.

Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level
ParticipantsVitaminsPlacebo
Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level711
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.34 · Risk ratio (rr): 0.63 · 95% CI 0.25 to 1.63
PrimarySevere or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure

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.

Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure
ParticipantsVitaminsPlacebo
Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure104
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.11 · Risk ratio (rr): 2.49 · 95% CI 0.78 to 7.94
PrimarySevere or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders

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.

Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders
ParticipantsVitaminsPlacebo
Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders1316
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.57 · Risk ratio (rr): 0.81 · 95% CI 0.39 to 1.68
PrimarySevere 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

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.

Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
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
ParticipantsVitaminsPlacebo
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 Group6046
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.18 · Risk ratio (rr): 1.30 · 95% CI 0.89 to 1.90
PrimarySevere or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death

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.

Time frame:
20 weeks through discharge or prior to discharge following delivery admission
Reported as:
Count of participants · Participants
Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death
ParticipantsVitaminsPlacebo
Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death1211
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.84 · Risk ratio (rr): 1.09 · 95% CI 0.48 to 2.46
SecondaryPreeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)

HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.

Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)
ParticipantsVitaminsPlacebo
Total Preeclampsia358332
Mild Preeclampsia212191
Severe Preeclampsia134129
HELLP Syndrome28
Eclampsia104
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.33 · Risk ratio (rr): 1.07 · 95% CI 0.93 to 1.24
SecondaryPregnancy Associated Hypertension
Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Pregnancy Associated Hypertension
ParticipantsVitaminsPlacebo
Pregnancy Associated Hypertension14571322
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.004 · Risk ratio (rr): 1.10 · 95% CI 1.03 to 1.17
SecondaryMedically Indicated Delivery Because of Hypertension
Time frame:
20 weeks through discharge following delivery
Reported as:
Count of participants · Participants
Medically Indicated Delivery Because of Hypertension
ParticipantsVitaminsPlacebo
Medically Indicated Delivery Because of Hypertension509473
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.25 · Risk ratio (rr): 1.07 · 95% CI 0.95 to 1.21
SecondaryAspartate Aminotransferase ≥100 U/Liter
Time frame:
20 weeks through discharge
Reported as:
Count of participants · Participants
Aspartate Aminotransferase ≥100 U/Liter
ParticipantsVitaminsPlacebo
Aspartate Aminotransferase ≥100 U/Liter3548
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.15 · Risk ratio (rr): 0.73 · 95% CI 0.47 to 1.12
SecondaryCreatinine ≥1.5 mg/dl (133 μmol/Liter)
Time frame:
20 weeks through discharge
Reported as:
Count of participants · Participants
Creatinine ≥1.5 mg/dl (133 μmol/Liter)
ParticipantsVitaminsPlacebo
Creatinine ≥1.5 mg/dl (133 μmol/Liter)912
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.51 · Risk ratio (rr): 0.75 · 95% CI 0.32 to 1.77
SecondaryAntepartum Bleeding
Time frame:
During pregnancy
Reported as:
Count of participants · Participants
Antepartum Bleeding
ParticipantsVitaminsPlacebo
Antepartum Bleeding5646
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.33 · Risk ratio (rr): 1.21 · 95% CI 0.82 to 1.79
SecondaryPremature Rupture of Membranes
Time frame:
During pregnancy
Reported as:
Count of participants · Participants
Premature Rupture of Membranes
ParticipantsVitaminsPlacebo
Premature Rupture of Membranes124129
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.74 · Risk ratio (rr): 0.96 · 95% CI 0.75 to 1.22
SecondaryPlacental Abruption
Time frame:
During pregnancy
Reported as:
Count of participants · Participants
Placental Abruption
ParticipantsVitaminsPlacebo
Placental Abruption2436
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.12 · Risk ratio (rr): 0.66 · 95% CI 0.40 to 1.11
SecondaryCesarean Delivery
Time frame:
Delivery
Reported as:
Count of participants · Participants
Cesarean Delivery
ParticipantsVitaminsPlacebo
Cesarean Delivery12691224
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.35 · Risk ratio (rr): 1.03 · 95% CI 0.97 to 1.11
SecondaryMaternal Death
Time frame:
Delivery through hospital discharge
Reported as:
Count of participants · Participants
Maternal Death
ParticipantsDietary Supplement/VitaminsPlacebo for Vitamin C and Vitamin E
Maternal Death11
SecondaryPostpartum Pulmonary Edema
Time frame:
After delivery through discharge
Reported as:
Count of participants · Participants
Postpartum Pulmonary Edema
ParticipantsVitaminsPlacebo
Postpartum Pulmonary Edema310
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.05 · Risk ratio (rr): 0.30 · 95% CI 0.08 to 1.08
SecondaryHematocrit ≤24% With Transfusion
Time frame:
Delivery admission to discharge
Reported as:
Count of participants · Participants
Hematocrit ≤24% With Transfusion
ParticipantsVitaminsPlacebo
Hematocrit ≤24% With Transfusion4059
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.05 · Risk ratio (rr): 0.67 · 95% CI 0.45 to 1.01
SecondaryMaternal Hospital Stay
Time frame:
Delivery through discharge
Reported as:
Median · days
Maternal Hospital Stay
daysVitaminsPlacebo
Maternal Hospital Stay2.0 (2.0 to 3.0)2.0 (2.0 to 3.0)
Statistical analysis
  • Vitamins vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.65
SecondaryGestational Age at Delivery
Time frame:
Delivery
Reported as:
Median · weeks
Gestational Age at Delivery
weeksVitaminsPlacebo
Gestational Age at Delivery38.9 ± 3.538.8 ± 3.5
Statistical analysis
  • Vitamins vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.21
SecondaryPreterm Birth
Time frame:
Delivery
Reported as:
Count of participants · Participants
Preterm Birth
ParticipantsVitaminsPlacebo
<37 weeks' gestation513526
<32 weeks' gestation149173
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.63 · Risk ratio (rr): 0.97 · 95% CI 0.87 to 1.09
  • Vitamins vs Placebo · Chi-squared · p = 0.16 · Risk ratio (rr): 0.86 · 95% CI 0.69 to 1.06
SecondaryFetal or Neonatal Death
Time frame:
During pregnancy or thorugh discharge
Reported as:
Count of participants · Participants
Fetal or Neonatal Death
ParticipantsVitaminsPlacebo
All Fetal or Neonatal Deaths113122
Fetal loss at < 20 weeks5559
Fetal death at ≥20 weeks3836
Neonatal death2027
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.53 · Risk ratio (rr): 0.92 · 95% CI 0.72 to 1.19
SecondaryBirth Weight
Time frame:
At birth
Reported as:
Mean · grams
Birth Weight
gramsVitaminsPlacebo
Birth Weight3247 ± 5753244 ± 581
Statistical analysis
  • Vitamins vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.55
SecondarySmall for Gestational Age

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)

Time frame:
At birth
Reported as:
Count of participants · Participants
Small for Gestational Age
ParticipantsVitaminsPlacebo
Small for Gestational Age133132
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.98 · Risk ratio (rr): 1.00 · 95% CI 0.79 to 1.27
SecondaryBirth Weight <2500 Grams
Time frame:
At birth
Reported as:
Count of participants · Participants
Birth Weight <2500 Grams
ParticipantsVitaminsPlacebo
Birth Weight <2500 Grams345369
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.32 · Risk ratio (rr): 0.93 · 95% CI 0.81 to 1.07
SecondaryAdmission to NICU

NICU denotes neonatal intensive care unit.

Time frame:
Delivery through discharge
Reported as:
Count of participants · Participants
Admission to NICU
ParticipantsVitaminsPlacebo
Admission to NICU577557
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.58 · Risk ratio (rr): 1.03 · 95% CI 0.92 to 1.15
SecondaryRespiratory Distress Syndrome
Time frame:
Delivery through discharge
Reported as:
Count of participants · Participants
Respiratory Distress Syndrome
ParticipantsVitaminsPlacebo
Respiratory Distress Syndrome150144
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.75 · Risk ratio (rr): 1.04 · 95% CI 0.83 to 1.30
SecondaryIntraventricular Hemorrhage, Grade III or IV
Time frame:
Delivery through discharge
Reported as:
Count of participants · Participants
Intraventricular Hemorrhage, Grade III or IV
ParticipantsVitaminsPlacebo
Intraventricular Hemorrhage, Grade III or IV67
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.78 · Risk ratio (rr): 0.85 · 95% CI 0.29 to 2.54
SecondarySepsis
Time frame:
Delivery through discharge
Reported as:
Count of participants · Participants
Sepsis
ParticipantsVitaminsPlacebo
Sepsis3023
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.34 · Risk ratio (rr): 1.30 · 95% CI 0.76 to 2.23
SecondaryNecrotizing Enterocolitis
Time frame:
Delivery through discharge
Reported as:
Count of participants · Participants
Necrotizing Enterocolitis
ParticipantsVitaminsPlacebo
Necrotizing Enterocolitis1014
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.41 · Risk ratio (rr): 0.71 · 95% CI 0.32 to 1.60
SecondaryRetinopathy of Prematurity
Time frame:
Within 1 month of birth
Reported as:
Count of participants · Participants
Retinopathy of Prematurity
ParticipantsVitaminsPlacebo
Retinopathy of Prematurity1916
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.62 · Risk ratio (rr): 1.18 · 95% CI 0.61 to 2.30
SecondaryApgar Score <=3 at 5 Minutes
Time frame:
At birth
Reported as:
Number · participants
Apgar Score <=3 at 5 Minutes
participantsVitaminsPlacebo
Apgar Score <=3 at 5 Minutes2327
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.56 · Risk ratio (rr): 0.85 · 95% CI 0.49 to 1.48
SecondaryNeonatal Hospital Stay
Time frame:
Birth through discharge from hospital
Reported as:
Median · days
Neonatal Hospital Stay
daysVitaminsPlacebo
Neonatal Hospital Stay2.0 (2.0 to 3.0)2.0 (2.0 to 3.0)
Statistical analysis
  • Vitamins vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.79
Post-hocAnalysis of Primary Composite Outcome in Participants Randomized on or After the 13th Week of Pregnancy

Subgroup 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.

Time frame:
During pregnancy
Reported as:
Count of participants · Participants
Analysis of Primary Composite Outcome in Participants Randomized on or After the 13th Week of Pregnancy
ParticipantsVitaminsPlacebo
Analysis of Primary Composite Outcome in Participants Randomized on or After the 13th Week of Pregnancy161158
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.86 · Risk ratio (rr): 1.02 · 95% CI 0.82 to 1.26
Post-hocAnalysis of Primary Composite Outcome in Participants Randomized Before the 13th Week of Pregnancy

Subgroup 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.

Time frame:
During pregnancy
Reported as:
Count of participants · Participants
Analysis of Primary Composite Outcome in Participants Randomized Before the 13th Week of Pregnancy
ParticipantsVitaminsPlacebo
Analysis of Primary Composite Outcome in Participants Randomized Before the 13th Week of Pregnancy144127
Statistical analysis
  • Vitamins vs Placebo · Chi-squared · p = 0.32 · Risk ratio (rr): 1.12 · 95% CI 0.89 to 1.42

Adverse events

Collected over 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.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vitamins1/5,087 (0%)108/5,087 (2.1%)0/5,087 (0%)
Placebo1/5,065 (0%)173/5,065 (3.4%)0/5,065 (0%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventVitaminsPlacebo
Fetal DeathPregnancy, puerperium and perinatal conditions45/508795/5065
Neonatal deathGeneral disorders20/508727/5065
Fetal birth defectsCongenital, familial and genetic disorders6/508721/5065
Renal and Urinary disordersRenal and urinary disorders4/50879/5065
BleedingPregnancy, puerperium and perinatal conditions9/50877/5065
HemorrhagePregnancy, puerperium and perinatal conditions4/50875/5065
InfectionInfections and infestations5/50872/5065
DVT/PERespiratory, thoracic and mediastinal disorders2/50871/5065
Fetal atrial flutter/arrythmia/bradycardiaCongenital, familial and genetic disorders2/50871/5065
Infant SeizuresNervous system disorders2/50870/5065

Baseline characteristics

Age, Continuous
Age, Continuous(years)Daily Vitamin SupplementsPlacebo for Vitamins C and ETotal
Mean23.5 ± 5.223.5 ± 5.223.5 ± 5.2
Sex: Female, Male
Sex: Female, Male(Participants)Daily Vitamin SupplementsPlacebo for Vitamins C and ETotal
Female5087506510152
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Daily Vitamin SupplementsPlacebo for Vitamins C and ETotal
Black126812952563
Hispanic160215663168
Other221722044421
Week of pregnancy at randomization
Week of pregnancy at randomization(weeks)Daily Vitamin SupplementsPlacebo for Vitamins C and ETotal
Mean13.4 ± 2.113.4 ± 2.113.4 ± 2.1
<13th week of pregnancy at randomization
<13th week of pregnancy at randomization(Participants)Daily Vitamin SupplementsPlacebo for Vitamins C and ETotal
Count of participants222722034430
Prepregnancy body-mass index
Prepregnancy body-mass index(kg/m2)Daily Vitamin SupplementsPlacebo for Vitamins C and ETotal
Mean25.4 ± 6.025.4 ± 5.925.4 ± 6.0
Smoker
Smoker(Participants)Daily Vitamin SupplementsPlacebo for Vitamins C and ETotal
Count of participants8127811593
Educational level
Educational level(year)Daily Vitamin SupplementsPlacebo for Vitamins C and ETotal
Mean12.8 ± 2.712.8 ± 2.712.8 ± 2.7

6 further baseline measures are reported on the registry.

08

Study locations

16 sites
  • University of Alabama - Birmingham
    Birmingham, Alabama 35233, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Wayne State University
    Detroit, Michigan 48201, United States
  • Columbia University
    New York, New York 10032, United States
  • University of North Carolina - Chapel Hill
    Chapel Hill, North Carolina 27599, United States
  • Wake Forest University School of Medicine
    Winston-Salem, North Carolina 27157, United States
  • Case Western University
    Cleveland, Ohio 44109, United States
  • Ohio State University
    Columbus, Ohio 43210, United States
  • Oregon Health and Sciences University
    Portland, Oregon 97239, United States
  • Drexel University
    Philadelphia, Pennsylvania 19107, United States
  • University of Pittsburgh Magee Womens Hospital
    Pittsburgh, Pennsylvania 15213, United States
  • Brown University
    Providence, Rhode Island 02905, United States
  • University of Texas - Southwest
    Dallas, Texas 75235, United States
  • University of Texas Medical Branch
    Galveston, Texas 77555, United States
  • University of Texas - Houston
    Houston, Texas 77030, United States
  • University of Utah Medical Center
    Salt Lake City, Utah 84132, United States
09

References and documents

Publications

  • Hauth JC, Clifton RG, Roberts JM, Myatt L, Spong CY, Leveno KJ, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal insulin resistance and preeclampsia. Am J Obstet Gynecol. 2011 Apr;204(4):327.e1-6. doi: 10.1016/j.ajog.2011.02.024. PubMed 21458622 ↗
  • Carreno CA, Clifton RG, Hauth JC, Myatt L, Roberts JM, Spong CY, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Sciscione A, Tolosa JE, Saade GR, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Excessive early gestational weight gain and risk of gestational diabetes mellitus in nulliparous women. Obstet Gynecol. 2012 Jun;119(6):1227-33. doi: 10.1097/AOG.0b013e318256cf1a. Erratum In: Obstet Gynecol. 2012 Sep;120(3):710. Saade, George R [added]. PubMed 22617588 ↗
  • Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Iams JD, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012 Jun;119(6):1234-42. doi: 10.1097/AOG.0b013e3182571669. PubMed 22617589 ↗
  • Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Grobman WA, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). The utility of uterine artery Doppler velocimetry in prediction of preeclampsia in a low-risk population. Obstet Gynecol. 2012 Oct;120(4):815-22. doi: 10.1097/AOG.0b013e31826af7fb. PubMed 22996099 ↗
  • Weissgerber TL, Gandley RE, McGee PL, Spong CY, Myatt L, Leveno KJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Haptoglobin phenotype, preeclampsia risk and the efficacy of vitamin C and E supplementation to prevent preeclampsia in a racially diverse population. PLoS One. 2013;8(4):e60479. doi: 10.1371/journal.pone.0060479. Epub 2013 Apr 3. PubMed 23573260 ↗
  • Johnson J, Clifton RG, Roberts JM, Myatt L, Hauth JC, Spong CY, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Samuels P, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Pregnancy outcomes with weight gain above or below the 2009 Institute of Medicine guidelines. Obstet Gynecol. 2013 May;121(5):969-975. doi: 10.1097/AOG.0b013e31828aea03. PubMed 23635732 ↗
  • Myatt L, Clifton RG, Roberts JM, Spong CY, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Sciscione A, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Can changes in angiogenic biomarkers between the first and second trimesters of pregnancy predict development of pre-eclampsia in a low-risk nulliparous patient population? BJOG. 2013 Sep;120(10):1183-91. doi: 10.1111/1471-0528.12128. Epub 2013 Jan 18. PubMed 23331974 ↗
  • Makhlouf MA, Clifton RG, Roberts JM, Myatt L, Hauth JC, Leveno KJ, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Iams JD, Sciscione A, Tolosa JE, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units Network. Adverse pregnancy outcomes among women with prior spontaneous or induced abortions. Am J Perinatol. 2014 Oct;31(9):765-72. doi: 10.1055/s-0033-1358771. Epub 2013 Dec 17. PubMed 24347257 ↗
  • Cantu J, Clifton RG, Roberts JM, Leveno KJ, Myatt L, Reddy UM, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Samuels P, Sciscione A, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Laboratory abnormalities in pregnancy-associated hypertension: frequency and association with pregnancy outcomes. Obstet Gynecol. 2014 Nov;124(5):933-940. doi: 10.1097/AOG.0000000000000509. PubMed 25437721 ↗
  • Weissgerber TL, McGee PL, Myatt L, Hauth JC, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Samuels P, Sciscione AC, Harper M, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Haptoglobin phenotype and abnormal uterine artery Doppler in a racially diverse cohort. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1728-33. doi: 10.3109/14767058.2013.876622. Epub 2014 Jan 13. PubMed 24345080 ↗
  • Abramovici A, Gandley RE, Clifton RG, Leveno KJ, Myatt L, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Samuels P, Sciscione A, Harper M, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units Network. Prenatal vitamin C and E supplementation in smokers is associated with reduced placental abruption and preterm birth: a secondary analysis. BJOG. 2015 Dec;122(13):1740-7. doi: 10.1111/1471-0528.13201. Epub 2014 Dec 17. PubMed 25516497 ↗
  • Basraon SK, Mele L, Myatt L, Roberts JM, Hauth JC, Leveno KJ, Varner MW, Wapner RJ, Thorp JM Jr, Peaceman AM, Ramin SM, Sciscione A, Tolosa JE, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Relationship of Early Pregnancy Waist-to-Hip Ratio versus Body Mass Index with Gestational Diabetes Mellitus and Insulin Resistance. Am J Perinatol. 2016 Jan;33(1):114-21. doi: 10.1055/s-0035-1562928. Epub 2015 Sep 9. PubMed 26352680 ↗
  • McDonnold M, Mele LM, Myatt L, Hauth JC, Leveno KJ, Reddy UM, Mercer BM; Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units (MFMU) Network. Waist-to-Hip Ratio versus Body Mass Index as Predictor of Obesity-Related Pregnancy Outcomes. Am J Perinatol. 2016 May;33(6):618-24. doi: 10.1055/s-0035-1569986. Epub 2016 Jan 20. PubMed 26788786 ↗
  • Hughes BL, Clifton RG, Hauth JC, Leveno KJ, Myatt L, Reddy UM, Varner MW, Wapner RJ, Mercer BM, Peaceman AM, Ramin SM, Tolosa JE, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Is Mid-trimester Insulin Resistance Predictive of Subsequent Puerperal Infection? A Secondary Analysis of Randomized Trial Data. Am J Perinatol. 2016 Aug;33(10):983-90. doi: 10.1055/s-0036-1583188. Epub 2016 Apr 27. PubMed 27120478 ↗
  • Silver RM, Myatt L, Hauth JC, Leveno KJ, Peaceman AM, Ramin SM, Samuels P, Saade G, Sorokin Y, Clifton RG, Reddy UM. Cell-Free Total and Fetal DNA in First Trimester Maternal Serum and Subsequent Development of Preeclampsia. Am J Perinatol. 2017 Jan;34(2):191-198. doi: 10.1055/s-0035-1570383. Epub 2016 Jul 11. PubMed 27398706 ↗
  • Tita AT, Doherty L, Roberts JM, Myatt L, Leveno KJ, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman A, Ramin SM, Carpenter MW, Iams J, Sciscione A, Harper M, Tolosa JE, Saade GR, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Adverse Maternal and Neonatal Outcomes in Indicated Compared with Spontaneous Preterm Birth in Healthy Nulliparas: A Secondary Analysis of a Randomized Trial. Am J Perinatol. 2018 Jun;35(7):624-631. doi: 10.1055/s-0037-1608787. Epub 2017 Nov 30. PubMed 29190847 ↗
  • Roberts JM, Myatt L, Spong CY, Thom EA, Hauth JC, Leveno KJ, Pearson GD, Wapner RJ, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Harper M, Smith WJ, Saade G, Sorokin Y, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Vitamins C and E to prevent complications of pregnancy-associated hypertension. N Engl J Med. 2010 Apr 8;362(14):1282-91. doi: 10.1056/NEJMoa0908056. PubMed 20375405 ↗
  • Hauth JC, Clifton RG, Roberts JM, Spong CY, Myatt L, Leveno KJ, Pearson GD, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Vitamin C and E supplementation to prevent spontaneous preterm birth: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):653-658. doi: 10.1097/AOG.0b013e3181ed721d. PubMed 20733448 ↗

Individual participant data

Plan to share: Yes — The data will be shared after completion of the trial an publication of the main analyses per NIH Policy. Requests should be emailed to mfmudatasets@bsc.gwu.edu.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00135707
Lead sponsor
The George Washington University Biostatistics Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Aug 26, 2005
Start date
Jun 2003
Primary completion
Oct 2008
Completion
Jan 2009
Results posted
Nov 20, 2018
Last update
Feb 21, 2019

Study contacts

Menachem Miodovnik, MD
study director · NICHD Project Scientist
Rebecca Clifton, Ph.D.
principal investigator · George Washington University Biostatistics Center
James M Roberts, MD
study chair · University of Pittsburgh - Magee Womens

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pre-Eclampsia→

Other studies from this sponsor

The George Washington University Biostatistics Center

Start the discussion