Trial · NCT00135707
Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
NCT00135707, Phase 3, Completed, The George Washington University Biostatistics Center; results first posted 2018-11-20
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS). Trials, record NCT00135707. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00135707
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
- NCT number
- NCT00135707
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 10,154 participants, actual
- Lead sponsor
- The George Washington University Biostatistics Center
- Conditions
- Preeclampsia
- Interventions
- Dietary Supplement/Vitamins, Placebo for Vitamin C and Vitamin E
- First posted
- 2005-08-26
- Last updated
- 2019-02-21
- Results first posted
- 2018-11-20
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate | 20 weeks through discharge following delivery | 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 |
| Primary | Severe Hypertension | 20 weeks through discharge following delivery | 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. |
| Primary | Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels | 20 weeks through discharge following delivery | 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. |
| Primary | Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia | 20 weeks through discharge following delivery | 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. |
| Primary | Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level | 20 weeks through discharge following delivery | 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. |
| Primary | Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure | 20 weeks through discharge following delivery | 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. |
| Primary | Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders | 20 weeks through discharge following delivery | 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. |
| Primary | 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 | 20 weeks through discharge following delivery | 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. |
| Primary | Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death | 20 weeks through discharge or prior to discharge following delivery admission | 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. |
| Secondary | Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia) | 20 weeks through discharge following delivery | HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate | 20 weeks through discharge following delivery | The analysis was intent to treat. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Severe Hypertension | 20 weeks through discharge following delivery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels | 20 weeks through discharge following delivery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia | 20 weeks through discharge following delivery | participants | NUMBER | |
| PRIMARY | Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level | 20 weeks through discharge following delivery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure | 20 weeks through discharge following delivery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders | 20 weeks through discharge following delivery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | 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 | 20 weeks through discharge following delivery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death | 20 weeks through discharge or prior to discharge following delivery admission | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia) | 20 weeks through discharge following delivery | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate | Vitamins | 305 | Participants | ||
| Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate | Placebo | 285 | Participants | ||
| Severe Hypertension | Vitamins | 210 | Participants | ||
| Severe Hypertension | Placebo | 204 | Participants | ||
| Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels | Vitamins | 26 | Participants | ||
| Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels | Placebo | 33 | Participants | ||
| Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia | Vitamins | 21 | participants | ||
| Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia | Placebo | 31 | participants | ||
| Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level | Vitamins | 7 | Participants | ||
| Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level | Placebo | 11 | Participants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vitamins | 5,088 | |
| Overall Study | STARTED | Placebo | 5,066 | |
| Overall Study | COMPLETED | Vitamins | 4,993 | |
| Overall Study | COMPLETED | Placebo | 4,976 | |
| Overall Study | NOT COMPLETED | Vitamins | 95 | |
| Overall Study | NOT COMPLETED | Placebo | 90 |
Source ClinicalTrials.gov
Adverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Peripartum Cardiomyopathy | Cardiac disorders | Vitamins | 1 | 5,087 | |
| serious | Peripartum Cardiomyopathy | Cardiac disorders | Placebo | 1 | 5,065 | |
| serious | Fetal Death | Pregnancy, puerperium and perinatal conditions | Vitamins | 45 | 5,087 | |
| serious | Fetal Death | Pregnancy, puerperium and perinatal conditions | Placebo | 95 | 5,065 | |
| serious | Bleeding | Pregnancy, puerperium and perinatal conditions | Vitamins | 9 | 5,087 | |
| serious | Bleeding | Pregnancy, puerperium and perinatal conditions | Placebo | 7 | 5,065 | |
| serious | Renal and Urinary disorders | Renal and urinary disorders | Vitamins | 4 | 5,087 | |
| serious | Renal and Urinary disorders | Renal and urinary disorders | Placebo | 9 | 5,065 | |
| serious | Hemorrhage | Pregnancy, puerperium and perinatal conditions | Vitamins | 4 | 5,087 | |
| serious | Hemorrhage | Pregnancy, puerperium and perinatal conditions | Placebo | 5 | 5,065 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vitamins | 1 | 5,087 |
| Total, all-cause mortality | Placebo | 1 | 5,065 |
| Total, other adverse events | Vitamins | 0 | 5,087 |
| Total, other adverse events | Placebo | 0 | 5,065 |
| Total, serious adverse events | Vitamins | 108 | 5,087 |
| Total, serious adverse events | Placebo | 173 | 5,065 |
Source ClinicalTrials.gov
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants17
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10HD021410 | Multicenter Network of Maternal Fetal Medicine Units | CARITIS, STEVE N | MAGEE-WOMEN'S RES INST AND FOUNDATION | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027869 | NICHD Materal Fetal Medicine Units Network | TITA, ALAN THEVENET N. | UNIVERSITY OF ALABAMA AT BIRMINGHAM | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD027915 | NICHD Maternal Fetal Medicine Units Network | IAMS, JAY | OHIO STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1992 to 2015 | NIH RePORTER |
| U10HD027917 | Co-Operative Multicenter Trials in Obstetrics & Maternal Fetal Medicine | GONIK, BERNARD | WAYNE STATE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1991 to 2015 | NIH RePORTER |
| U10HD034116 | Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network (U10) | CASEY, BRIAN M | UT SOUTHWESTERN MEDICAL CENTER | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
| U10HD034208 | Maternal Fetal Medicine Units Network | VARNER, MICHAEL W. | UNIVERSITY OF UTAH | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 1996 to 2015 | NIH RePORTER |
| U10HD040485 | Maternal Fetal Medicine Network | WAPNER, RONALD | COLUMBIA UNIVERSITY HEALTH SCIENCES | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040500 | Brown/WIH Eunice Kennedy Shriver NICHD MFM Units Network Site | ROUSE, DWIGHT J | WOMEN AND INFANTS HOSPITAL-RHODE ISLAND | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040512 | NICHD Maternal Fetal Medicine Units Network | GROBMAN, WILLIAM ADAM | NORTHWESTERN UNIVERSITY AT CHICAGO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
| U10HD040544 | Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network | CHIEN, EDWARD K | CASE WESTERN RESERVE UNIVERSITY | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2001 to 2015 | NIH RePORTER |
1 to 10 of 17
See all 17 grantsTrial comparisons33
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vitamins vs Placebo: Pregnancy Associated Hypertension | Trial comparisons |
| Vitamins vs Placebo: Admission to NICU | Trial comparisons |
| Vitamins vs Placebo: 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 | Trial comparisons |
| Vitamins vs Placebo: Small for Gestational Age | Trial comparisons |
| Vitamins vs Placebo: Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders | Trial comparisons |
| Vitamins vs Placebo: Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels | Trial comparisons |
| Vitamins vs Placebo: Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia | Trial comparisons |
| Vitamins vs Placebo: Creatinine ≥1.5 mg/dl (133 μmol/Liter) | Trial comparisons |
| Vitamins vs Placebo: Severe Hypertension | Trial comparisons |
| Dietary Supplement/Vitamins vs Placebo for Vitamin C and Vitamin E: Maternal Death | Trial comparisons |
1 to 10 of 33
See all 33 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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