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Trial record 3 of 8 for:    nichd Preeclampsia/Eclampsia

Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS) (CAPPS)

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ClinicalTrials.gov Identifier: NCT00135707
Recruitment Status : Completed
First Posted : August 26, 2005
Last Update Posted : May 13, 2010
Information provided by:

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Preeclampsia Dietary Supplement: Vitamins Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia and An Observational Cohort Study to Predict Preeclampsia
Study Start Date : June 2003
Primary Completion Date : February 2008
Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Vitamins
Vitamins C & E
Dietary Supplement: Vitamins

Vit C (500 mg) and Vit E (200 IU) per capsule, two capsules daily between 9 - 16 weeks gestation.

Placebo - two capsules daily between 9 - 16 weeks gestation.

Other Name: Ascorbic Acid and d-alpha-Tocopheryl Acetate
Placebo Comparator: Placebo
Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell
Dietary Supplement: Vitamins

Vit C (500 mg) and Vit E (200 IU) per capsule, two capsules daily between 9 - 16 weeks gestation.

Placebo - two capsules daily between 9 - 16 weeks gestation.

Other Name: Ascorbic Acid and d-alpha-Tocopheryl Acetate

Outcome Measures

Primary Outcome Measures :
  1. Severe hypertension (blood pressure [BP]>= 160/110) or mild hypertension (BP> 140/90) >= 20 weeks gestation in conjunction with one of the following: [ Time Frame: During pregnancy ]
  2. platelet count < 100,000 mm3 [ Time Frame: During pregnancy ]
  3. serum creatinine >= 1.5 mg/dL [ Time Frame: During pregnancy ]
  4. eclamptic seizure [ Time Frame: During pregnancy ]
  5. growth restriction (<3rd percentile) [ Time Frame: During pregnancy ]
  6. indicated preterm birth (<32 weeks) for hypertension related disorders [ Time Frame: During pregnancy ]
  7. fetal/neonatal death [ Time Frame: During pregnancy or within 1 month of birth ]
  8. SGOT >= 100 U/L [ Time Frame: During pregnancy ]

Secondary Outcome Measures :
  1. preeclampsia (mild, severe, HELLP [hemolysis, elevated liver enzymes, and low platelet count], eclampsia) [ Time Frame: During pregnancy ]
  2. gestational hypertension [ Time Frame: During pregnancy ]
  3. serious maternal morbidity [ Time Frame: During pregnancy or birth ]
  4. neonatal morbidity and mortality [ Time Frame: within 1 month following birth ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

RCT Inclusion Criteria:

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

Observational Inclusion Criteria:

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

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135707

United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western University
Cleveland, Ohio, United States, 44109
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas - Southwest
Dallas, Texas, United States, 75235
University of Texas Medical Branch
Galveston, Texas, United States, 77555
University of Texas - Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Catherine Spong, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Elizabeth A Thom, Ph.D. George Washington University Biostatistics Center
Study Chair: James M Roberts, MD University of Pittsburgh - Magee Womens
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Catherine Y Spong, MD, Chief, Pregnancy and Perinatology Branch, NICHD, NIH
ClinicalTrials.gov Identifier: NCT00135707     History of Changes
Other Study ID Numbers: HD36801-CAPPS
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD027860 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD034136 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
U01HD036801 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD053118 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2005    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: May 2010

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents