Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00135707
First received: August 24, 2005
Last updated: May 12, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Preeclampsia
Dietary Supplement: Vitamins
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia and An Observational Cohort Study to Predict Preeclampsia

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • platelet count < 100,000 mm3 [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • serum creatinine >= 1.5 mg/dL [ Time Frame: During pregnancy ] [ Designated as safety issue: Yes ]
  • eclamptic seizure [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • growth restriction (<3rd percentile) [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • indicated preterm birth (<32 weeks) for hypertension related disorders [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • fetal/neonatal death [ Time Frame: During pregnancy or within 1 month of birth ] [ Designated as safety issue: No ]
  • SGOT >= 100 U/L [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • preeclampsia (mild, severe, HELLP [hemolysis, elevated liver enzymes, and low platelet count], eclampsia) [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • gestational hypertension [ Time Frame: During pregnancy ] [ Designated as safety issue: No ]
  • serious maternal morbidity [ Time Frame: During pregnancy or birth ] [ Designated as safety issue: No ]
  • neonatal morbidity and mortality [ Time Frame: within 1 month following birth ] [ Designated as safety issue: No ]

Enrollment: 10154
Study Start Date: June 2003
Study Completion Date: January 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135707

Locations
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
Investigators
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:
No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional 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, U10HD027869, U10HD027917, U10HD027860, U10HD027915, U10HD034116, U10HD034208, U10HD034136, U10HD040500, U10HD040485, U10HD040544, U10HD040545, U10HD040560, U10HD040512, U01HD036801, U10HD053097, U10HD053118
Study First Received: August 24, 2005
Last Updated: May 12, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Antioxidants
Ascorbic Acid
Vitamin E
Alpha-Tocopherol
Tocopherols
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014