Status:
COMPLETED
Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preeclampsia
Eligibility:
FEMALE
Phase:
PHASE3
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...
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 bee...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
10154 Patients enrolled
Trial Details
Trial ID
NCT00135707
Start Date
June 1 2003
End Date
January 1 2009
Last Update
February 21 2019
Active Locations (16)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Wayne State University
Detroit, Michigan, United States, 48201
4
Columbia University
New York, New York, United States, 10032