Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS) (CAPPS)
Preeclampsia
About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring Antioxidants, Preeclampsia, Pregnancy, Hypertension
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
Sites / Locations
- University of Alabama - Birmingham
- Northwestern University
- Wayne State University
- Columbia University
- University of North Carolina - Chapel Hill
- Wake Forest University School of Medicine
- Case Western University
- Ohio State University
- Oregon Health and Sciences University
- Drexel University
- University of Pittsburgh Magee Womens Hospital
- Brown University
- University of Texas - Southwest
- University of Texas Medical Branch
- University of Texas - Houston
- University of Utah Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dietary Supplement/Vitamins
Placebo for Vitamin C and Vitamin E
1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery.
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.