Objective
To determine whether antioxidants reduce the frequency
of serious maternal and infant complications associated
with pregnancy related hypertension.
Project Status
No Longer Recruiting
Conclusion
Therapy initiated with the antioxidant Vitamins C and E prior to
17 weeks gestation in nulliparous low risk women does not reduce the
frequency of complications associated with pregnancyrelated
hypertension, nor
does this treatment reduce the diagnosis of preeclampsia.
Clinical Centers
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List of the Participating Clinical Centers
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Design Type
- Double masked randomized clinical trial stratified by
clinical center
Major Eligibility Criteria
- Gestational age 90
- 166 weeks
- Singleton pregnancy
- Nulliparous
- BP < 135/85; no antihypertensive medication/diuretics
- Proteinuria 0 or trace
- No Vitamin C or E > amount in prenatal vitamins
- Informed consent
Groups
- Experimental: Vitamin C/ Vitamin E capsules
- Placebo: matching capsules
Sample Size
- Trial goal = 10000 (5000/group)
Scheduled Evaluations/Data Collection
- Pre-Randomization
- History
- Dating ultrasound if not done
- Blood pressure
- Dipstick urine
- Urine and blood collection
- Placebo compliance check
- Post-Randomization
- Visits q 4 weeks for pill count, assess side effects,
dispense study drug, BP,urine protein, weight
- At week 24 and 32: urine and blood collection
- Delivery
- BP, maternal blood, urine, UV cord blood
- Chart review for diagnostic criteria
Management Protocol
- Coded Medication
- Daily dose (1000mg Vitamin C/400IU Vitamin E) or
placebo until delivery
Outcome Measures
- Primary
- BP ≥ 160/110 or BP > 140/90 ≥ 20 weeks and one of:
- SGOT (AST) ≥ 100 U/L
- Platelets < 100,000/mm3
- Creatinine ≥ 1.5 mg/dL
- Eclampsia
- Fetal/neonatal death
- SGA < 3rd %ile
- Preterm delivery < 32wks
- Secondary:
- Preeclampsia (Mild, Severe, Eclampsia, HELLP)
- Gestational hypertension
- Serious maternal morbidity
- Neonatal morbidity and mortality
Timetable
- Enrollment: May 2003 - Apr 2005
- Data Collecton: May 2003 - Mar 2006
- Closeout/final analysis: Apr 2006 - Nov 2006
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