Phase 3 N=10,154 Randomized Triple-blind Prevention

Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)

Preeclampsia

Bottom Line

View on ClinicalTrials.gov: NCT00135707 ↗

Enrolled (actual)

10,154

Serious AEs

2.8%

Results posted

Nov 2018

Primary outcome: Primary: Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate — 305; 285 Participants — p=0.42

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dietary Supplement/Vitamins (Drug); Placebo for Vitamin C and Vitamin E (Drug)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: The George Washington University Biostatistics Center
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate	305; 285	0.42
PRIMARY Severe Hypertension	210; 204	0.79
PRIMARY Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels	26; 33	0.35
PRIMARY Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia	21; 31	0.16
PRIMARY Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level	7; 11	0.34
PRIMARY Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure	10; 4	0.11
PRIMARY Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders	13; 16	0.57
PRIMARY Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the 3rd Percentile) Adjusted for Sex and Race or Ethnic Group	60; 46	0.18
PRIMARY Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death	12; 11	0.84
SECONDARY Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia)	358; 332; 212; 191; 134; 129	0.33
SECONDARY Pregnancy Associated Hypertension	1457; 1322	0.004 sig
SECONDARY Medically Indicated Delivery Because of Hypertension	509; 473	0.25
SECONDARY Aspartate Aminotransferase ≥100 U/Liter	35; 48	0.15
SECONDARY Creatinine ≥1.5 mg/dl (133 μmol/Liter)	9; 12	0.51
SECONDARY Antepartum Bleeding	56; 46	0.33
SECONDARY Premature Rupture of Membranes	124; 129	0.74
SECONDARY Placental Abruption	24; 36	0.12
SECONDARY Cesarean Delivery	1269; 1224	0.35
SECONDARY Maternal Death	1; 1	—
SECONDARY Postpartum Pulmonary Edema	3; 10	0.05
SECONDARY Hematocrit ≤24% With Transfusion	40; 59	0.05
SECONDARY Maternal Hospital Stay	2.0; 2.0	0.65
SECONDARY Gestational Age at Delivery	38.9; 38.8	0.21
SECONDARY Preterm Birth	513; 526; 149; 173	0.63
SECONDARY Fetal or Neonatal Death	113; 122; 55; 59; 38; 36	0.53
SECONDARY Birth Weight	3247; 3244	0.55
SECONDARY Small for Gestational Age	133; 132	0.98
SECONDARY Birth Weight <2500 Grams	345; 369	0.32
SECONDARY Admission to NICU	577; 557	0.58
SECONDARY Respiratory Distress Syndrome	150; 144	0.75
SECONDARY Intraventricular Hemorrhage, Grade III or IV	6; 7	0.78
SECONDARY Sepsis	30; 23	0.34
SECONDARY Necrotizing Enterocolitis	10; 14	0.41
SECONDARY Retinopathy of Prematurity	19; 16	0.62
SECONDARY Apgar Score <=3 at 5 Minutes	23; 27	0.56
SECONDARY Neonatal Hospital Stay	2.0; 2.0	0.79

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00135707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.