Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
Imethibitishwa Mwisho: | 01/31/2019 |
Iliyowasilishwa Kwanza: | 08/23/2005 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 08/23/2005 |
Iliyotumwa Kwanza: | 08/25/2005 |
Sasisho la Mwisho Liliwasilishwa: | 02/18/2019 |
Sasisho la Mwisho Lilichapishwa: | 02/20/2019 |
Tarehe ya matokeo ya kwanza yaliyowasilishwa: | 10/31/2012 |
Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa: | 10/22/2018 |
Tarehe ya matokeo ya kwanza kuchapishwa: | 11/19/2018 |
Tarehe halisi ya kuanza kwa masomo: | 05/31/2003 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 09/30/2008 |
Tarehe ya Kukamilisha Utafiti: | 12/31/2008 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Dietary Supplement/Vitamins
Drug: Placebo for Vitamin C and Vitamin E
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
Experimental: Dietary Supplement/Vitamins 1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery. | Drug: Dietary Supplement/Vitamins Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery. |
Placebo Comparator: Placebo for Vitamin C and Vitamin E 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. | Drug: Placebo for Vitamin C and Vitamin E Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery. |
Vigezo vya Kustahiki
Jinsia Inastahiki Kujifunza | Female |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | 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 |
Matokeo
Hatua za Matokeo ya Msingi
1. Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate [20 weeks through discharge following delivery]
2. Severe Hypertension [20 weeks through discharge following delivery]
3. Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels [20 weeks through discharge following delivery]
4. Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia [20 weeks through discharge following delivery]
5. Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level [20 weeks through discharge following delivery]
6. Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure [20 weeks through discharge following delivery]
7. Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders [20 weeks through discharge following delivery]
8. 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 [20 weeks through discharge following delivery]
9. Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death [20 weeks through discharge or prior to discharge following delivery admission]
Hatua za Matokeo ya Sekondari
1. Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia) [20 weeks through discharge following delivery]
2. Pregnancy Associated Hypertension [20 weeks through discharge following delivery]
3. Medically Indicated Delivery Because of Hypertension [20 weeks through discharge following delivery]
4. Aspartate Aminotransferase ≥100 U/Liter [20 weeks through discharge]
5. Creatinine ≥1.5 mg/dl (133 μmol/Liter) [20 weeks through discharge]
6. Antepartum Bleeding [During pregnancy]
7. Premature Rupture of Membranes [During pregnancy]
8. Placental Abruption [During pregnancy]
9. Cesarean Delivery [Delivery]
10. Maternal Death [Delivery through hospital discharge]
11. Postpartum Pulmonary Edema [After delivery through discharge]
12. Hematocrit ≤24% With Transfusion [Delivery admission to discharge]
13. Maternal Hospital Stay [Delivery through discharge]
14. Gestational Age at Delivery [Delivery]
15. Preterm Birth [Delivery]
16. Fetal or Neonatal Death [During pregnancy or thorugh discharge]
17. Birth Weight [At birth]
18. Small for Gestational Age [At birth]
19. Birth Weight <2500 Grams [At birth]
20. Admission to NICU [Delivery through discharge]
21. Respiratory Distress Syndrome [Delivery through discharge]
22. Intraventricular Hemorrhage, Grade III or IV [Delivery through discharge]
23. Sepsis [Delivery through discharge]
24. Necrotizing Enterocolitis [Delivery through discharge]
25. Retinopathy of Prematurity [Within 1 month of birth]
26. Apgar Score <=3 at 5 Minutes [At birth]
27. Neonatal Hospital Stay [Birth through discharge from hospital]