Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135707
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2005-08-24
Brief Title:
Combined Antioxidant and Preeclampsia Prediction Studies CAPPS
Sponsor:
The George Washington University Biostatistics Center
Organization:
The George Washington University Biostatistics Center
Study Overview
Official Title:
A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia and An Observational Cohort Study to Predict Preeclampsia
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPPS
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 the mother and fetus This study of preeclampsia consists of two parts 1 a randomized placebo controlled multicenter clinical trial of 10000 low-risk nulliparous women between 9 and 16 weeks gestation and 2 an observational cohort study of 4000 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
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
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 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 10000 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 4000 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
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 10000 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 4000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10HD053118 | NIH | None | httpsreporternihgovquickSearchU10HD053118 |
| U10HD021410 | NIH | None | None |
| U10HD027869 | NIH | None | None |
| U10HD027917 | NIH | None | None |
| U10HD027860 | NIH | None | None |
| U10HD027915 | NIH | None | None |
| U10HD034116 | NIH | None | None |
| U10HD034208 | NIH | None | None |
| U10HD034136 | NIH | None | None |
| U10HD040500 | NIH | None | None |
| U10HD040485 | NIH | None | None |
| U10HD040544 | NIH | None | None |
| U10HD040545 | NIH | None | None |
| U10HD040560 | NIH | None | None |
| U10HD040512 | NIH | None | None |
| U01HD036801 | NIH | None | None |
| U10HD053097 | NIH | None | None |