PreeclampsiaPhase 3NCT00097110
RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
A Phase 3 study testing Vitamin C and E in people with Preeclampsia and Eclampsia, run by NICHD Global Network for Women's and Children's Health at 1 site in Brazil.
Trial summary
The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. This study tests the likelihood that the joint administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Eclampsia, HELLP Syndrome
- What is being tested?
- Vitamin C and E
- How many people
- 734 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2003to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age between 12 weeks and 19 weeks, 6 days, inclusive
- Chronic hypertension
- History of preeclampsia/eclampsia
- Attendance at a participating hospital (Recife, Botucatu, Campinas and Porto Alegre, Brazil)
Who cannot join
- Planned delivery elsewhere.
- Multifetal gestation.
- Allergy to vitamin C or vitamin E.
- Requirement for aspirin or anticoagulant medication.
- Proteinuria ≥ 2+ on dipstick urine test; or proteinuria = 1+ on dipstick and ≥ 300 mg/24 hours.
- Pre-pregnancy diabetes mellitus.
Show all 9Show fewer
- Known fetal anomaly incompatible with life.
- Prior participation in the study.
- Unwillingness to take the study medication.
Trial locations and contacts
1 site in 1 country.
About this study
The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. This study tests the likelihood that the joint administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia.
Read the detailed description
The maternal, perinatal and neonatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. In Sao Paulo, 22 percent of maternal deaths are attributable to hypertensive complications of pregnancy, which ranks as the number one cause of maternal death. Recent advances in the understanding of the pathophysiology of preeclampsia suggest the possibility of antioxidant therapy for the prevention of preeclampsia. The primary hypothesis is that the joint administration of the antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia. Secondary outcomes include severity of preeclampsia; incidence of gestational hypertension; incidence of premature rupture of the membranes; incidence of preterm birth; incidence of low birth weight infants; biomarker level correlation with preeclampsia.
Study sites are high-risk obstetrical clinics in the Brazilian cities of Recife, Botucatu, Campinas, and Porto Alegre. The sample size was based on an estimated risk of preeclampsia/eclampsia of 21-25% in the control group. The study hypothesizes a 40% absolute reduction of risk of preeclampsia; early treatment withdrawal of 3%; withdrawal of consent or loss to follow-up of 10%; calculated at a 0.05 significance level with 80% power. Seven hundred thirty-four obstetric patients with chronic hypertension or preeclampsia in the prior pregnancy presenting for care between 12 weeks and 19 weeks', 6 days gestation will be randomized to a double-blinded placebo controlled trial to receive a daily dose of either vitamin E (400 International Units) and vitamin C (1000 mg) or placebo from the time of enrollment to delivery. The use of MEMS caps enables researchers to accurately track compliance.
- Conditions
- Preeclampsia, Eclampsia, HELLP Syndrome, Pregnancy
- Being tested
- Vitamin C and E
- Keywords
- Vitamin C, Vitamin E, Preeclampsia, Antioxidants, Global Network, Preterm birth, Low birth weight infants, Brazil, Brasil, Maternal and child health, International, Women's health
- Medical subject headings
- Pre-Eclampsia, Eclampsia, HELLP Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C and EDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of preeclampsia
Secondary outcomes (7)
Severity of preeclampsia
Incidence of gestational hypertension or preeclampsia
Frequency of abruptio placentae
Incidence of preterm birth
Incidence of small for gestational age
Incidence of low birth weight infants
Biomarker level correlation with preeclampsia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2004 (estimated)
- Study startJul 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 734 participants
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Cincinnati, Universidade Federal de Pernambuco, Feculdade de Medicina da Universidade de Sao Paulo - Brasil, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil, University of Campinas, Brazil, Hospital de Clinicas de Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Joseph A. Spinnato, M.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097110
- Sponsor's protocol ID
- GN 05
- Other IDs
- U01HD040565
- Status last verified
- Nov 2013
- First submitted
- 17 Nov 2004
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spinnato JA 2nd, Freire S, Pinto e Silva JL, Rudge MV, Martins-Costa S, Koch MA, Goco N, Santos Cde B, Cecatti JG, Costa R, Ramos JG, Moss N, Sibai BM. Antioxidant supplementation and premature rupture of the membranes: a planned secondary analysis. Am J Obstet Gynecol. 2008 Oct;199(4):433.e1-8. doi: 10.1016/j.ajog.2008.07.011.
PubMed 18928997Spinnato JA 2nd, Freire S, Pinto E Silva JL, Cunha Rudge MV, Martins-Costa S, Koch MA, Goco N, Santos Cde B, Cecatti JG, Costa R, Ramos JG, Moss N, Sibai BM. Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1311-8. doi: 10.1097/01.AOG.0000289576.43441.1f.
PubMed 18055726
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil
- ClinicalTrials.gov ID
- NCT00097110
- Acronym / sponsor ID
- GN 05
- Conditions
- Preeclampsia, Eclampsia, HELLP Syndrome, Pregnancy
- Keywords
- Vitamin C, Vitamin E, Preeclampsia, Antioxidants, Global Network, Preterm birth, Low birth weight infants, Brazil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 734 participants
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, University of Cincinnati, Universidade Federal de Pernambuco, Feculdade de Medicina da Universidade de Sao Paulo - Brasil, Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil, University of Campinas, Brazil, Hospital de Clinicas de Porto Alegre
- Study start
- Jul 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 18 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The perinatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. This study tests the likelihood that the joint administration of antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia.
Detailed description
The maternal, perinatal and neonatal morbidity and mortality rates for Brazil are five to ten-fold higher than those reported for upper income countries. In Sao Paulo, 22 percent of maternal deaths are attributable to hypertensive complications of pregnancy, which ranks as the number one cause of maternal death. Recent advances in the understanding of the pathophysiology of preeclampsia suggest the possibility of antioxidant therapy for the prevention of preeclampsia. The primary hypothesis is that the joint administration of the antioxidants vitamin C (1000 mg) and vitamin E (400 IU) will reduce the incidence of preeclampsia among chronically hypertensive pregnant patients and patients with a past history of preeclampsia/eclampsia. Secondary outcomes include severity of preeclampsia; incidence of gestational hypertension; incidence of premature rupture of the membranes; incidence of preterm birth; incidence of low birth weight infants; biomarker level correlation with preeclampsia.
Study sites are high-risk obstetrical clinics in the Brazilian cities of Recife, Botucatu, Campinas, and Porto Alegre. The sample size was based on an estimated risk of preeclampsia/eclampsia of 21-25% in the control group. The study hypothesizes a 40% absolute reduction of risk of preeclampsia; early treatment withdrawal of 3%; withdrawal of consent or loss to follow-up of 10%; calculated at a 0.05 significance level with 80% power. Seven hundred thirty-four obstetric patients with chronic hypertension or preeclampsia in the prior pregnancy presenting for care between 12 weeks and 19 weeks', 6 days gestation will be randomized to a double-blinded placebo controlled trial to receive a daily dose of either vitamin E (400 International Units) and vitamin C (1000 mg) or placebo from the time of enrollment to delivery. The use of MEMS caps enables researchers to accurately track compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age between 12 weeks and 19 weeks, 6 days, inclusive
- Chronic hypertension
- History of preeclampsia/eclampsia
- Attendance at a participating hospital (Recife, Botucatu, Campinas and Porto Alegre, Brazil)
Key exclusion criteria (9 listed)
- Planned delivery elsewhere.
- Multifetal gestation.
- Allergy to vitamin C or vitamin E.
- Requirement for aspirin or anticoagulant medication.
- Proteinuria ≥ 2+ on dipstick urine test; or proteinuria = 1+ on dipstick and ≥ 300 mg/24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C and E | Drug | – |
Primary outcome
Incidence of preeclampsia
7 secondary outcomes
Severity of preeclampsia
Incidence of gestational hypertension or preeclampsia
Frequency of abruptio placentae
Incidence of preterm birth
Incidence of small for gestational age
Incidence of low birth weight infants
Biomarker level correlation with preeclampsia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 18928997Spinnato JA 2nd, Freire S, Pinto e Silva JL, Rudge MV, Martins-Costa S, Koch MA, Goco N, Santos Cde B, Cecatti JG, Costa R, Ramos JG, Moss N, Sibai BM. Antioxidant supplementation and premature rupture of the membranes: a planned secondary analysis. Am J Obstet Gynecol. 2008 Oct;199(4):433.e1-8. doi: 10.1016/j.ajog.2008.07.011.
- Derived from this study: PubMed 18055726Spinnato JA 2nd, Freire S, Pinto E Silva JL, Cunha Rudge MV, Martins-Costa S, Koch MA, Goco N, Santos Cde B, Cecatti JG, Costa R, Ramos JG, Moss N, Sibai BM. Antioxidant therapy to prevent preeclampsia: a randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1311-8. doi: 10.1097/01.AOG.0000289576.43441.1f.
- Global Network for Women's and Children's Health ResearchLink provided by the sponsor.
- RTI InternationalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph A. Spinnato, M.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin C and E in people with Preeclampsia and Eclampsia, run by NICHD Global Network for Women's and Children's Health at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of preeclampsia. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097110, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.