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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD021410 | U.S. NIH Grant/Contract | View source | |
| U10HD027869 | U.S. NIH Grant/Contract | View source | |
| U10HD027917 | U.S. NIH Grant/Contract | View source | |
| U10HD027860 | U.S. NIH Grant/Contract | View source | |
| U10HD027915 | U.S. NIH Grant/Contract | View source | |
| U10HD034116 | U.S. NIH Grant/Contract | View source | |
| U10HD034208 | U.S. NIH Grant/Contract | View source | |
| U10HD034136 | U.S. NIH Grant/Contract | View source | |
| U10HD040500 | U.S. NIH Grant/Contract | View source | |
| U10HD040485 | U.S. NIH Grant/Contract | View source | |
| U10HD040544 | U.S. NIH Grant/Contract | View source | |
| U10HD040545 | U.S. NIH Grant/Contract | View source | |
| U10HD040560 | U.S. NIH Grant/Contract | View source | |
| U10HD040512 | U.S. NIH Grant/Contract | View source | |
| U01HD036801 | U.S. NIH Grant/Contract | View source | |
| U10HD053097 | U.S. NIH Grant/Contract | View source | |
| U10HD053118 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement/Vitamins | Experimental | 1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery. |
|
| Placebo for Vitamin C and Vitamin E | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Supplement/Vitamins | Drug | Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate | Severe hypertension (blood pressure [BP]>= 160/110) or mild hypertension (BP>= 140/90) >= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death | 20 weeks through discharge following delivery |
| Severe Hypertension | Included here are women who had severe hypertension only and those who had severe hypertension with elevated liver enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or fetal death after 20 weeks of gestation, or neonatal death. | 20 weeks through discharge following delivery |
| Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels | Elevated liver enzyme levels are specified as an aspartate aminotransferase level of >= 100 U per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | 20 weeks through discharge following delivery |
| Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia | Thrombocytopenia defined as a platelet count of <100,000 per cubic millimeter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | 20 weeks through discharge following delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia) | HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count. | 20 weeks through discharge following delivery |
| Pregnancy Associated Hypertension |
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RCT Inclusion Criteria:
Observational Inclusion Criteria:
Exclusion Criteria RCT and Observational:
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| Name | Affiliation | Role |
|---|---|---|
| Menachem Miodovnik, MD | NICHD Project Scientist | Study Director |
| Rebecca Clifton, Ph.D. | George Washington University Biostatistics Center | Principal Investigator |
| James M Roberts, MD | University of Pittsburgh - Magee Womens | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21458622 | Background | Hauth JC, Clifton RG, Roberts JM, Myatt L, Spong CY, Leveno KJ, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal insulin resistance and preeclampsia. Am J Obstet Gynecol. 2011 Apr;204(4):327.e1-6. doi: 10.1016/j.ajog.2011.02.024. | |
| 22617588 |
| Label | URL |
|---|---|
| The public website of the NICHD Maternal-Fetal Medicine Units (MFMU) Network | View source |
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The data will be shared after completion of the trial an publication of the main analyses per NIH Policy. Requests should be emailed to mfmudatasets@bsc.gwu.edu.
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Women who were no more than 15 weeks pregnant and who consented to participate in the study were given a supply of placebo and asked to return within 2 weeks. Those who returned, who had taken at least 50% of the placebo they were supposed to have taken, and who still met the eligibility criteria were randomly assigned to receive study drug.
The trial was conducted from July 2003 through February 2008 at the 16 clinical centers and the independent data coordinating center of the MFMU Network. Gestational age at randomization was between 9 weeks 0 days and 16 weeks 6 days. Women were eligible for inclusion if they had not had a previous pregnancy that lasted beyond 19 weeks 6 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamins | Vitamins C & E |
| FG001 | Placebo | Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo for Vitamin C and Vitamin E | Drug | Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery. |
|
| Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level | Elevated serum creatinine defined as ≥1.5 mg per deciliter or 132.6 μmol per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | 20 weeks through discharge following delivery |
| Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure | Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | 20 weeks through discharge following delivery |
| Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders | Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | 20 weeks through discharge following delivery |
| 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 | Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | 20 weeks through discharge following delivery |
| Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death | Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | 20 weeks through discharge or prior to discharge following delivery admission |
| 20 weeks through discharge following delivery |
| Medically Indicated Delivery Because of Hypertension | 20 weeks through discharge following delivery |
| Aspartate Aminotransferase ≥100 U/Liter | 20 weeks through discharge |
| Creatinine ≥1.5 mg/dl (133 μmol/Liter) | 20 weeks through discharge |
| Antepartum Bleeding | During pregnancy |
| Premature Rupture of Membranes | During pregnancy |
| Placental Abruption | During pregnancy |
| Cesarean Delivery | Delivery |
| Maternal Death | Delivery through hospital discharge |
| Postpartum Pulmonary Edema | After delivery through discharge |
| Hematocrit ≤24% With Transfusion | Delivery admission to discharge |
| Maternal Hospital Stay | Delivery through discharge |
| Gestational Age at Delivery | Delivery |
| Preterm Birth | Delivery |
| Fetal or Neonatal Death | During pregnancy or thorugh discharge |
| Birth Weight | At birth |
| Small for Gestational Age | A baby whose birth weight is less than the 3rd percentile is considered to be small for gestational age (adjusted for sex and race or ethnic group) | At birth |
| Birth Weight <2500 Grams | At birth |
| Admission to NICU | NICU denotes neonatal intensive care unit. | Delivery through discharge |
| Respiratory Distress Syndrome | Delivery through discharge |
| Intraventricular Hemorrhage, Grade III or IV | Delivery through discharge |
| Sepsis | Delivery through discharge |
| Necrotizing Enterocolitis | Delivery through discharge |
| Retinopathy of Prematurity | Within 1 month of birth |
| Apgar Score <=3 at 5 Minutes | At birth |
| Neonatal Hospital Stay | Birth through discharge from hospital |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Case Western University | Cleveland | Ohio | 44109 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Brown University | Providence | Rhode Island | 02905 | United States |
| University of Texas - Southwest | Dallas | Texas | 75235 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| University of Texas - Houston | Houston | Texas | 77030 | United States |
| University of Utah Medical Center | Salt Lake City | Utah | 84132 | United States |
| Carreno CA, Clifton RG, Hauth JC, Myatt L, Roberts JM, Spong CY, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Sciscione A, Tolosa JE, Saade GR, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Excessive early gestational weight gain and risk of gestational diabetes mellitus in nulliparous women. Obstet Gynecol. 2012 Jun;119(6):1227-33. doi: 10.1097/AOG.0b013e318256cf1a. |
| 22617589 | Background | Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Iams JD, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. First-trimester prediction of preeclampsia in nulliparous women at low risk. Obstet Gynecol. 2012 Jun;119(6):1234-42. doi: 10.1097/AOG.0b013e3182571669. |
| 22996099 | Background | Myatt L, Clifton RG, Roberts JM, Spong CY, Hauth JC, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Grobman WA, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). The utility of uterine artery Doppler velocimetry in prediction of preeclampsia in a low-risk population. Obstet Gynecol. 2012 Oct;120(4):815-22. doi: 10.1097/AOG.0b013e31826af7fb. |
| 23573260 | Background | Weissgerber TL, Gandley RE, McGee PL, Spong CY, Myatt L, Leveno KJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Haptoglobin phenotype, preeclampsia risk and the efficacy of vitamin C and E supplementation to prevent preeclampsia in a racially diverse population. PLoS One. 2013;8(4):e60479. doi: 10.1371/journal.pone.0060479. Epub 2013 Apr 3. |
| 23635732 | Background | Johnson J, Clifton RG, Roberts JM, Myatt L, Hauth JC, Spong CY, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Samuels P, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Pregnancy outcomes with weight gain above or below the 2009 Institute of Medicine guidelines. Obstet Gynecol. 2013 May;121(5):969-975. doi: 10.1097/AOG.0b013e31828aea03. |
| 23331974 | Background | Myatt L, Clifton RG, Roberts JM, Spong CY, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Sciscione A, Tolosa JE, Saade G, Sorokin Y, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Can changes in angiogenic biomarkers between the first and second trimesters of pregnancy predict development of pre-eclampsia in a low-risk nulliparous patient population? BJOG. 2013 Sep;120(10):1183-91. doi: 10.1111/1471-0528.12128. Epub 2013 Jan 18. |
| 24347257 | Background | Makhlouf MA, Clifton RG, Roberts JM, Myatt L, Hauth JC, Leveno KJ, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Iams JD, Sciscione A, Tolosa JE, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units Network. Adverse pregnancy outcomes among women with prior spontaneous or induced abortions. Am J Perinatol. 2014 Oct;31(9):765-72. doi: 10.1055/s-0033-1358771. Epub 2013 Dec 17. |
| 25437721 | Background | Cantu J, Clifton RG, Roberts JM, Leveno KJ, Myatt L, Reddy UM, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Samuels P, Sciscione A, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Laboratory abnormalities in pregnancy-associated hypertension: frequency and association with pregnancy outcomes. Obstet Gynecol. 2014 Nov;124(5):933-940. doi: 10.1097/AOG.0000000000000509. |
| 24345080 | Background | Weissgerber TL, McGee PL, Myatt L, Hauth JC, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Samuels P, Sciscione AC, Harper M, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Haptoglobin phenotype and abnormal uterine artery Doppler in a racially diverse cohort. J Matern Fetal Neonatal Med. 2014 Nov;27(17):1728-33. doi: 10.3109/14767058.2013.876622. Epub 2014 Jan 13. |
| 25516497 | Background | Abramovici A, Gandley RE, Clifton RG, Leveno KJ, Myatt L, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman AM, Samuels P, Sciscione A, Harper M, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units Network. Prenatal vitamin C and E supplementation in smokers is associated with reduced placental abruption and preterm birth: a secondary analysis. BJOG. 2015 Dec;122(13):1740-7. doi: 10.1111/1471-0528.13201. Epub 2014 Dec 17. |
| 26352680 | Background | Basraon SK, Mele L, Myatt L, Roberts JM, Hauth JC, Leveno KJ, Varner MW, Wapner RJ, Thorp JM Jr, Peaceman AM, Ramin SM, Sciscione A, Tolosa JE, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Relationship of Early Pregnancy Waist-to-Hip Ratio versus Body Mass Index with Gestational Diabetes Mellitus and Insulin Resistance. Am J Perinatol. 2016 Jan;33(1):114-21. doi: 10.1055/s-0035-1562928. Epub 2015 Sep 9. |
| 26788786 | Background | McDonnold M, Mele LM, Myatt L, Hauth JC, Leveno KJ, Reddy UM, Mercer BM; Eunice Kennedy Shriver National Institute of Child Health Human Development Maternal-Fetal Medicine Units (MFMU) Network. Waist-to-Hip Ratio versus Body Mass Index as Predictor of Obesity-Related Pregnancy Outcomes. Am J Perinatol. 2016 May;33(6):618-24. doi: 10.1055/s-0035-1569986. Epub 2016 Jan 20. |
| 27120478 | Background | Hughes BL, Clifton RG, Hauth JC, Leveno KJ, Myatt L, Reddy UM, Varner MW, Wapner RJ, Mercer BM, Peaceman AM, Ramin SM, Tolosa JE, Saade G, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Is Mid-trimester Insulin Resistance Predictive of Subsequent Puerperal Infection? A Secondary Analysis of Randomized Trial Data. Am J Perinatol. 2016 Aug;33(10):983-90. doi: 10.1055/s-0036-1583188. Epub 2016 Apr 27. |
| 27398706 | Background | Silver RM, Myatt L, Hauth JC, Leveno KJ, Peaceman AM, Ramin SM, Samuels P, Saade G, Sorokin Y, Clifton RG, Reddy UM. Cell-Free Total and Fetal DNA in First Trimester Maternal Serum and Subsequent Development of Preeclampsia. Am J Perinatol. 2017 Jan;34(2):191-198. doi: 10.1055/s-0035-1570383. Epub 2016 Jul 11. |
| 29190847 | Background | Tita AT, Doherty L, Roberts JM, Myatt L, Leveno KJ, Varner MW, Wapner RJ, Thorp JM Jr, Mercer BM, Peaceman A, Ramin SM, Carpenter MW, Iams J, Sciscione A, Harper M, Tolosa JE, Saade GR, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Adverse Maternal and Neonatal Outcomes in Indicated Compared with Spontaneous Preterm Birth in Healthy Nulliparas: A Secondary Analysis of a Randomized Trial. Am J Perinatol. 2018 Jun;35(7):624-631. doi: 10.1055/s-0037-1608787. Epub 2017 Nov 30. |
| 20375405 | Result | Roberts JM, Myatt L, Spong CY, Thom EA, Hauth JC, Leveno KJ, Pearson GD, Wapner RJ, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Carpenter MW, Samuels P, Sciscione A, Harper M, Smith WJ, Saade G, Sorokin Y, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Vitamins C and E to prevent complications of pregnancy-associated hypertension. N Engl J Med. 2010 Apr 8;362(14):1282-91. doi: 10.1056/NEJMoa0908056. |
| 20733448 | Result | Hauth JC, Clifton RG, Roberts JM, Spong CY, Myatt L, Leveno KJ, Pearson GD, Varner MW, Thorp JM Jr, Mercer BM, Peaceman AM, Ramin SM, Sciscione A, Harper M, Tolosa JE, Saade G, Sorokin Y, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units Network (MFMU). Vitamin C and E supplementation to prevent spontaneous preterm birth: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):653-658. doi: 10.1097/AOG.0b013e3181ed721d. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Vitamin Supplements | 1000mg of Vitamin C and 400IU of Vitamin E per capsule, twice daily between randomization (at 9 to 16 weeks) up to delivery. |
| BG001 | Placebo for Vitamins C and 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Race or ethnic group was self-reported. | Count of Participants | Participants |
| |||||||||||||||
| Week of pregnancy at randomization | Mean | Standard Deviation | weeks |
| |||||||||||||||
| <13th week of pregnancy at randomization | Count of Participants | Participants |
| ||||||||||||||||
| Prepregnancy body-mass index | The body-mass index is the weight in kilograms divided by the square of the height in meters. Prepregnancy weight used to calculate body-mass index was self-reported. Values were unavailable for 99 women in the vitamin group and 111 in the placebo group. | Mean | Standard Deviation | kg/m2 |
| ||||||||||||||
| Smoker | Count of Participants | Participants |
| ||||||||||||||||
| Educational level | Mean | Standard Deviation | year |
| |||||||||||||||
| Use of prenatal vitamins or multivitamins | Count of Participants | Participants |
| ||||||||||||||||
| Daily dose of vitamin C | Median | Inter-Quartile Range | mg |
| |||||||||||||||
| Daily dose of vitamin E | Median | Inter-Quartile Range | IU |
| |||||||||||||||
| Previous pregnancy | Count of Participants | Participants |
| ||||||||||||||||
| Family history of preeclampsia | Family history is based on self-reported preeclampsia in a first-degree relative (mother, sister, or grandmother). | Count of Participants | Participants |
| |||||||||||||||
| Blood pressure | Mean | Standard Deviation | mm Hg |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate | Severe hypertension (blood pressure [BP]>= 160/110) or mild hypertension (BP>= 140/90) >= 20 weeks gestation in conjunction with one of the following: elevated liver enzymes, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, an indicated preterm birth before 32 weeks of gestation owing to hypertension-related disorders, a fetus that was small for gestational age (below 3rd percentile) adjusted for sex and race or ethnic group, fetal death after 20 weeks of gestation, or neonatal death | The analysis was intent to treat. | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Primary | Severe Hypertension | Included here are women who had severe hypertension only and those who had severe hypertension with elevated liver enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, medically indicated preterm birth, fetal-growth restriction, or fetal death after 20 weeks of gestation, or neonatal death. | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Primary | Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels | Elevated liver enzyme levels are specified as an aspartate aminotransferase level of >= 100 U per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Primary | Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia | Thrombocytopenia defined as a platelet count of <100,000 per cubic millimeter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | Posted | Number | participants | 20 weeks through discharge following delivery |
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| Primary | Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level | Elevated serum creatinine defined as ≥1.5 mg per deciliter or 132.6 μmol per liter. Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Primary | Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure | Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Primary | Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders | Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| 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 | Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Primary | Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death | Women who met more than one component of the primary outcome were counted for each component. Therefore, the number of women for all individual components combined is greater than the number of women with the primary outcome. | Posted | Count of Participants | Participants | 20 weeks through discharge or prior to discharge following delivery admission |
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| Secondary | Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia) | HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count. | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Secondary | Pregnancy Associated Hypertension | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Secondary | Medically Indicated Delivery Because of Hypertension | Posted | Count of Participants | Participants | 20 weeks through discharge following delivery |
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| Secondary | Aspartate Aminotransferase ≥100 U/Liter | Posted | Count of Participants | Participants | 20 weeks through discharge |
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| Secondary | Creatinine ≥1.5 mg/dl (133 μmol/Liter) | Posted | Count of Participants | Participants | 20 weeks through discharge |
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| Secondary | Antepartum Bleeding | Posted | Count of Participants | Participants | During pregnancy |
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| Secondary | Premature Rupture of Membranes | Posted | Count of Participants | Participants | During pregnancy |
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| Secondary | Placental Abruption | Posted | Count of Participants | Participants | During pregnancy |
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| Secondary | Cesarean Delivery | Posted | Count of Participants | Participants | Delivery |
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| Secondary | Maternal Death | One maternal death in each group due to peripartum cardiomyopathy. | Posted | Count of Participants | Participants | Delivery through hospital discharge |
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| Secondary | Postpartum Pulmonary Edema | Posted | Count of Participants | Participants | After delivery through discharge |
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| Secondary | Hematocrit ≤24% With Transfusion | Posted | Count of Participants | Participants | Delivery admission to discharge |
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| Secondary | Maternal Hospital Stay | Posted | Median | Inter-Quartile Range | days | Delivery through discharge |
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| Secondary | Gestational Age at Delivery | Posted | Median | Standard Deviation | weeks | Delivery |
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| Secondary | Preterm Birth | Posted | Count of Participants | Participants | Delivery |
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| Secondary | Fetal or Neonatal Death | Posted | Count of Participants | Participants | During pregnancy or thorugh discharge |
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| Secondary | Birth Weight | Liveborn infants | Posted | Mean | Standard Deviation | grams | At birth |
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| Secondary | Small for Gestational Age | A baby whose birth weight is less than the 3rd percentile is considered to be small for gestational age (adjusted for sex and race or ethnic group) | Live born infants | Posted | Count of Participants | Participants | At birth |
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| Secondary | Birth Weight <2500 Grams | Live born infants | Posted | Count of Participants | Participants | At birth |
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| Secondary | Admission to NICU | NICU denotes neonatal intensive care unit. | Live born infants | Posted | Count of Participants | Participants | Delivery through discharge |
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| Secondary | Respiratory Distress Syndrome | Live born infants | Posted | Count of Participants | Participants | Delivery through discharge |
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| Secondary | Intraventricular Hemorrhage, Grade III or IV | Live born infants | Posted | Count of Participants | Participants | Delivery through discharge |
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| Secondary | Sepsis | Live born infants | Posted | Count of Participants | Participants | Delivery through discharge |
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| Secondary | Necrotizing Enterocolitis | Live born infants | Posted | Count of Participants | Participants | Delivery through discharge |
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| Secondary | Retinopathy of Prematurity | Live born infants | Posted | Count of Participants | Participants | Within 1 month of birth |
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| Secondary | Apgar Score <=3 at 5 Minutes | Posted | Number | participants | At birth |
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| Secondary | Neonatal Hospital Stay | Live born infants | Posted | Median | Inter-Quartile Range | days | Birth through discharge from hospital |
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| Post-Hoc | Analysis of Primary Composite Outcome in Participants Randomized on or After the 13th Week of Pregnancy | Subgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized on or after the 13th week of pregnancy. | Posted | Count of Participants | Participants | During pregnancy |
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| Post-Hoc | Analysis of Primary Composite Outcome in Participants Randomized Before the 13th Week of Pregnancy | Subgroup analysis of the primary composite outcome (severe pregnancy associated hypertension or severe or mild hypertension with elevated liver-enzyme levels, thrombocytopenia, elevated serum creatinine levels, eclamptic seizure, indicated preterm birth, fetal-growth restriction or prenatal death) in participants who were randomized before the 13th week of pregnancy. | Posted | Count of Participants | Participants | During pregnancy |
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Adverse event data was collected beginning with enrollment (between 9 weeks 0 days gestation and 16 weeks 6 days gestation) through the duration of the pregnancy, delivery, and hospital discharge for the mother and baby. This time period varies by participant and may cover anywhere from 9 weeks gestation to 42 weeks gestation.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamins | Vitamins C & E | 1 | 5,087 | 108 | 5,087 | 0 | 5,087 |
| EG001 | Placebo | Mineral Oil, Hydrogenated Vegetable Oil, Lecithin, Yellow wax, Soft Gelatin Shell | 1 | 5,065 | 173 | 5,065 | 0 | 5,065 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripartum Cardiomyopathy | Cardiac disorders | Non-systematic Assessment | Peripartum Cardiomyopathy resulting in death. |
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| Fetal Death | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Miscarriage, stillbirth, abortion |
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| Bleeding | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Placental abruption, vaginal bleeding |
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| Renal and Urinary disorders | Renal and urinary disorders | Non-systematic Assessment | Pyelonephritis and Urinary Tract Infection |
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| Hemorrhage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Postpartum hemorrhage, blood transfusion, hysterectomy |
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| Infection | Infections and infestations | Non-systematic Assessment | Group A strep sepsis, bacterial/ viral meningitis, cellulitis, sepsis, bacterial infection |
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| Respiratory distress/pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| DVT/PE | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Deep vein thrombosis, pulmonary embolism |
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| Colon resection | Surgical and medical procedures | Non-systematic Assessment |
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| Hodgkin's disease | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
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| Fetal birth defects | Congenital, familial and genetic disorders | Non-systematic Assessment |
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| Fetal atrial flutter/arrythmia/bradycardia | Congenital, familial and genetic disorders | Non-systematic Assessment |
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| Neonatal death | General disorders | Non-systematic Assessment |
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| Infant Seizures | Nervous system disorders | Systematic Assessment |
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| Birth injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Infant low platelet count | Blood and lymphatic system disorders | Systematic Assessment |
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| Infant - Soft Tissue Mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Umbilical hernia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypoxic Events | Nervous system disorders | Systematic Assessment | Hypoxic birth injury, hypoxic ischemic encephalopathy, ischemic stroke |
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Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Roberts | Dept of Obstetrics and Gynecology, University of Pittsburgh | 412-641-1427 | RSIJMR@mwri.magee.edu |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D014815 | Vitamins |
| D001205 | Ascorbic Acid |
| D024502 | alpha-Tocopherol |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D024505 | Tocopherols |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
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