Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS) (CAPPS)

• ClinicalTrials.gov Identifier: NCT00135707
• Recruitment Status: Completed
• First Posted: August 26, 2005
• Results First Posted: November 20, 2018
• Last Update Posted: February 21, 2019
• Sponsor: The George Washington University Biostatistics Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): The George Washington University Biostatistics Center

Study Description

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 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).

Condition or disease	Intervention/treatment	Phase
Preeclampsia	Drug: Dietary Supplement/Vitamins; Drug: Placebo for Vitamin C and Vitamin E	Phase 3

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia and An Observational Cohort Study to Predict Preeclampsia
• Study Start Date: June 2003
• Actual Primary Completion Date: October 2008
• Actual Study Completion Date: January 2009

Arms and Interventions

Arm	Intervention/treatment
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.; Other Name: Ascorbic Acid and d-alpha-Tocopheryl Acetate
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.

Outcome Measures

Primary Outcome Measures :

1. Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate [ Time Frame: 20 weeks through discharge following delivery ]
   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
2. Severe Hypertension [ Time Frame: 20 weeks through discharge following delivery ]
   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.
3. Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels [ Time Frame: 20 weeks through discharge following delivery ]
   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.
4. Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia [ Time Frame: 20 weeks through discharge following delivery ]
   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.
5. Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level [ Time Frame: 20 weeks through discharge following delivery ]
   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.
6. Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure [ Time Frame: 20 weeks through discharge following delivery ]
   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.
7. Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders [ Time Frame: 20 weeks through discharge following delivery ]
   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.
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 [ Time Frame: 20 weeks through discharge following delivery ]
   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.
9. Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death [ Time Frame: 20 weeks through discharge or prior to discharge following delivery admission ]
   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.

Secondary Outcome Measures :

1. Preeclampsia (Mild, Severe, HELLP Syndrome, Eclampsia) [ Time Frame: 20 weeks through discharge following delivery ]
   HELLP denotes hemolytic anemia, elevated liver enzymes, and low platelet count.
2. Pregnancy Associated Hypertension [ Time Frame: 20 weeks through discharge following delivery ]
3. Medically Indicated Delivery Because of Hypertension [ Time Frame: 20 weeks through discharge following delivery ]
4. Aspartate Aminotransferase ≥100 U/Liter [ Time Frame: 20 weeks through discharge ]
5. Creatinine ≥1.5 mg/dl (133 μmol/Liter) [ Time Frame: 20 weeks through discharge ]
6. Antepartum Bleeding [ Time Frame: During pregnancy ]
7. Premature Rupture of Membranes [ Time Frame: During pregnancy ]
8. Placental Abruption [ Time Frame: During pregnancy ]
9. Cesarean Delivery [ Time Frame: Delivery ]
10. Maternal Death [ Time Frame: Delivery through hospital discharge ]
11. Postpartum Pulmonary Edema [ Time Frame: After delivery through discharge ]
12. Hematocrit ≤24% With Transfusion [ Time Frame: Delivery admission to discharge ]
13. Maternal Hospital Stay [ Time Frame: Delivery through discharge ]
14. Gestational Age at Delivery [ Time Frame: Delivery ]
15. Preterm Birth [ Time Frame: Delivery ]
16. Fetal or Neonatal Death [ Time Frame: During pregnancy or thorugh discharge ]
17. Birth Weight [ Time Frame: At birth ]
18. Small for Gestational Age [ Time Frame: At birth ]
    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)
19. Birth Weight <2500 Grams [ Time Frame: At birth ]
20. Admission to NICU [ Time Frame: Delivery through discharge ]
    NICU denotes neonatal intensive care unit.
21. Respiratory Distress Syndrome [ Time Frame: Delivery through discharge ]
22. Intraventricular Hemorrhage, Grade III or IV [ Time Frame: Delivery through discharge ]
23. Sepsis [ Time Frame: Delivery through discharge ]
24. Necrotizing Enterocolitis [ Time Frame: Delivery through discharge ]
25. Retinopathy of Prematurity [ Time Frame: Within 1 month of birth ]
26. Apgar Score <=3 at 5 Minutes [ Time Frame: At birth ]
27. Neonatal Hospital Stay [ Time Frame: Birth through discharge from hospital ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama - Birmingham

Birmingham, Alabama, United States, 35233

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, Michigan

Wayne State University

Detroit, Michigan, United States, 48201

United States, New York

Columbia University

New York, New York, United States, 10032

United States, North Carolina

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Case Western University

Cleveland, Ohio, United States, 44109

Ohio State University

Columbus, Ohio, United States, 43210

United States, Oregon

Oregon Health and Sciences University

Portland, Oregon, United States, 97239

United States, Pennsylvania

Drexel University

Philadelphia, Pennsylvania, United States, 19107

University of Pittsburgh Magee Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

United States, Rhode Island

Brown University

Providence, Rhode Island, United States, 02905

United States, Texas

University of Texas - Southwest

Dallas, Texas, United States, 75235

University of Texas Medical Branch

Galveston, Texas, United States, 77555

University of Texas - Houston

Houston, Texas, United States, 77030

United States, Utah

University of Utah Medical Center

Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

The George Washington University Biostatistics Center

National Heart, Lung, and Blood Institute (NHLBI)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Study Director: Menachem Miodovnik, MD; NICHD Project Scientist
• Principal Investigator: Rebecca Clifton, Ph.D.; George Washington University Biostatistics Center
• Study Chair: James M Roberts, MD; University of Pittsburgh - Magee Womens

More Information

Additional Information:

The public website of the NICHD Maternal-Fetal Medicine Units (MFMU) Network 

Publications of Results:

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.

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.

Other Publications:

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.

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. Erratum In: Obstet Gynecol. 2012 Sep;120(3):710. Saade, George R [added].

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: The George Washington University Biostatistics Center
• ClinicalTrials.gov Identifier: NCT00135707
• Other Study ID Numbers: HD36801-CAPPS; U10HD021410 ( U.S. NIH Grant/Contract ); U10HD027869 ( U.S. NIH Grant/Contract ); U10HD027917 ( U.S. NIH Grant/Contract ); U10HD027860 ( U.S. NIH Grant/Contract ); U10HD027915 ( U.S. NIH Grant/Contract ); U10HD034116 ( U.S. NIH Grant/Contract ); U10HD034208 ( U.S. NIH Grant/Contract ); U10HD034136 ( U.S. NIH Grant/Contract ); U10HD040500 ( U.S. NIH Grant/Contract ); U10HD040485 ( U.S. NIH Grant/Contract ); U10HD040544 ( U.S. NIH Grant/Contract ); U10HD040545 ( U.S. NIH Grant/Contract ); U10HD040560 ( U.S. NIH Grant/Contract ); U10HD040512 ( U.S. NIH Grant/Contract ); U01HD036801 ( U.S. NIH Grant/Contract ); U10HD053097 ( U.S. NIH Grant/Contract ); U10HD053118 ( U.S. NIH Grant/Contract )
• First Posted: August 26, 2005
• Results First Posted: November 20, 2018
• Last Update Posted: February 21, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.

Keywords provided by The George Washington University Biostatistics Center:

Antioxidants; Preeclampsia; Pregnancy; Hypertension

Additional relevant MeSH terms:

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vitamins; Ascorbic Acid; Vitamin E; alpha-Tocopherol; Micronutrients; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents