The Effects of Aspirin in Gestation and Reproduction

NCT00467363 | Completed Results DMC

• 1 other identifier: EAGeR
• Study Type: interventional
• Target: 1,228
• Locations: 1 country
• Sites: 4

Brief Summary

The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.

Conditions

Birth; Spontaneous Abortion

Outcome Measures

Primary Outcomes (1)

• Live Birth

  Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .

  after delivery

Secondary Outcomes (14)

• hCG Recognized Pregnancy

  within 8-weeks of gestation

• Clinically Recognized Pregnancy

  8-weeks

• Early Pregnancy Loss (EPL)

  8 weeks

• Pregnancy Losses Occurring Less Than 10 Weeks

  less than 10-weeks

• Fetal Pregnancy Loss

  until 40 weeks

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

81mg of low-dose aspirin plus 400micrograms of folic acid.

Drug: acetylsalicylic-acid (aspirin)

Placebo

PLACEBO COMPARATOR

400micrograms of folic acid.

Dietary Supplement: Folic acid

Interventions

acetylsalicylic-acid (aspirin) DRUG

81mg of low-dose aspirin plus 400micrograms of folic acid.

Also known as: aspirin

Aspirin

Folic acid DIETARY_SUPPLEMENT

400micrograms of folic acid.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women experiencing one or two pregnancy losses at any point in gestation in the past that were not elective termination(s). At least one of these losses must be well documented by one of the following:
• Sonogram demonstrating anembryonic loss, embryonic loss or fetal death.
• Histologic confirmation of products of conception that were spontaneously passed per vagina or surgically obtained.
• Hospital records of fetus delivery.
• Late menses and positive serum hCG or positive urine hCG documented by hospital or clinic records followed by either a negative hospital/clinic pregnancy test or a decline in urinary hCG level over 3 days.
• Home pregnancy tests without hCG confirmation from a healthcare provider (either serum or urine) will not be accepted.
• No more than 5 pregnancies in total including the pregnancy loss(es).\*
• Up to two prior pregnancies that did not end in a loss.\*
• \*Women may have up to two pregnancies beyond 20 weeks that were not losses, two spontaneous pregnancy losses at any time in the past, and up to one therapeutic or elective termination (two therapeutic or elective terminations if no other pregnancies). Ectopic and molar pregnancies would, for the purpose of enrollment, be considered in the same category as therapeutic termination pregnancies. Women with more than two live births or those with more than two losses, regardless of the week of gestation of the loss, are excluded.
• Presence of intact tubes (both), ovaries (both), and uterus.
• Between 18 and 40 years of age at time of baseline visit.
• Regular menstrual periods between 21 - 42 days in length (within the last 12 months). Regular menstrual periods are defined as no more than an 8-day difference between the woman's shortest and longest cycle.
• No more than one missed menses in the past 12 months (other than those missed due to pregnancy or breastfeeding).
• Actively trying to conceive with a male partner and not using contraception by the baseline visit.
• Not currently pregnant at the baseline or randomization visits.

You may not qualify if:

• Currently undergoing/planned use of assisted reproductive techniques during trial (IVF; IUI; Clomid).
• History of infertility or sub-fertility. This includes any of the following:
• No conception after ≥ 1 year of unprotected intercourse and actively trying to conceive.
• Any prior medical treatment for infertility.
• Prior treatment for known pelvic inflammatory disease.
• Known male infertility or sperm abnormality (current partner).
• Known tubal occlusion, anovulation, uterine abnormality, or endometriosis stage III or IV.
• History of polycystic ovarian syndrome.
• Presence of unstable mental disorder. These include bipolar illness, schizophrenia, uncontrolled depression, uncontrolled anxiety disorder.
• Known current or recent alcohol abuse or illicit drug use.

Sponsors & Collaborators

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

Study Sites (4)

University of Colorado, Denver School of Medicine, Department of Obstetrics and Gynecology

Denver, Colorado, 80045, United States

Location

Women's Health Research Center, Department of Social and Preventive Medicine, University at Buffalo

Buffalo, New York, 14260, United States

Location

Moses Taylor Hospital

Scranton, Pennsylvania, 18510, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84112, United States

Location

Related Publications (42)

• Lee IT, Barnhart KT, Hwang WT, Hinkle SN, Johnstone E, Mills JL, Caniglia EC, Schisterman EF, Mendola P, Ryan GL, Hotaling J, Peterson CM, Van Voorhis BJ, Mumford SL. Association between markers of female adiposity and live birth among patients undergoing fertility treatment or attempting unassisted conception. Hum Reprod. 2025 Sep 1;40(9):1671-1680. doi: 10.1093/humrep/deaf124.

  PMID: 40605077 DERIVED

• Freeman JR, Whitcomb BW, Bertone-Johnson ER, O'Brien LM, Dunietz GL, Purdue-Smithe AC, Kim K, Silver RM, Schisterman EF, Mumford SL. Preconception sleep, pregnancy loss, and adverse pregnancy outcomes among women with a history of pregnancy loss. Hum Reprod. 2025 Jul 1;40(7):1366-1376. doi: 10.1093/humrep/deaf074.

  PMID: 40267399 DERIVED

• Freeman JR, Whitcomb BW, Bertone-Johnson ER, O'Brien LM, Dunietz GL, Purdue-Smithe AC, Kim K, Silver RM, Schisterman EF, Mumford SL. Sleep characteristics in association with risk of sporadic anovulation among eumenorrheic women. Chronobiol Int. 2025 Apr;42(4):500-510. doi: 10.1080/07420528.2025.2481165. Epub 2025 Mar 31.

  PMID: 40162646 DERIVED

• Nobles CJ, Mendola P, Kim K, Pollack AZ, Mumford SL, Perkins NJ, Silver RM, Schisterman EF. Preconception Phthalate Exposure and Women's Reproductive Health: Pregnancy, Pregnancy Loss, and Underlying Mechanisms. Environ Health Perspect. 2023 Dec;131(12):127013. doi: 10.1289/EHP12287. Epub 2023 Dec 13.

  PMID: 38088888 DERIVED

• Nobles CJ, Mendola P, Mumford SL, Silver RM, Kim K, Perkins NJ, Schisterman EF. The Relationship of Preconception and Early Pregnancy Isoprostanes with Fecundability and Pregnancy Loss. Epidemiology. 2023 Sep 1;34(5):759-766. doi: 10.1097/EDE.0000000000001631. Epub 2023 Jul 31.

  PMID: 37255247 DERIVED

• Freeman JR, Whitcomb BW, Bertone-Johnson ER, Balzer LB, O'Brien LM, Dunietz GL, Purdue-Smithe AC, Kim K, Silver RM, Schisterman EF, Mumford SL. Preconception sleep duration, sleep timing, and shift work in association with fecundability and live birth among women with a history of pregnancy loss. Fertil Steril. 2023 Feb;119(2):252-263. doi: 10.1016/j.fertnstert.2022.10.026. Epub 2022 Dec 29.

  PMID: 36586812 DERIVED

• Schliep KC, Hinkle SN, Kim K, Sjaarda LA, Silver RM, Stanford JB, Purdue-Smithe A, Plowden TC, Schisterman EF, Mumford SL. Prospectively assessed perceived stress associated with early pregnancy losses among women with history of pregnancy loss. Hum Reprod. 2022 Sep 30;37(10):2264-2274. doi: 10.1093/humrep/deac172.

  PMID: 35972454 DERIVED

• Zolton JR, Sjaarda LA, Mumford SL, Holland TL, Kim K, Flannagan KS, Yisahak SF, Hinkle SN, Connell MT, White MV, Perkins NJ, Silver RM, Hill MJ, DeCherney AH, Schisterman EF. Preconception hemoglobin A1c concentration in healthy women is not associated with fecundability or pregnancy loss. F S Rep. 2022 Jan 20;3(1):39-46. doi: 10.1016/j.xfre.2022.01.002. eCollection 2022 Mar.

  PMID: 35386497 DERIVED

• Zhong Y, Brooks MM, Kennedy EH, Bodnar LM, Naimi AI. Use of Machine Learning to Estimate the Per-Protocol Effect of Low-Dose Aspirin on Pregnancy Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e2143414. doi: 10.1001/jamanetworkopen.2021.43414.

  PMID: 35262718 DERIVED

• Purdue-Smithe AC, Kim K, Schliep KC, DeVilbiss EA, Hinkle SN, Ye A, Perkins NJ, Sjaarda LA, Silver RM, Schisterman EF, Mumford SL. Preconception caffeine metabolites, caffeinated beverage intake, and fecundability. Am J Clin Nutr. 2022 Apr 1;115(4):1227-1236. doi: 10.1093/ajcn/nqab435.

  PMID: 35030239 DERIVED

• Purdue-Smithe AC, Kim K, Andriessen VC, Pollack AZ, Sjaarda LA, Silver RM, Schisterman EF, Mumford SL. Preconception leukocyte telomere length and pregnancy outcomes among women with demonstrated fecundity. Hum Reprod. 2021 Nov 18;36(12):3122-3130. doi: 10.1093/humrep/deab201.

  PMID: 34477845 DERIVED

• Alkhalaf Z, Kim K, Kuhr DL, Radoc JG, Purdue-Smithe A, Pollack AZ, Yisahak SF, Silver RM, Thoma M, Kissell K, Perkins NJ, Sjaarda LA, Mumford SL. Markers of vitamin D metabolism and premenstrual symptoms in healthy women with regular cycles. Hum Reprod. 2021 Jun 18;36(7):1808-1820. doi: 10.1093/humrep/deab089.

  PMID: 33864070 DERIVED

• Naimi AI, Perkins NJ, Sjaarda LA, Mumford SL, Platt RW, Silver RM, Schisterman EF. The Effect of Preconception-Initiated Low-Dose Aspirin on Human Chorionic Gonadotropin-Detected Pregnancy, Pregnancy Loss, and Live Birth : Per Protocol Analysis of a Randomized Trial. Ann Intern Med. 2021 May;174(5):595-601. doi: 10.7326/M20-0469. Epub 2021 Jan 26.

  PMID: 33493011 DERIVED

• Mumford SL, Flannagan KS, Radoc JG, Sjaarda LA, Zolton JR, Metz TD, Plowden TC, Perkins NJ, DeVilbiss EA, Andriessen VC, A C PS, Kim K, Yisahak SF, Freeman JR, Alkhalaf Z, Silver RM, Schisterman EF. Cannabis use while trying to conceive: a prospective cohort study evaluating associations with fecundability, live birth and pregnancy loss. Hum Reprod. 2021 Apr 20;36(5):1405-1415. doi: 10.1093/humrep/deaa355.

  PMID: 33421071 DERIVED

• Flannagan KS, Mumford SL, Sjaarda LA, Radoc JG, Perkins NJ, Andriessen VC, Zolton JR, Silver RM, Schisterman EF. Is opioid use safe in women trying to conceive? Epidemiology. 2020 Nov;31(6):844-851. doi: 10.1097/EDE.0000000000001247.

  PMID: 33311959 DERIVED

• Sjaarda LA, Radoc JG, Flannagan KS, Mumford SL, Kim K, Perkins NJ, Silver RM, Schisterman EF. Urinary selective serotonin reuptake inhibitors across critical windows of pregnancy establishment: a prospective cohort study of fecundability and pregnancy loss. Fertil Steril. 2020 Dec;114(6):1278-1287. doi: 10.1016/j.fertnstert.2020.06.037. Epub 2020 Oct 14.

  PMID: 33066974 DERIVED

• Evans MB, Nobles CJ, Kim K, Hill MJ, DeCherney AH, Silver RM, Mumford SL, Sjaarda LA, Perkins NJ, Schisterman EF. Low-dose aspirin in reproductive health: effects on menstrual cycle characteristics. Fertil Steril. 2020 Dec;114(6):1263-1270. doi: 10.1016/j.fertnstert.2020.06.022. Epub 2020 Sep 4.

  PMID: 32896390 DERIVED

• Nobles CJ, Mendola P, Mumford SL, Silver RM, Kim K, Andriessen VC, Connell M, Sjaarda L, Perkins NJ, Schisterman EF. Preconception Blood Pressure and Its Change Into Early Pregnancy: Early Risk Factors for Preeclampsia and Gestational Hypertension. Hypertension. 2020 Sep;76(3):922-929. doi: 10.1161/HYPERTENSIONAHA.120.14875. Epub 2020 Aug 3.

  PMID: 32755413 DERIVED

• Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2.

  PMID: 32358837 DERIVED

• Yeung EH, Guan W, Zeng X, Salas LA, Mumford SL, de Prado Bert P, van Meel ER, Malmberg A, Sunyer J, Duijts L, Felix JF, Czamara D, Hamalainen E, Binder EB, Raikkonen K, Lahti J, London SJ, Silver RM, Schisterman EF. Cord blood DNA methylation reflects cord blood C-reactive protein levels but not maternal levels: a longitudinal study and meta-analysis. Clin Epigenetics. 2020 Apr 30;12(1):60. doi: 10.1186/s13148-020-00852-2.

  PMID: 32354366 DERIVED

• Russo LM, Whitcomb BW, Freeman JR, Mumford SL, Sjaarda LA, Perkins NJ, Schliep KC, Grewal J, Silver RM, Schisterman EF. Physical activity and incidence of subclinical and clinical pregnancy loss: a secondary analysis in the effects of aspirin in gestation and reproduction randomized trial. Fertil Steril. 2020 Mar;113(3):601-608.e1. doi: 10.1016/j.fertnstert.2019.10.027.

  PMID: 32192592 DERIVED

• Robinson SL, Mumford SL, Guan W, Zeng X, Kim K, Radoc JG, Trinh MH, Flannagan K, Schisterman EF, Yeung E. Maternal fatty acid concentrations and newborn DNA methylation. Am J Clin Nutr. 2020 Mar 1;111(3):613-621. doi: 10.1093/ajcn/nqz311.

  PMID: 31858113 DERIVED

• Agrawala S, Sjaarda LA, Omosigho UR, Perkins NJ, Silver RM, Mumford SL, Connell MT, Naimi AI, Halvorson LM, Schisterman EF. Effect of preconception low dose aspirin on pregnancy and live birth according to socioeconomic status: A secondary analysis of a randomized clinical trial. PLoS One. 2019 Apr 18;14(4):e0200533. doi: 10.1371/journal.pone.0200533. eCollection 2019.

  PMID: 30998747 DERIVED

• Mumford SL, Browne RW, Kim K, Nichols C, Wilcox B, Silver RM, Connell MT, Holland TL, Kuhr DL, Omosigho UR, Perkins NJ, Radin R, Sjaarda LA, Schisterman EF. Preconception Plasma Phospholipid Fatty Acids and Fecundability. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4501-4510. doi: 10.1210/jc.2018-00448.

  PMID: 30124893 DERIVED

• Mumford SL, Garbose RA, Kim K, Kissell K, Kuhr DL, Omosigho UR, Perkins NJ, Galai N, Silver RM, Sjaarda LA, Plowden TC, Schisterman EF. Association of preconception serum 25-hydroxyvitamin D concentrations with livebirth and pregnancy loss: a prospective cohort study. Lancet Diabetes Endocrinol. 2018 Sep;6(9):725-732. doi: 10.1016/S2213-8587(18)30153-0. Epub 2018 May 31.

  PMID: 29859909 DERIVED

• Gibbins KJ, Mumford SL, Sjaarda LA, Branch DW, Perkins NJ, Ye A, Schisterman EF, Silver RM. Preconception antiphospholipid antibodies and risk of subsequent early pregnancy loss. Lupus. 2018 Aug;27(9):1437-1445. doi: 10.1177/0961203318776089. Epub 2018 May 17.

  PMID: 29771194 DERIVED

• Russo LM, Whitcomb BW, Mumford SL, Hawkins M, Radin RG, Schliep KC, Silver RM, Perkins NJ, Kim K, Omosigho UR, Kuhr DL, Holland TL, Sjaarda LA, Schisterman EF. A prospective study of physical activity and fecundability in women with a history of pregnancy loss. Hum Reprod. 2018 Jul 1;33(7):1291-1298. doi: 10.1093/humrep/dey086.

  PMID: 29648647 DERIVED

• Nobles CJ, Mendola P, Mumford SL, Naimi AI, Yeung EH, Kim K, Park H, Wilcox B, Silver RM, Perkins NJ, Sjaarda L, Schisterman EF. Preconception Blood Pressure Levels and Reproductive Outcomes in a Prospective Cohort of Women Attempting Pregnancy. Hypertension. 2018 May;71(5):904-910. doi: 10.1161/HYPERTENSIONAHA.117.10705. Epub 2018 Apr 2.

  PMID: 29610265 DERIVED

• Kuhr DL, Sjaarda LA, Alkhalaf Z, Omosigho UR, Connell MT, Silver RM, Kim K, Perkins NJ, Holland TL, Plowden TC, Schisterman EF, Mumford SL. Vitamin D is associated with bioavailability of androgens in eumenorrheic women with prior pregnancy loss. Am J Obstet Gynecol. 2018 Jun;218(6):608.e1-608.e6. doi: 10.1016/j.ajog.2018.03.012. Epub 2018 Mar 13.

  PMID: 29548752 DERIVED

• Sjaarda LA, Mumford SL, Kuhr DL, Holland TL, Silver RM, Plowden TC, Perkins NJ, Schisterman EF. Association of testosterone and antimullerian hormone with time to pregnancy and pregnancy loss in fecund women attempting pregnancy. Fertil Steril. 2018 Mar;109(3):540-548.e1. doi: 10.1016/j.fertnstert.2017.11.014. Epub 2018 Feb 7.

  PMID: 29428315 DERIVED

• Radin RG, Sjaarda LA, Silver RM, Nobles CJ, Mumford SL, Perkins NJ, Wilcox BD, Pollack AZ, Schliep KC, Plowden TC, Schisterman EF. C-Reactive protein in relation to fecundability and anovulation among eumenorrheic women. Fertil Steril. 2018 Feb;109(2):232-239.e1. doi: 10.1016/j.fertnstert.2017.10.025. Epub 2018 Jan 6.

  PMID: 29317123 DERIVED

• Plowden TC, Schisterman EF, Sjaarda LA, Perkins NJ, Silver R, Radin R, Kim K, Galai N, DeCherney AH, Mumford SL. Thyroid-stimulating hormone, anti-thyroid antibodies, and pregnancy outcomes. Am J Obstet Gynecol. 2017 Dec;217(6):697.e1-697.e7. doi: 10.1016/j.ajog.2017.09.001. Epub 2017 Sep 14.

  PMID: 28917612 DERIVED

• Pugh SJ, Schisterman EF, Browne RW, Lynch AM, Mumford SL, Perkins NJ, Silver R, Sjaarda L, Stanford JB, Wactawski-Wende J, Wilcox B, Grantz KL. Preconception maternal lipoprotein levels in relation to fecundability. Hum Reprod. 2017 May 1;32(5):1055-1063. doi: 10.1093/humrep/dex052.

  PMID: 28333301 DERIVED

• Sjaarda LA, Radin RG, Silver RM, Mitchell E, Mumford SL, Wilcox B, Galai N, Perkins NJ, Wactawski-Wende J, Stanford JB, Schisterman EF. Preconception Low-Dose Aspirin Restores Diminished Pregnancy and Live Birth Rates in Women With Low-Grade Inflammation: A Secondary Analysis of a Randomized Trial. J Clin Endocrinol Metab. 2017 May 1;102(5):1495-1504. doi: 10.1210/jc.2016-2917.

  PMID: 28323989 DERIVED

• Radin RG, Sjaarda LA, Perkins NJ, Silver RM, Chen Z, Lesher LL, Galai N, Wactawski-Wende J, Mumford SL, Schisterman EF. Low-Dose Aspirin and Sporadic Anovulation in the EAGeR Randomized Trial. J Clin Endocrinol Metab. 2017 Jan 1;102(1):86-92. doi: 10.1210/jc.2016-2095.

  PMID: 27754808 DERIVED

• Hinkle SN, Mumford SL, Grantz KL, Silver RM, Mitchell EM, Sjaarda LA, Radin RG, Perkins NJ, Galai N, Schisterman EF. Association of Nausea and Vomiting During Pregnancy With Pregnancy Loss: A Secondary Analysis of a Randomized Clinical Trial. JAMA Intern Med. 2016 Nov 1;176(11):1621-1627. doi: 10.1001/jamainternmed.2016.5641.

  PMID: 27669539 DERIVED

• Zarek SM, Mitchell EM, Sjaarda LA, Mumford SL, Silver RM, Stanford JB, Galai N, Schliep KC, Radin RG, Plowden TC, DeCherney AH, Schisterman EF. Antimullerian hormone and pregnancy loss from the Effects of Aspirin in Gestation and Reproduction trial. Fertil Steril. 2016 Apr;105(4):946-952.e2. doi: 10.1016/j.fertnstert.2015.12.003. Epub 2015 Dec 17.

  PMID: 26707905 DERIVED

• Zarek SM, Mitchell EM, Sjaarda LA, Mumford SL, Silver RM, Stanford JB, Galai N, White MV, Schliep KC, DeCherney AH, Schisterman EF. Is Anti-Mullerian Hormone Associated With Fecundability? Findings From the EAGeR Trial. J Clin Endocrinol Metab. 2015 Nov;100(11):4215-21. doi: 10.1210/jc.2015-2474. Epub 2015 Sep 25.

  PMID: 26406293 DERIVED

• Radin RG, Mumford SL, Silver RM, Lesher LL, Galai N, Faraggi D, Wactawski-Wende J, Townsend JM, Lynch AM, Simhan HN, Sjaarda LA, Perkins NJ, Zarek SM, Schliep KC, Schisterman EF. Sex ratio following preconception low-dose aspirin in women with prior pregnancy loss. J Clin Invest. 2015 Sep;125(9):3619-26. doi: 10.1172/JCI82357. Epub 2015 Aug 17.

  PMID: 26280577 DERIVED

• Silver RM, Ahrens K, Wong LF, Perkins NJ, Galai N, Lesher LL, Faraggi D, Wactawski-Wende J, Townsend JM, Lynch AM, Mumford SL, Sjaarda L, Schisterman EF. Low-dose aspirin and preterm birth: a randomized controlled trial. Obstet Gynecol. 2015 Apr;125(4):876-884. doi: 10.1097/AOG.0000000000000736.

  PMID: 25751215 DERIVED

• Schisterman EF, Mumford SL, Schliep KC, Sjaarda LA, Stanford JB, Lesher LL, Wactawski-Wende J, Lynch AM, Townsend JM, Perkins NJ, Zarek SM, Tsai MY, Chen Z, Faraggi D, Galai N, Silver RM. Preconception low dose aspirin and time to pregnancy: findings from the effects of aspirin in gestation and reproduction randomized trial. J Clin Endocrinol Metab. 2015 May;100(5):1785-91. doi: 10.1210/jc.2014-4179. Epub 2015 Feb 24.

  PMID: 25710565 DERIVED

• Schisterman EF, Silver RM, Lesher LL, Faraggi D, Wactawski-Wende J, Townsend JM, Lynch AM, Perkins NJ, Mumford SL, Galai N. Preconception low-dose aspirin and pregnancy outcomes: results from the EAGeR randomised trial. Lancet. 2014 Jul 5;384(9937):29-36. doi: 10.1016/S0140-6736(14)60157-4. Epub 2014 Apr 2.

  PMID: 24702835 DERIVED

Related Links

• EAGeR Trial Home Page

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Aspirin; Folic Acid

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Enrique Schisterman
• Organization: NICHD

schistee@mail.nih.gov

(301) 435-6893

Study Officials

• Enrique F Schisterman, PhD

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

  PRINCIPAL INVESTIGATOR

• Jean Wactawski-Wende, PhD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Robert Silver, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Noya Galai, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

• Janet Townsend, M.D.

  The Commonwealth Medical College

  PRINCIPAL INVESTIGATOR

• Anne Lynch, M.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief and Senior Investigator

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 3, 2017
• Results First Posted: May 14, 2014

Record last verified: 2016-12

Locations

US (4)