BirthEAGeRNCT00467363
The Effects of Aspirin in Gestation and Reproduction
A study testing acetylsalicylic-acid (aspirin) and Folic acid in people with Birth and Spontaneous Abortion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth, Spontaneous Abortion
- What is being tested?
- acetylsalicylic-acid (aspirin) and Folic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,228 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 35Show fewer
- 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.
- Ability and willingness to give informed consent.
- Willingness to be randomized and to take daily study pills for 6 months to a possible 15 months
- Exclusions Criteria:
- Known allergies to aspirin or non-steroidal anti-inflammatory agents.
- Clinical indication for anticoagulant therapy. These include prior or current thrombosis, antiphospholipid syndrome (APS) or known major thrombophilia.
- Clinical indication for chronic use of NSAIDs such as rheumatoid arthritis.
- Indication for additional folic acid supplementation, such as prior infant with neural tube defect (NTD), seizure disorder.
- Medical contraindication to aspirin therapy. These include uncontrolled asthma, nasal polyps, bleeding disorders, or history of gastrointestinal ulcer.
- Presence of major medical disorders (regardless of severity). These include diabetes, hypertension, systemic lupus erythematosus (SLE), untreated or active cancer (any cancer in remission or non-melanoma skin cancer is not included in the exclusion criteria), liver disease, renal disease, rheumatoid arthritis, cardiac disease, pulmonary disease other than mild asthma, neurologic disease requiring medical treatment, uncontrolled hypothyroidism, uncontrolled seizure disorder. Untreated vitamin B12 deficiency, severe anemia (Hct < 30%), hemophilia, gout, nasal polyps, among others.
- 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.
- Current diagnosis of sexually transmitted infection (STI) (temporary exclusion)
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Women's Health Research Center, Department of Social and Preventive Medicine, University at Buffalo
Buffalo, New York, 14260
University of Colorado, Denver School of Medicine, Department of Obstetrics and Gynecology
Denver, Colorado, 80045
University of Utah Medical Center
Salt Lake City, Utah, 84112
Moses Taylor Hospital
Scranton, Pennsylvania, 18510
About this study
Official title: The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.
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.
Read the detailed description
Despite the fundamental nature of reproduction, for many it is a process fraught with frustration, inefficiency and imperfections, the effects of which can be severe. Infertility affects 10-15% of couples attempting to conceive. Among all women who conceive, the incidence of spontaneous abortion (SA) has been estimated to be between 15 and 31%, and in many cases the cause is unknown. Additionally, of the four million births yearly in the United States, between 8 and 15% will be born prematurely and experience increased morbidity and mortality as a result. An intervention with even a small absolute effect on any of these outcomes has great implications at the population level due to the large potential attributable benefit.
One such potential intervention is low-dose acetylsalicylic-acid (aspirin). Aspirin has been a primary target of interest because of its anti-inflammatory, vasodilatory and platelet aggregation inhibition properties. To evaluate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortion, we are conducting a multi-site randomized controlled trial study with two sites and one data coordinating center. Women aged 18-40 currently trying to become pregnant and who have had a single spontaneous abortion in the past year will be eligible for the study. The recruitment goal is 1600 women. Participating women will be randomly assigned to one of two treatment groups. Those randomized to treatment will receive daily low-dose aspirin. Those randomized to placebo will receive daily placebo. Both groups will receive folic acid daily in accordance with recommendations from the U.S. Public Health Service for prevention of birth defects. The duration of treatment regimens (LDA and folic acid or placebo and folic acid) will be 6 menstrual cycles, with those who become pregnant continuing until the end of pregnancy. Monthly urine and blood samples will be collected and questionnaires administered.
- Conditions
- Birth, Spontaneous Abortion
- Being tested
- acetylsalicylic-acid (aspirin), Folic acid
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetylsalicylic-acid (aspirin)Drug
Also called aspirin
81mg of low-dose aspirin plus 400micrograms of folic acid.
Folic acidDietary supplement
400micrograms of folic acid.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | 81mg of low-dose aspirin plus 400micrograms of folic acid. Receives: Drug: acetylsalicylic-acid (aspirin) |
| Placebo | Placebo comparator | 400micrograms of folic acid. Receives: Dietary Supplement: Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .
Measured: after delivery
Secondary outcomes (14)
hCG Recognized Pregnancy
Measured: within 8-weeks of gestation
Clinically Recognized Pregnancy
Measured: 8-weeks
Early Pregnancy Loss (EPL)
Implantation failures
Measured: 8 weeks
Pregnancy Losses Occurring Less Than 10 Weeks
Includes preembryonic and embryonic losses (exclusive of implantation failures)
Measured: less than 10-weeks
Fetal Pregnancy Loss
Measured: until 40 weeks
Stillbirth
Measured: 40 weeks
Ectopic Pregnancy
Measured: within 6 weeks
Molar Pregnancy
Measured: 8 weeks
Preeclampsia
Measured: until delivery
Small for Gestational Age Infant
birthweight
Measured: until delivery
Preterm Birth
Measured: until delivery
Abnormal Fetal Testing
Measured: 8 weeks
Fetal Intolerance of Labor
Measured: until delivery
Abruption
Partial or complete abruption (ie, premature separation of the placenta)
Measured: until delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Enrique Schisterman, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Enrique F Schisterman, PhD, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Jean Wactawski-Wende, PhD, Principal investigator, University at BuffaloRobert Silver, MD, Principal investigator, University of UtahNoya Galai, PhD, Principal investigator, University of HaifaJanet Townsend, M.D., Principal investigator, The Commonwealth Medical CollegeAnne Lynch, M.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467363
- Sponsor's protocol ID
- EAGeR
- Acronym
- EAGeR
- Status last verified
- Dec 2016
- First submitted
- 27 Apr 2007
- Last updated
- 3 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 40605077Freeman 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.
PubMed 40267399Freeman 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.
PubMed 40162646Nobles 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.
PubMed 38088888Nobles 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.
PubMed 37255247Freeman 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.
PubMed 36586812Schliep 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.
PubMed 35972454Zolton 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.
PubMed 35386497Zhong 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.
PubMed 35262718Purdue-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.
PubMed 35030239Purdue-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.
PubMed 34477845Alkhalaf 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.
PubMed 33864070Naimi 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.
PubMed 33493011Mumford 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.
PubMed 33421071Flannagan 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.
PubMed 33311959
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.
- ClinicalTrials.gov ID
- NCT00467363
- Acronym / sponsor ID
- EAGeR / EAGeR
- Conditions
- Birth, Spontaneous Abortion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,228 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jun 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Posted 14 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite the fundamental nature of reproduction, for many it is a process fraught with frustration, inefficiency and imperfections, the effects of which can be severe. Infertility affects 10-15% of couples attempting to conceive. Among all women who conceive, the incidence of spontaneous abortion (SA) has been estimated to be between 15 and 31%, and in many cases the cause is unknown. Additionally, of the four million births yearly in the United States, between 8 and 15% will be born prematurely and experience increased morbidity and mortality as a result. An intervention with even a small absolute effect on any of these outcomes has great implications at the population level due to the large potential attributable benefit.
One such potential intervention is low-dose acetylsalicylic-acid (aspirin). Aspirin has been a primary target of interest because of its anti-inflammatory, vasodilatory and platelet aggregation inhibition properties. To evaluate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortion, we are conducting a multi-site randomized controlled trial study with two sites and one data coordinating center. Women aged 18-40 currently trying to become pregnant and who have had a single spontaneous abortion in the past year will be eligible for the study. The recruitment goal is 1600 women. Participating women will be randomly assigned to one of two treatment groups. Those randomized to treatment will receive daily low-dose aspirin. Those randomized to placebo will receive daily placebo. Both groups will receive folic acid daily in accordance with recommendations from the U.S. Public Health Service for prevention of birth defects. The duration of treatment regimens (LDA and folic acid or placebo and folic acid) will be 6 menstrual cycles, with those who become pregnant continuing until the end of pregnancy. Monthly urine and blood samples will be collected and questionnaires administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: acetylsalicylic-acid (aspirin)81mg of low-dose aspirin plus 400micrograms of folic acid. |
| Placebo | Placebo comparator | Dietary Supplement: Folic acid400micrograms of folic acid. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (35 listed)
- 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:
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetylsalicylic-acid (aspirin)Also: aspirin81mg of low-dose aspirin plus 400micrograms of folic acid. | Drug | Aspirin |
| Folic acid400micrograms of folic acid. | Dietary supplement | Placebo |
Primary outcome
Live Birth
Time frame: after delivery
Live birth was obtained prospectively by maternal report and abstraction from medical records by trained staff .
14 secondary outcomes
hCG Recognized Pregnancy
Time frame: within 8-weeks of gestation
Clinically Recognized Pregnancy
Time frame: 8-weeks
Early Pregnancy Loss (EPL)
Time frame: 8 weeks
Pregnancy Losses Occurring Less Than 10 Weeks
Time frame: less than 10-weeks
Fetal Pregnancy Loss
Time frame: until 40 weeks
Stillbirth
Time frame: 40 weeks
Ectopic Pregnancy
Time frame: within 6 weeks
Molar Pregnancy
Time frame: 8 weeks
Preeclampsia
Time frame: until delivery
Small for Gestational Age Infant
Time frame: until delivery
Preterm Birth
Time frame: until delivery
Abnormal Fetal Testing
Time frame: 8 weeks
Fetal Intolerance of Labor
Time frame: until delivery
Abruption
Time frame: until delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40605077Lee 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.
- Derived from this study: PubMed 40267399Freeman 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.
- Derived from this study: PubMed 40162646Freeman 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.
- Derived from this study: PubMed 38088888Nobles 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.
- Derived from this study: PubMed 37255247Nobles 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.
- Derived from this study: PubMed 36586812Freeman 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.
- Derived from this study: PubMed 35972454Schliep 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.
- Derived from this study: PubMed 35386497Zolton 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.
- Derived from this study: PubMed 35262718Zhong 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.
- Derived from this study: PubMed 35030239Purdue-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.
- Derived from this study: PubMed 34477845Purdue-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.
- Derived from this study: PubMed 33864070Alkhalaf 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.
- EAGeR Trial Home PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique F Schisterman, PhD principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Jean Wactawski-Wende, PhD principal investigator
University at Buffalo
Robert Silver, MD principal investigator
University of Utah
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetylsalicylic-acid (aspirin) and Folic acid in people with Birth and Spontaneous Abortion, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth (time frame: after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00467363, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.