Premature BirthASPIRINNCT02409680
Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
A study testing Low dose aspirin in people with Premature Birth, run by NICHD Global Network for Women's and Children's Health at 14 sites in 7 countries.
Trial summary
Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premature Birth
- What is being tested?
- Low dose aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11,976 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 23 Mar 2016to 11 Apr 2019
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous women between 18 - 40 years of age. Minors who are ≥ 14 years of age may be enrolled if permitted by the country's ethical guidelines.
- No more than two previous first trimester pregnancy losses
- No medical contraindications to aspirin;
- Single live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with presence of a heartbeat.
Who cannot join
- Women prescribed daily aspirin for more than 7 days;
- Multiple gestations;
- Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion.);
- Hemoglobin < 7.0 gm/dl at screening;
- Any other medical conditions that may be considered a contraindication per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, or any other known significant disease)
- Blood pressure ≥ 140/90 (Systolic blood pressure ≥ 140 and diastolic ≥ 90 at screening)
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
United States7 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35233
Boston University
Boston, Massachusetts, 02215
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
University of Colorado, Denver
Denver, Colorado, 80045
Indiana University
Indianapolis, Indiana, 46202
Columbia University
New York, New York, 10032
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
India2 sites
KLE University's Jawaharlal Nehru Medical College
Belagavi, Karnataka
Lata Medical Research Foundation
Nagpur
Democratic Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa
Guatemala1 site
Institute of Nutrition of Central America and Panama (INCAP)
Guatemala City, 01015
About this study
Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).
Read the detailed description
Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the developed and developing world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially.
Hypothesis: The investigators' primary hypothesis is that nulliparous women with no more than two previous first trimester pregnancy losses who are treated with LDA daily beginning between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) through 36 0/7 weeks GA will reduce the risk of preterm birth from all causes.
Study Design Type: Prospective randomized, placebo-controlled, double-blinded multicenter clinical trial (patient level 1:1).
Population: Nulliparous women between the ages of 18 (or local age of majority) and 40 with no more than two previous first trimester pregnancy losses or any second trimester spontaneous pregnancy loss, a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks GA confirmed by ultrasound, and no contraindications to aspirin. Other medical conditions, such as sickle-cell anemia, may be considered a contraindication per the judgment of the site investigator.
Intervention: Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA)], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.
Outcomes:
The primary outcome is to determine whether daily LDA initiated between 6 0/7 weeks and 13 6/7 weeks and continued to 36 0/7 weeks reduces the risk of preterm birth (birth prior to 37 0/7 weeks of pregnancy) by 20%. This will be determined based on assessed date of delivery in comparison to the projected estimated date of delivery, independent of whether or not the preterm delivery is indicated or spontaneous.
Secondary outcomes include:
- Preeclampsia and eclampsia (hypertensive disorders of pregnancy)
- Small for gestational age
- Perinatal mortality
Other secondary outcomes of interest are:
Maternal outcomes:
- Vaginal bleeding
- Antepartum hemorrhage
- Postpartum hemorrhage
- Maternal mortality
- Late abortion
- Change in maternal hemoglobin
- Preterm, preeclampsia
Fetal outcomes:
- Preterm birth <34 0/7 weeks of pregnancy
- Birth weight <2500g and <1500g
- Fetal loss
- Spontaneous abortion
- Stillbirth
- Medical termination of pregnancy
- Conditions
- Premature Birth
- Being tested
- Low dose aspirin, Placebo
- Keywords
- Preterm birth, Low dose aspirin
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose aspirinDrug
Also called Acetylsalicylic acid (ASA)
Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | Women will be randomized equally to receive daily low dose aspirin (LDA) [also known as acetylsalicylic acid (ASA)] of 81 mg beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery. Receives: Drug: Low dose aspirin |
| Placebo Arm | Placebo comparator | Women will be randomized equally to receive an identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Preterm Birth
The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous.
Measured: At delivery
Secondary outcomes (3)
Incidence of Hypertensive Disorders of Pregnancy
- Hypertensive disorders of pregnancy is defined by the characterization of evidence of a hypertensive disorder, including either preeclampsia or eclampsia occurring during the pregnancy.
Measured: Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth)
Incidence of Small for Gestational Age (SGA)
- Small for gestational age (SGA) as defined by the INTERGROWTH-21st standard
Measured: At delivery or at Day 42 after delivery
Incidence of Perinatal Mortality
- Incidence of Perinatal Mortality
Measured: At delivery or at Day 42 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start23 Mar 2016
- Primary completion11 Apr 2019
- Study completion11 Apr 2019
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 (68)Papers the sponsor has linked to this study.
- Other trials for Premature 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11,976 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Thomas Jefferson University, Jawaharlal Nehru Medical College
- Responsible party
- Sponsor
- Investigators
- Marion Koso-Thomas, MD, Study director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409680
- Sponsor's protocol ID
- CP ASPIRIN
- Acronym
- ASPIRIN
- Status last verified
- Nov 2024
- First submitted
- 30 Mar 2015
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Abramovici A, Cantu J, Jenkins SM. Tocolytic therapy for acute preterm labor. Obstet Gynecol Clin North Am. 2012 Mar;39(1):77-87. doi: 10.1016/j.ogc.2011.12.003. Epub 2012 Jan 4.
PubMed 22370109Ananth CV, Joseph KS, Oyelese Y, Demissie K, Vintzileos AM. Trends in preterm birth and perinatal mortality among singletons: United States, 1989 through 2000. Obstet Gynecol. 2005 May;105(5 Pt 1):1084-91. doi: 10.1097/01.AOG.0000158124.96300.c7.
PubMed 15863548Anderson RN, Smith BL. Deaths: leading causes for 2001. Natl Vital Stat Rep. 2003 Nov 7;52(9):1-85.
PubMed 14626726Baschat AA, Guclu S, Kush ML, Gembruch U, Weiner CP, Harman CR. Venous Doppler in the prediction of acid-base status of growth-restricted fetuses with elevated placental blood flow resistance. Am J Obstet Gynecol. 2004 Jul;191(1):277-84. doi: 10.1016/j.ajog.2003.11.028.
PubMed 15295379Beck S, Wojdyla D, Say L, Betran AP, Merialdi M, Requejo JH, Rubens C, Menon R, Van Look PF. The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ. 2010 Jan;88(1):31-8. doi: 10.2471/BLT.08.062554. Epub 2009 Sep 25.
PubMed 20428351Becker DM, Segal J, Vaidya D, Yanek LR, Herrera-Galeano JE, Bray PF, Moy TF, Becker LC, Faraday N. Sex differences in platelet reactivity and response to low-dose aspirin therapy. JAMA. 2006 Mar 22;295(12):1420-7. doi: 10.1001/jama.295.12.1420.
PubMed 16551714Bower SJ, Harrington KF, Schuchter K, McGirr C, Campbell S. Prediction of pre-eclampsia by abnormal uterine Doppler ultrasound and modification by aspirin. Br J Obstet Gynaecol. 1996 Jul;103(7):625-9. doi: 10.1111/j.1471-0528.1996.tb09829.x.
PubMed 8688387CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group. Lancet. 1997 Jun 7;349(9066):1641-9.
PubMed 9186381Chavarria ME, Lara-Gonzalez L, Gonzalez-Gleason A, Garcia-Paleta Y, Vital-Reyes VS, Reyes A. Prostacyclin/thromboxane early changes in pregnancies that are complicated by preeclampsia. Am J Obstet Gynecol. 2003 Apr;188(4):986-92. doi: 10.1067/mob.2003.203.
PubMed 12712098Chien PF, Arnott N, Gordon A, Owen P, Khan KS. How useful is uterine artery Doppler flow velocimetry in the prediction of pre-eclampsia, intrauterine growth retardation and perinatal death? An overview. BJOG. 2000 Feb;107(2):196-208. doi: 10.1111/j.1471-0528.2000.tb11690.x.
PubMed 10688503CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. Lancet. 1994 Mar 12;343(8898):619-29.
PubMed 7906809ACOG committee opinion no. 561: Nonmedically indicated early-term deliveries. Obstet Gynecol. 2013 Apr;121(4):911-915. doi: 10.1097/01.AOG.0000428649.57622.a7.
PubMed 23635710Coomarasamy A, Braunholtz D, Song F, Taylor R, Khan KS. Individualising use of aspirin to prevent pre-eclampsia: a framework for clinical decision making. BJOG. 2003 Oct;110(10):882-8. No abstract available.
PubMed 14550356Coomarasamy A, Honest H, Papaioannou S, Gee H, Khan KS. Aspirin for prevention of preeclampsia in women with historical risk factors: a systematic review. Obstet Gynecol. 2003 Jun;101(6):1319-32. doi: 10.1016/s0029-7844(03)00169-8.
PubMed 12798543Duley L, Henderson-Smart DJ, Knight M, King JF. Antiplatelet agents for preventing pre-eclampsia and its complications. Cochrane Database Syst Rev. 2004;(1):CD004659. doi: 10.1002/14651858.CD004659.
PubMed 14974075
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
- ClinicalTrials.gov ID
- NCT02409680
- Acronym / sponsor ID
- ASPIRIN / CP ASPIRIN
- Conditions
- Premature Birth
- Keywords
- Preterm birth, Low dose aspirin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,976 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Thomas Jefferson University, Jawaharlal Nehru Medical College
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Posted 8 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).
Detailed description
Background: Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the developed and developing world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) holds promise to reduce the rate of PTB substantially.
Hypothesis: The investigators' primary hypothesis is that nulliparous women with no more than two previous first trimester pregnancy losses who are treated with LDA daily beginning between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) through 36 0/7 weeks GA will reduce the risk of preterm birth from all causes.
Study Design Type: Prospective randomized, placebo-controlled, double-blinded multicenter clinical trial (patient level 1:1).
Population: Nulliparous women between the ages of 18 (or local age of majority) and 40 with no more than two previous first trimester pregnancy losses or any second trimester spontaneous pregnancy loss, a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks GA confirmed by ultrasound, and no contraindications to aspirin. Other medical conditions, such as sickle-cell anemia, may be considered a contraindication per the judgment of the site investigator.
Intervention: Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA)], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.
Outcomes:
The primary outcome is to determine whether daily LDA initiated between 6 0/7 weeks and 13 6/7 weeks and continued to 36 0/7 weeks reduces the risk of preterm birth (birth prior to 37 0/7 weeks of pregnancy) by 20%. This will be determined based on assessed date of delivery in comparison to the projected estimated date of delivery, independent of whether or not the preterm delivery is indicated or spontaneous.
Secondary outcomes include:
- Preeclampsia and eclampsia (hypertensive disorders of pregnancy)
- Small for gestational age
- Perinatal mortality
Other secondary outcomes of interest are:
Maternal outcomes:
- Vaginal bleeding
- Antepartum hemorrhage
- Postpartum hemorrhage
- Maternal mortality
- Late abortion
- Change in maternal hemoglobin
- Preterm, preeclampsia
Fetal outcomes:
- Preterm birth <34 0/7 weeks of pregnancy
- Birth weight <2500g and <1500g
- Fetal loss
- Spontaneous abortion
- Stillbirth
- Medical termination of pregnancy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Drug: Low dose aspirinWomen will be randomized equally to receive daily low dose aspirin (LDA) [also known as acetylsalicylic acid (ASA)] of 81 mg beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery. |
| Placebo Arm | Placebo comparator | Drug: PlaceboWomen will be randomized equally to receive an identical appearing placebo beginning between 6 0/7 weeks and 13 6/7 weeks GA and continuing until 36 0/7 weeks GA or delivery. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous women between 18 - 40 years of age. Minors who are ≥ 14 years of age may be enrolled if permitted by the country's ethical guidelines.
- No more than two previous first trimester pregnancy losses
- No medical contraindications to aspirin;
- Single live intrauterine pregnancy (IUP) between 6 0/7 and 13 6/7 weeks GA corroborated by an early dating ultrasound and with presence of a heartbeat.
Key exclusion criteria (6 listed)
- Women prescribed daily aspirin for more than 7 days;
- Multiple gestations;
- Fetal anomaly by ultrasound (Note most fetal anomalies are not detectable by ultrasounds done at this early gestation. Subsequent discovery of a fetal anomaly is not viewed as an exclusion.);
- Hemoglobin < 7.0 gm/dl at screening;
- Any other medical conditions that may be considered a contraindication per the judgment of the site investigator (e.g., Lupus, Type 1 Diabetes, or any other known significant disease)
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 |
|---|---|---|
| Low dose aspirinAlso: Acetylsalicylic acid (ASA)Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly. | Drug | Intervention Arm |
| PlaceboPlacebo | Drug | Placebo Arm |
Primary outcome
Incidence of Preterm Birth
Time frame: At delivery
The primary outcome of this study is incidence of preterm birth, which will be defined as delivery at or after 20 0/7 weeks and prior to 37 0/7 weeks. This will be determined based on actual date of delivery in comparison to the projected estimated due date (EDD), independent of whether or not the preterm delivery is indicated or spontaneous.
3 secondary outcomes
Incidence of Hypertensive Disorders of Pregnancy
Time frame: Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth)
Incidence of Small for Gestational Age (SGA)
Time frame: At delivery or at Day 42 after delivery
Incidence of Perinatal Mortality
Time frame: At delivery or at Day 42 after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22370109Abramovici A, Cantu J, Jenkins SM. Tocolytic therapy for acute preterm labor. Obstet Gynecol Clin North Am. 2012 Mar;39(1):77-87. doi: 10.1016/j.ogc.2011.12.003. Epub 2012 Jan 4.
- Background: PubMed 15863548Ananth CV, Joseph KS, Oyelese Y, Demissie K, Vintzileos AM. Trends in preterm birth and perinatal mortality among singletons: United States, 1989 through 2000. Obstet Gynecol. 2005 May;105(5 Pt 1):1084-91. doi: 10.1097/01.AOG.0000158124.96300.c7.
- Background: PubMed 14626726Anderson RN, Smith BL. Deaths: leading causes for 2001. Natl Vital Stat Rep. 2003 Nov 7;52(9):1-85.
- Background: PubMed 15295379Baschat AA, Guclu S, Kush ML, Gembruch U, Weiner CP, Harman CR. Venous Doppler in the prediction of acid-base status of growth-restricted fetuses with elevated placental blood flow resistance. Am J Obstet Gynecol. 2004 Jul;191(1):277-84. doi: 10.1016/j.ajog.2003.11.028.
- Background: PubMed 20428351Beck S, Wojdyla D, Say L, Betran AP, Merialdi M, Requejo JH, Rubens C, Menon R, Van Look PF. The worldwide incidence of preterm birth: a systematic review of maternal mortality and morbidity. Bull World Health Organ. 2010 Jan;88(1):31-8. doi: 10.2471/BLT.08.062554. Epub 2009 Sep 25.
- Background: PubMed 16551714Becker DM, Segal J, Vaidya D, Yanek LR, Herrera-Galeano JE, Bray PF, Moy TF, Becker LC, Faraday N. Sex differences in platelet reactivity and response to low-dose aspirin therapy. JAMA. 2006 Mar 22;295(12):1420-7. doi: 10.1001/jama.295.12.1420.
- Background: PubMed 8688387Bower SJ, Harrington KF, Schuchter K, McGirr C, Campbell S. Prediction of pre-eclampsia by abnormal uterine Doppler ultrasound and modification by aspirin. Br J Obstet Gynaecol. 1996 Jul;103(7):625-9. doi: 10.1111/j.1471-0528.1996.tb09829.x.
- Background: PubMed 9186381CAST: randomised placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. CAST (Chinese Acute Stroke Trial) Collaborative Group. Lancet. 1997 Jun 7;349(9066):1641-9.
- Background: PubMed 12712098Chavarria ME, Lara-Gonzalez L, Gonzalez-Gleason A, Garcia-Paleta Y, Vital-Reyes VS, Reyes A. Prostacyclin/thromboxane early changes in pregnancies that are complicated by preeclampsia. Am J Obstet Gynecol. 2003 Apr;188(4):986-92. doi: 10.1067/mob.2003.203.
- Background: PubMed 10688503Chien PF, Arnott N, Gordon A, Owen P, Khan KS. How useful is uterine artery Doppler flow velocimetry in the prediction of pre-eclampsia, intrauterine growth retardation and perinatal death? An overview. BJOG. 2000 Feb;107(2):196-208. doi: 10.1111/j.1471-0528.2000.tb11690.x.
- Background: PubMed 7906809CLASP: a randomised trial of low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. CLASP (Collaborative Low-dose Aspirin Study in Pregnancy) Collaborative Group. Lancet. 1994 Mar 12;343(8898):619-29.
- Background: PubMed 23635710ACOG committee opinion no. 561: Nonmedically indicated early-term deliveries. Obstet Gynecol. 2013 Apr;121(4):911-915. doi: 10.1097/01.AOG.0000428649.57622.a7.
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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.
Marion Koso-Thomas, MD study director
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose aspirin in people with Premature Birth, run by NICHD Global Network for Women's and Children's Health at 14 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, India, Democratic Republic of the Congo, Guatemala, Kenya and 2 more countries. 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 8 Sep 2021). 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?
Incidence of Preterm Birth (time frame: At 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 NCT02409680, which also lists 68 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 21 Nov 2024.