Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
NCT ID: NCT02409680
Last Updated: 2024-11-21
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
11976 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-03-23
Study Completion Date
2019-04-11
Brief Summary
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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).
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Detailed Description
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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
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
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Premature Birth
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Intervention Arm
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.
Group Type
ACTIVE_COMPARATOR
Low dose aspirin
Intervention Type
DRUG
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.
Placebo Arm
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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo
Interventions
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Low dose aspirin
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.
Intervention Type
DRUG
Placebo
Placebo
Intervention Type
DRUG
Other Intervention Names
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Acetylsalicylic acid (ASA)
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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)
* 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)
Minimum Eligible Age
18 Years
Maximum Eligible Age
40 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Thomas Jefferson University
OTHER
Sponsor Role
collaborator
Jawaharlal Nehru Medical College
OTHER
Sponsor Role
collaborator
NICHD Global Network for Women's and Children's Health
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Marion Koso-Thomas, MD
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
Site Status
University of Colorado, Denver
Denver, Colorado, United States
Site Status
Indiana University
Indianapolis, Indiana, United States
Site Status
Boston University
Boston, Massachusetts, United States
Site Status
Columbia University
New York, New York, United States
Site Status
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Site Status
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Site Status
Kinshasa School of Public Health
Kinshasa, , Democratic Republic of the Congo
Site Status
Institute of Nutrition of Central America and Panama (INCAP)
Guatemala City, , Guatemala
Site Status
KLE University's Jawaharlal Nehru Medical College
Belagavi, Karnataka, India
Site Status
Lata Medical Research Foundation
Nagpur, , India
Site Status
Moi University School of Medicine
Eldoret, , Kenya
Site Status
The Aga Khan University
Karachi, , Pakistan
Site Status
University Teaching Hospital
Lusaka, , Zambia
Site Status
Countries
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United States
Democratic Republic of the Congo
Guatemala
India
Kenya
Pakistan
Zambia
References
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Yu Y, Cheng Y, Fan J, Chen XS, Klein-Szanto A, Fitzgerald GA, Funk CD. Differential impact of prostaglandin H synthase 1 knockdown on platelets and parturition. J Clin Invest. 2005 Apr;115(4):986-95. doi: 10.1172/JCI23683. Epub 2005 Mar 17.
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Bucher S, Nowak K, Otieno K, Tenge C, Marete I, Rutto F, Kemboi M, Achieng E, Ekhaguere OA, Nyongesa P, Esamai FO, Liechty EA. Birth weight and gestational age distributions in a rural Kenyan population. BMC Pediatr. 2023 Mar 8;23(1):112. doi: 10.1186/s12887-023-03925-2.
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DERIVED
Hoffman MK, Goudar SS, Kodkany BS, Metgud M, Somannavar M, Okitawutshu J, Lokangaka A, Tshefu A, Bose CL, Mwapule A, Mwenechanya M, Chomba E, Carlo WA, Chicuy J, Figueroa L, Garces A, Krebs NF, Jessani S, Zehra F, Saleem S, Goldenberg RL, Kurhe K, Das P, Patel A, Hibberd PL, Achieng E, Nyongesa P, Esamai F, Liechty EA, Goco N, Hemingway-Foday J, Moore J, Nolen TL, McClure EM, Koso-Thomas M, Miodovnik M, Silver R, Derman RJ; ASPIRIN Study Group. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Jan 25;395(10220):285-293. doi: 10.1016/S0140-6736(19)32973-3.
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DERIVED
Hoffman MK, Goudar SS, Kodkany BS, Goco N, Koso-Thomas M, Miodovnik M, McClure EM, Wallace DD, Hemingway-Foday JJ, Tshefu A, Lokangaka A, Bose CL, Chomba E, Mwenechanya M, Carlo WA, Garces A, Krebs NF, Hambidge KM, Saleem S, Goldenberg RL, Patel A, Hibberd PL, Esamai F, Liechty EA, Silver R, Derman RJ. A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study. BMC Pregnancy Childbirth. 2017 May 3;17(1):135. doi: 10.1186/s12884-017-1312-x.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CP ASPIRIN
Identifier Type: -
Identifier Source: org_study_id
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