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Trial record 15 of 253 for:    ASPIRIN AND low-dose aspirin

Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) (ASPIRIN)

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ClinicalTrials.gov Identifier: NCT02409680
Recruitment Status : Active, not recruiting
First Posted : April 7, 2015
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Thomas Jefferson University
KLE University's Jawaharlal Nehru Medical College
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Premature Birth Drug: Low dose aspirin Drug: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
Study Start Date : March 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.
Other Name: Acetylsalicylic acid (ASA)

Placebo Comparator: 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.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Preterm Birth [ Time Frame: At delivery ]
    The primary outcome of this study is 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.


Secondary Outcome Measures :
  1. Hypertensive disorders of pregnancy [ Time Frame: During 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.

  2. Small for gestational age (SGA) [ Time Frame: At delivery or at Day 42 after delivery ]
    - Small for gestational age (SGA)

  3. Perinatal mortality [ Time Frame: At delivery or at Day 42 after delivery ]
    - Perinatal mortality


Other Outcome Measures:
  1. Maternal Outcome 1 - Vaginal bleeding [ Time Frame: At delivery or at Day 42 after delivery ]
    - Vaginal bleeding

  2. Maternal Outcome 2 - Antepartum hemorrhage [ Time Frame: At delivery or at Day 42 after delivery ]
    - Antepartum hemorrhage

  3. Maternal Outcome 3 - Postpartum hemorrhage [ Time Frame: At delivery or at Day 42 after delivery ]
    - Postpartum hemorrhage

  4. Maternal Outcome 4 - Maternal mortality [ Time Frame: At delivery or at Day 42 after delivery ]
    - Maternal mortality

  5. Maternal Outcome 5 - Late abortion [ Time Frame: At delivery or at Day 42 after delivery ]
    - Late abortion

  6. Maternal Outcome 6 - Change in maternal hemoglobin [ Time Frame: At enrollment, 4 weeks post enrollment, and 26-30 weeks GA. ]
    - Change in maternal hemoglobin

  7. Maternal Outcome 7 - Preterm, preeclampsia [ Time Frame: At delivery or at Day 42 after delivery ]
    - Preterm, preeclampsia

  8. Fetal Outcome 1 - Preterm birth <34 0/7 weeks of pregnancy [ Time Frame: At delivery ]
    - Preterm birth <34 0/7 weeks of pregnancy

  9. Fetal Outcome 2 - Birth weight <2500g [ Time Frame: At delivery ]
    - Birth weight <2500g

  10. Fetal Outcome 3 - Birth weight <1500g [ Time Frame: At delivery ]
    - Birth weight <1500g

  11. Fetal Outcome 4 - Fetal loss [ Time Frame: At delivery ]
    - Fetal loss

  12. Fetal Outcome 5 - Spontaneous abortion [ Time Frame: At delivery ]
    - Spontaneous abortion

  13. Fetal Outcome 6 - Stillbirth [ Time Frame: At delivery ]
    - Stillbirth

  14. Fetal Outcome 7 - Medical termination of pregnancy [ Time Frame: At delivery ]
    - Medical termination of pregnancy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409680


Locations
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United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
United States, Colorado
University of Colorado, Denver
Denver, Colorado, United States, 80045
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02215
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Congo, The Democratic Republic of the
Kinshasa School of Public Health
Kinshasa, Congo, The Democratic Republic of the
Guatemala
Institute of Nutrition of Central America and Panama (INCAP)
Guatemala City, Guatemala, 01015
India
KLE University's Jawaharlal Nehru Medical College
Belgaum, Karnataka, India
Lata Medical Research Foundation
Nagpur, India
Kenya
Moi University School of Medicine
Eldoret, Kenya, 30100
Pakistan
The Aga Khan University
Karachi, Pakistan, 74800
Zambia
University Teaching Hospital
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Thomas Jefferson University
KLE University's Jawaharlal Nehru Medical College
Investigators
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Study Director: Marion Koso-Thomas, MD NIH/NICHD

Publications:
March of Dimes, Save the Children, WHO. (2012). Born Too Soon: The Global Action Report on Preterm Birth. (M. V. K. CP Howson JE Lawn., Ed.). Geneva: World Health Organization.
Mathews, T. J., Menacker, F., & MacDorman, M. F. (2004). Infant mortality statistics from the 2002 period: linked birth/infant death data set. National Vital Statistics Reports : From the Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System, 53(10), 1-29. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/15622996
RE, B., & AS, B. (2006). Preterm Birth: Causes, Consequences, and Prevention. (I. of M. of the Academies, Ed.). Washington, DC: The National Academies Press.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT02409680     History of Changes
Other Study ID Numbers: CP ASPIRIN
First Posted: April 7, 2015    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: September 2018

Keywords provided by NICHD Global Network for Women's and Children's Health:
Preterm birth
Low dose aspirin

Additional relevant MeSH terms:
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Aspirin
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics