Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) (ASPIRIN)
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| ClinicalTrials.gov Identifier: NCT02409680 |
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Recruitment Status :
Completed
First Posted : April 7, 2015
Results First Posted : September 8, 2021
Last Update Posted : September 8, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Premature Birth | Drug: Low dose aspirin Drug: Placebo | Not Applicable |
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 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) |
| Actual Study Start Date : | March 23, 2016 |
| Actual Primary Completion Date : | April 11, 2019 |
| Actual Study Completion Date : | April 11, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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) |
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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.
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Drug: Placebo
Placebo |
- 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.
- Incidence of Hypertensive Disorders of Pregnancy [ Time Frame: Evidence of hypertensive disorder during the pregnancy (prior to delivery/birth) ]- Hypertensive disorders of pregnancy is defined by the characterization of evidence of a hypertensive disorder, including either preeclampsia or eclampsia occurring during the pregnancy.
- Incidence of Small for Gestational Age (SGA) [ Time Frame: At delivery or at Day 42 after delivery ]- Small for gestational age (SGA) as defined by the INTERGROWTH-21st standard
- Incidence of Perinatal Mortality [ Time Frame: At delivery or at Day 42 after delivery ]- Incidence of Perinatal Mortality
- Maternal Outcome 1 - Incidence of Vaginal Bleeding [ Time Frame: At delivery or at Day 42 after delivery ]- Vaginal bleeding
- Maternal Outcome 2 - Incidence of Antepartum Hemorrhage [ Time Frame: At delivery or at Day 42 after delivery ]- Antepartum hemorrhage
- Maternal Outcome 3 - Incidence of Postpartum Hemorrhage [ Time Frame: At delivery or at Day 42 after delivery ]- Postpartum hemorrhage
- Maternal Outcome 4 - Incidence of Maternal Mortality [ Time Frame: At delivery or at Day 42 after delivery ]- Incidence of Maternal Mortality
- Maternal Outcome 5 - Incidence of Late Abortion [ Time Frame: At delivery or at Day 42 after delivery ]- Incidence of Late Abortion
- Maternal Outcome 6 - Change in Maternal Hemoglobin [ Time Frame: At enrollment, 4 weeks post enrollment, and 26-30 weeks GA. ]Hemoglobin < 7.0 gm/dl at 26-30 weeks gestation or a drop of 3.5+ gm/dl from screening to 26-30 weeks gestation
- Maternal Outcome 7 - Incidence of Preterm, Preeclampsia [ Time Frame: At delivery or at Day 42 after delivery ]Early preterm delivery (<34 weeks) and hypertensive disorders (i.e.: preeclampsia)
- Fetal Outcome 1 - Incidence of Early Preterm Delivery (<34 Weeks) [ Time Frame: At delivery ]- Early preterm delivery (<34 weeks)
- Fetal Outcome 2 - Incidence of Actual Birth Weight <2500g [ Time Frame: At delivery ]- Birth weight <2500g
- Fetal Outcome 3 - Incidence of Actual Birth Weight <1500g [ Time Frame: At delivery ]- Birth weight <1500g
- Fetal Outcome 4 - Incidence of Fetal Loss [ Time Frame: At delivery ]- Incidence of Fetal Loss
- Fetal Outcome 5 - Incidence of Spontaneous Abortion [ Time Frame: At delivery ]- Incidence of Spontaneous Abortion
- Fetal Outcome 6 - Incidence of All Stillbirth [ Time Frame: At delivery ]- Incidence of All stillbirth
- Fetal Outcome 7 - Incidence of Medical Termination of Pregnancy [ Time Frame: At delivery ]- Incidence of Medical Termination of Pregnancy
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
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
| 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 | |
| Study Director: | Marion Koso-Thomas, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Documents provided by NICHD Global Network for Women's and Children's Health:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | NICHD Global Network for Women's and Children's Health |
| ClinicalTrials.gov Identifier: | NCT02409680 |
| Other Study ID Numbers: |
CP ASPIRIN |
| First Posted: | April 7, 2015 Key Record Dates |
| Results First Posted: | September 8, 2021 |
| Last Update Posted: | September 8, 2021 |
| Last Verified: | August 2021 |
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Preterm birth Low dose aspirin |
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Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Aspirin 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 |