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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02409680
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : December 24, 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

Tracking Information
First Submitted Date  ICMJE March 30, 2015
First Posted Date  ICMJE April 7, 2015
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE March 23, 2016
Actual Primary Completion Date April 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02409680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • 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.
  • Small for gestational age (SGA) [ Time Frame: At delivery or at Day 42 after delivery ]
    - Small for gestational age (SGA)
  • Perinatal mortality [ Time Frame: At delivery or at Day 42 after delivery ]
    - Perinatal mortality
Original Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2015)
  • Preeclampsia and eclampsia [ Time Frame: At delivery or at Day 42 after delivery ]
    - Preeclampsia and eclampsia
  • Small for gestational age (SGA) [ Time Frame: At delivery or at Day 42 after delivery ]
    - Small for gestational age (SGA)
  • Perinatal mortality [ Time Frame: At delivery or at Day 42 after delivery ]
    - Perinatal mortality
Current Other Pre-specified Outcome Measures
 (submitted: February 22, 2019)
  • Maternal Outcome 1 - Vaginal bleeding [ Time Frame: At delivery or at Day 42 after delivery ]
    - Vaginal bleeding
  • Maternal Outcome 2 - Antepartum hemorrhage [ Time Frame: At delivery or at Day 42 after delivery ]
    - Antepartum hemorrhage
  • Maternal Outcome 3 - Postpartum hemorrhage [ Time Frame: At delivery or at Day 42 after delivery ]
    - Postpartum hemorrhage
  • Maternal Outcome 4 - Maternal mortality [ Time Frame: At delivery or at Day 42 after delivery ]
    - Maternal mortality
  • Maternal Outcome 5 - Late abortion [ Time Frame: At delivery or at Day 42 after delivery ]
    - Late abortion
  • Maternal Outcome 6 - Change in maternal hemoglobin [ Time Frame: At enrollment, 4 weeks post enrollment, and 26-30 weeks GA. ]
    - Change in maternal hemoglobin
  • Maternal Outcome 7 - Preterm, preeclampsia [ Time Frame: At delivery or at Day 42 after delivery ]
    - Preterm, preeclampsia
  • Fetal Outcome 1 - Preterm birth <34 0/7 weeks of pregnancy [ Time Frame: At delivery ]
    - Preterm birth <34 0/7 weeks of pregnancy
  • Fetal Outcome 2 - Birth weight <2500g [ Time Frame: At delivery ]
    - Birth weight <2500g
  • Fetal Outcome 3 - Birth weight <1500g [ Time Frame: At delivery ]
    - Birth weight <1500g
  • Fetal Outcome 4 - Fetal loss [ Time Frame: At delivery ]
    - Fetal loss
  • Fetal Outcome 5 - Spontaneous abortion [ Time Frame: At delivery ]
    - Spontaneous abortion
  • Fetal Outcome 6 - Stillbirth [ Time Frame: At delivery ]
    - Stillbirth
  • Fetal Outcome 7 - Medical termination of pregnancy [ Time Frame: At delivery ]
    - Medical termination of pregnancy
Original Other Pre-specified Outcome Measures
 (submitted: April 6, 2015)
  • Maternal Outcome 1 - Vaginal bleeding [ Time Frame: At delivery or at Day 42 after delivery ]
    - Vaginal bleeding
  • Maternal Outcome 2 - Antepartum hemorrhage [ Time Frame: At delivery or at Day 42 after delivery ]
    - Antepartum hemorrhage
  • Maternal Outcome 3 - Postpartum hemorrhage [ Time Frame: At delivery or at Day 42 after delivery ]
    - Postpartum hemorrhage
  • Maternal Outcome 4 - Maternal mortality [ Time Frame: At delivery or at Day 42 after delivery ]
    - Maternal mortality
  • Maternal Outcome 5 - Late abortion [ Time Frame: At delivery or at Day 42 after delivery ]
    - Late abortion
  • Maternal Outcome 6 - Change in maternal hemoglobin [ Time Frame: At delivery or at Day 42 after delivery ]
    - Change in maternal hemoglobin
  • Fetal Outcome 1 - Preterm birth <34 0/7 weeks of pregnancy [ Time Frame: At delivery ]
    - Preterm birth <34 0/7 weeks of pregnancy
  • Fetal Outcome 2 - Birth weight <2500g and <1500g [ Time Frame: At delivery ]
    - Birth weight <2500g and <1500g
  • Fetal Outcome 3- Fetal loss [ Time Frame: At delivery ]
    - Fetal loss
  • Fetal Outcome 4- Spontaneous abortion [ Time Frame: At delivery ]
    - Spontaneous abortion
  • Fetal Outcome 5- Stillbirth [ Time Frame: At delivery ]
    - Stillbirth
  • Fetal Outcome 6- Medical termination of pregnancy [ Time Frame: At delivery ]
    - Medical termination of pregnancy
 
Descriptive Information
Brief Title  ICMJE Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
Official Title  ICMJE Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Premature Birth
Intervention  ICMJE
  • 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)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Low dose aspirin
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2019)
11976
Original Estimated Enrollment  ICMJE
 (submitted: April 6, 2015)
11000
Actual Study Completion Date  ICMJE April 11, 2019
Actual Primary Completion Date April 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Congo, The Democratic Republic of the,   Guatemala,   India,   Kenya,   Pakistan,   United States,   Zambia
Removed Location Countries Congo
 
Administrative Information
NCT Number  ICMJE NCT02409680
Other Study ID Numbers  ICMJE CP ASPIRIN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NICHD Global Network for Women's and Children's Health
Study Sponsor  ICMJE NICHD Global Network for Women's and Children's Health
Collaborators  ICMJE
  • Thomas Jefferson University
  • KLE University's Jawaharlal Nehru Medical College
Investigators  ICMJE
Study Director: Marion Koso-Thomas, MD NIH/NICHD
PRS Account NICHD Global Network for Women's and Children's Health
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP