Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

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
    

Intervention name(s): Low dose aspirin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Acetylsalicylic acid (ASA)
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Preterm birth; Low dose aspirin