Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN) (NCT02409680) | Clinical Trial Compass
CompletedNot Applicable
Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
United States11,976 participantsStarted 2016-03-23
Plain-language 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).
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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.
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)
What they're measuring
1
Incidence of Preterm Birth
Timeframe: At delivery
Trial details
NCT IDNCT02409680
SponsorNICHD Global Network for Women's and Children's Health