ASPIRIN- Preterm Birth Prevention Study
- Conditions
- Health Condition 1: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2016/05/006970
- Lead Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4829
Nulliparous women between 18 â?? 40 years of age.
-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 heart rate greater than 110 bpm
-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, hypertension, or any other known significant disease)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method