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

Completed · Not applicable · Has a placebo group

Conditions studied: Premature Birth

In brief

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).

Key facts

Study ID

NCT02409680

Run by

NICHD Global Network for Women's and Children's Health

People needed

11976

Starts

2016-03-23

Expected to finish

2019-04-11

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• University of Colorado, Denver — Denver, Colorado, United States
• Indiana University — Indianapolis, Indiana, United States
• Boston University — Boston, Massachusetts, United States
• Columbia University — New York, New York, United States
• University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Kinshasa School of Public Health — Kinshasa, Democratic Republic of the Congo
• Institute of Nutrition of Central America and Panama (INCAP) — Guatemala City, Guatemala
• KLE University's Jawaharlal Nehru Medical College — Belagavi, Karnataka, India
• Lata Medical Research Foundation — Nagpur, India
• Moi University School of Medicine — Eldoret, Kenya
• The Aga Khan University — Karachi, Pakistan
• University Teaching Hospital — Lusaka, Zambia

Full record on ClinicalTrials.gov

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