Overview

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

Status:
Completed
Trial end date:
2019-04-11
Target enrollment:
0
Participant gender:
Female
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborators:
Jawaharlal Nehru Medical College
KLE University's Jawaharlal Nehru Medical College
Thomas Jefferson University
Treatments:
Aspirin
Criteria
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)