N/A
N=11,976
Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)
Premature Birth
Bottom Line
View on ClinicalTrials.gov: NCT02409680 ↗Enrolled (actual)
11,976
Serious AEs
14.2%
Results posted
Sep 2021
Primary outcome: Primary: Incidence of Preterm Birth — 668; 754 Participants — p=0.012
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low dose aspirin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NICHD Global Network for Women's and Children's Health
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Preterm Birth |
668; 754 | 0.012 sig |
| SECONDARY Incidence of Hypertensive Disorders of Pregnancy |
352; 325 | 0.299 |
| SECONDARY Incidence of Small for Gestational Age (SGA) |
1506; 1564 | 0.171 |
| SECONDARY Incidence of Perinatal Mortality |
264; 309 | 0.048 sig |
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).
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02409680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.