CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11,976 enrolled
Drug / intervention
Low dose aspirin +1 moredrug
Likely dose
Low dose aspirin 81 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02409680
NCT02409680N/ACompleted

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

NICHD Global Network for Women's and Children's Health·interventional·Posted Apr 7, 2015·Updated Nov 21, 2024

In Brief

A clinical study evaluating Low dose aspirin and Placebo for Premature Birth. Completed, enrolled 11,976 participants across 14 sites in 7 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Birth
CountriesDemocratic Republic of the Congo, Guatemala, India, Kenya, Pakistan, United States, Zambia

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 7, 2015
Enrollment StartMar 23, 2016
Primary CompletionApr 11, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.2 years ago

Interventions

Low dose aspirindrug

Daily administration of low dose (81 mg) aspirin \[also known as acetylsalicylic acid (ASA\], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.

Placebodrug

Placebo