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

NCT02409680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11976

Last updated 2024-11-21

Study results available
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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).

Conditions

  • Premature Birth

Interventions

DRUG

Low dose aspirin

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.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Thomas Jefferson University

    collaborator OTHER

  • Jawaharlal Nehru Medical College

    collaborator OTHER

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

    lead NETWORK

Principal Investigators

  • Marion Koso-Thomas, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-23
Primary Completion
2019-04-11
Completion
2019-04-11

Countries

  • United States
  • Democratic Republic of the Congo
  • Guatemala
  • India
  • Kenya
  • Pakistan
  • Zambia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02409680 on ClinicalTrials.gov