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Aspirin for Prevention of Preeclampsia in Healthy, Nulliparous Obese and Overweight Pregnant Women

NCT03725891 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2019-01-10

No results posted yet for this study

Summary

Preeclampsia is a pregnancy-specific syndrome that affects 3 - 5% of pregnancies. It is one of the main causes of maternal, fetal and neonatal morbidity and mortality, resulting in approximately 40,000 maternal deaths worldwide each year. Fortunately, preeclampsia-related deaths have been reduced remarkably in recent decades thanks to improvements in antenatal care and therapeutic interventions, and prophylactic use of low-dose aspirin in women who are at a higher risk of developing preeclampsia.

Effective prevention is rarely available for obstetric complications. Aspirin is one of them. Several meta-analyses456 suggested that aspirin prescription reduced the risk of preeclampsia and fetal growth restriction by 40-50% in an aspirin-dose-response pattern.

Conditions

Interventions

DRUG

Aspirin 162 mg

Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first

DRUG

Aspirin 81 mg

placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

DRUG

placebo

placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • hany f sallam, md · Aswan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2021-11-30
Completion
2022-01-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03725891 on ClinicalTrials.gov