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

NCT03725891 | Unknown DMC

• 1 other identifier: aswu/196/7/18
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Preeclampsia

Keywords

preeclampsia; low dose aspirin; high risk pregnancy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With early onset Preeclampsia

  The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300 mg in 24 hrs) before 34 weeks gestation

  6 months

Secondary Outcomes (3)

• Number of Participants With preeclampsia between 37 and 41

  6 months

• The number of cases of Fetal Growth Restriction

  6 months

• The number of cases of preterm birth

  6 months

Study Arms (2)

Aspirin 162 mg

ACTIVE COMPARATOR

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

Drug: Aspirin 162 mg

Aspirin 81 mg plus placebo

ACTIVE COMPARATOR

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

Drug: Aspirin 81 mg; Drug: placebo

Interventions

Aspirin 162 mg DRUG

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

Also known as: Active Comparator

Aspirin 162 mg

Aspirin 81 mg DRUG

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

Also known as: Active Comparator

Aspirin 81 mg plus placebo

placebo DRUG

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

Also known as: Active Comparator

Aspirin 81 mg plus placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: This will be a randomized control trial to estimate the efficacy of two doses (81 mg versus 162 mg) of aspirin for prevention of preeclampsia in healthy, nulliparous obese and overweight pregnant women identified in the first trimester.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• healthy, nulliparous obese and overweight pregnant women identified in the first trimester.
• Give written informed consent.

You may not qualify if:

• Multiple gestations,
• fetal aneuploidy
• major fetal structural anomaly
• bleeding disorder
• allergy to aspirin
• women already on aspirin or heparin.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam, md

CONTACT

01022336052; hany.farouk@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: both participants and researchers will be blinded to the intervention given
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a randomized control trial to estimate the efficacy of two doses (81 mg versus 162 mg) of aspirin for prevention of preeclampsia in healthy, nulliparous obese and overweight pregnant women identified in the first trimester.

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: January 1, 2022
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)