Aspirin for Prevention of Preeclampsia

NCT03726177 | Unknown DMC

• 1 other identifier: aswu 194/7/18
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Prophylaxis with low-dose aspirin has been recommended to prevent preeclampsia, the rationale being that hypertension and abnormalities of coagulation in this disease are caused in part by an imbalance between vasodilating and vasoconstricting prostaglandins. Low-dose aspirin therapy inhibits thromboxane production more than prostacyclin production and therefore should protect against vasoconstriction and pathologic blood coagulation in the placenta. Initially, several single-center trials, mostly among women at increased risk for preeclampsia, demonstrated a substantial reduction in the risk of proteinuric hypertension as well as reductions in the incidences of preterm birth, infants small for gestational age, and perinatal death,

Conditions

Preeclampsia

Keywords

preeclampsia; low dose aspirin; high risk pregnancy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With early 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)

• Prevention of 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 two 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 two 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

Aspirin 81mg 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: Placebo to asprin

aspirin 81 mg plus placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The population of interest involves women attending the study hospital for antenatal care and delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women presenting prior to 17+0 weeks' gestation.
• Moderate to high risk of preeclampsia.
• One or more of the following: previous history of preeclampsia, antiphospholipid antibodies, pre-existing diabetes, pre-existing hypertension, pre-existing renal disease, autoimmune disease, nulliparity, family history of preeclampsia, elevated BMI \> 25, and maternal age \<20 or \>35.
• 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 (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in High-Risk Pregnant Women identified in the first trimester to be at high risk.

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: January 1, 2021
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)