Aspirin for Prevention of Preeclampsia

Not Applicable

• Conditions: Preeclampsia
• Interventions: Drug: aspirin 162 mg; Drug: aspirin 81 mg; Drug: placebo

• Registration Number: NCT03726177
• Lead Sponsor: Aswan University Hospital

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,

Detailed Description

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 Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2018-12-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10
• Primary Completion: 2020-11-30
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin 162 mg	aspirin 162 mg	Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
aspirin 81 mg plus placebo	aspirin 81 mg	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
aspirin 81 mg plus placebo	placebo	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With early Preeclampsia	6 months	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

Secondary Outcome Measures

Name	Time	Method
The number of cases of Fetal Growth Restriction	6 months	The number of cases of fetal growth restriction, defined as a fetal weight below the 10th percentile and an abnormal umbilical cord doppler that appear in both groups at any given time during pregnancy.
Prevention of preeclampsia between 37 and 41	6 months	The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.
The number of cases of preterm birth	6 months	The number of cases delivered before 37 weeks gestation

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt