Aspirin for Prevention of Preeclampsia

Preeclampsia Clinical Trial

Official title:

Comparison of Two Doses (81 mg Versus 162mg) of Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03726177
• Other study ID #: aswu 194/7/18
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: January 2019
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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,

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 1, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• aspirin 162 mg
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
• aspirin 81 mg
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
• placebo
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevention of preeclampsia between 37 and 41	The number of cases of preeclampsia that appear in both groups between 37 and 41 weeks of pregnancy.	6 months
Secondary	The number of cases of Fetal Growth Restriction	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.	6 months
Secondary	The number of cases of preterm birth	The number of cases delivered before 37 weeks gestation	6 months