An interventional study of aspirin 162 mg and aspirin 81 mg in Preeclampsia, sponsored by Aswan University Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by Aswan University Hospital · Not applicable, Interventional, and Prevention
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,
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.
904 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's planned enrollment of 600 is above the median of 110 across 478 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Aswan University Hospital is the lead sponsor of 97 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
Drug: aspirin 162 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
Drug: aspirin 81 mg · Drug: placebo
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
Also known as: Active Comparator
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Also known as: active comparator
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Also known as: Placebo to asprin
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
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
The number of cases of preterm birth
The number of cases delivered before 37 weeks gestation
Time frame: 6 months
Plan to share: No
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This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin
Aswan University Hospital