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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aspirin 162 mg | Active Comparator | Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspirin 162 mg | Drug | Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The number of cases of Fetal Growth Restriction |
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Inclusion Criteria:
Exclusion Criteria:
The population of interest involves women attending the study hospital for antenatal care and delivery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f sallam, md | Contact | 01022336052 | 002 | hany.farouk@aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | Recruiting | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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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.
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both participants and researchers will be blinded to the intervention given.
| aspirin 81 mg | Drug | Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first |
|
|
| placebo | Drug | placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first |
|
|
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 |
| The number of cases of preterm birth | The number of cases delivered before 37 weeks gestation | 6 months |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |