Preeclampsia
Conditions
Keywords
preeclampsia, low dose aspirin, high risk pregnancy
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.
Interventions
DRUGaspirin 162 mg
Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
DRUGaspirin 81 mg
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
DRUGplacebo
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
both participants and researchers will be blinded to the intervention given.
Intervention model 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| The number of cases of preterm birth | 6 months | The number of cases delivered before 37 weeks gestation |
Countries
Egypt
Contacts
Primary Contacthany f sallam, md
Outcome results
None listed