Status:
WITHDRAWN
Sildenafil Citrate Added to Low Molecular Weight Heparin and Low Dose Aspirin in High-risk Pregnancy
Lead Sponsor:
Fayoum University Hospital
Conditions:
High Risk Pregnancy
Eligibility:
FEMALE
25-35 years
Brief Summary
Anticoagulant therapy is indicated during pregnancy for the prevention and treatment of venous thromboembolism, systemic embolism in patients with mechanical heart valves and, in combination with aspi...
Detailed Description
Pregnancy is considered an acquired hypercoagulable state due to increased concentration of coagulation factors, decreased levels of anticoagulants and decreased fibrinolytic capacity. Adverse pregnan...
Eligibility Criteria
Inclusion
- high-risk pregnant women (women with current preeclampsia, IUGR and oligohydramnios)
- gestational age 28-37 weeks
- no major medical illness contraindicating sildenafil use (cardiovascular disease, sickle cell anaemia, retinopathy, hearing loss, liver diseases)
- willingness to sign informed consent for study randomization
Exclusion
- gestational age less than 28 weeks
- refusal of Doppler studies or sildenafil use
- contraindication or allergy to sildenafil
- those who can't present for monitoring visits or follow medication instructions
- those with major medical illness including cardiovascular disease and diabetes mellitus
- multiple pregnancies
- suspected chromosomal or fetal congenital anomalies (documented by level II ultrasound examination)
- users of any vasodilator agents
- those who had maternal or fetal emergencies necessitating delivery at time of recruitment in the study or with diastolic blood pressure more than 110 mmHg
- BMI is more than 34 that would impede accurate measurement of fetal biometry and Doppler parameters
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04110444
Start Date
January 1 2017
End Date
December 1 2023
Last Update
March 31 2022
Active Locations (1)
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1
sahar M.Y elbaradie
Al Fayyum, Egypt