Status:
UNKNOWN
Early Versus Late Post Caesarean Section Oral Anticoagulation Initiation and Risk of Maternal Complications in Patients With Mechanical Heart Valve Prosthesis
Lead Sponsor:
Cairo University
Conditions:
Maternal Complications After Oral Anticoagulation When Initiated Early and Late After Caesarean Section Done for Patients With Mechanical Heart Valve Prosthesis
Eligibility:
FEMALE
Phase:
NA
Brief Summary
A randomized cohort study applied to patients with mechanical heart valve prosthesis who will be delivered by caesarean section at or after 28 weeks of gestation . Using a table of random numbers, par...
Detailed Description
-Background and Rationale: Cardiac valve replacement surgery has saved the lives of hundreds of thousands of patients with acquired (e.g. rheumatic) or congenital cardiac disorders (McLintock, 2011)....
Eligibility Criteria
Inclusion
- Pregnant women with mechanical prosthetic heart valves who are planned to deliver by caesarean delivery, provided that the gestational age at delivery is 28 weeks of gestation or more whether singleton or multi-fetal pregnancy.
Exclusion
- Patients with right-sided mechanical heart valves.
- Patients with a history of any thrombotic events e.g. Stuck prosthetic valve, or cerebrovascular stroke, etc.
- Patients with hypertensive disorders.
- Diabetic patients.
- Patients with known bleeding disorders or coagulation defects.
- Patients with known thrombophilia.
- Patients who refuse to share in the study.
Key Trial Info
Start Date :
April 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04855110
Start Date
April 19 2021
End Date
March 1 2022
Last Update
April 22 2021
Active Locations (1)
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1
Faculty of medicine (Kasr Alainy), cairo university
Cairo, Egypt, 12613