Early Versus Late Post Caesarean Section Oral Anticoagulation Initiation and Risk of Maternal Com… (NCT04855110) | Clinical Trial Compass
UnknownNot Applicable
Early Versus Late Post Caesarean Section Oral Anticoagulation Initiation and Risk of Maternal Complications in Patients With Mechanical Heart Valve Prosthesis
Egypt114 participantsStarted 2021-04-19
Plain-language 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, participants will be divided into 2 equal groups. Group A (57 patients) in which warfarin will be started day 2 after caesarean delivery (i.e. 24 hours postoperative), and group B (57 patients) in which warfarin will be started day 5 after caesarean delivery, then maternal complications are compared among these 2 groups.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of subcutaneous and / or sub-rectus hematoma
Timeframe: 14 days
2
Occurrence of intra-abdominal bleeding
Timeframe: 14 days
3
Need for blood transfusion
Timeframe: 14 days
4
Need for abdominal re-exploration or wound hematoma evacuation
Timeframe: 14 days
5
Need for any other intervention e.g. redo valve replacement surgery in case of a stuck valve
Timeframe: 14 days
6
Occurrence of a valve thrombosis or other thromboembolic manifestations e.g. stroke