Blood Loss During Cesarean Delivery in Placenta Previa Patients (NCT05340205) | Clinical Trial Compass
CompletedPhase 4
Blood Loss During Cesarean Delivery in Placenta Previa Patients
Egypt81 participantsStarted 2022-05-04
Plain-language summary
To compare the efficacy and safety profile of intravenous tranexamic acid versus intrauterine misoprostol in reducing the blood loss during and after cesarean delivery in pregnant women diagnosed with placenta previa
Who can participate
Age range
18 Years – 40 Years
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:
* Parity: primigravida or multigravida.
* Gestational age: ≥ 36 weeks (confirmed by the first day of the last menstrual period or first trimester ultrasound scan).
* Candidate for termination of pregnancy by cesarean delivery.
* Singleton living healthy normally growing fetus.
* Cesarean delivery under spinal anesthesia.
* Pregnancies complicated with placenta previa diagnosed preoperatively by ultrasonography (placenta previa was defined as placenta partially or totally covers the cervix)
Exclusion Criteria:
* Patients diagnosed with morbidly adherent placenta.
* Placenta previa cases requiring cesarean hysterectomy in the primary surgery.
* Patients with preoperative anemia (Hemoglobin \<9 gm/dl).
* History of thromboembolic event.
* Known allergy to tranexamic acid or prostaglandins.
* Bronchial asthma or other contraindications of misoprostol.
* Patients with other risk factors of postpartum hemorrhage (e.g., polyhydramnios, fetal macrosomia, uterine fibroid).
* Patients known to have bleeding tendency (e.g., those receiving anticoagulation, patients with thrombocytopenia, factor VIII or IX deficiency or Von Willebrand's disease).
* More than 2 previous cesarean deliveries procedures.
* Prolonged procedure (more than 2 hours from skin incision to skin closure).
* Concomitant maternal medical disorders (either chronic or pregnancy induced)
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
To compare the estimated blood loss during cesarean delivery among the three groups