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 range18 Years – 40 Years
SexFEMALE
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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)
What they're measuring
1
To compare the estimated blood loss during cesarean delivery among the three groups