Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT05340205
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05340205
Study Brief:
Protocol Section:
NCT05340205