Status:
COMPLETED
Blood Loss During Cesarean Delivery in Placenta Previa Patients
Lead Sponsor:
Cairo University
Conditions:
Placenta Previa
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief 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...
Detailed Description
Placenta previa is defined as complete or partial covering of the internal os of the cervix with the placenta, at more than 16 weeks of gestation. It affects 0.3% to 2% of pregnancies in the third tri...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT05340205
Start Date
May 4 2022
End Date
January 5 2023
Last Update
January 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kasralainy Cairo University
Giza, Egypt