Overview

Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section

Status:
Not yet recruiting
Trial end date:
2024-08-31
Target enrollment:
0
Participant gender:
Female
Summary
The study will include 444 pregnant patients undergoing cesarean section in Kasr Al Aini. Following a proper medical history taking, examination will be done, investigations including laboratory tests and obstetric ultrasound will be done. Then, the patients will be divided into 4 groups, receiving Oxytocin only (Group 1), Oxytocin + Tranexamic acid (Group 2), Oxtytocin and Misoprostol (Group 3) or Oxytocin and Carbetocin (Group 4) followed by collection of necessary data.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Cairo University
Treatments:
Carbetocin
Misoprostol
Oxytocin
Tranexamic Acid
Criteria
Inclusion Criteria:

- 2. Pregnant women candidate for LSCS. 3. Age: 20-40 years old. 4. Full term
pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric
ultrasound scan).

5. Singleton pregnancies. 6. One or more of the following criteria to be considered as
high-risk case for PPH (RCOG, 2016):

1. Maternal Anemia (hemoglobin < 10 g%).

2. Known placenta previa.

3. Proven or suspected case of placental abruption.

4. Preeclampsia or gestational hypertension.

5. Polyhydramnios (DVP > 8cm).

6. Macrosomia (> 4 Kg)

7. Previous history of uterine atony or postpartum hemorrhage).

8. Prolonged labour (>12 hours).

7. CS under spinal anesthesia.

Exclusion Criteria:

- 1. Fetal death (IUFD). 2. Fetal anomalies. 3. IUGR (Estimated fetal weight below the
5th centile) 4. Women presenting with an obstetric emergency necessitating immediate
surgery (Cord prolapse, severe antepartum hemorrhage, severe fetal distress etc.) 5.
More than 2 previous CS procedures. 6. Prolonged procedure (more than 2 hours from
skin incision to skin closure). 7. History of prostaglandin, Tranexamic acid or
carbetocin allergy. 8. Multifetal pregnancies. 9. Abnormally invasive placenta. 10.
Known deep venous thrombosis