Cesarean Section Complications Clinical Trial
Official title:
The Effect of Intramyometrial Tranexamic Acid Versus Intramyometrial Oxytocin in Reducing Blood Loss During and After Elective Cesarean Section in Term Primigravida: A Double-blinded, Randomized, Comparative-placebo Trial
Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent research has shown Egypt to be the third-largest country globally, with an estimated 52% cesarean sections (3). However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter of blood following a vaginal birth and losing over one thousand milliliter after the cesarean section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in poor countries, and the estimated mortality number due to postpartum bleeding is one hundred thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to diminish maternal mortality and morbidity (7). The most successful technique for decreasing PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | January 1, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | nclusion Criteria: - Women booked for a primary elective cesarean section, not in active labor - Aged between 20-40 years. - BMI 18.5-29.9 kg/ m2 pre-pregnancy weight - Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0 days and 41 weeks, 6 days). - Singleton pregnancies. - Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes) - Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of gestational age) - Certain congenital fetal malformation and skeletal disorders (Several congenital anomalies are controversial indications for cesarean delivery; these include fetal neural tube defects (to avoid sac rupture), particularly defects that are larger than 5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008) Exclusion Criteria: - Placenta previa. - Maternal hypertension and Preeclampsia. - Diabetes mellitus. - Severe medical disorder (renal or hepatic). - Multiple Fibroid uterus. - Multiple pregnancies. - Polyhydramnios. - Previous uterine surgery as myomectomy. - Contraindication to spinal anesthesia. - Blood coagulopathy and bleeding disorder. - Marked maternal anemia (Preoperative hemoglobin <9 gm/dl). - Contraindications to TXA or oxytocin therapy (e.g. allergy) |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of medicine - Fayoum university | Fayoum |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Fayoum University Hospital |
Egypt,
Boerma T, Ronsmans C, Melesse DY, Barros AJD, Barros FC, Juan L, Moller AB, Say L, Hosseinpoor AR, Yi M, de Lyra Rabello Neto D, Temmerman M. Global epidemiology of use of and disparities in caesarean sections. Lancet. 2018 Oct 13;392(10155):1341-1348. do — View Citation
Brun R, Spoerri E, Schaffer L, Zimmermann R, Haslinger C. Induction of labor and postpartum blood loss. BMC Pregnancy Childbirth. 2019 Jul 25;19(1):265. doi: 10.1186/s12884-019-2410-8. — View Citation
El-Zanati FJICAfPM, Economic SRib, Knowledge SJU, B PoH. Egypt Health Issues Survey, Ministry of Health and Population, El-Zanaty and Associates and, ICF International. 2015:25-50.
Kebede BA, Abdo RA, Anshebo AA, Gebremariam BM. Prevalence and predictors of primary postpartum hemorrhage: An implication for designing effective intervention at selected hospitals, Southern Ethiopia. PLoS One. 2019 Oct 31;14(10):e0224579. doi: 10.1371/journal.pone.0224579. eCollection 2019. — View Citation
Visconti F, Quaresima P, Rania E, Palumbo AR, Micieli M, Zullo F, Venturella R, Di Carlo C. Difficult caesarean section: A literature review. Eur J Obstet Gynecol Reprod Biol. 2020 Mar;246:72-78. doi: 10.1016/j.ejogrb.2019.12.026. Epub 2020 Jan 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood loss | Estimation of Intraoperative and postoperative blood loss. | 24 hours | |
Secondary | Need of extra utero-tonic drugs | Need of extra utero-tonic drugs | 2 hours |
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