Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section
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ClinicalTrials.gov Identifier: NCT06010368 |
Recruitment Status :
Not yet recruiting
First Posted : August 24, 2023
Last Update Posted : April 9, 2024
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Condition or disease | Intervention/treatment | Phase |
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Cesarean Section Complications Tranexamic Acid Oxytocin Post Partum Hemorrhage | Drug: Tranexamic acid injection Drug: Oxytocin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | patients assigned to the oxytocin group (n = 75): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation. In TXA group (n=75): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated. |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | A double-blind study is one in which neither the participants nor the experimenters know who is receiving a particular treatment. This procedure is utilized to prevent bias in research results. Double-blind studies are particularly useful for preventing bias due to demand characteristics or the placebo effect. In a double-blind study, the investigators who interact with the participants would not know who will receive the actual drug and who will receive a placebo. |
Primary Purpose: | Prevention |
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 |
Estimated Study Start Date : | June 1, 2024 |
Estimated Primary Completion Date : | December 1, 2025 |
Estimated Study Completion Date : | January 1, 2026 |
Arm | Intervention/treatment |
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Experimental: Group 1: Tranexamic acid group
In TXA group (n=75): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.
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Drug: Tranexamic acid injection
In TXA group (n=75): 1 g from tranexamic acid (kapron®, Amoun, Egypt) shall also be watered down in 10 cc of Saline, and 5 cc shall be injected in each uterine corn before the placenta is separated.
Other Name: kapron |
Experimental: Group 2: oxytocin group
to the oxytocin group (n = 75): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation
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Drug: Oxytocin
the oxytocin group (n = 75): 5 I.U of oxytocin (syntocinone 5 I.U/1ML NONARTIS-EGYPT) shall be watered down in 10 cc of saline, and 5 cc shall be injected into each uterine corn before the placental separation
Other Name: syntocinone |
- Blood loss [ Time Frame: 24 hours ]Estimation of Intraoperative and postoperative blood loss.
- Need of extra utero-tonic drugs [ Time Frame: 2 hours ]Need of extra utero-tonic drugs
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Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06010368
Contact: Ahmed N Afifi, MD | 01098670624 | dr_nagy.ahmed@yahoo.com |
Egypt | |
faculty of medicine - Fayoum university | |
Fayoum, Egypt, 63514 | |
Contact: Sahar M El-baradie, MD 01001560674 smb11@fayoum.edu.eg | |
Principal Investigator: Ahmed N Afifi, MD |
Principal Investigator: | Ahmed N Afifi, MD | Fayoum University | |
Study Director: | Sahar M El-baradie, MD | Fayoum University |
Other Publications:
Responsible Party: | ahmed nagy shaker ramadan, Assistant lecturer of obstetrics and gynecology, Cairo University |
ClinicalTrials.gov Identifier: | NCT06010368 |
Other Study ID Numbers: |
AN2023-3 |
First Posted: | August 24, 2023 Key Record Dates |
Last Update Posted: | April 9, 2024 |
Last Verified: | April 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Postpartum Hemorrhage Hemorrhage Pathologic Processes Obstetric Labor Complications Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Puerperal Disorders Uterine Hemorrhage Tranexamic Acid |
Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |