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Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

Primary Purpose

Cesarean Section Complications, Tranexamic Acid, Oxytocin

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid injection
Oxytocin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • faculty of medicine - Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1: Tranexamic acid group

Group 2: oxytocin group

Arm Description

In TXA group (n=25): 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.

to the oxytocin group (n = 25): 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

Outcomes

Primary Outcome Measures

Blood loss
Estimation of Intraoperative and postoperative blood loss.

Secondary Outcome Measures

Need of extra utero-tonic drugs
Need of extra utero-tonic drugs

Full Information

First Posted
August 21, 2023
Last Updated
August 24, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06010368
Brief Title
Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
Study design: This study is a double-blinded prospective randomized comparative Clinical trial to compare and evaluate the effectiveness of intra-myometrial oxytocin injection and intra-myometrial tranexamic acid injection in reducing the risk of postpartum bleeding after cesarean delivery in primigravida at term. The study will be conducted in the kasr Al-Ainy hospital, Maternity hospital, Cairo University, Cairo, Egypt, during October 2021 to October 2022. After The Ethical Research Committee approval on study protocol, fifty primigravida women at term pregnancy, undergoing elective cesarean delivery will be divided and allocated randomly into two groups after fulfillment eligibility criteria. Fifty women will be included in this clinical study at admission to the labor ward. Written informed permission will be acquired following advising about this study and potential implications. A history in details and clinical examination for all patients to rule out general health problems. Vaginal and Abdominal examinations will be done. Routine preoperative investigations and obstetric ultrasound examinations will be done for all women to ensure that all inclusion criteria were present. The computer will be used for randomization to allocate the patients into two equal groups. Randomization cards will be produced, sealed and stored; sequentially black wrappers will be numbered. The hospital pharmacy is producing packages, and physicians and nurses were unaware of their contents. For the entire length of the trial, all study personnel and participants are blinded to therapy. A senior registrar will execute a cesarean section before the commencement of research, which performs at least 300 cesarean sections. All cesarean section will be operated via spinal anesthesia; the abdomen will be entered through the Pfannenstiel incision. The sealed envelope is carried to the operating room and transferred without informing the researcher or the patients about their contents. The anesthesiologist is administering the medication (Oxytocin or tranexamic acid). After fetal birth and before placental delivery, patients assigned to the oxytocin group (n = 25): 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=25): 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. The primary outcome is to decrease Intra and postoperative blood loss to reduce PPH risk after CS. After a skin incision, the estimated blood loss would begin. The towels are weighted in (mg) with their covers, using an exact digital balance, before and following the operation, and the weight variation is measured between dryish and saturated towels. Blood loss is counted as follows during the operation: volume contents in the suction container in (ml) (X), the towel weight variation in (gm), (Y) (weight of saturated towels in (gm) - weight of dry towel in (gm)), the amniotic liquid amount in (ml) (Z). Operational blood loss in (ml) = (X+Y) - Z (18). All women are calculated according to the underlying law for permissible blood loss. Allowable blood loss = The estimated volume of blood x (initial hematocrit - final lowest acceptable hematocrit)/ initial hematocrit, an estimated volume of blood = weight of the patient in (kg) multiplies by average volume of blood (75-85 ml/kg) (19).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications, Tranexamic Acid, Oxytocin, Post Partum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
patients assigned to the oxytocin group (n = 25): 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=25): 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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Tranexamic acid group
Arm Type
Experimental
Arm Description
In TXA group (n=25): 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.
Arm Title
Group 2: oxytocin group
Arm Type
Experimental
Arm Description
to the oxytocin group (n = 25): 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
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
kapron
Intervention Description
In TXA group (n=25): 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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
syntocinone
Intervention Description
the oxytocin group (n = 25): 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
Primary Outcome Measure Information:
Title
Blood loss
Description
Estimation of Intraoperative and postoperative blood loss.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Need of extra utero-tonic drugs
Description
Need of extra utero-tonic drugs
Time Frame
2 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
waleed M El-khayat, MD
Phone
01005135542
Email
waleed_elkhyat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed A Taymour, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine - Cairo university
City
Cairo
State/Province
Kasr El Ainy
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed T aneis, MD
Phone
202 23653269
First Name & Middle Initial & Last Name & Degree
waleed M El khyat, MD

12. IPD Sharing Statement

Citations:
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.
Results Reference
background
PubMed Identifier
31671143
Citation
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.
Results Reference
background
PubMed Identifier
31345178
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.
Results Reference
background
PubMed Identifier
31962259
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.
Results Reference
result
PubMed Identifier
30322584
Citation
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. doi: 10.1016/S0140-6736(18)31928-7.
Results Reference
result

Learn more about this trial

Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

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