The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
Primary Purpose
High Risk Pregnant Women Undergoing Elective Cesarean Section
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
Sponsored by
About this trial
This is an interventional prevention trial for High Risk Pregnant Women Undergoing Elective Cesarean Section focused on measuring high risk pregnancy, cesarean section., tranexamic acid
Eligibility Criteria
Inclusion Criteria:
High risk women undergoing elective C-section
- Hypertensive patients.
- Obese patients.
- Patients on LMWH.
- Transverse lie
- DM ( Type 1 & Gestational )
- Cardiac ( Not on Anticoagulants )
- Placenta Previa ( Not in PAS )
- Previous uterine scar ( > previous 2 C- section )
Exclusion Criteria:
- Patients with bleeding tendency.
- HELLP Syndrome.
- Emergency C- section.
- Mechanical prosthetic valve
- Atrial Fibrillation.
- Allery to tranexamic acid
- Placenta Accreta , Increta , percreata.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
preoperative
uterine incision
placebo
Arm Description
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision
1ml of normal saline will be given
Outcomes
Primary Outcome Measures
Reduction of blood loss during C-section.
ml
Prevention of 1ry postpartum hemorrhage.
ml
Secondary Outcome Measures
Reduction of hospital stay.
Number of days
Decrease risk of maternal blood transfusion
Number of blood products units
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05434533
Brief Title
The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
Official Title
The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 3, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)
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
The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients.
Comparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.
Detailed Description
All patients will undergo the following
I. History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination.
III. Laboratory: Hemoglobin, Hematocrit before & after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia.
VI. Calculation of blood loss:
The quantity of blood loss (ml) is calculated from 3 components :
(weight of used towels during surgery - weight of used towels prior to surgery),plus
(volume of blood sucked in suction container after placental delivery) ,plus
(weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight)
Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (Vitello, Dominic J., et al).
VII. Informed Consent: will be obtained from all participants including the pregnant women who are included in the study .
All patients will receive routine ecbolics ( oxytocin ) after delivery of baby.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk Pregnant Women Undergoing Elective Cesarean Section
Keywords
high risk pregnancy, cesarean section., tranexamic acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preoperative
Arm Type
Experimental
Arm Description
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation
Arm Title
uterine incision
Arm Type
Experimental
Arm Description
1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision
Arm Title
placebo
Arm Type
No Intervention
Arm Description
1ml of normal saline will be given
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)
Intervention Description
IV 1gm
Primary Outcome Measure Information:
Title
Reduction of blood loss during C-section.
Description
ml
Time Frame
1 hour
Title
Prevention of 1ry postpartum hemorrhage.
Description
ml
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Reduction of hospital stay.
Description
Number of days
Time Frame
48 hours
Title
Decrease risk of maternal blood transfusion
Description
Number of blood products units
Time Frame
48 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
High risk women undergoing elective C-section
Hypertensive patients.
Obese patients.
Patients on LMWH.
Transverse lie
DM ( Type 1 & Gestational )
Cardiac ( Not on Anticoagulants )
Placenta Previa ( Not in PAS )
Previous uterine scar ( > previous 2 C- section )
Exclusion Criteria:
Patients with bleeding tendency.
HELLP Syndrome.
Emergency C- section.
Mechanical prosthetic valve
Atrial Fibrillation.
Allery to tranexamic acid
Placenta Accreta , Increta , percreata.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman Hany, MD
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
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