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

Primary Purpose

Postpartum Hemorrhage, Blood Loss, Postoperative, Cesarean Section Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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): Maternal Anemia (hemoglobin < 10 g%). Known placenta previa. Proven or suspected case of placental abruption. Preeclampsia or gestational hypertension. Polyhydramnios (DVP > 8cm). Macrosomia (> 4 Kg) Previous history of uterine atony or postpartum hemorrhage). 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Oxytocin Group

    Tranexamic acid

    Misoprostol

    Carbetocin

    Arm Description

    o In Oxytocin group (n=111), patients will receive 10 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) given as infusion in 500 ml lactated ringer/s solution at a rate of 125ml/hour after delivery of the placenta.

    o In Tranexamic group (n=111), patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision). Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.

    o In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.

    o In carbetocin group (n=111) 100 microgram carbetocin (Pabal, Ferring, Kiel, Germany) will be given as an intravenous bolus dose following the delivery of the placenta. Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.

    Outcomes

    Primary Outcome Measures

    Estimated Blood Loss
    To compare the estimated blood loss (EBL) during and after cesarean delivery among the four groups.

    Secondary Outcome Measures

    Need for additional ecbolics
    The Use of additional ecbolics denoting uterine atony (i.e. 10 IU intravenous infusion of oxytocin with 500 ml lactated ringer at a rate of 125 ml/hour and 1mL [0.2 mg] intramuscular ergometrine with or without 600 microgram rectal misoprostol postoperatively)
    Excessive blood loss and need for blood transfusion
    The occurrence of excessive blood loss (> 1000 mL) together with the need for blood transfusion within the first 24 hours postoperatively.
    Side effects
    The occurrence of any maternal side effects (among the four groups).

    Full Information

    First Posted
    September 23, 2023
    Last Updated
    September 28, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06060327
    Brief Title
    Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section
    Official Title
    The Efficacy and Safety of Tranexamic Acid Versus Uterotonic Agents in Reducing Blood Loss During and After Cesarean Section Among High-risk Patients: a Comparative Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    August 31, 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
    Yes

    5. Study Description

    Brief 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.
    Detailed Description
    The study will include (444) pregnant women attending for cesarean delivery in Kasr Elaini hospital (faculty of medicine - Cairo university). The following will be done to all participants: Informed written consent: after discussing the nature of the study as well as the expected value, outcome, and possible adverse effects. Full medical history: including full obstetric history and current pregnancy history (entailing the 1st day of LMP). Thorough Clinical Examination: general (maternal body weight and vital signs) and full obstetric examination. Obstetric ultrasonography: to confirm singleton pregnancy, gestational age and the eligibility of the current pregnancy to participate in the study. Preoperative laboratory tests: including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests. Group allocation: Before surgery, participants will be randomly and equally assigned into four groups; Tranexamic Acid group, Misoprostol group, Carbetocin group and Oxytocin group. Randomization will be performed using computer-generated random numbers. In Oxytocin group (n=111), patients will receive 10 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) given as infusion in 500 ml lactated ringer/s solution at a rate of 125ml/hour after delivery of the placenta. In Tranexamic group (n=111), patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision). In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta. In carbetocin group (n=111) 100 microgram carbetocin (Pabal, Ferring, Kiel, Germany) will be given as an intravenous bolus dose following the delivery of the placenta. In all groups, patients will additionally receive 5 IU oxytocin given as slow intravenous bolus following delivery of the baby. All cesarean sections will be done under spinal anesthesia by the following operative steps: pfannensteil incision, transverse lower uterine segment incision, immediate cord clamping (< 30 seconds) and the placenta will be removed by controlled cord traction after its spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in anatomical manner (adequate hemostasis will be ensured in all operative steps). The number and the difference of weight of operative towels (before and after LSCS) and amount of blood in suction unit will be recorded. Fluid monitoring will be performed through rate of infusion and urine output. A complete blood count test will be performed 12 hours after delivery. Estimated Blood Loss (EBL) will be evaluated as follows: The number of operative towels used. The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss). EBL calculation according to the formula which is EBL equals EBV times Preoperative hematocrit minus Postoperative hematocrit divided by Postoperative hematocrit. Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85). In Tranexamic Acid group (n=111), the time interval between drug administration and fetal delivery will be recorded. All patients will be followed up following the delivery as regard occurrence of primary postpartum hemorrhage (within the first 24 hours), the need for blood transfusion (within the first 24 hours), misoprostol-related side effects (in the first 6 hours) (i.e., shivering, pyrexia >38C0, headache, nausea, vomiting with or without the need for antiemetic drugs), carbetocin - related side effects (i.e., nausea, vomiting, flushing, dizziness, syncope) and the occurrence of thromboembolic events (within one week of delivery). The EBL will be compared among the four groups together with occurrence of the above-mentioned drugs side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Hemorrhage, Blood Loss, Postoperative, Cesarean Section Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized controlled clinical trial including 4 groups comprising of 111 each. Group 1 will receive Oxytocin only, Group 2 will receive Oxytocin and Tranexamic acid, Group 3 will receive Oxytocin and Misoprostol and Group 4 will receive Oxytocin and Carbetocin.
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    444 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Oxytocin Group
    Arm Type
    Active Comparator
    Arm Description
    o In Oxytocin group (n=111), patients will receive 10 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) given as infusion in 500 ml lactated ringer/s solution at a rate of 125ml/hour after delivery of the placenta.
    Arm Title
    Tranexamic acid
    Arm Type
    Active Comparator
    Arm Description
    o In Tranexamic group (n=111), patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision). Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.
    Arm Title
    Misoprostol
    Arm Type
    Active Comparator
    Arm Description
    o In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.
    Arm Title
    Carbetocin
    Arm Type
    Active Comparator
    Arm Description
    o In carbetocin group (n=111) 100 microgram carbetocin (Pabal, Ferring, Kiel, Germany) will be given as an intravenous bolus dose following the delivery of the placenta. Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid
    Other Intervention Name(s)
    Misoprostol, Carbetocin, Oxytocin
    Intervention Description
    Giving oxytocin only, or oxytocin in addition to Tranexamic acid, Misoprostol or Carbetocin the mentioned doses and by the mention routes, then comparing the estimated blood loss in each group.
    Primary Outcome Measure Information:
    Title
    Estimated Blood Loss
    Description
    To compare the estimated blood loss (EBL) during and after cesarean delivery among the four groups.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Need for additional ecbolics
    Description
    The Use of additional ecbolics denoting uterine atony (i.e. 10 IU intravenous infusion of oxytocin with 500 ml lactated ringer at a rate of 125 ml/hour and 1mL [0.2 mg] intramuscular ergometrine with or without 600 microgram rectal misoprostol postoperatively)
    Time Frame
    1 year
    Title
    Excessive blood loss and need for blood transfusion
    Description
    The occurrence of excessive blood loss (> 1000 mL) together with the need for blood transfusion within the first 24 hours postoperatively.
    Time Frame
    1 year
    Title
    Side effects
    Description
    The occurrence of any maternal side effects (among the four groups).
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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): Maternal Anemia (hemoglobin < 10 g%). Known placenta previa. Proven or suspected case of placental abruption. Preeclampsia or gestational hypertension. Polyhydramnios (DVP > 8cm). Macrosomia (> 4 Kg) Previous history of uterine atony or postpartum hemorrhage). 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr K Rasheed, MsC
    Phone
    00201228201234
    Email
    amr_rasheed@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moutaz M Elsherbini, MD
    Phone
    00201001588300
    Email
    mizosherbini@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amr K Rasheed, MsC
    Organizational Affiliation
    Assistant Lecturer, Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28040124
    Citation
    Chen CY, Su YN, Lin TH, Chang Y, Horng HC, Wang PH, Yeh CC, Chang WH, Huang HY. Carbetocin in prevention of postpartum hemorrhage: Experience in a tertiary medical center of Taiwan. Taiwan J Obstet Gynecol. 2016 Dec;55(6):804-809. doi: 10.1016/j.tjog.2016.07.009.
    Results Reference
    result
    PubMed Identifier
    27536161
    Citation
    Prata N, Weidert K. Efficacy of misoprostol for the treatment of postpartum hemorrhage: current knowledge and implications for health care planning. Int J Womens Health. 2016 Jul 29;8:341-9. doi: 10.2147/IJWH.S89315. eCollection 2016.
    Results Reference
    result
    PubMed Identifier
    30122082
    Citation
    Della Corte L, Saccone G, Locci M, Carbone L, Raffone A, Giampaolino P, Ciardulli A, Berghella V, Zullo F. Tranexamic acid for treatment of primary postpartum hemorrhage after vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2020 Mar;33(5):869-874. doi: 10.1080/14767058.2018.1500544. Epub 2018 Sep 10.
    Results Reference
    result

    Learn more about this trial

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

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