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Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section

Sponsor
Aswan University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05072860
Collaborator
(none)
150
Enrollment
2
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

In hypertensive women having an elective cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical tranexamic acid
  • Other: : normal saline
 N/A

Detailed Description

patients were allocated to one of two groups after induction of anesthesia. they received temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a double-blinded randomized controlled triala double-blinded randomized controlled trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
a double-blinded randomized controlled trial
Primary Purpose:
Prevention
Official Title:
The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Hypertensive Women Undergoing Elective Cesarean Section: A Randomized Controlled Trial
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Topical tranexamic acid

temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo

Drug: Topical tranexamic acid
temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
Other Names:
  • experimental

    		•
    Placebo Comparator: normal saline

    temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid

    Other: : normal saline
    temporary uterine packing with gauze of the dimensions soaked with placebo to 2 gm tranexamic diluted in 60ml saline acid
    Other Names:
  • Placebo Comparator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. intraoperative blood loss [30 minutes]

      measures the intraoperative blood loss by direct and gravimetric methods

    Secondary Outcome Measures

    1. need of blood transfusion [12 hours]

      number of unites of blood transfusion

    2. need of uterotonic [24 hours]

      misoprostol, oxytocin etc

    3. change in hemoglobin [24 hours]

      change in hemoglobin

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • hypertensive women undergoing elective cesarean section
    Exclusion Criteria:

    • Patients with cardiac, hepatic, renal, or thromboembolic disease. ,

    • patients with the high possibility of the morbid adherent placenta,

    • known coagulopathy and

    • those presented with severe antepartum hemorrhage

    • refuse to participate

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Aswan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    hany farouk, A Professor, Aswan University Hospital
    ClinicalTrials.gov Identifier:
    NCT05072860
    Other Study ID Numbers:
    • aswu/542/7/21
    First Posted:
    Oct 11, 2021
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Postpartum Hemorrhage
    Hemorrhage
    Tranexamic Acid

    Study Results

    No Results Posted as of Oct 11, 2021