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Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT03741075
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.

Various conservative measures have been developed to avoid hysterectomy and preserve fertility in patients with PP. Bilateral Uterine artery ligation (BUAL) is one of the reported surgical procedures carried out in these cases as it is easy and quick. It can be used alone or with adjunctive measures with a fair success rate. The aim is to reduce the blood supply to the uterus and to prevent postpartum hemorrhage.

Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.


Condition or disease Intervention/treatment Phase
Cesarean Section Complications Procedure: BUA Drug: topical tranexamic acid Drug: placebo Not Applicable

Detailed Description:
Study inclusion criteria will be women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures Eligible participants were allocated to one of two groups. Group (I): patients managed by bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures. Group (II): patients received 1 gm TA (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) topically applied to the placental bed plus BUA when not respond to uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The current study was a double-blind randomized controlled trial will be conducted at a tertiary University Hospital
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used
Primary Purpose: Prevention
Official Title: Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Hemorrhagic Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: BUAL plus placebo
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus 200 ml saline topical application to placental bed
Procedure: BUA
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Other Name: Active Comparator

Drug: placebo
topical application of 200ml saline to the placental bed after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Other Name: Placebo to tranexamic acid

Experimental: BUAL plus topical tranexamic acid
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus topical application of 20ml saline contains 2 gm tranexamic acid
Procedure: BUA
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Other Name: Active Comparator

Drug: topical tranexamic acid
topical application of 200ml saline contains 2 gm tranexamic acid to the placental bed after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Other Name: active comparator




Primary Outcome Measures :
  1. Number of Participants with postpartum hemorrhage [ Time Frame: 6 hours post operative ]
    number pf participants with blood loss > 1000ml


Secondary Outcome Measures :
  1. intraoperative blood loss [ Time Frame: during the operation ]
    amount of blood loss during cesarean section

  2. The number of participant needed for blood transfusion [ Time Frame: 24 hours post operative ]
    Calculation of the number of participant needed for blood transfusion

  3. The number of participant needed of extra surgical maneuvers [ Time Frame: 24 hours post operative ]
    Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion Criteria:

  • patients with the high possibility of morbid adherent placenta
  • those presented with severe antepartum hemorrhage
  • Patients with cardiac, hepatic, renal, or thromboembolic disease;
  • hypersensitivity or contraindications of use of tranexamic acid
  • patient refuses to consent

Information from the National Library of Medicine

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): NCT03741075


Contacts
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Contact: hany f sallam, md 01022336052 ext 002 hany.farouk@aswu.edu.eg

Locations
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Egypt
Aswan University Recruiting
Aswan, Egypt, 81528
Contact: hany f sallam, md    01092440504 ext 002    nahla.elsayed@aswu.ed.eg   
Contact: Nahla w Shady, m    1019240504 ext 002    nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital
Investigators
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Principal Investigator: hany f sallam, md Aswan University Hospital

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Responsible Party: hany farouk, Principal Investigator, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03741075     History of Changes
Other Study ID Numbers: aswu/198/18
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hany farouk, Aswan University Hospital:
placenta previa
tranexamic acid
uterine artery ligation

Additional relevant MeSH terms:
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Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Tranexamic Acid
Hemostatics
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants