Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Cesarean Delivery

NCT03741075 | Unknown DMC

• 1 other identifier: aswu/198/18
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

placenta previa; tranexamic acid; uterine artery ligation

Outcome Measures

Primary Outcomes (1)

• Number of Participants with postpartum hemorrhage

  number pf participants with blood loss \> 1000ml

  6 hours post operative

Secondary Outcomes (3)

• intraoperative blood loss

  during the operation

• The number of participant needed for blood transfusion

  24 hours post operative

• The number of participant needed of extra surgical maneuvers

  24 hours post operative

Study Arms (2)

BUAL plus placebo

ACTIVE COMPARATOR

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; Drug: placebo

BUAL plus topical tranexamic acid

EXPERIMENTAL

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; Drug: topical tranexamic acid

Interventions

BUA PROCEDURE

bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Also known as: Active Comparator

BUAL plus placebo; BUAL plus topical tranexamic acid

topical tranexamic acid DRUG

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

Also known as: active comparator

BUAL plus topical tranexamic acid

placebo DRUG

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

Also known as: Placebo to tranexamic acid

BUAL plus placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam, md

CONTACT

01022336052; hany.farouk@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The current study was a double-blind randomized controlled trial will be conducted at a tertiary University Hospital

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 14, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2020
• Study Completion: January 1, 2021
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

EG (1)