Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Cesarean Delivery

Not Applicable

• Conditions: Cesarean Section Complications
• Interventions: Procedure: BUA; Drug: placebo; Drug: topical tranexamic acid

• Registration Number: NCT03741075
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-14
• Study Start: 2018-12-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-08
• Last Update Posted: 2019-01-10
• Primary Completion: 2020-11-30
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BUAL plus placebo	BUA	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
BUAL plus placebo	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
BUAL plus topical tranexamic acid	BUA	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
BUAL plus topical tranexamic acid	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

Primary Outcome Measures

Name	Time	Method
Number of Participants with postpartum hemorrhage	6 hours post operative	number pf participants with blood loss \> 1000ml

Secondary Outcome Measures

Name	Time	Method
The number of participant needed for blood transfusion	24 hours post operative	Calculation of the number of participant needed for blood transfusion
The number of participant needed of extra surgical maneuvers	24 hours post operative	Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation
intraoperative blood loss	during the operation	amount of blood loss during cesarean section

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt