An interventional study of BUA and topical tranexamic acid in Cesarean Section Complications, sponsored by Aswan University Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by Aswan University Hospital · Not applicable, Interventional, and Prevention
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.
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.
93 studies on the registry are indexed under Placenta Previa; 20 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 53 interventional studies indexed under Placenta Previa.
Browse Placenta Previa studies →Aswan University Hospital is the lead sponsor of 95 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
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
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
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
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
Number of Participants with postpartum hemorrhage
number pf participants with blood loss \> 1000ml
Time frame: 6 hours post operative
intraoperative blood loss
amount of blood loss during cesarean section
Time frame: during the operation
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
Time frame: 24 hours post operative
The number of participant needed of extra surgical maneuvers
Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation
Time frame: 24 hours post operative
Plan to share: Undecided
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Aswan University Hospital