Cesarean Section Complications
Conditions
Keywords
placenta previa, tranexamic acid, uterine artery ligation
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.
Interventions
PROCEDUREBUA
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
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
DRUGplacebo
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
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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
Intervention model description
The current study was a double-blind randomized controlled trial will be conducted at a tertiary University Hospital
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with postpartum hemorrhage | 6 hours post operative | number pf participants with blood loss \> 1000ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative blood loss | during the operation | amount of blood loss during cesarean section |
| 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 |
Countries
Egypt
Contacts
Primary Contacthany f sallam, md
Outcome results
None listed