- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03570710
Reducing Blood Loss During Cesarean Hysterectomy for Placenta Accreta Spectrum
Reducing Blood Loss During Cesarean Hysterectomy for Placenta Accreta Spectrum With Intravenous Versus Topical Tranexamic Acid: A Double-blind Randomized Controlled Trial
PAS is an obstetrics condition that is closely linked with massive obstetrical hemorrhage with a varied incidence about once in every 533 live births. It is considered one of the causes of massive transfusion (>4 units of packed red blood cells) and cesarean hysterectomy.
It is estimated that peripartum hysterectomies are performed in approximately0.08% of all deliveries. A large study from the United Kingdom noted that 38% were a result of PAS. More recently, population-based analyses show that PAS is the indication for the majority of peripartum hysterectomies.
Bleeding at the time of peripartum hysterectomy for PAS is often substantial. Nearly 90% of patients need blood products, while 38% of patients need a massive blood transfusion.
There is a 30% risk of an ICU admission, thromboembolic disease, readmission, reoperation, poor wound healing, and a reported rate of surgical re-exploration ranging from 4% to 33%. The risk of maternal death reported being as high as 7% (although less in most recent series) Therefore, adequate homeostatic techniques are essential. Currently, surgical hemostasis can be secured by a variety of methods, including mechanical sutures (or clamping), electric coagulation, ultrasonically activated scalpel or drugs.
TA 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 . However, concerns about possible thromboembolic events with the parental administration of TA has stimulated increasing interest in its topical Use
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eligible participants were allocated to one of three groups. Group (I): patients received 110 ml normal saline IV just before skin incision Group (II): patients received 1 gm TA (2 ampoules of Capron 500 mg /5 ml; Amoun, Cairo, Egypt) intravenous just before skin incision. Group (III): patients received 2 gm topical TA (4 ampoules of Capron 500 mg/5 ml) applied on the placental bed after placental delivery. Patients were randomized to three groups, each compromised of 43 patients according to a three-blocked randomization list which was coded (1 or 2 or 3) at 1:1:1 ratio. The three parallel groups were prepared using a Computer-generated randomization system. The allocated groups will be concealed in serially numbered sealed opaque envelopes that will only be opened after recruitment. The patient allocation will be performed prior to the induction of anesthesia by an independent person, who will not otherwise be involved in this study. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used. In all eligible participants, CH was performed under general anesthesia by the same operative and anesthesia team. A dose of 1 g of first-generation cephalosporin (Cefazolin®; Bristol Mayers Squibb, Cairo, Egypt) was administered intravenously immediately prior to skin incision. The abdomen was exposed through Pfannensteil incision. After skin incision, the subcutaneous fat and abdominal fascia were opened crosswise, and the rectus muscle was opened on the midline, the parietal peritoneum was opened longitudinally, the visceral peritoneum was opened transversely and dissected downwards with the bladder and kept against symphysis pubis by a Doyen retractor, followed by transverse incision of the uterus at the upper border of the placenta to avoid transplacental incision which provoke severe bleeding.
Eligible participants were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min. Throughout the operation irrigation was done by 60 ml of (2g tranexamic acid (10 ml) diluted in 100 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.).At the end of operation another dose of 60 ml of (1g tranexamic acid (10 ml) diluted in 50 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.) was left intraabdominal then 1 intraperitoneal suction drain was routinely used in all patients the drains were closed for 3 hour postoperative , after that time the drains were opened and removed on the second postoperative day unless otherwise indicated.. To ensure a sufficiently high concentration of topical tranexamic acid, it was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moistens at least 1500 cm2.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aswan, Egypt, 81528
- AswanUH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all pregnant women with a single fetus scheduled for elective cesarean hysterectomy for placenta accreta spectrum
Exclusion Criteria:
- Patients with a cardiac, hepatic, renal or thromboembolic disease.
- patients with pelvic endometriosis and adnexal mass.
- patients had an allergy to tranexamic acid.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: normal saline arm group
110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy
|
110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy
Other Names:
|
Active Comparator: intravenous tranexamic acid group
1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Amoun, Cairo, Egypt) intravenous just before skin incision plus110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy
|
1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Amoun, Cairo, Egypt) intravenous just before skin incision plus110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy
Other Names:
|
Active Comparator: Topical tranexamic acid group
2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy plus110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy plus In topical tranexamic acid group gauze soaked with 2g tranexamic acid (20 ml) diluted in 200 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.)
applied on the pelvic bed after Cesarean hysterectomy.
To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface.
20 ml moisten at least 1500 cm2.
|
2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy plus110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy plus In topical tranexamic acid group gauze soaked with 2g tranexamic acid (20 ml) diluted in 200 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.)
applied on the pelvic bed after Cesarean hysterectomy.
To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface.
20 ml moisten at least 1500 cm2.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
intraoperative blood loss
Time Frame: during the operation
|
intraoperative blood loss
|
during the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative blood loss
Time Frame: 6 hours post operative
|
postoperative blood loss
|
6 hours post operative
|
blood transfusion
Time Frame: intraoperative and 12 hour post operative
|
intraoperative and 12 hour post operative
|
intraoperative and 12 hour post operative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- aswu/183/10/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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