Reducing Blood Loss During Cesarean Hysterectomy for Placenta Accreta Spectrum

NCT ID: NCT03570710

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-08-01

Brief Summary

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

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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

intravenous tranexamic acid

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Topical tranexamic acid

Intervention Type: DRUG

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.

Interventions

intravenous tranexamic acid

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

Intervention Type: DRUG

Topical tranexamic acid

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.

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

Other Intervention Names

Active Comparator; Active Comparator; Placebo Comparator

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AswanUH

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/183/10/17

Identifier Type: -

Identifier Source: org_study_id