Reducing Blood Loss During Cesarean Hysterectomy for Placenta Accreta Spectrum

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

Conditions

• Cesarean Section Complications

Interventions

DRUG

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

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.

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

Sponsors & Collaborators

• Aswan University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2021-06-30

Completion

2021-08-01

Countries

• Egypt

Study Locations