Reducing Blood Loss During Cesarean Hysterectomy for Placenta Accreta Spectrum

NCT03570710 | Completed

• 1 other identifier: aswu/183/10/17
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section Complications

Keywords

cesarean section; placenta accreta spectrum; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• intraoperative blood loss

  intraoperative blood loss

  during the operation

Secondary Outcomes (2)

• postoperative blood loss

  6 hours post operative

• blood transfusion

  intraoperative and 12 hour post operative

Study Arms (3)

normal saline arm group

PLACEBO COMPARATOR

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

Drug: Normal saline

intravenous tranexamic acid group

ACTIVE COMPARATOR

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: intravenous tranexamic acid

Topical tranexamic acid group

ACTIVE COMPARATOR

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: Topical tranexamic acid

Interventions

intravenous tranexamic acid 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

Also known as: Active Comparator

intravenous tranexamic acid group

Topical tranexamic acid 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.

Also known as: Active Comparator

Topical tranexamic acid group

Normal saline 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

Also known as: Placebo Comparator

normal saline arm group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• all pregnant women with a single fetus scheduled for elective cesarean hysterectomy for placenta accreta spectrum

You may not qualify if:

• Patients with a cardiac, hepatic, renal or thromboembolic disease.
• patients with pelvic endometriosis and adnexal mass.
• patients had an allergy to tranexamic acid.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

AswanUH

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 27, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2021
• Study Completion: August 1, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

EG (1)