Role of Tranexamic Acid Versus Uterine Cooling at Caesarean Section

NCT02780245 | Completed Phase 4 DMC

• 1 other identifier: OG2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare role of a prophylactic predefined intravenous Tranexamic Acid dose versus intraoperative Uterine Cooling in reducing blood loss and incidence of postpartum hemorrhage at secondary CS.

Conditions

Hemorrhage of Cesarean Section and/or Perineal Wound; Postpartum Hemorrhage; Uterine Atony

Keywords

Caesarean Section; Tranexamic Acid; Postpartum Hemorrhage; Ecbolics

Outcome Measures

Primary Outcomes (1)

• Total blood loss volume

  Estimation of Total Blood Loss Volume (ml) during CS and in the PACU.

  Up to 3 hours

Secondary Outcomes (5)

• Hematocrit value (Hct)

  6 hours postoperative period

• Overall blood loss volume greater than 1000 cc

  Up to 9 hours

• Need for Additional Ecbolics

  Intraoperative

• Need for other surgical measures to stop bleeding

  Intraoperative

• Transfusion of Blood or Blood Products

  Up to 3 hours

Other Outcomes (4)

• Blood Pressure

  Up to 3 hours

• Maternal Side effects of intervention administered

  Up to 9 hours

• APGAR Scores

  up to 2 hours

Study Arms (2)

Group (X) Prophylactic Tranexamic Acid

EXPERIMENTAL

Intravenously at 20 minutes preoperatively had an intervention of a single bolus TXA dose of 20•0 mg/kg, which was administered in Z solution (500•0 ml normal saline containing a prophylactic antibiotic 1•0 g) (NCT02739815).

Drug: Tranexamic Acid

Group (Y) Intraoperative Uterine Cooling

EXPERIMENTAL

Firstly intravenously at 20 minutes preoperatively had only the Z solution, and secondly \[Intraoperatively immediately following delivery of the fetus the uterus was been externalized in the usual fashion, and the body of the uterus cephalad to the hysterotomy incision was been wrapped in sterile surgical towels saturated in sterile and iced normal saline. These towels came from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels was been kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen\].

Procedure: Intraoperative Uterine Cooling

Interventions

Tranexamic Acid DRUG

At 20 minutes preoperatively, TXA of 20 mg/kg was administered in Z Solution (500•0 ml normal saline containing a prophylactic antibiotic 1•0 g).

Also known as: TXA

Group (X) Prophylactic Tranexamic Acid

Intraoperative Uterine Cooling PROCEDURE

Intraoperatively immediately following delivery of the fetus the uterus was been externalized in the usual fashion, and the body of the uterus cephalad to the hysterotomy incision was been wrapped in sterile surgical towels saturated in sterile and iced normal saline. These towels came from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels was been kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.

Group (Y) Intraoperative Uterine Cooling

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who attended Talkha Central Hospital for planned or emergency secondary CS.
• Singleton pregnancy at term with gestational age (G.A) between 38±5 and 40 weeks.

Sponsors & Collaborators

• Talkha Central Hospital: lead

Study Sites (1)

Talkha Central Hospital

Al Mansurah, Al-Dakahliya, 35511, Egypt

Location

Related Publications (26)

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  BACKGROUND

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  BACKGROUND

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• Mitchell JL, Stecher J, Crowson J, Rich D. Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial [31]. Obstetrics & Gynecology. 2015 May 1;125:9S-10S.

  BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage; Uterine Inertia

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dystocia

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Amro M Hetta, M.B., Ch.B.

  Talkha Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Amro M. Hetta

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 23, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)