Foley's Catheter Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Intrauterine Inflated Foley's Catheter Balloon Plus Intravenous Tranexamic Acid During Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). The Bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. It has been used in cases of uterine atony and placenta previa with a success rate of 90%. However, Bakri balloon is not available in all countries.

The aim of this study is to evaluate the efficacy of the use of intrauterine inflated Foley's catheter balloon with or without intravenous tranexamic acid to control PPH during cesarean delivery in cases of placenta previa.

Study Overview

• Status: Unknown
• Conditions: Placenta Previa
• Intervention / Treatment: Procedure: Foley's Catheter; Drug: TA; Drug: Placebo

Detailed Description

Eligible participants were allocated to one of two groups. Group (I): patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. Group (II): patients received 1 gm tranexamic acid (TA), (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus Intrauterine Inflated Foley's Catheter Balloon. In group I, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. Neither the surgeon nor the anesthetist will know the nature of the IV administered drug before cesarean section.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hany f sallam, md; Phone Number: 01022336052; Email: hany.farouk@aswu.edu.eg

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa

Exclusion Criteria:

• Patients with a cardiac, hepatic, renal or thromboembolic disease
• patients with the high possibility of the morbid adherent placenta
• known coagulopathy or thromboembolic disease
• those presented with severe antepartum hemorrhage
• hypersensitivity or contraindications of use of tranexamic acid
• patient refuses to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Foley's Catheter plus TA; patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus 1 gm tranexamic acid in 100ml saline intravenous just before skin incision	Procedure: Foley's Catheter; patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.; Other Names: Active Comparator; Drug: TA; patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline; Other Names: active comparator
Active Comparator: Foley's Catheter plus placebo to TA; patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus single injection of 100 ml intravenous saline before skin incision	Procedure: Foley's Catheter; patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.; Other Names: Active Comparator; Drug: Placebo; patients received 100 ml saline just before skin incision; Other Names: Placebo to TA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with postpartum hemorrhage	number of participant with blood loss > 1000ml	24 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss	amount of blood loss during cesarean section	during the operation
The number of participant needed for blood transfusion	Calculation of the number of participant needed for blood transfusion	24 hours postoperative
number of participant need of extra surgical maneuvers	number of participant need of extra surgical maneuvers like internal iliac ligation or hysterectomy	24 hours post operative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 12, 2018
• First Posted (Actual): November 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: cesarean section; tranexamic acid; placenta previa; Foley's Catheter Balloon
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Previa
• Other Study ID Numbers: aswu/199/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No