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

Primary Purpose

Placenta Previa

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Foley's Catheter
TA
Placebo
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa focused on measuring placenta previa, tranexamic acid, cesarean section, Foley's Catheter Balloon

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aswan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Foley's Catheter plus TA

Foley's Catheter plus placebo to TA

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants with postpartum hemorrhage
number of participant with blood loss > 1000ml

Secondary Outcome Measures

intraoperative blood loss
amount of blood loss during cesarean section
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
number of participant need of extra surgical maneuvers
number of participant need of extra surgical maneuvers like internal iliac ligation or hysterectomy

Full Information

First Posted
November 12, 2018
Last Updated
January 8, 2019
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03741114
Brief Title
Foley's Catheter Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa
Official Title
Intrauterine Inflated Foley's Catheter Balloon Plus Intravenous Tranexamic Acid During Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa
Keywords
placenta previa, tranexamic acid, cesarean section, Foley's Catheter Balloon

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Foley's Catheter plus TA
Arm Type
Active Comparator
Arm Description
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
Arm Title
Foley's Catheter plus placebo to TA
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Foley's Catheter
Other Intervention Name(s)
Active Comparator
Intervention Description
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.
Intervention Type
Drug
Intervention Name(s)
TA
Other Intervention Name(s)
active comparator
Intervention Description
patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo to TA
Intervention Description
patients received 100 ml saline just before skin incision
Primary Outcome Measure Information:
Title
Number of Participants with postpartum hemorrhage
Description
number of participant with blood loss > 1000ml
Time Frame
24 hours post operative
Secondary Outcome Measure Information:
Title
intraoperative blood loss
Description
amount of blood loss during cesarean section
Time Frame
during the operation
Title
The number of participant needed for blood transfusion
Description
Calculation of the number of participant needed for blood transfusion
Time Frame
24 hours postoperative
Title
number of participant need of extra surgical maneuvers
Description
number of participant need of extra surgical maneuvers like internal iliac ligation or hysterectomy
Time Frame
24 hours post operative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hany f sallam, md
Phone
01022336052
Email
hany.farouk@aswu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hany f sallam, md
Phone
01092440504
Ext
002
Email
nahla.elsayed@aswu.ed.eg
First Name & Middle Initial & Last Name & Degree
Nahla w Shady, m
Phone
1019240504
Ext
002
Email
nahla.elsayed@aswu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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