NCT03741114

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2018

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

November 12, 2018

Last Update Submit

January 8, 2019

Conditions

Placenta Previa

Keywords

placenta previatranexamic acidcesarean sectionFoley's Catheter Balloon

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with postpartum hemorrhage

    number of participant with blood loss \> 1000ml

    24 hours post operative

Secondary Outcomes (3)

  • intraoperative blood loss

    during the operation

  • The number of participant needed for blood transfusion

    24 hours postoperative

  • number of participant need of extra surgical maneuvers

    24 hours post operative

Study Arms (2)

Foley's Catheter plus TA

ACTIVE COMPARATOR

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 CatheterDrug: TA

Foley's Catheter plus placebo to TA

ACTIVE COMPARATOR

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 CatheterDrug: Placebo

Interventions

Foley's CatheterPROCEDURE

patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.

Also known as: Active Comparator
Foley's Catheter plus TAFoley's Catheter plus placebo to TA
TADRUG

patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline

Also known as: active comparator
Foley's Catheter plus TA
PlaceboDRUG

patients received 100 ml saline just before skin incision

Also known as: Placebo to TA
Foley's Catheter plus placebo to TA

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • hany f sallam, md

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hany f sallam, md

CONTACT

01022336052hany.farouk@aswu.edu.eg

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 was used.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2018

First Posted

November 14, 2018

Study Start

December 1, 2018

Primary Completion

November 30, 2020

Study Completion

February 1, 2021

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

EG(1)