NCT04518163

Brief Summary

Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade

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
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

August 15, 2020

Last Update Submit

September 18, 2020

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

  • mean Blood loss after placental separation

    by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

    30 minutes

Secondary Outcomes (2)

  • Number of Participants with postpartum hemorrhage

    12 hours

  • The number of participant needed of extra surgical maneuvers

    30minutes

Study Arms (2)

study group

EXPERIMENTAL

Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus 1gm tranexamic acid by intravenous infusion

Drug: Tranexamic AcidDevice: Bakri Balloon

control group

ACTIVE COMPARATOR

Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus saline by intravenous infusion

Drug: placebo to TADevice: Bakri Balloon

Interventions

Tranexamic AcidDRUG

Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision

Also known as: TA
study group
placebo to TADRUG

Intravenous 110 ml saline by slow infusion before skin incision

Also known as: saline
control group
Bakri BalloonDEVICE

Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally

Also known as: BBT
control groupstudy group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen undergoing elective cesarean delivery for complete placenta previa
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

You may not qualify if:

  • patients with the high possibility of morbid adherent placenta
  • those presented with severe antepartum hemorrhage
  • Patients with cardiac, hepatic, renal, or thromboembolic disease;
  • 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 Hospital

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • nahla w Shady, md

    Aswan universirty

    STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052hanygyne@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind randomized controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 19, 2020

Study Start

September 1, 2020

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)