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Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

NCT04518163 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2020-09-21

No results posted yet for this study

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

Conditions

  • Placenta Previa

Interventions

DRUG

Tranexamic Acid

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

DRUG

placebo to TA

Intravenous 110 ml saline by slow infusion before skin incision

DEVICE

Bakri Balloon

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

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • nahla w Shady, md · Aswan universirty

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-06-30
Completion
2022-07-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518163 on ClinicalTrials.gov