NCT03060889

Brief Summary

Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa

Trial Health

100
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_3

Status
completed

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

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

January 10, 2017

Last Update Submit

February 21, 2017

Conditions

Placenta Previa

Keywords

Cesarean sectionplacenta previaTranexamic acid

Outcome Measures

Primary Outcomes (1)

  • intra operative blood loss in ml

    Calculation of blood loss during cesarean section in the two groups to detect efficacy of Tranexamic acid in reducing blood loss

    intraoperative during cesarean section

Study Arms (2)

Cases

ACTIVE COMPARATOR

Tranexamic acid 10 mg/ kg body weight will be given by intravenous infusion with induction of anesthesia in elective cesarean section for non complicated cases of placenta previa

Drug: Tranexamic acid

Controls

NO INTERVENTION

Control group will not receive Tranexamic acid

Interventions

Tranexamic acidDRUG

10 mg/kg body weight will be given with induction of anesthesia by intravenous infusion

Cases

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Term pregnancy (more than 37 weeks of gestation)
  • Diagnosis of placenta previa was confirmed by ultrasound
  • The patient hemoglobin percentage is more than 10 mg/dl

You may not qualify if:

  • Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
  • Emergency lower segment cesarean section
  • Associated medical comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta Previa

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2017

First Posted

February 23, 2017

Study Start

February 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02