NCT02604719

Brief Summary

The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2015

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

November 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

November 12, 2015

Last Update Submit

November 27, 2015

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • PPH defined as blood loss ≥500 cc

    measured by pads placed under women buttocks

    the first 24hours

Secondary Outcomes (1)

  • severe PPH (>1000 cc), .

    first 24 hours

Study Arms (2)

tanexamic acid and Ethamsylate

EXPERIMENTAL

10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth

Drug: Tranexamic Acid and Ethamsylate

placebo

PLACEBO COMPARATOR

10 ml normal saline will be administered intravenously just after birth

Drug: Tranexamic Acid and Ethamsylate

Interventions

Tranexamic Acid and EthamsylateDRUG

The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.

Also known as: kapron and dycinon
placebotanexamic acid and Ethamsylate

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing elective caesarean section
  • Patient having one or more risk factor for PPH
  • Multiple pregnancy
  • Polyhydramnios (AFI \>25cm)
  • Macrocosmic baby (\>4.5 Kg)
  • Prolonged , augmented and obstructed labour
  • Obese patients(BMI \>30)
  • Premature rapture of membranes
  • Previous history of PPH
  • Age ≥18 years
  • Gestational Age ≥ 35 Weeks
  • Informed Oral Consent From The Patient

You may not qualify if:

  • History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke)
  • History of epilepsy or seizure
  • Any Known Cardiovascular , renal or liver Disease
  • Autoimmune Diseases
  • Sickle Cell Disease
  • Severe hemorrhagic Disease
  • Placenta Previa.
  • Morbidly adherent Placenta
  • Abruptio placenta
  • Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome
  • Administration Of low molecular weight heparin or Anti platelets the week before delivery .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic AcidEthamsylate

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Central Study Contacts

ahmed Dr alanwar, MD

CONTACT

+201111486669eladwar@hotmail.com

ahmed Dr kotb, MD

CONTACT

+201008681999ahmedmkotp@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
dr.ahmed alanwar

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 13, 2015

Study Start

November 1, 2015

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

November 30, 2015

Record last verified: 2015-11