Tampostat for Management of Postpartum Hemorrhage

NCT02416089 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2018-11-26

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety, feasibility and applicability of a new device 'Tampostat' in the management of primary postpartum hemorrhage and compare the efficacy of 'Tampostat' in terms of arresting primary PPH with that of the conventional condom catheter.

Conditions

  • Postpartum Hemorrhage

Interventions

DEVICE

Tampostat

DEVICE

Condom catheter tamponade

Sponsors & Collaborators

  • Grand Challenges Canada

    collaborator OTHER
  • Jibon Health Technologies, Inc.

    collaborator INDUSTRY
  • Shaheed Suhrawardi Medical College Hospital

    collaborator UNKNOWN
  • Dhaka Medical College

    collaborator OTHER
  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Aminur Rahman, MBBS,MSc · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Bangladesh

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 NCT02416089 on ClinicalTrials.gov