Tampostat for Management of Postpartum Hemorrhage

November 22, 2018 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh

Tampostat: A Low-cost, Self-regulating Tamponade for Management of Postpartum Hemorrhage in Bangladesh

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This will be a 2-year study having two parts. Part A will be a Proof of Concept (POC) study that will be conducted at the Obstetrical Ward of Shaheed Suhrawardi Medical College Hospital (ShSMCH) and Dhaka Medical College Hospital (DMCH). There is no sample size estimation of this POC study that will assess safety, feasibility and applicability of using Tampostat on 5 consenting women with PPH for each hospital. Part B of the study will be an open label, randomized clinical trial that will be conducted at the Obstetrical Ward of Dhaka Medical College Hospital (DMCH). In this part, 344 consenting women with primary PPH will be enrolled, and allocated to either Tampostat or the control intervention in equal numbers per randomization (172 patients in each arm). In both these parts, Tampostat will be used only when Active Management of Third Stage of Labour (AMTSL) has failed to prevent PPH within 24 hours after delivery. All the doctors involved in the provision of care and treatment to PPH patients will be trained on the WHO's standard of care; they will also receive training on appropriate use of the devices to be used in this trial. An expert committee constituted of OBGYN professionals, clinical trial specialists, and statisticians will oversee the technical management of patients, data collection and their procedures, and ethical issues in this trial.

Study Type

Interventional

Enrollment (Actual)

344

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Obstetrical Ward of Shaheed Suhrawardi Medical College Hospital (ShSMCH) and Dhaka Medical College Hospital (DMCH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women who delivered their baby at the site hospital, or attended the site hospital with PPH that started within the last 24 hours.
  2. Women with primary PPH have received AMTSL.
  3. PPH is due to atonic uterus.
  4. Provides written informed consent for enrolment in the study.

Exclusion Criteria:

  1. Primary PPH caused by retained placenta or ruptured uterus.
  2. Women who delivered before 28 weeks of gestation.
  3. Women not willing to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tampostat
Tampostat™ is a self-regulating, low cost, pressure based emergency obstetric device designed specifically for use in low-resource settings. It has 6 parts: probe, condom, O ring, nerve centre, tube and bulb pump. It offers significant benefits over the current model by simplifying the insertion process, reducing the need for constant monitoring, eliminating leakage and the need for sterile saline, and using a pressure-based mechanism to apply consistent pressure to all women regardless of uterus size.Women who develop PPH even after applying AMTSL at the hospital or women who visit the hospital with PPH within 24 hours after delivery will be managed by Tampostat for the intervention arm or by the condom catheter tamponade in the control arm(172 patients in each arm)
Device: Tampostat
Active Comparator: Condom catheter tamponade
Condom catheter tamponade have been used by medical professionals for several years in the management of atonic (primary) PPH. In this approach, Sterile rubber catheter fitted with a condom as a tamponade balloon device and using normal saline to inflate the condom.
Device: Condom catheter tamponade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Tampostat as measured by number of serious adverse events in primary PPH management
Time Frame: 2 months
The safety of Tampostat [no. of Serious adverse events i.e. Incidence of air embolism, injury to the uterine wall, pain during inflation of condom & continuation of vaginal /uterine bleeding during use of Tampostat] in primary PPH management.
2 months
Efficacy of Tampostat as measured by number of successful cases in arresting bleeding in Primary PPH
Time Frame: 12 months
Efficacy [number of successful cases in arresting bleeding due to primary PPH from atonic uterus] of Tampostat in the management of primary postpartum hemorrhage (PPH)
12 months
Comparison of the efficacy of Tampostat as measured by number of successful cases in arresting primary PPH and the time takes to arrest the bleeding with that of the condom catheter tamponade
Time Frame: 12 months
Comparison of the efficacy of Tampostat in terms of arresting primary PPH due to atonic uterus with that of the conventional condom catheter tamponade [no. of successful cases in arresting primary post partum bleeding using Tampostat and condom catheter and the time both takes to arrest the bleeding]
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as measured by number of physicians consider Tampostat as a feasible device in arresting primary PPH
Time Frame: 2 months
The feasibility of Tampostat[number of physicians consider Tampostat as a feasible device in arresting primary PPH due to atonic uterus] in the management of primary PPH by
2 months
Applicability of Tampostat as measured by rating by service providers using pre established scoring system in the management of primary PPH
Time Frame: 2 months
Applicability[rating by service providers on applicability of the device using pre established scoring system]of Tampostat in the management of primary PPH due to atonic uterus.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

Grand Challenges Canada
Dhaka Medical College
Jibon Health Technologies, Inc.
Shaheed Suhrawardi Medical College Hospital

Investigators

  • Principal Investigator: Aminur Rahman, MBBS,MSc, International Centre for Diarrhoeal Disease Research, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

November 22, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-14095

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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