ClinicalTrials.gov
ClinicalTrials.gov Menu

Tampostat for Management of Postpartum Hemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02416089
Recruitment Status : Terminated
First Posted : April 14, 2015
Last Update Posted : November 26, 2018
Sponsor:
Collaborators:
Grand Challenges Canada
Jibon Health Technologies, Inc.
Shaheed Suhrawardi Medical College Hospital
Dhaka Medical College
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief 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.

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Device: Tampostat Device: Condom catheter tamponade Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tampostat: A Low-cost, Self-regulating Tamponade for Management of Postpartum Hemorrhage in Bangladesh
Study Start Date : April 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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. 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)

  3. 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]


Secondary Outcome Measures :
  1. 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. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416089


Locations
Bangladesh
Obstetrical Ward of Shaheed Suhrawardi Medical College Hospital (ShSMCH) and Dhaka Medical College Hospital (DMCH)
Dhaka, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Grand Challenges Canada
Jibon Health Technologies, Inc.
Shaheed Suhrawardi Medical College Hospital
Dhaka Medical College
Investigators
Principal Investigator: Aminur Rahman, MBBS,MSc International Centre for Diarrhoeal Disease Research, Bangladesh

Publications of Results:
Seligman, B. and X. Liu, Economic assessment of interventions for reducing postpartum hemorrhage in developing countries. 2006: Abt Associates.
Organization, W.H., Make Every Mother and Child Count: The World Health Report. 2005: World Health Organization.
National Institute of Population Research and Training (NIPORT), M.E., and icddr,b, Bangladesh Maternal Mortality and Health Care Survey 2010, M.E. NIPORT, and icddr,b, Editor. 2012: Dhaka.
Rather, S.Y., et al., Use of condom to control intractable PPH. JK science, 2010. 12(3)

Other Publications:
Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT02416089     History of Changes
Other Study ID Numbers: PR-14095
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2016

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Tampostat
Tamponade
Postpartum hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage