Clinical Trial: Tampostat for Management of Postpartum Hemorrhage

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Detailed Summary: 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.
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Current Primary Outcome:

• 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.
• 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)
• 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]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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
• 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.

Original Secondary Outcome: Same as current

Information By: International Centre for Diarrhoeal Disease Research, Bangladesh

Dates:
Date Received: March 16, 2015
Date Started: April 2015
Date Completion: March 2017
Last Updated: November 28, 2016
Last Verified: November 2016