Tampostat for Management of Postpartum Hemorrhage
|ClinicalTrials.gov Identifier: NCT02416089|
Recruitment Status : Terminated
First Posted : April 14, 2015
Last Update Posted : November 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Device: Tampostat Device: Condom catheter tamponade||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||344 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
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
- 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]
- 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.
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
|Obstetrical Ward of Shaheed Suhrawardi Medical College Hospital (ShSMCH) and Dhaka Medical College Hospital (DMCH)|
|Principal Investigator:||Aminur Rahman, MBBS,MSc||International Centre for Diarrhoeal Disease Research, Bangladesh|