Postpartum Hemorrhage
Conditions
Keywords
Tampostat, Tamponade, Postpartum hemorrhage
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 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.
Interventions
DEVICETampostat
DEVICECondom catheter tamponade
Sponsors
Grand Challenges Canada
Jibon Health Technologies, Inc.
Shaheed Suhrawardi Medical College Hospital
Dhaka Medical College
International Centre for Diarrhoeal Disease Research, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Tampostat as measured by number of serious adverse events in primary PPH management | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as measured by number of physicians consider Tampostat as a feasible device in arresting primary PPH | 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 | 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. |
Countries
Bangladesh
Outcome results
None listed