Clinical trial NCT02416089: Tampostat for Management of Postpartum Hemorrhage
Official title: Tampostat: A Low-cost, Self-regulating Tamponade for Management of Postpartum Hemorrhage in Bangladesh
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Postpartum Hemorrhage
Keywords: Tampostat
Tamponade
Postpartum hemorrhage
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Jibon Health Technologies, Inc.
name: Shaheed Suhrawardi Medical College Hospital
name: Dhaka Medical College
First posted: 2015-04-14
Enrollment: 344
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Safety of Tampostat as measured by number of serious adverse events in primary PPH management
timeFrame: 2 months
measure: Efficacy of Tampostat as measured by number of successful cases in arresting bleeding in Primary PPH
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Feasibility as measured by number of physicians consider Tampostat as a feasible device in arresting primary PPH
timeFrame: 2 months
measure: Applicability of Tampostat as measured by rating by service providers using pre established scoring system in the management of primary PPH
timeFrame: 2 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Obstetrical Ward of Shaheed Suhrawardi Medical College Hospital (ShSMCH) and Dhaka Medical College Hospital (DMCH)
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Aminur Rahman, MBBS,MSc
role: PRINCIPAL_INVESTIGATOR
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