Tampostat for Management of Postpartum Hemorrhage

International Centre for Diarrhoeal Disease Research (icddr,b)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Postpartum Hemorrhage

Treatments: Device: Condom catheter tamponade; Device: Tampostat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02416089

PR-14095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 344 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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344 participants in 2 patient groups

Tampostat

Experimental group

Description:

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)

Treatment:

Device: Tampostat

Condom catheter tamponade

Active Comparator group

Description:

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.

Treatment:

Device: Condom catheter tamponade