Tampostat for Management of Postpartum Hemorrhage

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02416089
• Other study ID #: PR-14095
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2016
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 344
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Device:
• Tampostat

• Condom catheter tamponade

Locations

Country	Name	City	State
Bangladesh	Obstetrical Ward of Shaheed Suhrawardi Medical College Hospital (ShSMCH) and Dhaka Medical College Hospital (DMCH)	Dhaka

Sponsors (5)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka Medical College, Grand Challenges Canada, Jibon Health Technologies, Inc., Shaheed Suhrawardi Medical College Hospital

Country where clinical trial is conducted

Bangladesh, 

References & Publications (20)

Abu-Heija AT, Jallad FF. Emergency peripartum hysterectomy at the Princess Badeea Teaching Hospital in north Jordan. J Obstet Gynaecol Res. 1999 Jun;25(3):193-5. — View Citation

Akhter S, Begum MR, Kabir Z, Rashid M, Laila TR, Zabeen F. Use of a condom to control massive postpartum hemorrhage. MedGenMed. 2003 Sep 11;5(3):38. — View Citation

Bakri YN, Amri A, Abdul Jabbar F. Tamponade-balloon for obstetrical bleeding. Int J Gynaecol Obstet. 2001 Aug;74(2):139-42. — View Citation

Condous GS, Arulkumaran S, Symonds I, Chapman R, Sinha A, Razvi K. The "tamponade test" in the management of massive postpartum hemorrhage. Obstet Gynecol. 2003 Apr;101(4):767-72. — View Citation

Doumouchtsis SK, Papageorghiou AT, Arulkumaran S. Systematic review of conservative management of postpartum hemorrhage: what to do when medical treatment fails. Obstet Gynecol Surv. 2007 Aug;62(8):540-7. Review. — View Citation

Georgiou C. Balloon tamponade in the management of postpartum haemorrhage: a review. BJOG. 2009 May;116(6):748-57. doi: 10.1111/j.1471-0528.2009.02113.x. Review. — View Citation

Georgiou C. Intraluminal pressure readings during the establishment of a positive 'tamponade test' in the management of postpartum haemorrhage. BJOG. 2010 Feb;117(3):295-303. doi: 10.1111/j.1471-0528.2009.02436.x. Epub 2009 Nov 26. — View Citation

Khan KS, Wojdyla D, Say L, Gülmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet. 2006 Apr 1;367(9516):1066-1074. doi: 10.1016/S0140-6736(06)68397-9. Review. — View Citation

Lalonde A, Daviss BA, Acosta A, Herschderfer K. Postpartum hemorrhage today: ICM/FIGO initiative 2004-2006. Int J Gynaecol Obstet. 2006 Sep;94(3):243-53. Epub 2006 Jul 12. — View Citation

Mirski MA, Lele AV, Fitzsimmons L, Toung TJ. Diagnosis and treatment of vascular air embolism. Anesthesiology. 2007 Jan;106(1):164-77. Review. — View Citation

National Institute of Population Research and Training (NIPORT), M.E., and icddr,b, Bangladesh Maternal Mortality and Health Care Survey 2010, M.E. NIPORT, and icddr,b, Editor. 2012: Dhaka.

Organization, W.H., Make Every Mother and Child Count: The World Health Report. 2005: World Health Organization.

Prendiville WJ, Elbourne D, McDonald S. Active versus expectant management in the third stage of labour. Cochrane Database Syst Rev. 2000;(3):CD000007. Review. Update in: Cochrane Database Syst Rev. 2009;(3):CD000007. — View Citation

Rather, S.Y., et al., Use of condom to control intractable PPH. JK science, 2010. 12(3)

Rathore AM, Gupta S, Manaktala U, Gupta S, Dubey C, Khan M. Uterine tamponade using condom catheter balloon in the management of non-traumatic postpartum hemorrhage. J Obstet Gynaecol Res. 2012 Sep;38(9):1162-7. doi: 10.1111/j.1447-0756.2011.01843.x. Epub — View Citation

Seligman, B. and X. Liu, Economic assessment of interventions for reducing postpartum hemorrhage in developing countries. 2006: Abt Associates.

Seror J, Allouche C, Elhaik S. Use of Sengstaken-Blakemore tube in massive postpartum hemorrhage: a series of 17 cases. Acta Obstet Gynecol Scand. 2005 Jul;84(7):660-4. — View Citation

Shaikh N, Ummunisa F. Acute management of vascular air embolism. J Emerg Trauma Shock. 2009 Sep;2(3):180-5. doi: 10.4103/0974-2700.55330. — View Citation

Tindell K, Garfinkel R, Abu-Haydar E, Ahn R, Burke TF, Conn K, Eckardt M. Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review. BJOG. 2013 Jan;120(1):5-14. doi: 10.1111/j.1471-0528.2012.03454 — View Citation

Vitthala S, Tsoumpou I, Anjum ZK, Aziz NA. Use of Bakri balloon in post-partum haemorrhage: a series of 15 cases. Aust N Z J Obstet Gynaecol. 2009 Apr;49(2):191-4. doi: 10.1111/j.1479-828X.2009.00968.x. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Tampostat as measured by number of serious adverse events in primary PPH management	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.	2 months
Primary	Efficacy of Tampostat as measured by number of successful cases in arresting bleeding in Primary PPH	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)	12 months
Primary	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	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]	12 months
Secondary	Feasibility as measured by number of physicians consider Tampostat as a feasible device in arresting primary PPH	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	2 months
Secondary	Applicability of Tampostat as measured by rating by service providers using pre established scoring system in the management of primary PPH	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.	2 months