Tampostat for Management of Postpartum Hemorrhage

NCT02416089 | Terminated Phase 1 DMC

• 1 other identifier: PR-14095
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Hemorrhage

Keywords

Tampostat; Tamponade; Postpartum hemorrhage

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Feasibility as measured by number of physicians consider Tampostat as a feasible device in arresting primary PPH

  2 months

• Applicability of Tampostat as measured by rating by service providers using pre established scoring system in the management of primary PPH

  2 months

Study Arms (2)

Tampostat

EXPERIMENTAL

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)

Device: Tampostat

Condom catheter tamponade

ACTIVE COMPARATOR

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

Interventions

Tampostat DEVICE

Tampostat

Condom catheter tamponade DEVICE

Condom catheter tamponade

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who delivered their baby at the site hospital, or attended the site hospital with PPH that started within the last 24 hours.
• Women with primary PPH have received AMTSL.
• PPH is due to atonic uterus.
• Provides written informed consent for enrolment in the study.

You may not qualify if:

• Primary PPH caused by retained placenta or ruptured uterus.
• Women who delivered before 28 weeks of gestation.
• Women not willing to participate in the study.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Grand Challenges Canada: collaborator
• Jibon Health Technologies, Inc.: collaborator
• Shaheed Suhrawardi Medical College Hospital: collaborator
• Dhaka Medical College: collaborator

Study Sites (1)

Obstetrical Ward of Shaheed Suhrawardi Medical College Hospital (ShSMCH) and Dhaka Medical College Hospital (DMCH)

Dhaka, Bangladesh

Location

Related Publications (21)

• 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. doi: 10.1016/s0029-7844(03)00046-2.

  PMID: 12681884 BACKGROUND

• 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.

  PMID: 19432609 BACKGROUND

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

  RESULT

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

  RESULT

• Khan KS, Wojdyla D, Say L, Gulmezoglu 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.

  PMID: 16581405 RESULT

• 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.

  RESULT

• 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. doi: 10.1016/j.ijgo.2006.04.016. Epub 2006 Jul 12.

  PMID: 16842791 RESULT

• Prendiville WJ, Elbourne D, McDonald S. Active versus expectant management in the third stage of labour. Cochrane Database Syst Rev. 2000;(3):CD000007. doi: 10.1002/14651858.CD000007.

  PMID: 10908457 RESULT

• 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. doi: 10.1111/j.1447-0756.1999.tb01146.x.

  PMID: 10467792 RESULT

• Bakri YN, Amri A, Abdul Jabbar F. Tamponade-balloon for obstetrical bleeding. Int J Gynaecol Obstet. 2001 Aug;74(2):139-42. doi: 10.1016/s0020-7292(01)00395-2.

  PMID: 11502292 RESULT

• 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. doi: 10.1097/01.ogx.0000271137.81361.93.

  PMID: 17634155 RESULT

• 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.

  PMID: 19432563 RESULT

• 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. doi: 10.1111/j.0001-6349.2005.00713.x.

  PMID: 15954876 RESULT

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

  RESULT

• 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 2012 Apr 30.

  PMID: 22540529 RESULT

• 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.x. Epub 2012 Aug 13.

  PMID: 22882240 RESULT

• 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.

  PMID: 19943825 RESULT

• Mirski MA, Lele AV, Fitzsimmons L, Toung TJ. Diagnosis and treatment of vascular air embolism. Anesthesiology. 2007 Jan;106(1):164-77. doi: 10.1097/00000542-200701000-00026.

  PMID: 17197859 RESULT

• 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.

  PMID: 20009308 RESULT

• 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.

  PMID: 14600674 RESULT

• Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.

  PMID: 32609374 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aminur Rahman, MBBS,MSc

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 14, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 26, 2018

Record last verified: 2016-11

Locations

BA (1)