Sponsor study identifier
interventional
405
1 country
1
Study Start
February 8, 2017
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
August 18, 2020
Actual (reported)The purpose of this study is to evaluate the impact of early intrauterine tamponade with a Belfort-Dildy balloon catheter in immediate postpartum hemorrhage(IPPH) after vaginal delivery and refractory to first-line uterotonic treatment, ie performed at the same time as second line uterotonic treatment, as compared tolate intrauterine tamponade performed in case of failure of second line uterotonic treatment, on the final severity of PPH. ).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 18, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2014
Actual (reported)August 27, 2014
Actual (reported)February 8, 2017
Actual (reported)June 30, 2020
Actual (reported)August 18, 2020
Actual (reported)Proportion of women who received at least 3 RBC units for the treatment of PPH and /or who had a calculated peripartum blood loss > 1000 ml.
With Calculated peripartum blood loss= estimated blood volume × ((prepartum Ht - Day 2postpartum Ht)/prepartum Ht ) and Estimated blood volume (ml) = booking weight (kg) × 85)
1 day
Other markers of severe hemorrhage
1 day
Other markers of severe hemorrhage
24 hours
Other markers of severe hemorrhage
8 days
Other markers of severe hemorrhage
8 days
Other markers of severe hemorrhage
8 days
Intrauterine tamponade with the Belfort-Dildy balloon, performed in the 15 minutes after randomization at the same time as the second line uterotonic treatment.
Intrauterine tamponade with the Belfort-Dildy balloon, performed if failure of second line uterotonic treatment, ie persisting bleeding 30 minutes after the beginning of this infusion.
CHI de Poissy Saint Germain en Laye
Poissy, 78303, France
Laas E, Bui C, Popowski T, Mbaku OM, Rozenberg P. Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemorrhage. Am J Obstet Gynecol. 2012 Oct;207(4):281.e1-7. doi: 10.1016/j.ajog.2012.08.028. Epub 2012 Aug 17.
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.
Patrick ROZENBERG, MD
Department of Obstetrics, Poissy-Saint Germain Hospital Center
Catherine DENEUX - THARAUX, MD, PhD
Institut National de la Santé Et de la Recherche Médicale, France
405 participants (actual enrollment reported by the registry).
First Submitted
August 6, 2014
First Posted
August 27, 2014
Study Start
February 8, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P. Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study. BJOG. 2017 Jul;124(8):1255-1262. doi: 10.1111/1471-0528.14382. Epub 2016 Oct 25.
Rozenberg P, Sentilhes L, Goffinet F, Vayssiere C, Senat MV, Haddad B, Morel O, Garabedian C, Vivanti A, Perrotin F, Kayem G, Azria E, Raynal P, Verspyck E, Sananes N, Gallot D, Bretelle F, Seco A, Winer N, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial. Am J Obstet Gynecol. 2023 Nov;229(5):542.e1-542.e14. doi: 10.1016/j.ajog.2023.05.014. Epub 2023 May 18.
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.
Primary Completion
June 30, 2020
Actual (reported)Study Completion
August 18, 2020
Actual (reported)Last Updated
September 5, 2025
Record last verified: 2025-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: