Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage

Gary A. Dildy, Michael A. Belfort, Charles Adair, Kimberly Destefano, Donna Robinson, Garrett Lam, Thomas H. Strong, Clive Polon, Robert Massaro, Jayasri Bukkapatnam, James W. Van Hook, Iskander Kassis, Shiraz Sunderji

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

Objective When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony. Study Design These data are from a postmarketing surveillance study of a novel dual-balloon catheter tamponade device, the Belfort-Dildy Obstetrical Tamponade System (ebb). Results A total of 57 women were enrolled: 55 women had the diagnosis of postpartum hemorrhage, and 51 women had uterine balloon placement within the uterine cavity. This study reports the outcomes in the 51 women who had uterine balloon placement within the uterine cavity for treatment of postpartum hemorrhage, as defined by the "Instructions for Use." We further assessed 4 subgroups: uterine atony only (n = 28 women), placentation abnormalities (n = 8 women), both uterine atony and placentation abnormalities (n = 9 women), and neither uterine atony nor placentation abnormalities (n = 6 women). The median (range) time interval between delivery and balloon placement was 2.2 hours (0.3-210 hours) for the entire cohort (n = 51 women) and 1.3 hours (0.5-7.0 hours) for the uterine atony only group (n = 28 women). Bleeding decreased in 22/51 of cases (43%), stopped in 28/51 of cases (55%), thus decreased or stopped in 50/51 of the cases (98%) after balloon placement. Nearly one-half (23/51) of all women required uterine balloon volumes of >500 mL to control bleeding. Conclusion We conclude that uterine/vaginal balloon tamponade is very useful in the management of postpartum hemorrhage because of uterine atony and abnormal placentation.

Original languageEnglish (US)
Pages (from-to)136.e1-136.e6
JournalAmerican Journal of Obstetrics and Gynecology
Volume210
Issue number2
DOIs
StatePublished - Jan 1 2014

Fingerprint

Postpartum Hemorrhage
Uterine Inertia
Catheters
Placentation
Hemorrhage
Uterine Balloon Tamponade
Balloon Occlusion
Uterine Contraction
Uterus
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology

Cite this

Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage. / Dildy, Gary A.; Belfort, Michael A.; Adair, Charles; Destefano, Kimberly; Robinson, Donna; Lam, Garrett; Strong, Thomas H.; Polon, Clive; Massaro, Robert; Bukkapatnam, Jayasri; Van Hook, James W.; Kassis, Iskander; Sunderji, Shiraz.

In: American Journal of Obstetrics and Gynecology, Vol. 210, No. 2, 01.01.2014, p. 136.e1-136.e6.

Research output: Contribution to journalArticle

Dildy, GA, Belfort, MA, Adair, C, Destefano, K, Robinson, D, Lam, G, Strong, TH, Polon, C, Massaro, R, Bukkapatnam, J, Van Hook, JW, Kassis, I & Sunderji, S 2014, 'Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage', American Journal of Obstetrics and Gynecology, vol. 210, no. 2, pp. 136.e1-136.e6. https://doi.org/10.1016/j.ajog.2013.09.015
Dildy, Gary A. ; Belfort, Michael A. ; Adair, Charles ; Destefano, Kimberly ; Robinson, Donna ; Lam, Garrett ; Strong, Thomas H. ; Polon, Clive ; Massaro, Robert ; Bukkapatnam, Jayasri ; Van Hook, James W. ; Kassis, Iskander ; Sunderji, Shiraz. / Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage. In: American Journal of Obstetrics and Gynecology. 2014 ; Vol. 210, No. 2. pp. 136.e1-136.e6.
@article{64baa3997bbb47c8a0d87599fd8ba9c5,
title = "Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage",
abstract = "Objective When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony. Study Design These data are from a postmarketing surveillance study of a novel dual-balloon catheter tamponade device, the Belfort-Dildy Obstetrical Tamponade System (ebb). Results A total of 57 women were enrolled: 55 women had the diagnosis of postpartum hemorrhage, and 51 women had uterine balloon placement within the uterine cavity. This study reports the outcomes in the 51 women who had uterine balloon placement within the uterine cavity for treatment of postpartum hemorrhage, as defined by the {"}Instructions for Use.{"} We further assessed 4 subgroups: uterine atony only (n = 28 women), placentation abnormalities (n = 8 women), both uterine atony and placentation abnormalities (n = 9 women), and neither uterine atony nor placentation abnormalities (n = 6 women). The median (range) time interval between delivery and balloon placement was 2.2 hours (0.3-210 hours) for the entire cohort (n = 51 women) and 1.3 hours (0.5-7.0 hours) for the uterine atony only group (n = 28 women). Bleeding decreased in 22/51 of cases (43{\%}), stopped in 28/51 of cases (55{\%}), thus decreased or stopped in 50/51 of the cases (98{\%}) after balloon placement. Nearly one-half (23/51) of all women required uterine balloon volumes of >500 mL to control bleeding. Conclusion We conclude that uterine/vaginal balloon tamponade is very useful in the management of postpartum hemorrhage because of uterine atony and abnormal placentation.",
author = "Dildy, {Gary A.} and Belfort, {Michael A.} and Charles Adair and Kimberly Destefano and Donna Robinson and Garrett Lam and Strong, {Thomas H.} and Clive Polon and Robert Massaro and Jayasri Bukkapatnam and {Van Hook}, {James W.} and Iskander Kassis and Shiraz Sunderji",
year = "2014",
month = "1",
day = "1",
doi = "10.1016/j.ajog.2013.09.015",
language = "English (US)",
volume = "210",
pages = "136.e1--136.e6",
journal = "American Journal of Obstetrics and Gynecology",
issn = "0002-9378",
publisher = "Mosby Inc.",
number = "2",

}

TY - JOUR

T1 - Initial experience with a dual-balloon catheter for the management of postpartum hemorrhage

AU - Dildy, Gary A.

AU - Belfort, Michael A.

AU - Adair, Charles

AU - Destefano, Kimberly

AU - Robinson, Donna

AU - Lam, Garrett

AU - Strong, Thomas H.

AU - Polon, Clive

AU - Massaro, Robert

AU - Bukkapatnam, Jayasri

AU - Van Hook, James W.

AU - Kassis, Iskander

AU - Sunderji, Shiraz

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Objective When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony. Study Design These data are from a postmarketing surveillance study of a novel dual-balloon catheter tamponade device, the Belfort-Dildy Obstetrical Tamponade System (ebb). Results A total of 57 women were enrolled: 55 women had the diagnosis of postpartum hemorrhage, and 51 women had uterine balloon placement within the uterine cavity. This study reports the outcomes in the 51 women who had uterine balloon placement within the uterine cavity for treatment of postpartum hemorrhage, as defined by the "Instructions for Use." We further assessed 4 subgroups: uterine atony only (n = 28 women), placentation abnormalities (n = 8 women), both uterine atony and placentation abnormalities (n = 9 women), and neither uterine atony nor placentation abnormalities (n = 6 women). The median (range) time interval between delivery and balloon placement was 2.2 hours (0.3-210 hours) for the entire cohort (n = 51 women) and 1.3 hours (0.5-7.0 hours) for the uterine atony only group (n = 28 women). Bleeding decreased in 22/51 of cases (43%), stopped in 28/51 of cases (55%), thus decreased or stopped in 50/51 of the cases (98%) after balloon placement. Nearly one-half (23/51) of all women required uterine balloon volumes of >500 mL to control bleeding. Conclusion We conclude that uterine/vaginal balloon tamponade is very useful in the management of postpartum hemorrhage because of uterine atony and abnormal placentation.

AB - Objective When uterotonics fail to cause sustained uterine contractions and satisfactory control of hemorrhage after delivery, tamponade of the uterus can be effective in decreasing hemorrhage secondary to uterine atony. Study Design These data are from a postmarketing surveillance study of a novel dual-balloon catheter tamponade device, the Belfort-Dildy Obstetrical Tamponade System (ebb). Results A total of 57 women were enrolled: 55 women had the diagnosis of postpartum hemorrhage, and 51 women had uterine balloon placement within the uterine cavity. This study reports the outcomes in the 51 women who had uterine balloon placement within the uterine cavity for treatment of postpartum hemorrhage, as defined by the "Instructions for Use." We further assessed 4 subgroups: uterine atony only (n = 28 women), placentation abnormalities (n = 8 women), both uterine atony and placentation abnormalities (n = 9 women), and neither uterine atony nor placentation abnormalities (n = 6 women). The median (range) time interval between delivery and balloon placement was 2.2 hours (0.3-210 hours) for the entire cohort (n = 51 women) and 1.3 hours (0.5-7.0 hours) for the uterine atony only group (n = 28 women). Bleeding decreased in 22/51 of cases (43%), stopped in 28/51 of cases (55%), thus decreased or stopped in 50/51 of the cases (98%) after balloon placement. Nearly one-half (23/51) of all women required uterine balloon volumes of >500 mL to control bleeding. Conclusion We conclude that uterine/vaginal balloon tamponade is very useful in the management of postpartum hemorrhage because of uterine atony and abnormal placentation.

UR - http://www.scopus.com/inward/record.url?scp=84893639496&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84893639496&partnerID=8YFLogxK

U2 - 10.1016/j.ajog.2013.09.015

DO - 10.1016/j.ajog.2013.09.015

M3 - Article

VL - 210

SP - 136.e1-136.e6

JO - American Journal of Obstetrics and Gynecology

JF - American Journal of Obstetrics and Gynecology

SN - 0002-9378

IS - 2

ER -