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Thomas F Burke - One of the best experts on this subject based on the ideXlab platform.
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uterine Balloon Tamponade for the treatment of postpartum hemorrhage a systematic review and meta analysis
American Journal of Obstetrics and Gynecology, 2020Co-Authors: Daniela Suarezrebling, Sebastian Suarez, Agustin Condeagudelo, Anderson Borovacpinheiro, Melody J Eckardt, Gerhard Theron, Thomas F BurkeAbstract:Objective To assess the efficacy, effectiveness, and safety of uterine Balloon Tamponade for treating postpartum hemorrhage. Study Design We searched electronic databases (from their inception to August 2019) and bibliographies. We included randomized controlled trials, nonrandomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of uterine Balloon Tamponade in women with postpartum hemorrhage. The primary outcome was the success rate of uterine Balloon Tamponade for treating postpartum hemorrhage (number of uterine Balloon Tamponade success cases/total number of women treated with uterine Balloon Tamponade). For meta-analyses, we calculated pooled success rate for all studies, and relative risk with 95% confidence intervals for studies that included a comparative arm. Results Ninety-one studies, including 4729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 nonrandomized studies, and 69 case series). The overall pooled uterine Balloon Tamponade success rate was 85.9% (95% confidence interval, 83.9–87.9%). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The uterine Balloon Tamponade success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of 2 randomized trials that compared uterine Balloon Tamponade vs no uterine Balloon Tamponade in postpartum hemorrhage due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (relative risk, 0.59; 95% confidence interval, 0.02–16.69). A meta-analysis of 2 nonrandomized before-and-after studies showed that introduction of uterine Balloon Tamponade in protocols for managing severe postpartum hemorrhage significantly decreased the use of arterial embolization (relative risk, 0.29; 95% confidence interval, 0.14–0.63). A nonrandomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used uterine Balloon Tamponade than that which did not use uterine Balloon Tamponade (3.0/1000 vs 5.1/1000; P Conclusion Uterine Balloon Tamponade has a high success rate for treating severe postpartum hemorrhage and appears to be safe. The evidence on uterine Balloon Tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies. Further research is needed to determine the most effective programmatic and healthcare delivery strategies on uterine Balloon Tamponade introduction and use.
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mechanical properties of the every second matters for mothers uterine Balloon Tamponade esm ubt device in vitro tests
American Journal of Perinatology Reports, 2019Co-Authors: Kamyar Mollazadehmoghaddam, Anderson Borovacpinheiro, Michelle Dundek, Anuj Bellare, Alice Won, Thomas F BurkeAbstract:Objective Postpartum hemorrhage (PPH) is the most common cause of maternal mortality and morbidity worldwide, most of which occurs in resource-poor settings. Placement of a uterine Balloon may be life-saving in uncontrolled PPH. The Every Second Matters for Mothers-Uterine Balloon Tamponade (ESM-UBT) device is an ultra-low-cost uterine Balloon designed for global access. The purpose of this study was to evaluate the mechanical properties of the ESM-UBT device. Study design Intraluminal pressures, diameters, and burst volumes of condom uterine Balloons and Foley catheter Balloons of ESM-UBT devices were measured in open air and inside uterus models. Condom uterine Balloons were tested with uterus model sizes of 100, 250, and 500mL. The condom-catheter O-ring attachment tensile strength was also evaluated. Results All 28 samples of ESM-UBT condom uterine Balloons maintained their integrity for at least 3 hours when subjected to pressures of 200 mm Hg or greater across each of the tested uterine volumes. No Foley catheter Balloons burst after instillation of 30mL, O-rings withstood forces of 15.4 ± 2.1 N, and condom uterine Balloons stretched to 35.8 ± 2.1 cm without loss of integrity. Conclusion The mechanical properties of the ESM-UBT device make it attractive for scale across resource-poor settings.
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time for global scale up not randomized trials of uterine Balloon Tamponade for postpartum hemorrhage
International Journal of Gynecology & Obstetrics, 2018Co-Authors: Thomas F Burke, Poonam V Shivkumar, Vincent Tarimo, Monica Oguttu, Kusum Thapa, Lorraine Garg, Saroja Pande, Juzar Fidvi, Vidyadhar B Bangal, Jose OchoaAbstract:Maternal death is the greatest health disparity globally, with postpartum hemorrhage the most common cause. As senior leaders in obstetrics and maternal health from Bolivia, Canada, Colombia, Cote d'Ivoire, Honduras, India, Kenya, Nepal, Niger, Norway, Peru, Tanzania, the UK, the USA, and Zambia, we are deeply disturbed by recent calls for randomized controlled trials (RCTs) of uterine Balloon Tamponade (UBT) in women with uncontrolled postpartum hemorrhage (PPH). Our collective experience, in combination with mounting evidence, unequivocally supports the effectiveness of commercial and condom UBTs in averting death and disability from PPH associated with atonic uterus. We believe it would be highly unethical to embark on an RCT of UBT, now or in the future, unless compared with a proven equivalent intervention. This article is protected by copyright. All rights reserved.
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innovative uses of condom uterine Balloon Tamponade for postpartum hemorrhage in india and tanzania
Case Reports in Obstetrics and Gynecology, 2018Co-Authors: Jennifer Makin, Daniela Suarezrebling, Poonam V Shivkumar, Vincent Tarimo, Thomas F BurkeAbstract:Background. Postpartum hemorrhage is the most common cause of maternal deaths worldwide, the majority of which occur in low-resource settings. Uterine Balloon Tamponade (UBT) is an effective method of addressing uncontrolled postpartum hemorrhage (PPH) from uterine atony; however, UBT devices are often not affordable. We report on three novel uses of an ultra-low-cost condom uterine Balloon Tamponade (ESM-UBT) device. Cases. ESM-UBT devices were used in innovative ways to arrest severe uncontrolled pregnancy-related hemorrhage among three women in India and Tanzania. The first had sustained deep vaginal lacerations, the second a cervical pregnancy, and the third a complete molar pregnancy. Conclusion. The ESM-UBT device may be useful for control of obstetric hemorrhage caused by complex vaginal tears as well as cervical and molar pregnancies.
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innovative uses of condom uterine Balloon Tamponade for postpartum hemorrhage in india and tanzania
Case Reports in Obstetrics and Gynecology, 2018Co-Authors: Jennifer Makin, Daniela Suarezrebling, Poonam V Shivkumar, Vincent Tarimo, Thomas F BurkeAbstract:Background. Postpartum hemorrhage is the most common cause of maternal deaths worldwide, the majority of which occur in low-resource settings. Uterine Balloon Tamponade (UBT) is an effective method of addressing uncontrolled postpartum hemorrhage (PPH) from uterine atony; however, UBT devices are often not affordable. We report on three novel uses of an ultra-low-cost condom uterine Balloon Tamponade (ESM-UBT) device. Cases. ESM-UBT devices were used in innovative ways to arrest severe uncontrolled pregnancy-related hemorrhage among three women in India and Tanzania. The first had sustained deep vaginal lacerations, the second a cervical pregnancy, and the third a complete molar pregnancy. Conclusion. The ESM-UBT device may be useful for control of obstetric hemorrhage caused by complex vaginal tears as well as cervical and molar pregnancies.
Melody J Eckardt - One of the best experts on this subject based on the ideXlab platform.
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uterine Balloon Tamponade for the treatment of postpartum hemorrhage a systematic review and meta analysis
American Journal of Obstetrics and Gynecology, 2020Co-Authors: Daniela Suarezrebling, Sebastian Suarez, Agustin Condeagudelo, Anderson Borovacpinheiro, Melody J Eckardt, Gerhard Theron, Thomas F BurkeAbstract:Objective To assess the efficacy, effectiveness, and safety of uterine Balloon Tamponade for treating postpartum hemorrhage. Study Design We searched electronic databases (from their inception to August 2019) and bibliographies. We included randomized controlled trials, nonrandomized studies, and case series that reported on the efficacy, effectiveness, and/or safety of uterine Balloon Tamponade in women with postpartum hemorrhage. The primary outcome was the success rate of uterine Balloon Tamponade for treating postpartum hemorrhage (number of uterine Balloon Tamponade success cases/total number of women treated with uterine Balloon Tamponade). For meta-analyses, we calculated pooled success rate for all studies, and relative risk with 95% confidence intervals for studies that included a comparative arm. Results Ninety-one studies, including 4729 women, met inclusion criteria (6 randomized trials, 1 cluster randomized trial, 15 nonrandomized studies, and 69 case series). The overall pooled uterine Balloon Tamponade success rate was 85.9% (95% confidence interval, 83.9–87.9%). The highest success rates corresponded to uterine atony (87.1%) and placenta previa (86.8%), and the lowest to placenta accreta spectrum (66.7%) and retained products of conception (76.8%). The uterine Balloon Tamponade success rate was lower in cesarean deliveries (81.7%) than in vaginal deliveries (87.0%). A meta-analysis of 2 randomized trials that compared uterine Balloon Tamponade vs no uterine Balloon Tamponade in postpartum hemorrhage due to uterine atony after vaginal delivery showed no significant differences between the study groups in the risk of surgical interventions or maternal death (relative risk, 0.59; 95% confidence interval, 0.02–16.69). A meta-analysis of 2 nonrandomized before-and-after studies showed that introduction of uterine Balloon Tamponade in protocols for managing severe postpartum hemorrhage significantly decreased the use of arterial embolization (relative risk, 0.29; 95% confidence interval, 0.14–0.63). A nonrandomized cluster study reported that use of invasive procedures was significantly lower in the perinatal network that routinely used uterine Balloon Tamponade than that which did not use uterine Balloon Tamponade (3.0/1000 vs 5.1/1000; P Conclusion Uterine Balloon Tamponade has a high success rate for treating severe postpartum hemorrhage and appears to be safe. The evidence on uterine Balloon Tamponade efficacy and effectiveness from randomized and nonrandomized studies is conflicting, with experimental studies suggesting no beneficial effect, in contrast with observational studies. Further research is needed to determine the most effective programmatic and healthcare delivery strategies on uterine Balloon Tamponade introduction and use.
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safety of a condom uterine Balloon Tamponade esm ubt device for uncontrolled primary postpartum hemorrhage among facilities in kenya and sierra leone
BMC Pregnancy and Childbirth, 2018Co-Authors: Aparna Ramanathan, Melody J Eckardt, Brett D Nelson, Monica Oguttu, Moytrayee Guha, Zaid Altawil, Thomas F BurkeAbstract:Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine Balloon Tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine Balloon Tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.
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Safety of a condom uterine Balloon Tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone
BMC Pregnancy and Childbirth, 2018Co-Authors: Aparna Ramanathan, Melody J Eckardt, Brett D Nelson, Monica Oguttu, Moytrayee Guha, Zaid Altawil, Thomas BurkeAbstract:Background Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine Balloon Tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine Balloon Tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. Methods Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. Results Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. Conclusion The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.
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provider experiences with improvised uterine Balloon Tamponade for the management of uncontrolled postpartum hemorrhage in kenya
International Journal of Gynecology & Obstetrics, 2016Co-Authors: Abirami Natarajan, Melody J Eckardt, Anna A Pendleton, Brett D Nelson, Roy Ahn, Monica Oguttu, Lidu Dulo, Thomas F BurkeAbstract:Objective To understand healthcare providers’ experiences with improvised uterine Balloon Tamponade (UBT) for the management of uncontrolled postpartum hemorrhage (PPH).
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provider experience of uterine Balloon Tamponade for the management of postpartum hemorrhage in sierra leone
International Journal of Gynecology & Obstetrics, 2016Co-Authors: Abirami Natarajan, Melody J Eckardt, Brett D Nelson, Roy Ahn, J Kamara, Anne Marie Williams, Samuel A Kargbo, Thomas F BurkeAbstract:Abstract Objective To understand healthcare providers’ experience of incorporating uterine Balloon Tamponade (UBT) into the national postpartum hemorrhage (PPH) clinical pathway after UBT training. Methods In a qualitative study, semi-structured interviews were undertaken with healthcare providers from 50 centers in Freetown, Sierra Leone, between May and June 2014. All eligible healthcare providers (undergone UBT training, actively conducted deliveries, and treated cases of PPH since UBT training) on duty at the time of center visit were interviewed. Results Sixty-one providers at 47 facilities were interviewed. Bleeding was controlled in 28 (93%) of 30 cases of UBT device placement. Participants reported that UBT devices were easy to insert with only minor challenges, and enabled providers to manage most cases of uncontrolled PPH at their own facility and to refer others in a stable condition. Reported barriers to optimal UBT use included insufficient training and practical experience, and a scarcity of preassembled UBT devices. Facilitators of UBT use included widespread acceptance of UBT, comprehensive and enthusiastic training, and ready availability of UBT devices. Conclusion UBT—used either as a primary endpoint or en route to obtaining advanced care—has been well accepted and integrated into the national PPH pathway by providers in health facilities in Freetown.
Brett D Nelson - One of the best experts on this subject based on the ideXlab platform.
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safety of a condom uterine Balloon Tamponade esm ubt device for uncontrolled primary postpartum hemorrhage among facilities in kenya and sierra leone
BMC Pregnancy and Childbirth, 2018Co-Authors: Aparna Ramanathan, Melody J Eckardt, Brett D Nelson, Monica Oguttu, Moytrayee Guha, Zaid Altawil, Thomas F BurkeAbstract:Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine Balloon Tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine Balloon Tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.
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Safety of a condom uterine Balloon Tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone
BMC Pregnancy and Childbirth, 2018Co-Authors: Aparna Ramanathan, Melody J Eckardt, Brett D Nelson, Monica Oguttu, Moytrayee Guha, Zaid Altawil, Thomas BurkeAbstract:Background Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine Balloon Tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine Balloon Tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. Methods Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. Results Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. Conclusion The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.
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shock progression and survival after use of a condom uterine Balloon Tamponade package in women with uncontrolled postpartum hemorrhage
International Journal of Gynecology & Obstetrics, 2017Co-Authors: Thomas F Burke, Vincent Tarimo, Monica Oguttu, Moytrayee Guha, Sandra Dansobamfo, Brett D NelsonAbstract:Objective To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device. Methods In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement. Results Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25). Conclusion The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony. This article is protected by copyright. All rights reserved.
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shock progression and survival after use of a condom uterine Balloon Tamponade package in women with uncontrolled postpartum hemorrhage
International Journal of Gynecology & Obstetrics, 2017Co-Authors: Thomas F Burke, Vincent Tarimo, Monica Oguttu, Moytrayee Guha, Sandra Dansobamfo, Brett D NelsonAbstract:Objective To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device. Methods In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement. Results Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25). Conclusion The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony. This article is protected by copyright. All rights reserved.
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provider experiences with improvised uterine Balloon Tamponade for the management of uncontrolled postpartum hemorrhage in kenya
International Journal of Gynecology & Obstetrics, 2016Co-Authors: Abirami Natarajan, Melody J Eckardt, Anna A Pendleton, Brett D Nelson, Roy Ahn, Monica Oguttu, Lidu Dulo, Thomas F BurkeAbstract:Objective To understand healthcare providers’ experiences with improvised uterine Balloon Tamponade (UBT) for the management of uncontrolled postpartum hemorrhage (PPH).
Patrick Rozenberg - One of the best experts on this subject based on the ideXlab platform.
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intrauterine Balloon Tamponade for severe postpartum hemorrhage
Obstetrics & Gynecology, 2017Co-Authors: Mathilde Revert, Patrick Rozenberg, Jonathan Cottenet, Catherine QuantinAbstract:OBJECTIVE To compare the rates of invasive procedures (surgical or vascular) for hemorrhage control between a perinatal network that routinely used intrauterine Balloon Tamponade and another perinatal network that did not in postpartum hemorrhage management. METHODS This population-based retrospective cohort study included all women (72,529) delivering between 2011 and 2012 in the 19 maternity units in two French perinatal networks: a pilot (in which Balloon Tamponade was used) and a control network. Outcomes were assessed based on discharge abstract data from the national French medical information system. General and obstetric characteristics were included in two separate multivariate logistic models according to the mode of delivery (vaginal and cesarean) to estimate the independent association of the network with invasive procedures. RESULTS Invasive procedures (pelvic vessel ligation, arterial embolization, hysterectomy) were used in 298 women and in 4.1 per 1,000 deliveries (95% CI 3.7-4.6). The proportion of women with at least one invasive procedure was significantly lower in the pilot network (3.0/1,000 vs 5.1/1,000, P<.01). Among women who delivered vaginally, the use of arterial embolization was also significantly lower in the pilot than the control network (0.2/1,000 vs 3.7/1,000, P<.01) as it was for those who delivered by cesarean (1.3/1,000 vs 5.7/1,000, P<.01). After controlling for potential confounding factors, the risk of an invasive procedure among women who delivered vaginally remained significantly lower in the pilot network (adjusted odds ratio [OR] 0.14, 95% CI 0.08-0.27), but not for women who delivered by cesarean (adjusted OR 1.19, 95% CI 0.87-1.61). CONCLUSION The use of intrauterine Balloon Tamponade in routine clinical practice was associated with a significantly lower use of invasive procedures for hemorrhage control among women undergoing vaginal delivery.
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uterine Balloon Tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage a randomised controlled trial in benin and mali
BMJ Open, 2017Co-Authors: Alexandre Dumont, Cecile Bodin, Benjamin Hounkpatin, Thomas Popowski, Mamadou Traore, R X Perrin, Patrick RozenbergAbstract:Objective To assess the effectiveness of low-cost uterine Tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage (PPH) in low-resource settings. Design Randomised controlled trial. Setting Seven healthcare facilities in Cotonou, Benin and Bamako, Mali. Population Women delivering vaginally who had clinically diagnosed PPH that was suspected to be due to uterine atony, who were unresponsive to oxytocin and who needed additional uterotonics. Methods Women were randomly assigned to receive uterine Balloon Tamponade with a condom-catheter device or no Tamponade; both groups were also given intrarectal or sublingual misoprostol. Main outcome measure Proportion of women with invasive surgery or who died before hospital discharge. Results The proportion of primary composite outcome did not differ significantly between the Tamponade arm (16%; 9/57) and the standard second line treatment arm (7%; 4/59): relative risk 2.33 (95% CI 0.76 to 7.14, p=0.238). A significantly increased proportion of women with Tamponade and misoprostol versus misoprostol alone had total blood loss more than 1000 mL: relative risk 1.52 (95% CI 1.15 to 2.00, p=0.01). Case fatality rate was higher in the Tamponade group (10%; 6/57) than in the control group (2%; 1/59) (p=0.059). Trial registration number ISRCT Registry Number 01202389; Post-results.
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Intrauterine Balloon Tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study
BJOG: An International Journal of Obstetrics and Gynaecology, 2017Co-Authors: Mathilde Revert, Jonathan Cottenet, Catherine Quantin, Pierre Raynal, E. Cibot, Patrick RozenbergAbstract:Objective: To evaluate the effectiveness of intrauterine Balloon Tamponade (IUBT) for management of severe postpartum haemorrhage (PPH). To identify the factors predicting IUBT failure. Design: Prospective cohort study. Setting: Ten maternity units in a perinatal network. Population: Women treated by IUBT from July 2010 to March 2013. Methods: The global IUBT success rate was expressed as the number of women with severe PPH who were successfully treated by IUBT divided by the total number treated by IUBT. IUBT failure was defined as the need for arterial embolisation or surgery. Logistic regression analysis was used to estimate factors predicting IUBT failure. Main outcome measures: Global IUBT success rate. Factors associated with IUBT failure. Results: Intrauterine Balloon Tamponade was attempted in 226 women: 171 after vaginal delivery (VD) (75.7%) and 55 during or after caesarean delivery (CD) (24.3%). The global success rate was 83.2% (188/226) and was significantly higher after VD (152/171, 88.9%) than CD (36/55, 65.5%, P < 0.01). The percentage of CD was significantly higher in the failure group (50.0 versus 19.1%, P < 0.01), as was mean (SD) estimated blood loss before IUBT: 1508 ± 675 ml versus 1064 ± 476, P < 0.01. Coagulopathy was significantly more frequent in the failure group (50.0% versus 17.2%, P < 0.01). CD [Odds ratio (OR) 3.5; 95% CI 1.6–7.6], estimated blood loss before IUBT (OR 3.2; 95% CI 1.5–6.8) and coagulopathy (OR 5.6; 95% CI 2.5–13.0) were predictive of IUBT failure. Conclusion: Intrauterine Balloon Tamponade is an effective method for treating severe PPH. Early Balloon deployment before the development of coagulopathy increases its success rate. Tweetable abstract: Intrauterine Balloon Tamponade is effective for achieving haemostasis in intractable postpartum haemorrhages.
Monica Oguttu - One of the best experts on this subject based on the ideXlab platform.
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time for global scale up not randomized trials of uterine Balloon Tamponade for postpartum hemorrhage
International Journal of Gynecology & Obstetrics, 2018Co-Authors: Thomas F Burke, Poonam V Shivkumar, Vincent Tarimo, Monica Oguttu, Kusum Thapa, Lorraine Garg, Saroja Pande, Juzar Fidvi, Vidyadhar B Bangal, Jose OchoaAbstract:Maternal death is the greatest health disparity globally, with postpartum hemorrhage the most common cause. As senior leaders in obstetrics and maternal health from Bolivia, Canada, Colombia, Cote d'Ivoire, Honduras, India, Kenya, Nepal, Niger, Norway, Peru, Tanzania, the UK, the USA, and Zambia, we are deeply disturbed by recent calls for randomized controlled trials (RCTs) of uterine Balloon Tamponade (UBT) in women with uncontrolled postpartum hemorrhage (PPH). Our collective experience, in combination with mounting evidence, unequivocally supports the effectiveness of commercial and condom UBTs in averting death and disability from PPH associated with atonic uterus. We believe it would be highly unethical to embark on an RCT of UBT, now or in the future, unless compared with a proven equivalent intervention. This article is protected by copyright. All rights reserved.
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safety of a condom uterine Balloon Tamponade esm ubt device for uncontrolled primary postpartum hemorrhage among facilities in kenya and sierra leone
BMC Pregnancy and Childbirth, 2018Co-Authors: Aparna Ramanathan, Melody J Eckardt, Brett D Nelson, Monica Oguttu, Moytrayee Guha, Zaid Altawil, Thomas F BurkeAbstract:Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine Balloon Tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine Balloon Tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.
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Safety of a condom uterine Balloon Tamponade (ESM-UBT) device for uncontrolled primary postpartum hemorrhage among facilities in Kenya and Sierra Leone
BMC Pregnancy and Childbirth, 2018Co-Authors: Aparna Ramanathan, Melody J Eckardt, Brett D Nelson, Monica Oguttu, Moytrayee Guha, Zaid Altawil, Thomas BurkeAbstract:Background Postpartum hemorrhage is the leading cause of maternal mortality in low- and middle-income countries. While evidence on uterine Balloon Tamponade efficacy for severe hemorrhage is encouraging, little is known about safety of this intervention. The objective of this study was to evaluate the safety of an ultra-low-cost uterine Balloon Tamponade package (named ESM-UBT) for facility-based management of uncontrolled postpartum hemorrhage (PPH) in Kenya and Sierra Leone. Methods Data were collected on complications/adverse events in all women who had an ESM-UBT device placed among 92 facilities in Sierra Leone and Kenya, between September 2012 and December 2015, as part of a multi-country study. Three expert maternal health investigator physicians analyzed each complication/adverse event and developed consensus on whether there was a potential causal relationship associated with use of the ESM-UBT device. Adverse events/complications specifically investigated included death, hysterectomy, uterine rupture, perineal or cervical injury, serious or minor infection, and latex allergy/anaphylaxis. Results Of the 201 women treated with an ESM-UBT device in Kenya and Sierra Leone, 189 (94.0%) survived. Six-week or longer follow-up was recorded in 156 of the 189 (82.5%). A causal relationship between use of an ESM-UBT device and one death, three perineal injuries and one case of mild endometritis could not be completely excluded. Three experts found a potential association between these injuries and an ESM-UBT device highly unlikely. Conclusion The ESM-UBT device appears safe for use in women with uncontrolled PPH. Trial registration Trial registration was not completed as data was collected as a quality assurance measure for the ESM-UBT kit.
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shock progression and survival after use of a condom uterine Balloon Tamponade package in women with uncontrolled postpartum hemorrhage
International Journal of Gynecology & Obstetrics, 2017Co-Authors: Thomas F Burke, Vincent Tarimo, Monica Oguttu, Moytrayee Guha, Sandra Dansobamfo, Brett D NelsonAbstract:Objective To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device. Methods In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement. Results Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25). Conclusion The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony. This article is protected by copyright. All rights reserved.
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shock progression and survival after use of a condom uterine Balloon Tamponade package in women with uncontrolled postpartum hemorrhage
International Journal of Gynecology & Obstetrics, 2017Co-Authors: Thomas F Burke, Vincent Tarimo, Monica Oguttu, Moytrayee Guha, Sandra Dansobamfo, Brett D NelsonAbstract:Objective To examine the outcomes of women in advanced shock from uncontrolled postpartum hemorrhage (PPH) who underwent placement of an Every Second Matters for Mothers and Babies Uterine Balloon Tamponade (ESM-UBT) device. Methods In a prospective case series, data were collected for women who received an ESM-UBT device at healthcare facilities in Kenya, Senegal, Sierra Leone, and Tanzania between September 1, 2012, and September 30, 2016. Shock class was assigned on the basis of recorded blood pressures and mental status at the time of UBT placement. Results Data for 306 women with uncontrolled PPH from uterine atony across 117 facilities were analyzed. Normal vital signs or class I/II shock were reported for 166 (54.2%). In this group, one death occurred and was attributed to PPH (survival rate 99.4%). There were no cases of shock progression. One hundred and eleven (36.3%) were in class III shock and 29 (9.5%) in class IV shock; the respective survival rates were 97.3% (n=108) and 86.2% (n=25). Conclusion The ESM-UBT device arrests hemorrhage, prevents shock progression, and is associated with high survival rates among women with uncontrolled PPH from uterine atony. This article is protected by copyright. All rights reserved.
