Intrauterine Balloon Tamponade for Severe Postpartum Hemorrhage

Revert, Mathilde; Rozenberg, Patrick; Cottenet, Jonathan; Quantin, Catherine

doi:10.1097/aog.0000000000002405

Cited by 62 publications

(37 citation statements)

References 31 publications

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“…Further, results of both studies suggest possible harm. In contrast, studies conducted in high‐resource settings show that UBT introduction was associated with a decline in invasive procedures for PPH . These conflicting findings may be explained by differences in study contexts, as both our study and the Dumont trial were conducted in LMIC where the clinical benefit of UBT may be attenuated by the lack of system capacity to address obstetric emergencies such as refractory PPH adequately.…”

Section: Discussioncontrasting

confidence: 60%

“…Observational and before‐and‐after studies from high‐resource settings show a decline in invasive procedures for PPH (i.e. surgical intervention or uterine artery embolisation) associated with UBT introduction . Most research on UBT in high‐resource settings has evaluated costly devices such as the Bakri balloon, but a similar effect can be achieved using the low‐cost alternative of tying a condom to the end of a urinary catheter .…”

Section: Introductionmentioning

confidence: 99%

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The effectiveness and safety of introducing condom‐catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster‐randomised trial

Anger

Dabash

Durocher

et al. 2019

BJOG

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ObjectiveTo assess the effectiveness of introducing condom‐catheter uterine balloon tamponade (UBT) for postpartum haemorrhage (PPH) management in low‐ and middle‐income settings.DesignStepped wedge, cluster‐randomised trial.SettingEighteen secondary‐level hospitals in Uganda, Egypt and Senegal.PopulationWomen with vaginal delivery from October 2016 to March 2018.MethodsUse of condom‐catheter UBT for PPH management was introduced using a half‐day training and provision of pre‐packaged UBT kits. Hospitals were randomised to when UBT was introduced. The incident rate (IR) of study outcomes was compared in the control (i.e. before UBT) and intervention (i.e. after UBT) periods. Mixed effects regression models accounted for clustering (random effect) and time period (fixed effect).Main outcome measuresCombined IR of PPH‐related invasive surgery and/or maternal death.ResultsThere were 28 183 and 31 928 deliveries in the control and intervention periods, respectively. UBT was used for 9/1357 and 55/1037 women diagnosed with PPH in control and intervention periods, respectively. PPH‐related surgery or maternal death occurred in 19 women in the control period (IR = 6.7/10 000 deliveries) and 37 in the intervention period (IR = 11.6/10 000 deliveries). The adjusted IR ratio was 4.08 (95% confidence interval 1.07–15.58). Secondary outcomes, including rates of transfer and blood transfusion, were similar in the trial periods.ConclusionsIntroduction of condom‐catheter UBT in these settings did not improve maternal outcomes and was associated with an increase in the combined incidence of PPH‐related surgery and maternal death. The lack of demonstrated benefit of UBT introduction with respect to severe outcomes warrants reflection on its role.Tweetable abstractStepped wedge trial shows UBT introduction does not reduce the combined incidence of PPH‐related surgery or death.

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Section: Discussioncontrasting

confidence: 60%

Section: Introductionmentioning

confidence: 99%

The effectiveness and safety of introducing condom‐catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster‐randomised trial

Anger

Dabash

Durocher

et al. 2019

BJOG

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“…Since then, IUBT has been widely used clinically in PPH due to placental site bleeding and PPH due to uterine atony. It is effective for avoiding the use of invasive procedures to treat persistent PPH and the overall success rate of IUBT is in the range of 55%–95% . However, because the majority of previous studies have been small cohort studies, there is no consensus regarding the proper management of IUBT.…”

Section: Introductionmentioning

confidence: 99%

The association between intrauterine balloon tamponade volume and postpartum hemorrhage outcomes

Park

et al. 2019

Intl J Gynecology & Obste

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Objective:To determine the effect of intrauterine balloon tamponade (IUBT) on the outcomes of postpartum hemorrhage (PPH) according to the balloon volume and to investigate the clinical factors associated with poor PPH outcomes.Methods: A retrospective cohort study was conducted in which patients with PPH underwent IUBT from January 2016 to August 2018. Patients with an IUBT volume greater than 350 mL (n=76) were compared to patients with an IUBT volume less than 350 mL (n=213). The clinical outcomes related to PPH included blood transfusion, estimated blood loss (EBL) after balloon placement, uterine artery embolization (UAE) after IUBT, and postpartum hospitalization. The results were analyzed by multivariate logistic regression models.Results: None of the clinical outcomes related to PPH and evaluated in our study were favorable in patients with an IUBT volume greater than 350 mL. Other factors associated with poor PPH outcomes after IUBT were placental site hemorrhage, shock index (SI) before IUBT, and antenatal hemoglobin. Conclusion:It is better to avoid unnecessary balloon inflation in IUBT if the bleeding is reduced, and more attention should be paid to the procedure when the balloon is large (≥350 mL) than when it is small (<350 mL).

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“…First, uterotonics, crystalloids, and TXA were already included in the first response bundle, and therefore did not need to be listed as bundle components. Second, IBT is currently recommended by the WHO, but is considered controversial by some members owing to recently published evidence . Third, in cases where IBT or NASG is not available, or for use during the period before IBT and NASG are applied, bimanual uterine compression and external aortic compression were suggested for bundle inclusion by some experts.…”

Section: Resultsmentioning

confidence: 99%

“…By contrast, the issues raised about the response to refractory PPH may merit further analyses and discussions. Although several publications have reported positive outcomes with IBTs, a randomized controlled trial reported safety concerns associated with implementation of a condom catheter IBT . Similarly, preliminary results of a stepped‐wedge cluster randomized trial in Egypt, Senegal, and Uganda raised safety concerns associated with the implementation of an improvised condom catheter IBT for treatment for unresponsive PPH (based on communication from the Gynuity Health Projects research team received on 2/8/2018).…”

Section: Discussionmentioning

confidence: 99%

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation

Althabe

Therrien

Pingray

et al. 2019

Intl J Gynecology & Obste

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Objective To systematically develop evidence‐based bundles for care of postpartum hemorrhage (PPH). Methods An international technical consultation was conducted in 2017 to develop draft bundles of clinical interventions for PPH taken from the WHO's 2012 and 2017 PPH recommendations and based on the validated “GRADE Evidence‐to‐Decision” framework. Twenty‐three global maternal‐health experts participated in the development process, which was informed by a systematic literature search on bundle definitions, designs, and implementation experiences. Over a 6‐month period, the expert panel met online and via teleconferences, culminating in a 2‐day in‐person meeting. Results The consultation led to the definition of two care bundles for facility implementation. The “first response to PPH bundle” comprises uterotonics, isotonic crystalloids, tranexamic acid, and uterine massage. The “response to refractory PPH bundle” comprises compressive measures (aortic or bimanual uterine compression), the non‐pneumatic antishock garment, and intrauterine balloon tamponade (IBT). Advocacy, training, teamwork, communication, and use of best clinical practices were defined as PPH bundle supporting elements. Conclusion For the first response bundle, further research should assess its feasibility, acceptability, and effectiveness; and identify optimal implementation strategies. For the response to refractory bundle, further research should address pending controversies, including the operational definition of refractory PPH and effectiveness of IBT devices.

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Intrauterine Balloon Tamponade for Severe Postpartum Hemorrhage

Abstract: 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.

Cited by 62 publications

References 31 publications

The effectiveness and safety of introducing condom‐catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster‐randomised trial

The effectiveness and safety of introducing condom‐catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster‐randomised trial

The association between intrauterine balloon tamponade volume and postpartum hemorrhage outcomes

Postpartum hemorrhage care bundles to improve adherence to guidelines: A WHO technical consultation

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