Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study

Meher, Shireen; Cuthbert, Anna; Kirkham, Jamie J; Williamson, Paula; Ábalos, Edgardo; Aflaifel, Nasreen; Bhutta, Zulfiqar A; Bishop, Alex; Blum, Jennifer; Collins, Peter William; Devane, Declan; Ducloy-Bouthors, A.-S.; Fawole, Bukola; Gülmezoglu, A Metin; Gutteridge, Kathryn; Gyte, Gillian ML; Homer, Caroline; Mallaiah, S.; Smith, Jeffrey M.; Weeks, Andrew; Alfirević, Z̄arko

doi:10.1111/1471-0528.15335

Cited by 92 publications

(78 citation statements)

References 17 publications

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“…The most frequently reported outcomes for MCAD deficiency were focused on the risk of life-threatening consequences and manifestations of the disease. This emphasis on mortality-related outcomes is seen in COSs for other potentially life-threatening conditions like post-partum haemorrhage [29] and fetal growth restriction [30]. By contrast, for PKU, there was a dominance of the pathophysiological manifestations core area, similar to that seen in a review of outcomes for type II diabetes [28], and for children with feeding tubes and neurological impairments [22].…”

Section: Discussionmentioning

confidence: 88%

Outcomes in pediatric studies of medium-chain acyl-coA dehydrogenase (MCAD) deficiency and phenylketonuria (PKU): a review

Pugliese

Tingley

Chow

et al. 2020

Orphanet J Rare Dis

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Background: Inherited metabolic diseases (IMDs) are a group of individually rare single-gene diseases. For many IMDs, there is a paucity of high-quality evidence that evaluates the effectiveness of clinical interventions. Clinical effectiveness trials of IMD interventions could be supported through the development of core outcome sets (COSs), a recommended minimum set of standardized, high-quality outcomes and associated outcome measurement instruments to be incorporated by all trials in an area of study. We began the process of establishing pediatric COSs for two IMDs, medium-chain acyl-CoA dehydrogenase (MCAD) deficiency and phenylketonuria (PKU), by reviewing published literature to describe outcomes reported by authors, identify heterogeneity in outcomes across studies, and assemble a candidate list of outcomes. Methods: We used a comprehensive search strategy to identify primary studies and guidelines relevant to children with MCAD deficiency and PKU, extracting study characteristics and outcome information from eligible studies including outcome measurement instruments for select outcomes. Informed by an established framework and a previously published pediatric COS, outcomes were grouped into five, mutually-exclusive, a priori core areas: growth and development, life impact, pathophysiological manifestations, resource use, and death.

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Section: Discussionmentioning

confidence: 88%

Outcomes in pediatric studies of medium-chain acyl-coA dehydrogenase (MCAD) deficiency and phenylketonuria (PKU): a review

Pugliese

Tingley

Chow

et al. 2020

Orphanet J Rare Dis

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“…The definition of persistent postpartum hemorrhage enabled us to overcome differences between caregivers regarding estimation of blood loss and establish a clear point in time at which an additional intervention (ie, intrauterine balloon tamponade or uterine artery embolization) was deemed necessary following failure of initial management. Another key strength is that the composite primary outcome consisted of two postpartum hemorrhage‐related core outcome sets (peripartum hysterectomy and maternal death), allowing our results to be potentially included in systematic reviews or meta‐analyses on persistent postpartum hemorrhage . Furthermore, the extensive TeMpOH‐1 database made it possible to include many characteristics as potential confounders in the propensity score model.…”

Section: Discussionmentioning

confidence: 99%

“…Another key strength is that the composite primary outcome consisted of two postpartum hemorrhage-related core outcome sets (peripartum hysterectomy and maternal death), allowing our results to be potentially included in systematic reviews or metaanalyses on persistent postpartum hemorrhage. 31 Intrauterine balloon tamponade has been incorporated as a management option into multiple national guidelines for postpartum hemorrhage. [32][33][34][35] In non-comparative studies, success rates of intrauterine balloon tamponade to control bleeding after childbirth varied between 67% and 91%.…”

Section: Discussionmentioning

confidence: 99%

Comparison of outcome between intrauterine balloon tamponade and uterine artery embolization in the management of persistent postpartum hemorrhage: A propensity score‐matched cohort study

Ramler

Henriquez

Akker

et al. 2019

Acta Obstet Gynecol Scand

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Introduction The aim of this study was to compare the outcomes of women who were initially managed by intrauterine balloon tamponade or uterine artery embolization because of persistent postpartum hemorrhage demanding an immediate intervention to control bleeding. Material and methods Propensity score‐matched cohort study including women who had intrauterine balloon tamponade or uterine artery embolization as initial management strategy to control persistent postpartum hemorrhage, that is, refractory to first‐line therapy combined with at least one uterotonic agent. The primary outcome measure was a composite of peripartum hysterectomy and/or maternal mortality. Secondary outcomes measures were total volume of blood loss and total number of packed red blood cells transfused. Results Our 1:1 propensity score‐matched cohort comprised of 50 women who had intrauterine balloon tamponade and 50 women who underwent uterine artery embolization at a blood loss between 1000 and 7000 mL. There was no statistically significant difference in the hysterectomy risk between the two groups (n = 6 in each group, odds ratio [OR] 1.00, 95% confidence interval [CI] .30‐3.34), in total volume of blood loss (median 4500 mL, interquartile range [IQR] 3600‐5400) for balloon vs 4000 mL (IQR 3250‐5000) for embolization, P = 0.382) or in total units of packed red blood cells transfused (median 7 (IQR 5‐10) for balloon vs 6 [IQR 4‐9] for embolization, P = 0.319). Fifteen women (30%) who were initially managed by an intrauterine balloon still underwent uterine artery embolization, of whom one had an embolization‐related thrombo‐embolic event. Maternal mortality occurred in neither of the intervention groups. Conclusions No difference in the risk of peripartum hysterectomy and/or maternal death was observed between women who had intrauterine balloon tamponade and women who underwent uterine artery embolization as an initial management for persistent postpartum hemorrhage. Although this study was underpowered to demonstrate equivalence, our study design provides a framework for future research in which intrauterine balloon tamponade may prove to be a suitable intervention of first choice in the management of persistent postpartum hemorrhage.

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“…Feasibility was assessed by examining reported problems related to UBT. Core outcome sets for PPH treatment were published after protocol development and were not used …”

Section: Methodsmentioning

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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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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Core outcome sets for prevention and treatment of postpartum haemorrhage: an international Delphi consensus study

Abstract: Core outcome sets for PPH: nine core outcomes for PPH prevention and 12 core outcomes for PPH treatment.

Cited by 92 publications

References 17 publications

Outcomes in pediatric studies of medium-chain acyl-coA dehydrogenase (MCAD) deficiency and phenylketonuria (PKU): a review

Outcomes in pediatric studies of medium-chain acyl-coA dehydrogenase (MCAD) deficiency and phenylketonuria (PKU): a review

Comparison of outcome between intrauterine balloon tamponade and uterine artery embolization in the management of persistent postpartum hemorrhage: A propensity score‐matched cohort study

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

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