87 research outputs found
Implementing E-MOTIVE for detection and treatment of postpartum haemorrhage in South Africa
Postpartum haemorrhage is the leading cause of preventable maternal mortality in South Africa. In a significant breakthrough in the management of PPH, the E-MOTIVE trial found that a multifaceted health service intervention reduced severe PPH after vaginal delivery by 60% in 78 hospitals in Nigeria, Kenya, Tanzania and SA. The E-MOTIVE approach comprises objective blood loss measurement monitored every 15 minutes during the first hour after delivery to detect PPH early and trigger a bundle of first-line treatments, including massaging the uterus, oxytocin infusion, tranexamic acid infusion, intravenous crystalloid fluids, examination for the cause, emptying the bladder and, if necessary, escalation of care. E-MOTIVE was integrated into the existing Essential Steps in Managing Obstetric Emergencies algorithm. Certain research-related elements of the trial setting cannot be replicated in routine practice. Therefore, we need to develop local strategies to ensure the essential clinical elements of the intervention are implemented. Potential strategies include incorporating the E-MOTIVE principles into national guidelines, ongoing training strategies and ensuring all facilities are equipped with necessary medication, equipment and delegations. This breakthrough intervention provides hope for women in SA, and requires a purposeful, co-ordinated implementation strategy on a national scale to reach all levels of the health service
The effect of calcium supplementation on blood pressure in non-pregnant women with previous pre-eclampsia: A randomized placebo-controlled study
Background: Low dietary calcium is associated with the hypertensive disorders of pregnancy, and evidence suggests that the risks associated with pre-eclampsia are reduced by calcium supplementation. In the general (non-pregnant) population, low dietary calcium intake is associated with hypertension with inconsistent evidence that calcium supplementation may reduce blood pressure. Women with pre-eclampsia are also at risk of hypertension later in life. An exploratory sub-study among early participants enrolled in the WHO long-term calcium supplementation in women at high risk of pre-eclampsia (CAP) study reported a trend to more blood pressure reduction with calcium in non-pregnant women with previous severe as opposed to non-severe pre-eclampsia. The current study reports the effects of low-dose calcium supplementation in non-pregnant women in the complete trial cohort. Methods: The CAP Study was a multi-country randomized, double-blind placebo-controlled clinical trial to test the hypothesis that calcium deficiency may play a role in the genesis of pre-eclampsia in early pregnancy. From 2011 to 2016, non-pregnant women who had pre-eclampsia or eclampsia in their most recent pregnancy were randomized to receive either 500 mg/day elemental calcium or placebo. In this sub-study we compared the change in blood pressure from baseline to the 12-week visit between participants receiving calcium versus placebo for those not pregnant at the 12-week visit. Results: Of 1355 women randomized, 810 attended a 12-week visit without being pregnant, of whom 791 had blood pressure measurements available for both baseline and 12-week visits. There was a greater reduction in blood pressure in the calcium group compared with the placebo group for systolic pressure (difference 3.1 mmHg, 95% CI 0.8 to 5.4) and mean arterial pressure (MAP) (difference 2.0 mmHg, 95% CI 0.1 to 3.8). The difference in diastolic blood pressure reduction (1.4 mmHg, 95% CI −0.5 to 3.3) was not statistically significant (p = 0.140). For women with previous pre-eclampsia with severe features (n = 447), there was significantly greater reduction in blood pressure in the calcium than the placebo group (difference for systolic 4.0, 95% CI 0.7 to 7.3; diastolic 3.0, 95% CI 0.5 to 5.5 and mean arterial pressure 3.3, 95% CI 0.8 to 5.9 mmHg). For women with previous pre-eclampsia without severe features (n = 344), there were no significant differences between calcium and placebo groups. ANOVA analysis found no statistically significant interaction between previous pre-eclampsia severity and treatment, for systolic (p = 0.372), diastolic (p = 0.063) or mean blood pressure (p = 0.103). Conclusions: Low-dose calcium supplementation significantly reduced systolic and mean arterial pressure in non-pregnant women with previous pre-eclampsia. We did not confirm a greater calcium effect in women with previous pre-eclampsia with severe versus non-severe features. The effect of low-dose calcium is of importance since even modest blood pressure reductions at a population level may have important benefits in terms of reduced major complications of hypertension. This study adds to the mounting evidence of health benefits which could be achieved for populations with low dietary calcium through strategies to increase calcium intake, particularly among women at high risk due to previous pre-eclampsia.Fil: Hofmeyr, G Justus. University Of Botswana; Botsuana. University of the Witwatersrand; SudáfricaFil: Seuc, Armando. Organizacion Mundial de la Salud; ArgentinaFil: Betrán, Ana Pilar. Organizacion Mundial de la Salud; ArgentinaFil: Cormick, Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Singata, Mandisa. University Of Botswana; Botsuana. University of the Witwatersrand; SudáfricaFil: Fawcus, Sue. University of Cape Town; SudáfricaFil: Mose, Simpiwe. University of the Witwatersrand; SudáfricaFil: Frank, Karlyn. University of the Witwatersrand; SudáfricaFil: Hall, David. Tygerberg Hospital; Sudáfrica. Stellenbosch University; SudáfricaFil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Roberts, James M.. University of Pittsburgh; Estados UnidosFil: Magee, Laura A.. King’s College London; Reino UnidoFil: von Dadelszen, Peter. King’s College London; Reino Unid
Constructing evidence-based clinical intrapartum care algorithms for decision-support tools
AimTo describe standardised iterative methods used by a multidisciplinary group to develop evidence-based clinical intrapartum care algorithms for the management of uneventful and complicated labours.PopulationSingleton, term pregnancies considered to be at low risk of developing complications at admission to the birthing facility.SettingHealth facilities in low- and middle-income countries.Search strategyLiterature reviews were conducted to identify standardised methods for algorithm development and examples from other fields, and evidence and guidelines for intrapartum care. Searches for different algorithm topics were last updated between January and October 2020 and included a combination of terms such as 'labour', 'intrapartum', 'algorithms' and specific topic terms, using Cochrane Library and MEDLINE/PubMED, CINAHL, National Guidelines Clearinghouse and Google.Case scenariosNine algorithm topics were identified for monitoring and management of uncomplicated labour and childbirth, identification and management of abnormalities of fetal heart rate, liquor, uterine contractions, labour progress, maternal pulse and blood pressure, temperature, urine and complicated third stage of labour. Each topic included between two and four case scenarios covering most common deviations, severity of related complications or critical clinical outcomes.ConclusionsIntrapartum care algorithms provide a framework for monitoring women, and identifying and managing complications during labour and childbirth. These algorithms will support implementation of WHO recommendations and facilitate the development by stakeholders of evidence-based, up to date, paper-based or digital reminders and decision-support tools. The algorithms need to be field tested and may need to be adapted to specific contexts.Tweetable abstractEvidence-based intrapartum care clinical algorithms for a safe and positive childbirth experience
Formative research to design an implementation strategy for a postpartum hemorrhage initial response treatment bundle (E-MOTIVE): study protocol
BACKGROUND:
Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide. When PPH occurs, early identification of bleeding and prompt management using evidence-based guidelines, can avert most PPH-related severe morbidities and deaths. However, adherence to the World Health Organization recommended practices remains a critical challenge. A potential solution to inefficient and inconsistent implementation of evidence-based practices is the application of a ‘clinical care bundle’ for PPH management. A clinical care bundle is a set of discrete, evidence-based interventions, administered concurrently, or in rapid succession, to every eligible person, along with teamwork, communication, and cooperation. Once triggered, all bundle components must be delivered. The E-MOTIVE project aims to improve the detection and first response management of PPH through the implementation of the “E-MOTIVE” bundle, which consists of (1) Early PPH detection using a calibrated drape, (2) uterine Massage, (3) Oxytocic drugs, (4) Tranexamic acid, (5) Intra Venous fluids, and (6) genital tract Examination and escalation when necessary. The objective of this paper is to describe the protocol for the formative phase of the E-MOTIVE project, which aims to design an implementation strategy to support the uptake of this bundle into practice.
METHODS:
We will use behavior change and implementation science frameworks [e.g. capability, opportunity, motivation and behavior (COM-B) and theoretical domains framework (TDF)] to guide data collection and analysis, in Kenya, Nigeria, South Africa, Sri Lanka, and Tanzania. There are four methodological components: qualitative interviews; surveys; systematic reviews; and design workshops. We will triangulate findings across data sources, participant groups, and countries to explore factors influencing current PPH detection and management, and potentially influencing E-MOTIVE bundle implementation. We will use these findings to develop potential strategies to improve implementation, which will be discussed and agreed with key stakeholders from each country in intervention design workshops.
DISCUSSION:
This formative protocol outlines our strategy for the systematic development of the E-MOTIVE implementation strategy. This focus on implementation considers what it would take to support roll-out and implementation of the E-MOTIVE bundle. Our approach therefore aims to maximize internal validity in the trial alongside future scalability, and implementation of the E-MOTIVE bundle in routine practice, if proven to be effective.
TRIAL REGISTRATION:
ClinicalTrials.gov: NCT0434166
Maternal deaths from bleeding associated with caesarean delivery: A national emergency
Maternal mortality in South Africa in 2001: From demographic census to epidemiological investigation
<p>Abstract</p> <p>Background</p> <p>Maternal mortality remains poorly researched in Africa, and is likely to worsen dramatically as a consequence of HIV/AIDS.</p> <p>Methods</p> <p>The 2001 census of South Africa included a question on deaths in the previous 12 months, and two questions on external causes and maternal mortality, defined as "pregnancy-related deaths". A microdata sample from the census permits researchers to assess levels and differentials in maternal mortality, in a country severely affected by high death rates from HIV/AIDS and from external causes.</p> <p>Results</p> <p>After correcting for several minor biases, our estimate of the Maternal Mortality Ratio (MMR) in 2001 was 542 per 100,000 live births. This level is much higher than previous estimates dating from pre-HIV/AIDS times. This high level occurred despite a relatively low proportion of maternal deaths (6.4%) among deaths of women aged 15–49 years, and was due to the astonishingly high level of adult mortality, some 4.7 times higher than expected from mortality below age 15 or above age 50. The main reasons for these excessive levels were HIV/AIDS and external causes of deaths. Our regional estimates of MMR were found to be consistent with other findings in the Cape Town area, and with the Agincourt DSS. The differentials in MMR were considerable: 1 to 9.2 for population groups (race), 1 to 3.2 for provinces, and 1 to 2.4 for levels of education. Relationship with income and wealth were complex, with highest values for middle income and middle wealth index. The effect of urbanization was small, and reversed in a multivariate analysis. Higher risks in provinces were not necessarily associated with lower income, lower education or higher proportions of home delivery, but correlated primarily with the prevalence of HIV/AIDS.</p> <p>Conclusion</p> <p>Demographic census microdata offer the opportunity to conduct an epidemiologic analysis of maternal mortality. In the case of South Africa, the level of MMR increased dramatically over the past 10 years, most likely because of HIV/AIDS. Indirect causes of maternal deaths appear much more important than direct obstetric causes. The MMR appears no longer to be a reliable measure of the quality of obstetric care or a measure of safe motherhood.</p
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage
Background: Delays in the detection or treatment of postpartum hemorrhage can result in complications or death. A blood-collection drape can help provide objective, accurate, and early diagnosis of postpartum hemorrhage, and delayed or inconsistent use of effective interventions may be able to be addressed by a treatment bundle.Methods: We conducted an international, cluster-randomized trial to assess a multicomponent clinical intervention for postpartum hemorrhage in patients having vaginal delivery. The intervention included a calibrated blood-collection drape for early detection of postpartum hemorrhage and a bundle of first-response treatments (uterine massage, oxytocic drugs, tranexamic acid, intravenous fluids, examination, and escalation), supported by an implementation strategy (intervention group). Hospitals in the control group provided usual care. The primary outcome was a composite of severe postpartum hemorrhage (blood loss, ≥1000 ml), laparotomy for bleeding, or maternal death from bleeding. Key secondary implementation outcomes were the detection of postpartum hemorrhage and adherence to the treatment bundle.Results: A total of 80 secondary-level hospitals across Kenya, Nigeria, South Africa, and Tanzania, in which 210,132 patients underwent vaginal delivery, were randomly assigned to the intervention group or the usual-care group. Among hospitals and patients with data, a primary-outcome event occurred in 1.6% of the patients in the intervention group, as compared with 4.3% of those in the usual-care group (risk ratio, 0.40; 95% confidence interval [CI], 0.32 to 0.50; P<0.001). Postpartum hemorrhage was detected in 93.1% of the patients in the intervention group and in 51.1% of those in the usual-care group (rate ratio, 1.58; 95% CI, 1.41 to 1.76), and the treatment bundle was used in 91.2% and 19.4%, respectively (rate ratio, 4.94; 95% CI, 3.88 to 6.28).Conclusions: Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients having vaginal delivery
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