Heat stable carbetocin or oxytocin for prevention of postpartum hemorrhage among women at risk: A secondary analysis of the CHAMPION trial.

Objective: To examine whether the observed non-inferiority of heat-stable carbetocin (HSC), compared with oxytocin, was influenced by biologic (macrosomia, parity 3 or more, or history of postpartum hemorrhage [PPH]) and/or pharmacologic (induction or augmentation) risk factors for PPH.

Methods: The present study is a secondary analysis of the CHAMPION non-inferiority randomized trial-a two-arm, double-blind, active-controlled study conducted at 23 hospitals in 10 countries, between July 2015 and January 2018. Women with singleton pregnancies, expected to deliver vaginally with cervical dilatation up to 6 cm were eligible.

Duration of third stage labour and postpartum blood loss: a secondary analysis of the WHO CHAMPION trial data.

Background: Obstetric haemorrhage continues to be a leading cause of maternal mortality, contributing to more than a quarter of the 2,443,000 maternal deaths reported between 2003 and 2009. During this period, about 70% of the haemorrhagic deaths occurred postpartum. In addition to other identifiable risk factors for greater postpartum blood loss, the duration of the third stage of labour (TSL) seems to be important, as literature shows that a longer TSL can be associated with more blood loss.

Effect of heat stable carbetocin vs oxytocin for preventing postpartum haemorrhage on post delivery hemoglobin-a randomized controlled trial.

Objective: To compare the effect of heat-stable carbetocin 100 μg IM versus oxytocin 10 IU IM on post-delivery hemoglobin level.

Setting: Hospital based study in Southern India.

Population: Women delivering vaginally who were enrolled in the WHO CHAMPION trial in a single facility in India.

There is life beyond the statistical significance.

This article challenges the "tyranny of P-value" and promote more valuable and applicable interpretations of the results of research on health care delivery. We provide here solid arguments to retire statistical significance as the unique way to interpret results, after presenting the current state of the debate inside the scientific community. Instead, we promote reporting the much more informative confidence intervals and eventually adding exact P-values.

Cost of hospital care of women with postpartum haemorrhage in India, Kenya, Nigeria and Uganda: a financial case for improved prevention.

Objective: Access to quality, effective lifesaving uterotonics in low and middle-income countries (LMICs) remains a major barrier to reducing maternal deaths from postpartum haemorrhage (PPH). Our objective was to assess the costs of care for women who receive different preventative uterotonics, and with PPH and no-PPH so that the differences, if significant, can inform better resource allocation for maternal health care.

Methods: The costs of direct hospital care of women who received oxytocin or heat-stable carbetocin for prevention of PPH in selected tertiary care facilities in India, Kenya, Nigeria, and Uganda were assessed.

Antenatal Dexamethasone for Early Preterm Birth in Low-Resource Countries.

Background: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain.

Methods: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo.

Distribution of postpartum blood loss: modeling, estimation and application to clinical trials.

Background: The loss of large amounts of blood postpartum can lead to severe maternal morbidity and mortality. Understanding the nature of postpartum blood loss distribution is critical for the development of efficient analysis techniques when comparing treatments to prevent this event. When blood loss is measured, resulting in a continuous volume measure, often this variable is categorized in classes, and reduced to an indicator of volume greater than a cutoff point.

Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth.

Background: Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin.

Prevention of postpartum haemorrhage: a distributional approach for analysis.

Background: There is empirical evidence that measured postpartum blood loss has a lognormal distribution. This feature can be used to analyze events of the type 'blood loss greater than a certain cutoff point' using a lognormal approach, which takes into account all the quantitative observations, as opposed to dichotomizing the variable blood loss volume into two categories. This lognormal approach uses all the information contained in the data and is expected to provide more efficient estimates of proportions and relative risk when comparing treatments to prevent postpartum haemorrhage.

The World Health Organization fetal growth charts: concept, findings, interpretation, and application.

Ultrasound biometry is an important clinical tool for the identification, monitoring, and management of fetal growth restriction and development of macrosomia. This is even truer in populations in which perinatal morbidity and mortality rates are high, which is a reason that much effort is put onto making the technique available everywhere, including low-income societies. Until recently, however, commonly used reference ranges were based on single populations largely from industrialized countries.

Antenatal corticosteroids for women at risk of imminent preterm birth in low-resource countries: the case for equipoise and the need for efficacy trials.

The scientific basis for antenatal corticosteroids (ACS) for women at risk of preterm birth has rapidly changed in recent years. Two landmark trials-the Antenatal Corticosteroid Trial and the Antenatal Late Preterm Steroids Trial-have challenged the long-held assumptions on the comparative health benefits and harms regarding the use of ACS for preterm birth across all levels of care and contexts, including resource-limited settings. Researchers, clinicians, programme managers, policymakers and donors working in low-income and middle-income countries now face challenging questions of whether, where and how ACS can be used to optimise outcomes for both women and preterm newborns.

Community health promotion and medical provision for neonatal health-CHAMPION cluster randomised trial in Nagarkurnool district, Telangana (formerly Andhra Pradesh), India.

Background: In the mid-2000s, neonatal mortality accounted for almost 40% of deaths of children under 5 years worldwide, and constituted 65% of infant deaths in India. The neonatal mortality rate in Andhra Pradesh was 44 per 1,000 live births, and was higher in the rural areas and tribal regions, such as the Nagarkurnool division of Mahabubnagar district (which became Nagarkurnool district in Telangana in 2014). The aim of the CHAMPION trial was to investigate whether a package of interventions comprising community health promotion and provision of health services (including outreach and facility-based care) could lead to a reduction of the order of 25% in neonatal mortality.

Correction: The World Health Organization Fetal Growth Charts: A Multinational Longitudinal Study of Ultrasound Biometric Measurements and Estimated Fetal Weight.

[This corrects the article DOI: 10.1371/journal.pmed.

The World Health Organization Fetal Growth Charts: A Multinational Longitudinal Study of Ultrasound Biometric Measurements and Estimated Fetal Weight.

Background: Perinatal mortality and morbidity continue to be major global health challenges strongly associated with prematurity and reduced fetal growth, an issue of further interest given the mounting evidence that fetal growth in general is linked to degrees of risk of common noncommunicable diseases in adulthood. Against this background, WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use.

Methods And Findings: We conducted a multinational prospective observational longitudinal study of fetal growth in low-risk singleton pregnancies of women of high or middle socioeconomic status and without known environmental constraints on fetal growth.

Effects of community health interventions on under-5 mortality in rural Guinea-Bissau (EPICS): a cluster-randomised controlled trial.

Background: Evidence suggests that community-based interventions that promote improved home-based practices and care-seeking behaviour can have a large impact on maternal and child mortality in regions where rates are high. We aimed to assess whether an intervention package based on the WHO Integrated Management of Childhood Illness handbook and community mobilisation could reduce under-5 mortality in rural Guinea-Bissau, where the health service infrastructure is weak.

Methods: We did a non-masked cluster-randomised controlled trial (EPICS) in the districts of Tombali and Quinara in Guinea-Bissau.

Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial.

Background: Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low-income countries and contributes to nearly a quarter of maternal deaths globally. The current available interventions for prevention of postpartum haemorrhage, oxytocin and carbetocin, are limited by their need for refrigeration to maintain potency, as the ability to maintain a cold chain across the drug distribution and storage network is inconsistent, thus restricting their use in countries with the highest burden of maternal mortality. We describe a randomized, double-blind non-inferiority trial comparing a newly developed room temperature stable formulation of carbetocin to the standard intervention (oxytocin) for the prevention of PPH after vaginal birth.

Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A.

Objectives: To compare rates of unintended pregnancy, method continuation and reasons for removal among women using the 52-mg levonorgestrel (daily release 20 microg) intrauterine device (LNG-IUD) or the copper T 380 A IUD (TCu380A).

Study Design: This was an open-label 7-year randomized controlled trial in 20 centres, 11 of which in China. Data on 1884 women with interval insertion of the LNG-IUD and 1871 of the TCu380A were analysed using life tables with 30-day intervals and Cox proportional hazards models.

Alternative versus standard packages of antenatal care for low-risk pregnancy.

Background: The number of visits for antenatal (prenatal) care developed without evidence of how many visits are necessary. The content of each visit also needs evaluation.

Objectives: To compare the effects of antenatal care programmes with reduced visits for low-risk women with standard care.

The female condom learning curve: patterns of female condom failure over 20 uses.

Background: Male and female condom (FC) functional performance failure declines with user experience. With the recent availability of a wider range of FCs, it is important to know if women with experience in using one type of FC are more proficient in using another type, even if the FC design is quite different.

Study Design: A randomized, noninferiority crossover clinical trial assessed the function of four FCs (FC2, Woman's Condom, Cupid and VA w.

Performance and safety of the second-generation female condom (FC2) versus the Woman's, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial.

Background: New designs of female condom have been developed to reduce costs and improve acceptability. To secure regulatory approvals, clinical studies are needed to verify performance. We aimed to assess the functional performance and safety of three new condom types-the Woman's Condom, the VA worn-of-women (wow) Condom Feminine, and the Cupid female condom-against the existing second-generation female condom (FC2).