Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial.

OBJECTIVE: To assess the effectiveness of 600 microg oral misoprostol on postpartum haemorrhage (PPH) and postpartum anaemia in a low income country home birth situation. DESIGN: Double blind randomised controlled trial. SETTING: Twenty-six villages in rural Gambia with 52 traditional birth attendants (TBAs). SAMPLE: One thousand, two hundred and twenty-nine women delivering at home under the guidance of a trained TBA. METHODS: Active management of the third stage of labour using three 200-microg misoprostol tablets and placebo or four 0.5-mg ergometrine tablets (standard treatment) and placebo. Tablets were taken orally immediately after delivery. MAIN OUTCOME MEASURES: Measured blood loss, postpartum haemoglobin (Hb), difference between Hb at the last antenatal care visit and three to five days postpartum. RESULTS: The misoprostol group experienced lower incidence of measured blood loss > or =500 mL and postpartum Hb or = 2 g/dL was 16.4% with misoprostol and 21.2% with ergometrine [relative risk 0.77; 95% confidence interval (CI) 0.60-0.98; P= 0.02]. Shivering was significantly more common with misoprostol, while vomiting was more common with ergometrine. Only transient side effects were observed. CONCLUSIONS: Six hundred micrograms of oral misoprostol is a promising drug to prevent life-threatening PPH in this setting

Age of smoking initiation and risk of breast cancer in a sample of Ontario women

<p>Abstract</p> <p>Objectives</p> <p>To examine the association between time of smoking initiation and both the independent and joint effects of active and passive tobacco smoke exposure and the risk of breast cancer in a sample of Ontario women.</p> <p>Methods</p> <p>Data from two large population-based case-control studies conducted among Ontario women aged 25–75 years were combined for analysis (n = 12,768).</p> <p>Results</p> <p>Women who had ever smoked and were exposed to passive smoke had a significant increased risk of breast cancer (OR 1.13, 95%CI 1.01–1.25). A significant increased risk was also observed among women who initiated smoking: at age 26 or older (OR 1.26, 95%CI 1.03–1.55); more than five years from menarche (OR 1.26, 95%CI 1.12–1.42); and, after their first live birth (OR 1.25, 95%CI 1.02–1.52).</p> <p>Conclusion</p> <p>The results suggest that women who initiate smoking at an older age are at an increased risk of breast cancer.</p

Oxytocin via Uniject (a prefi lled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial

Background Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the effi cacy of these drugs when delivered by auxiliary midwives at maternity huts. Methods We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3–21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 μg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratifi ed by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153. Findings 28 maternity hut clusters were randomly assigned—14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group and 2·7 g/L (SD 17·8) in the oxytocin group. When adjusted for cluster design, the mean diff erence in haemoglobin decreases between groups was not signifi cant (0·3 g/L, 95% CI –8·26 to 8·92, p=0·71). Both drugs were well tolerated. Shivering was common in the misoprostol group, and nausea in the oxytocin group. Postpartum haemorrhage was diagnosed in one woman allocated to oxytocin, who was referred and transferred to a higher-level facility for additional care, and fully recovered. No other women were transferred. Interpretation In terms of eff ects on haemoglobin concentrations, neither oxytocin nor misoprostol was signifi cantly better than the other, and both drugs were safe and effi cacious when delivered by auxiliary midwives. The programmatic limitations of oxytocin, including short shelf life outside the cold chain, mean that misoprostol could be more appropriate for community-level prophylaxis of postpartum haemorrhage

Advancing maternal survival in the global context: are our strategies working?

There have been significant gains in improving maternal mortality over the last two decades. Researchers have suggested a variety of interventions and mechanisms to explain these improvements. While it is likely that much of what has been done in research and programs has contributed to this decline, the evidence regarding what works in the settings in which women deliver continues to face many challenges. We review the evidence for these improvements and suggest that there remain areas to focus on, particularly the births which currently take place in an unsupervised or substandard environments. We highlight the main areas where more evidence is needed, and end with a call to determine which of our interventions seem to have the most benefit; which do not; and where to invest future resources

Reproductive health services in KwaZulu Natal, South Africa: A situation analysis study focusing on HIV/AIDS services

This Horizons report examines the readiness of reproductive health services in South Africa, which are primarily geared to women, to deliver HIV and AIDS treatment, care, and prevention services. The goal of the study was to obtain information from a representative sample of provincial health care facilities offering reproductive health services in KwaZulu Natal to meet the growing demand for HIV/AIDS-related services. Ninety-eight hospitals, community health centers, and clinics participated in the situation analysis that identified gaps in service delivery and determined priorities for service integration. Results of the study were presented to a large audience of Department of Health, NGO, and donor agency staff with the hope that this workshop would set a trend for feedback and the use of research for service improvement

Interpreting and Reporting Results Based on Patient-Reported Outcomes

AbstractThis article deals with the incorporation of patient-reported outcomes (PROs) into clinical trials and focuses on issues associated with the interpretation and reporting of PRO data. The primary focus and context of this information relates to the evidentiary support and reporting for a labeling or advertising claim of a PRO benefit for a new or approved pharmaceutical product. This manuscript focuses on issues associated with assessing clinical significance and common pitfalls to avoid in presenting results related to PROs. Specifically, the questions addressed by this manuscript involve: What are the best methods to assess clinical significance for PROs? How should investigators present PRO data most effectively in a Food and Drug Administration (FDA) application? In labeling or in a scientific publication? Guidelinesfor interpreting clinical significance of PROs and for comprehensively reporting on the methods, measures and results of clinical trials that incorporate PROs are important for clinicians, regulatory agencies, and most of all to patients. Clear specifications for considering a finding on a PRO measure, as clinically meaningful, need to be determined by instrument developers and psychometricians; they need to be reported for all clinical trials involving PRO end points. Clinical trial reports need to be comprehensive, clear, and sufficient to enable any reader to understand the methods, PRO measures, statistical analysis, and results

Analysis and Interpretation of Results Based on Patient-Reported Outcomes

AbstractThis article is part of a series of manuscripts dealing with the incorporation of patient-reported outcomes (PROs) into clinical trials. The issues dealt with in this manuscript concern the common pitfalls to avoid in statistical analysis and interpretation of PROs. Specifically, the questions addressed by this manuscript involve the analysis pitfalls with PRO data in clinical trials and how can they be avoided (e.g.,missing data, multiplicity, null results etc.). The manuscript provides key literature for existing resources and proposes new guidelines

Methylmalonic acidemia (MMA) in pregnancy: a case series and literature review

IntroductionWomen with inherited metabolic disorders, including those with previously life‐limiting conditions such as MMA, are reaching child‐bearing age more often due to advances in early diagnosis and improved pediatric care. Information surrounding maternal and fetal complications associated with the underlying disorders remains largely unexplored.MethodsPregnancies affected by maternal MMA were ascertained through study 04‐HG‐0127 “Clinical and Basic Investigations of Methylmalonic Acidemia and Related Disorders” (clinicaltrials.gov identifier: NCT00078078) and via literature review. Prenatal and delivery records in study participants were reviewed.ResultsSeventeen pregnancies were identified in women with isolated MMA, including three abortions, one termination, and 13 completed pregnancies [three cases with cblA (four pregnancies), four cases of mut‐ (one cobalamin responsive, three non‐responsive), five cases with unknown type of MMA]. Seventeen percent (3/17) of the pregnancies resulted in a first trimester abortion, while 38.5 % (5/13) of the completed pregnancies resulted in preterm deliveries. A cesarean delivery rate of 53.8 % (7/13) was noted among the cohort. Fetal distress or nonreassuring fetal status was the indication for 57 % (4/7) cesarean deliveries. One patient was reported to have metabolic crisis as well as episodes of mild hyperammonemia. Malformations or adverse outcomes in the progeny were not observed.ConclusionAlthough there have been a small number of pregnancies identified in women with MMA, the cumulative results suggest that the majority of pregnancies can be complicated by cesarean delivery and increased risk of prematurity. A pregnancy registry could clarify perinatal complications and define management approaches needed to ensure optimal maternal and fetal outcomes in this growing patient population.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/147009/1/jimd0839.pd

Coordination Dynamics meets Active Inference and Artificial Intelligence (CD + AI2):A multi-pronged approach to understanding the dynamics of brain and the emergence of conscious agency

How do humans discover their ability to act on the world? By tethering a baby’s foot to a mobile (Fig. 1a) and measuring the motion of both in 3D, we explore how babies begin to make sense of their coordinative relationship with the world and realize their ability to make things happen (N= 16; mean age = 100.33 days). Machine and deep learning classification architectures (e.g., CapsNet) indicate that functionally connecting infants to a mobile via a tether influences the baby movement most where it matters, namely at the point of infant∼world connection (Table 1). Using dynamics as a guide, we have developed tools to identify the moment an infant switches from spontaneous to intentional action (Fig. 1b). Preliminary coordination dynamics analysis and active inference generative modeling indicate that moments of stillness hold important epistemic value for young infants discovering their ability to change the world around them (Fig. 1c). Finally, a model of slow~fast brain coordination dynamics based on a 3D extension of the Jirsa-Kelso Excitator successfully simulated the evolution of tethered foot activity as infants transition from spontaneous to ordered action. By tuning a small number of parameters, this model captures patterns of emergent goal-directed action (Fig. 1d). Meshing concepts, methods and tools of Active Inference, Artificial Intelligence and Coordination Dynamics at multiple levels of description, the CD + AI2 program of research aims to identify key control parameters that shift the infant system from spontaneous to intentional behavior. The potent combination of mathematical modeling and quantitative analysis along with empirical study allow us to express the emergence of agency in quantifiable, lawful terms