116 research outputs found

    Barriers to progress in pregnancy research:how can we break through?

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    The influence of hours worked prior to delivery on maternal and neonatal outcomes: a retrospective cohort study.

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    BACKGROUND: Long continuous periods of working contribute to fatigue, which is an established risk factor for adverse patient outcomes in many clinical specialties. The total number of hours worked by delivering clinicians before delivery therefore may be an important predictor of adverse maternal and neonatal outcomes. OBJECTIVE: We aimed to examine how rates of adverse delivery outcomes vary with the number of hours worked by the delivering clinician before delivery during both day and night shifts. STUDY DESIGN: We conducted a retrospective cohort study of 24,506 unscheduled deliveries at an obstetrics center in the United Kingdom from 2008-2013. We compared adverse outcomes between day shifts and night shifts using random-effects logistic regression to account for interoperator variability. Adverse outcomes were estimated blood loss of ≥1.5 L, arterial cord pH of ≤7.1, failed instrumental delivery, delayed neonatal respiration, severe perineal trauma, and any critical incident. Additive dynamic regression was used to examine the association between hours worked before delivery (up to 12 hours) and risk of adverse outcomes. Models were controlled for maternal age, maternal body mass index, parity, birthweight, gestation, obstetrician experience, and delivery type. RESULTS: We found no difference in the risk of any adverse outcome that was studied between day vs night shifts. Yet, risk of estimated blood loss of ≥1.5 L and arterial cord pH of ≤7.1 both varied by 30-40% within 12-hour shifts (P<.05). The highest risk of adverse outcomes occurred after 9-10 hours from the beginning of the shift for both day and night shifts. The risk of other adverse outcomes did not vary significantly by hours worked or by day vs night shift. CONCLUSION: Number of hours already worked before undertaking unscheduled deliveries significantly influences the risk of certain adverse outcomes. Our findings suggest that fatigue may play a role in increasing the risk of adverse delivery outcomes later in shifts and that obstetric work patterns could be better designed to minimize the risk of adverse delivery outcomes.ARA is supported by grant P2CHD047879, awarded to the Office of Population Research at Princeton University by The Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health. JGS is supported by a CAREER grant from the U.S. National Science Foundation (DMS-1255187).This is the author accepted manuscript. The final version is available from Elsevier via http://dx.doi.org/10.1016/j.ajog.2016.06.02

    Demand for Self-Managed Online Telemedicine Abortion in the United States During the Coronavirus Disease 2019 (COVID-19) Pandemic.

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    For many in the United States, abortion care is already difficult to access,1 and the coronavirus disease 2019 (COVID-19) pandemic has created yet more potential barriers—including infection risk at clinics and state policies limiting in-clinic services. The severity of these state policies varies, but, in the most extreme case, Texas effectively suspended all abortions for approximately 4 weeks.2 As a result, people may increasingly be seeking self-managed abortion outside the formal health care system. Using data from Aid Access, the sole online abortion telemedicine service in the United States, we assessed whether demand for self-managed medication abortion increased as in-clinic access became more challenging

    Neonatal, infant, and childhood growth following metformin versus insulin treatment for gestational diabetes: A systematic review and meta-analysis.

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    BACKGROUND: Metformin is increasingly offered as an acceptable and economic alternative to insulin for treatment of gestational diabetes mellitus (GDM) in many countries. However, the impact of maternal metformin treatment on the trajectory of fetal, infant, and childhood growth is unknown. METHODS AND FINDINGS: PubMed, Ovid Embase, Medline, Web of Science, ClinicalTrials.gov, and the Cochrane database were systematically searched (from database inception to 26 February 2019). Outcomes of GDM-affected pregnancies randomised to treatment with metformin versus insulin were included (randomised controlled trials and prospective randomised controlled studies) from cohorts including European, American, Asian, Australian, and African women. Studies including pregnant women with pre-existing diabetes or non-diabetic women were excluded, as were trials comparing metformin treatment with oral glucose-lowering agents other than insulin. Two reviewers independently assessed articles for eligibility and risk of bias, and conflicts were resolved by a third reviewer. Outcome measures were parameters of fetal, infant, and childhood growth, including weight, height, BMI, and body composition. In total, 28 studies (n = 3,976 participants) met eligibility criteria and were included in the meta-analysis. No studies reported fetal growth parameters; 19 studies (n = 3,723 neonates) reported measures of neonatal growth. Neonates born to metformin-treated mothers had lower birth weights (mean difference -107.7 g, 95% CI -182.3 to -32.7, I2 = 83%, p = 0.005) and lower ponderal indices (mean difference -0.13 kg/m3, 95% CI -0.26 to 0.00, I2 = 0%, p = 0.04) than neonates of insulin-treated mothers. The odds of macrosomia (odds ratio [OR] 0.59, 95% CI 0.46 to 0.77, p < 0.001) and large for gestational age (OR 0.78, 95% CI 0.62 to 0.99, p = 0.04) were lower following maternal treatment with metformin compared to insulin. There was no difference in neonatal height or incidence of small for gestational age between groups. Two studies (n = 411 infants) reported measures of infant growth (18-24 months of age). In contrast to the neonatal phase, metformin-exposed infants were significantly heavier than those in the insulin-exposed group (mean difference 440 g, 95% CI 50 to 830, I2 = 4%, p = 0.03). Three studies (n = 520 children) reported mid-childhood growth parameters (5-9 years). In mid-childhood, BMI was significantly higher (mean difference 0.78 kg/m2, 95% CI 0.23 to 1.33, I2 = 7%, p = 0.005) following metformin exposure than following insulin exposure, although the difference in absolute weights between the groups was not significantly different (p = 0.09). Limited evidence (1 study with data treated as 2 cohorts) suggested that adiposity indices (abdominal [p = 0.02] and visceral [p = 0.03] fat volumes) may be higher in children born to metformin-treated compared to insulin-treated mothers. Study limitations include heterogeneity in metformin dosing, heterogeneity in diagnostic criteria for GDM, and the scarcity of reporting of childhood outcomes. CONCLUSIONS: Following intrauterine exposure to metformin for treatment of maternal GDM, neonates are significantly smaller than neonates whose mothers were treated with insulin during pregnancy. Despite lower average birth weight, metformin-exposed children appear to experience accelerated postnatal growth, resulting in heavier infants and higher BMI by mid-childhood compared to children whose mothers were treated with insulin. Such patterns of low birth weight and postnatal catch-up growth have been reported to be associated with adverse long-term cardio-metabolic outcomes. This suggests a need for further studies examining longitudinal perinatal and childhood outcomes following intrauterine metformin exposure. This review protocol was registered with PROSPERO under registration number CRD42018117503.MRC (MC_ UU_12012/4), BHF (RG/17/12/33167) and Isaac Newton Trust/Wellcome Trust ISSF/ University of Cambridge Joint Research Gran

    Comparative impact of pharmacological treatments for gestational diabetes on neonatal anthropometry independent of maternal glycaemic control: A systematic review and meta-analysis

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    Funder: Isaac Newton Trust/Wellcome Trust ISSF/ University of Cambridge Joint Research GrantBackground: Fetal growth in gestational diabetes mellitus (GDM) is directly linked to maternal glycaemic control; however, this relationship may be altered by oral anti-hyperglycaemic agents. Unlike insulin, such drugs cross the placenta and may thus have independent effects on fetal or placental tissues. We investigated the association between GDM treatment and fetal, neonatal, and childhood growth. Methods and findings: PubMed, Ovid Embase, Medline, Web of Science, ClinicalTrials.gov, and Cochrane databases were systematically searched (inception to 12 February 2020). Outcomes of GDM-affected pregnancies randomised to treatment with metformin, glyburide, or insulin were included. Studies including preexisting diabetes or nondiabetic women were excluded. Two reviewers independently assessed eligibility and risk of bias, with conflicts resolved by a third reviewer. Maternal outcome measures were glycaemic control, weight gain, and treatment failure. Offspring anthropometric parameters included fetal, neonatal, and childhood weight and body composition data. Thirty-three studies (n = 4,944), from geographical locations including Europe, North Africa, the Middle East, Asia, Australia/New Zealand, and the United States/Latin America, met eligibility criteria. Twenty-two studies (n = 2,801) randomised women to metformin versus insulin, 8 studies (n = 1,722) to glyburide versus insulin, and 3 studies (n = 421) to metformin versus glyburide. Eleven studies (n = 2,204) reported maternal outcomes. No differences in fasting blood glucose (FBS), random blood glucose (RBS), or glycated haemoglobin (HbA1c) were reported. No studies reported fetal growth parameters. Thirty-three studies (n = 4,733) reported birth weight. Glyburide-exposed neonates were heavier at birth (58.20 g, 95% confidence interval [CI] 10.10–106.31, p = 0.02) with increased risk of macrosomia (odds ratio [OR] 1.38, 95% CI 1.01–1.89, p = 0.04) versus neonates of insulin-treated mothers. Metformin-exposed neonates were born lighter (−73.92 g, 95% CI −114.79 to −33.06 g, p < 0.001) with reduced risk of macrosomia (OR 0.60, 95% CI 0.45–0.79, p < 0.001) than insulin-exposed neonates. Metformin-exposed neonates were born lighter (−191.73 g, 95% CI −288.01 to −94.74, p < 0.001) with a nonsignificant reduction in macrosomia risk (OR 0.32, 95% CI 0.08–1.19, I2 = 0%, p = 0.09) versus glyburide-exposed neonates. Glyburide-exposed neonates had a nonsignificant increase in total fat mass (103.2 g, 95% CI −3.91 to 210.31, p = 0.06) and increased abdominal (0.90 cm, 95% CI 0.03–1.77, p = 0.04) and chest circumferences (0.80 cm, 95% CI 0.07–1.53, p = 0.03) versus insulin-exposed neonates. Metformin-exposed neonates had decreased ponderal index (−0.13 kg/m3, 95% CI −0.26 to −0.00, p = 0.04) and reduced head (−0.21, 95% CI −0.39 to −0.03, p = 0.03) and chest circumferences (−0.34 cm, 95% CI −0.62 to −0.05, p = 0.02) versus the insulin-treated group. Metformin-exposed neonates had decreased ponderal index (−0.09 kg/m3, 95% CI −0.17 to −0.01, p = 0.03) versus glyburide-exposed neonates. Study limitations include heterogeneity in dosing, heterogeneity in GDM diagnostic criteria, and few studies reporting longitudinal growth outcomes. Conclusions: Maternal randomisation to glyburide resulted in heavier neonates with a propensity to increased adiposity versus insulin- or metformin-exposed groups. Metformin-exposed neonates were lighter with reduced lean mass versus insulin- or glyburide-exposed groups, independent of maternal glycaemic control. Oral anti-hyperglycaemics cross the placenta, so effects on fetal anthropometry could result from direct actions on the fetus and/or placenta. We highlight a need for further studies examining the effects of intrauterine exposure to antidiabetic agents on longitudinal growth, and the importance of monitoring fetal growth and maternal glycaemic control when treating GDM. This review protocol was registered with PROSPERO (CRD42019134664/CRD42018117503)

    Management of fetal malposition in the second stage of labor: a propensity score analysis.

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    OBJECTIVE: We sought to determine the factors associated with selection of rotational instrumental vs cesarean delivery to manage persistent fetal malposition, and to assess differences in adverse neonatal and maternal outcomes following delivery by rotational instruments vs cesarean delivery. STUDY DESIGN: We conducted a retrospective cohort study over a 5-year period in a tertiary United Kingdom obstetrics center. In all, 868 women with vertex-presenting, single, liveborn infants at term with persistent malposition in the second stage of labor were included. Propensity score stratification was used to control for selection bias: the possibility that obstetricians may systematically select more difficult cases for cesarean delivery. Linear and logistic regression models were used to compare maternal and neonatal outcomes for delivery by rotational forceps or ventouse vs cesarean delivery, adjusting for propensity scores. RESULTS: Increased likelihood of rotational instrumental delivery was associated with lower maternal age (odds ratio [OR], 0.95; P < .01), lower body mass index (OR, 0.94; P < .001), lower birthweight (OR, 0.95; P < .01), no evidence of fetal compromise at the time of delivery (OR, 0.31; P < .001), delivery during the daytime (OR, 1.45; P < .05), and delivery by a more experienced obstetrician (OR, 7.21; P < .001). Following propensity score stratification, there was no difference by delivery method in the rates of delayed neonatal respiration, reported critical incidents, or low fetal arterial pH. Maternal blood loss was higher in the cesarean group (295.8 ± 48 mL, P < .001). CONCLUSION: Rotational instrumental delivery is often regarded as unsafe. However, we find that neonatal outcomes are no worse once selection bias is accounted for, and that the likelihood of severe obstetric hemorrhage is reduced. More widespread training of obstetricians in rotational instrumental delivery should be considered, particularly in light of rising cesarean delivery rates.During data analysis, A.R.A. was supported by an NICHD Predoctoral Fellowship under grant number F31HD079182 and by grant R24HD042849, awarded to the Population Research Center at The University of Texas at Austin. She is currently supported by grant R24HD047879 for Population Research at Princeton University. J.G.S. is partially funded by a CAREER grant from the National Science Foundation (DMS-1255187).This is the accepted version. It will be embargoed until 12 months after the final version is published by Elsevier. The final version is available from Elsevier at http://www.sciencedirect.com/science/article/pii/S000293781401078
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