Maternal and perinatal outcomes in pregnant women with confirmed severe and mild COVID-19 at one large maternity hospital in Chile.

OBJECTIVE AND METHODS: We conducted a prospective observational cohort study in 458 pregnant and puerperal women, with confirmed COVID-19 at Hospital San Jose, Santiago, Chile, to determine the impact of COVID-19 on pregnancy and confirm safety and feasibility of a management protocol based on clinical presentation of the disease. RESULTS: 25.5% (117/458) of women were severe and 74.4% (341/458) mild presentation. Three percent (9/341) of mild presentations required a subsequent hospitalization. Overall, 26/458 women (5.6%) were admitted to ICU, and 13/458 (2.8%) required mechanical ventilation. One maternal death occurred at 49-days postpartum. Severe presentation, infection above 24 weeks, and comorbidities were associated with an adverse maternal outcome. Of total deliveries, 16.5% (36/217) were <37 weeks. Perinatal mortality was 6/226 (2.7%), mostly due to the fetal component. CONCLUSIONS: A quarter of the women had severe COVID-19 that, combined with occurrence of disease in the second half of pregnancy, resulted in substantial maternal compromise. Perinatal morbidity and mortality in women with severe disease were high and warrant consideration. Outpatient management was safe for mild cases.

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

BACKGROUND: A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. METHODS: Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. RESULTS: Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. CONCLUSIONS: Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. TRIAL REGISTRATION: ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

WHO multicentre study for the development of growth standards from fetal life to childhood: the fetal component.

BACKGROUND: In 2006 WHO presented the infant and child growth charts suggested for universal application. However, major determinants for perinatal outcomes and postnatal growth are laid down during antenatal development. Accordingly, monitoring fetal growth in utero by ultrasonography is important both for clinical and scientific reasons. The currently used fetal growth references are derived mainly from North American and European population and may be inappropriate for international use, given possible variances in the growth rates of fetuses from different ethnic population groups. WHO has, therefore, made it a high priority to establish charts of optimal fetal growth that can be recommended worldwide. METHODS: This is a multi-national study for the development of fetal growth standards for international application by assessing fetal growth in populations of different ethnic and geographic backgrounds. The study will select pregnant women of high-middle socioeconomic status with no obvious environmental constraints on growth (adequate nutritional status, non-smoking), and normal pregnancy history with no complications likely to affect fetal growth. The study will be conducted in centres from ten developing and industrialized countries: Argentina, Brazil, Democratic Republic of Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand. At each centre, 140 pregnant women will be recruited between 8 + 0 and 12 + 6 weeks of gestation. Subsequently, visits for fetal biometry will be scheduled at 14, 18, 24, 28, 32, 36, and 40 weeks (+/- 1 week) to be performed by trained ultrasonographers.The main outcome of the proposed study will be the development of fetal growth standards (either global or population specific) for international applications. DISCUSSION: The data from this study will be incorporated into obstetric practice and national health policies at country level in coordination with the activities presently conducted by WHO to implement the use of the Child Growth Standards.

Feasibility and safety study of a new device (Odón device) for assisted vaginal deliveries: study protocol.

BACKGROUND: Intrapartum complications are responsible for approximately half of all maternal deaths, and two million stillbirth and neonatal deaths per year. Prolonged second stage of labour is associated with potentially fatal maternal complications such as haemorrhage and infection and it is a major cause of stillbirth and newborn morbidity and mortality. Currently, the three main options for managing prolonged second stage of labour are forceps, vacuum extractor and caesarean section. All three clinical practices require relatively expensive equipment (e.g., a surgical theatre for caesarean section) and/or highly trained staff which are often not available in low resource settings. The specific aim of the proposed study is to test the safety and feasibility of a new device (Odón device) to effectively deliver the fetus during prolonged second stage of labour. The Odón device is a low-cost technological innovation to facilitate operative vaginal delivery and designed to minimize trauma to the mother and baby. These features combined make it a potentially revolutionary development in obstetrics, particularly for improving intrapartum care and reducing maternal and perinatal morbidity and mortality in low resource settings. METHODS/DESIGN: This will be a hospital-based, multicenter prospective phase 1 cohort study with no control group. Delivery with the Odón device will be attempted under normal labour and non-emergency conditions on all the women enrolled in the study. One-hundred and thirty pregnant women will be recruited in tertiary care facilities in Argentina. Safety will be assessed by examining maternal and infant outcomes until discharge. Feasibility will be evaluated by observing successful expulsion of the fetal head after one-time application of the device under standardized conditions (full cervical dilation, anterior presentation, +2 station, normal fetal heart rate). TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR). Identifier: ACTRN12613000141741.

Do Italian women prefer cesarean section? Results from a survey on mode of delivery preferences.

BACKGROUND: About 20 million cesareans occur each year in the world and rates have steadily increased in almost all middle- and high-income countries over the last decades. Maternal request is often argued as one of the key forces driving this increase. Italy has the highest cesarean rate of Europe, yet there are no national surveys on the views of Italian women about their preferences on route of delivery. This study aimed to assess Italian women's preference for mode of delivery, as well as reasons and factors associated with this preference, in a nationally representative sample of women. METHODS: This cross sectional survey was conducted between December 2010-March 2011. An anonymous structured questionnaire asked participants what was their preferred mode of delivery and explored the reasons for this preference by assessing their agreement to a series of statements. Participants were also asked to what extent their preference was influenced by a series of possible sources. The 1st phase of the study was carried out among readers of a popular Italian women's magazine (Io Donna). In a 2nd phase, the study was complemented by a structured telephone interview. RESULTS: A total of 1000 Italian women participated in the survey and 80% declared they would prefer to deliver vaginally if they could opt. The preference for vaginal delivery was significantly higher among older (84.7%), more educated (87.6%), multiparous women (82.3%) and especially among those without any previous cesareans (94.2%). The main reasons for preferring a vaginal delivery were not wanting to be separated from the baby during the first hours of life, a shorter hospital stay and a faster postpartum recovery. The main reasons for preferring a cesarean were fear of pain, convenience to schedule the delivery and because it was perceived as being less traumatic for the baby. The source which most influenced the preference of these Italian women was their obstetrician, followed by friends or relatives. CONCLUSION: Four in five Italian women would prefer to deliver vaginally if they could opt. Factors associated with a higher preference for cesarean delivery were youth, nulliparity, lower education and a previous cesarean.

Inequities in the use of cesarean section deliveries in the world.

OBJECTIVE: The purpose of this study was to describe the unequal distribution in the performance of cesarean section delivery (CS) in the world and the resource-use implications of such inequity. STUDY DESIGN: We obtained data on the number of CSs performed in 137 countries in 2008. The consensus is that countries should achieve a 10% rate of CS; therefore, for countries that are below that rate, we calculated the cost to achieve a 10% rate. For countries with a CS rate of >15%, we calculated the savings that could be made by the achievement of a 15% rate. RESULTS: Fifty-four countries had CS rates of <10%, whereas 69 countries showed rates of >15%. The cost of the global saving by a reduction of CS rates to 15% was estimated to be $2.32 billion (US dollars); the cost to attain a 10% CS rate was $432 million (US dollars). CONCLUSION: CSs that are potentially medically unjustified appear to command a disproportionate share of global economic resources.

Ethnic disparity in spontaneous preterm birth and maternal pre-pregnancy body mass index.

PURPOSE: To investigate differences in pre-pregnancy BMI status in patients with spontaneous preterm birth (PTB) compared with term birth and assess the role of ethnicity as a risk modifier in BMI-associated PTB. METHODS: A case-control study involving self-reported African American and Caucasian women delivering singletons in Nashville, TN, USA, 2003-2009. Maternal pre-pregnancy BMI was recorded in 447 PTB-cases (African American = 145, Caucasian = 302) and 1315 term-birth controls (African American = 522; Caucasian = 793). Crude and adjusted odds ratio (OR and AOR) for PTB were calculated using normal BMI (18.5-24.9 kg/m(2)) as reference. Age, education, marital status, income, smoking, parity, previous PTB and pregnancy weight gain were included as covariates in logistic regression. RESULTS: No significant differences were noted in the OR for PTB among different BMI categories when women of different ethnicity were combined. Odds of PTB were greater in obese than in normal weight Caucasian women, even after adjusting for confounders (AOR = 1.84, 95%CI [1.15, 2.95]). Obese African American women had a decreased crude OR for PTB, although this was not significant after adjusting for confounders (AOR = 0.72, 95%CI [0.38, 1.40]). The odds for early PTB (<32 weeks) were decreased in obese compared with normal weight African American women (OR = 0.23, 95%CI [0.08, 0.70]), whereas they were increased in obese compared with normal weight Caucasian women (OR = 2.30, 95%CI [1.32, 4.00]). CONCLUSION: The risk for PTB in women with different pre-pregnancy BMI categories differs according to ethnicity.

Classifications for cesarean section: a systematic review.

BACKGROUND: Rising cesarean section (CS) rates are a major public health concern and cause worldwide debates. To propose and implement effective measures to reduce or increase CS rates where necessary requires an appropriate classification. Despite several existing CS classifications, there has not yet been a systematic review of these. This study aimed to 1) identify the main CS classifications used worldwide, 2) analyze advantages and deficiencies of each system. METHODS AND FINDINGS: Three electronic databases were searched for classifications published 1968-2008. Two reviewers independently assessed classifications using a form created based on items rated as important by international experts. Seven domains (ease, clarity, mutually exclusive categories, totally inclusive classification, prospective identification of categories, reproducibility, implementability) were assessed and graded. Classifications were tested in 12 hypothetical clinical case-scenarios. From a total of 2948 citations, 60 were selected for full-text evaluation and 27 classifications identified. Indications classifications present important limitations and their overall score ranged from 2-9 (maximum grade =14). Degree of urgency classifications also had several drawbacks (overall scores 6-9). Woman-based classifications performed best (scores 5-14). Other types of classifications require data not routinely collected and may not be relevant in all settings (scores 3-8). CONCLUSIONS: This review and critical appraisal of CS classifications is a methodologically sound contribution to establish the basis for the appropriate monitoring and rational use of CS. Results suggest that women-based classifications in general, and Robson's classification, in particular, would be in the best position to fulfill current international and local needs and that efforts to develop an internationally applicable CS classification would be most appropriately placed in building upon this classification. The use of a single CS classification will facilitate auditing, analyzing and comparing CS rates across different settings and help to create and implement effective strategies specifically targeted to optimize CS rates where necessary.

Portrayal of caesarean section in Brazilian women's magazines: 20 year review.

OBJECTIVE: To assess the quality and comprehensiveness of the information on caesarean section provided in Brazilian women's magazines. DESIGN: Review of articles published during 1988-2008 in top selling women's magazines. SETTING: Brazil, one of the countries with the highest caesarean section rates in the world. DATA SOURCES: Women's magazines with the largest distribution during the study period, identified through the official national media indexing organisations. SELECTION CRITERIA: Articles with objective scientific information or advice, comments, opinions, or the experience of ordinary women or celebrities on delivery by caesarean section. MAIN OUTCOME MEASURES: Sources of information mentioned by the author of the article, the accuracy and completeness of data presented on caesarean section, and alleged reasons why women would prefer to deliver though caesarean section. RESULTS: 118 articles were included. The main cited sources of information were health professionals (78% (n=92) of the articles). 71% (n=84) of the articles reported at least one benefit of caesarean section, and 82% (n=97) reported at least one short term maternal risk of caesarean section. The benefits most often attributed to delivery by caesarean section were reduction of pain and convenience for family or health professionals. The most frequently reported short term maternal risks of caesarean section were increased time to recover and that it is a less natural way of giving birth. Only one third of the articles mentioned any long term maternal risks or perinatal complications associated with caesarean section. Fear of pain was the main reported reason why women would prefer to deliver by caesarean section. CONCLUSIONS: Most of the articles published in Brazilian women's magazines do not use optimal sources of information. The portrayal of caesarean section is mostly balanced, not explicitly in favour of one or another route of delivery, but incomplete and may be leading women to underestimate the maternal/perinatal risks associated with this route of delivery.

Recent trends in maternal, newborn, and child health in Brazil: progress toward Millennium Development Goals 4 and 5.

We analyzed Brazil's efforts in reducing child mortality, improving maternal and child health, and reducing socioeconomic and regional inequalities from 1990 through 2007. We compiled and reanalyzed data from several sources, including vital statistics and population-based surveys. We also explored the roles of broad socioeconomic and demographic changes and the introduction of health sector and other reform measures in explaining the improvements observed. Our findings provide compelling evidence that proactive measures to reduce health disparities accompanied by socioeconomic progress can result in measurable improvements in the health of children and mothers in a relatively short interval. Our analysis of Brazil's successes and remaining challenges to reach and surpass Millennium Development Goals 4 and 5 can provide important lessons for other low- and middle-income countries.

Effects of calcium supplementation on fetal growth in mothers with deficient calcium intake: a randomised controlled trial.

Calcium supplementation in mothers with low calcium intake has been of interest recently because of its association with optimal fetal growth and improved pre-eclampsia-related outcomes. While the effects of calcium supplementation have demonstrated benefits in prolonging gestation and subsequently improving birthweight, no specific studies have identified the longitudinal effects of supplementation on fetal growth in utero. Data were analysed in the context of the World Health Organization trial of calcium supplementation in calcium-deficient women. Five hundred and ten healthy, primiparous pregnant Argentinean women were randomised (at <20 weeks gestation) to either placebo (n = 230) or calcium supplements (1500 mg calcium/day in 3 divided doses; n = 231). Growth parameters in utero were assessed with serial ultrasound scans. Birthweight, length, head, abdominal and thigh circumferences were recorded at delivery. No differences were found in fetal biometric measurements recorded at 20, 24, 28, 32 and 36 weeks gestation between fetuses of women who were supplemented with calcium and those who were not. Similarly, neonatal characteristics and anthropometric measurements recorded at delivery were comparable in both groups. We conclude that calcium supplementation of 1500 mg calcium/day in pregnant women with low calcium intake does not appear to impact on fetal somatic or skeletal growth.

Effects of calcium supplementation on uteroplacental and fetoplacental blood flow in low-calcium-intake mothers: a randomized controlled trial.

OBJECTIVE: We postulated that calcium supplementation of calcium-deficient pregnant women would lower vascular resistance in uteroplacental and fetoplacental circulations. STUDY DESIGN: Pulsatility index (PI) and resistance index (RI) (uterine and umbilical arteries) and presence of bilateral uterine artery diastolic notching were assessed by Doppler ultrasound between 20-36 weeks' gestation in 510 healthy, nulliparous Argentinean women with deficient calcium intake in a randomized, placebo-controlled, double-blinded trial. RESULTS: Average umbilical and uterine artery RI and PI tended to be lower in the supplemented group at each study week. Differences became statistically significant for umbilical artery RI and PI from 32 and 36 weeks, respectively. Estimated probabilities of bilateral uterine artery diastolic notching trended toward lower values in calcium-supplemented women. CONCLUSION: Calcium supplementation of pregnant women with deficient calcium intake may affect uteroplacental and fetoplacental blood flow by preserving the vasodilation of normal gestation.

Maternal BMI and preterm birth: a systematic review of the literature with meta-analysis.

OBJECTIVES: To examine the association between high prepregnancy maternal body mass index (BMI) and the risk of preterm birth (PTB). METHODS: A systematic review of the literature. We included cohorts and case-control studies published since 1968 that examined the association between BMI and PTB of all types, spontaneous (s), elective and with ruptured membranes (PPROM) in three gestational age categories: general (<37 weeks), moderate (32-36 weeks) and very (<32 weeks) PTB. RESULTS: 20,401 citations were screened and 39 studies (1,788,633 women) were included. Preobese (BMI, 25-29.9) and obese I (BMI, 30-34.9) women have a reduced risk for sPTB: AOR = 0.85 (95% CI: 0.80-0.92) and 0.83 (95% CI: 0.75-0.92), respectively. Their risk for moderate PTB was 1.20 (95% CI: 1.04-1.38) and 1.60 (95% CI: 1.32-1.94), respectively. Obese II women (BMI, 35-40) have an increased risk for PTB in general (AOR = 1.33, 95% CI: 1.12-1.57) moderate (AOR = 2.43, 95% CI: 1.46-4.05) and very PTB (AOR = 1.96, 95% CI: 1.66-2.31). Obese III women (BMI > 40) have an even higher risk for very PTB (AOR = 2.27, 95%CI: 1.76-2.94). High BMI does not modify the risk for PPROM and increases the risk for elective PTB. CONCLUSIONS: High maternal BMI may have different effects on different types of PTB.

Tackling health inequities in Chile: maternal, newborn, infant, and child mortality between 1990 and 2004.

OBJECTIVES: We analyzed trends in maternal, newborn, and child mortality in Chile between 1990 and 2004, after the introduction of national interventions and reforms, and examined associations between trends and interventions. METHODS: Data were provided by the Chilean Ministry of Health on all pregnancies between 1990 and 2004 (approximately 4,000,000). We calculated yearly maternal mortality ratios, stillbirth rates, and mortality rates for neonates, infants (aged > 28 days and < 1 year), and children aged 1 to 4 years. We also calculated these statistics by 5-year intervals for Chile's poorest to richest district quintiles. RESULTS: During the study period, the maternal mortality ratio decreased from 42.1 to 18.5 per 100,000 live births. The mortality rate for neonates decreased from 9.0 to 5.7 per 1000 births, for infants from 7.8 to 3.1 per 1000 births, and for young children from 3.1 to 1.7 per 1000 live births. The stillbirth rate declined from 6.0 to 5.0 per 1000 births. Disparities in these mortality statistics between the poorest and richest district quintiles also decreased, with the largest mortality reductions in the poorest quintile. CONCLUSIONS: During a period of socioeconomic development and health sector reforms, Chile experienced significant mortality and inequity reductions.

Nutritional influences on maternal autonomic function during pregnancy.

The objective of this study was to identify influences on longitudinal changes in autonomic function during pregnancy. We studied 195 low-income Peruvian women who were subjects in a randomized controlled trial of zinc supplementation and fetal neurobehavioral development. Maternal cardiorespiratory status and electrodermal activity were assessed at 20, 24, 28, 32, 36, and 38 weeks' gestation over a 50-min session. At baseline (10-16 weeks), and at 28 and 36 weeks' gestation, mass and height, arm and calf circumferences, and skinfold thicknesses were assessed, and blood was taken to measure hemoglobin, hematocrit, and plasma zinc concentration. Measures of heart period (HP), respiratory period (RP), respiratory sinus arrhythmia (RSA), skin conductance level (SCL), and mean arterial pressure (MAP) were analyzed using longitudinal models. Having a hemoglobin concentration <10.5 g.dL-1 at 28 weeks was associated with shorter HP and RP and lower RSA, and change in hemoglobin from baseline to 36 weeks was associated with decreased SCL. Further, 3 measures were associated with variation in fat or fat-free mass in the calf; RSA was negatively associated with changes in calf muscle area over pregnancy, while changes in calf fat area were positively associated with MAP and SCL. Variability in autonomic function during the second half of pregnancy is associated with hematologic status and changes in lower limb body composition across pregnancy.

Accuracy of diagnostic tests to detect asymptomatic bacteriuria during pregnancy.

OBJECTIVE: A dipslide is a plastic paddle coated with agar that is attached to a plastic cap that screws onto a sterile plastic vial. Our objective was to estimate the diagnostic accuracy of the dipslide culture technique to detect asymptomatic bacteriuria during pregnancy and to evaluate the accuracy of nitrate and leucocyte esterase dipslides for screening. METHODS: This was an ancillary study within a trial comparing single-day with 7-day therapy in treating asymptomatic bacteriuria. Clean-catch midstream samples were collected from pregnant women seeking routine care. Positive and negative likelihood ratios and sensitivity and specificity for the culture-based dipslide to detect and chemical dipsticks (nitrites, leukocyte esterase, or both) to screen were estimated using traditional urine culture as the "gold standard." RESULTS: : A total of 3,048 eligible pregnant women were screened. The prevalence of asymptomatic bacteriuria was 15%, with Escherichia coli the most prevalent organism. The likelihood ratio for detecting asymptomatic bacteriuria with a positive dipslide test was 225 (95% confidence interval [CI] 113-449), increasing the probability of asymptomatic bacteriuria to 98%; the likelihood ratio for a negative dipslide test was 0.02 (95% CI 0.01-0.05), reducing the probability of bacteriuria to less than 1%. The positive likelihood ratio of leukocyte esterase and nitrite dipsticks (when both or either one was positive) was 6.95 (95% CI 5.80-8.33), increasing the probability of bacteriuria to only 54%; the negative likelihood ratio was 0.50 (95% CI 0.45-0.57), reducing the probability to 8%. CONCLUSION: A pregnant woman with a positive dipslide test is very likely to have a definitive diagnosis of asymptomatic bacteriuria, whereas a negative result effectively rules out the presence of bacteriuria. Dipsticks that measure nitrites and leukocyte esterase have low sensitivity for use in screening for asymptomatic bacteriuria during gestation. CLINICAL TRIAL REGISTRATION: ISRCTN, isrctn.org, 1196608 LEVEL OF EVIDENCE: II.

Causes of stillbirths and early neonatal deaths: data from 7993 pregnancies in six developing countries.

OBJECTIVE: To report stillbirth and early neonatal mortality and to quantify the relative importance of different primary obstetric causes of perinatal mortality in 171 perinatal deaths from 7993 pregnancies that ended after 28 weeks in nulliparous women. METHODS: A review of all stillbirths and early newborn deaths reported in the WHO calcium supplementation trial for the prevention of pre-eclampsia conducted at seven WHO collaborating centres in Argentina, Egypt, India, Peru, South Africa and Viet Nam. We used the Baird-Pattinson system to assign primary obstetric causes of death and classified causes of early neonatal death using the International classification of diseases and related health problems, Tenth revision (ICD-10). FINDINGS: Stillbirth rate was 12.5 per 1000 births and early neonatal mortality rate was 9.0 per 1000 live births. Spontaneous preterm delivery and hypertensive disorders were the most common obstetric events leading to perinatal deaths (28.7% and 23.6%, respectively). Prematurity was the main cause of early neonatal deaths (62%). CONCLUSIONS: Advancements in the care of premature infants and prevention of spontaneous preterm labour and hypertensive disorders of pregnancy could lead to a substantial decrease in perinatal mortality in hospital settings in developing countries.