@article {7752, title = {Risk-adjusted operative delivery rates and maternal-neonatal outcomes as measures of quality assessment in obstetric care: a multicenter prospective study.}, journal = {BMC Pregnancy Childbirth}, volume = {15}, year = {2015}, month = {2015}, pages = {20}, abstract = {

BACKGROUND: Although the evaluation of caesarean delivery rates has been suggested as one of the most important indicators of quality in obstetrics, it has been criticized because of its controversial ability to capture maternal and neonatal outcomes. In an "ideal" process of labor and delivery auditing, both caesarean (CD) and assisted vaginal delivery (AVD) rates should be considered because both of them may be associated with an increased risk of complications. The aim of our study was to evaluate maternal and neonatal outcomes according to the outlier status for case-mix adjusted CD and AVD rates in the same obstetric population.

METHODS: Standardized data on 15,189 deliveries from 11 centers were prospectively collected. Multiple logistic regression was used to estimate the risk-adjusted probability of a woman in each center having an AVD or a CD. Centers were classified as "above", "below", or "within" the expected rates by considering the observed-to-expected rates and the 95\% confidence interval around the ratio. Adjusted maternal and neonatal outcomes were compared among the three groupings.

RESULTS: Centers classified as "above" or "below" the expected CD rates had, in both cases, higher adjusted incidence of composite maternal (2.97\%, 4.69\%, 3.90\% for "within", "above" and "below", respectively; p = 0.000) and neonatal complications (3.85\%, 9.66\%, 6.29\% for "within", "above" and "below", respectively; p = 0.000) than centers "within" CD expected rates. Centers with AVD rates above and below the expected showed poorer and better composite maternal (3.96\%, 4.61\%, 2.97\% for "within", "above" and "below", respectively; p = 0.000) and neonatal (6.52\%, 9.77\%, 3.52\% for "within", "above" and "below", respectively; p = 0.000) outcomes respectively than centers with "within" AVD rates.

CONCLUSIONS: Both risk-adjusted CD and AVD delivery rates should be considered to assess the level of obstetric care. In this context, both higher and lower-than-expected rates of CD and "above" AVD rates are significantly associated with increased risk of complications, whereas the "below" status for AVD showed a "protective" effect on maternal and neonatal outcomes.

}, issn = {1471-2393}, doi = {10.1186/s12884-015-0450-2}, author = {Maso, Gianpaolo and Monasta, Lorenzo and Piccoli, Monica and Ronfani, Luca and Montico, Marcella and De Seta, Francesco and Parolin, Sara and Businelli, Caterina and Travan, Laura and Alberico, Salvatore} } @article {3525, title = {Diabetes in pregnancy: timing and mode of delivery.}, journal = {Curr Diab Rep}, volume = {14}, year = {2014}, month = {2014 Jul}, pages = {506}, abstract = {

Diabetes in pregnancy represents a risk condition for adverse maternal and feto-neonatal outcomes and many of these complications might occur during labor and delivery. In this context, the obstetrician managing women with pre-existing and gestational diabetes should consider (1) how these conditions might affect labor and delivery outcomes; (2) what are the current recommendations on management; and (3) which other factors should be considered to decide about the timing and mode of delivery. The analysis of the studies considered in this review leads to the conclusion that the decision to deliver should be primarily intended to reduce the risk of stillbirth, macrosomia, and shoulder dystocia. In this context, this review provides useful information for managing specific subgroups of diabetic women that may present overlapping risk factors, such as women with insulin-requiring diabetes and/or obesity and/or prenatal suspicion of macrosomic fetus. To date, the lack of definitive evidences and the complexity of the problem suggest that the "appropriate" clinical management should be customized according with the clinical condition, the type and mode of intervention, its consequences on outcomes, and considering the woman{\textquoteright}s consent and informed decisions.

}, keywords = {Delivery, Obstetric, Diabetes Mellitus, Diabetes, Gestational, Female, Humans, Pregnancy, Pregnancy Complications}, issn = {1539-0829}, doi = {10.1007/s11892-014-0506-0}, author = {Maso, Gianpaolo and Piccoli, Monica and Parolin, Sara and Restaino, Stefano and Alberico, Salvatore} } @article {3566, title = {Effects of estroprogestins containing natural estrogen on vaginal flora.}, journal = {Gynecol Endocrinol}, volume = {30}, year = {2014}, month = {2014 Nov}, pages = {830-5}, abstract = {

Estroprogestins with "natural oestrogen" has represented a new option in terms of combined hormonal contraception. So, the aim of this study is to investigate how estroprogestins with natural estrogen may modify the vaginal niche. In literature, very few studies focused on the interaction between hormonal contraception and vaginal milieu. This is a prospective comparative study. We enrolled 60 women from January 2013 to September 2013, 30 of them were administered estradiol valerate dienogest (E2V+DNG - Klaira{\textregistered}) in a quadriphasic regimen, while the other 30 women were administered 17-β estradiol with nomestrol acetate (EV+NOMAC - Zoely{\textregistered}) in a monophasic regimen. After a baseline study of vaginal milieu at recruitment of patients (Gram stain with Nugent score, vaginal pH, vaginal wet mount for the quantification of leukocytes, Lactobacilli and/or presence of Candida), we performed the same follow-up after six months of estroprogestin therapy. Our results showed that the women treated with E2V+DNG had a trend of an improvement of vaginal health in terms of increase of lactobacillar flora and reduction of vaginal pH in place of women treated with EV+NOMAC that showed a reduction of cervical mucus. Finally, our data about the effects on vaginal flora exerted by two estroprogestin pills (EPs) containing a natural estrogen suggest slight, but interesting differences in terms of vaginal ecology. These differences could be related to the type of estrogen, type of progestin, regimen of administration and, after all, to the net balance between estrogenic and progestin component of the EPs.

}, keywords = {Adolescent, Adult, Drug Combinations, Estradiol, Female, Humans, Megestrol, Middle Aged, Nandrolone, Norpregnadienes, Prospective Studies, Vagina, Young Adult}, issn = {1473-0766}, doi = {10.3109/09513590.2014.936847}, author = {De Seta, Francesco and Restaino, Stefano and Banco, Rubina and Conversano, Ester and De Leo, Rossella and Tonon, Maddalena and Maso, Gianpaolo and Barbati, Giulia and Lello, Stefano} } @article {3591, title = {The implications of diagnosis of small for gestational age fetuses using European and South Asian growth charts: an outcome-based comparative study.}, journal = {ScientificWorldJournal}, volume = {2014}, year = {2014}, month = {2014}, pages = {474809}, abstract = {

The antenatal condition of small for gestational age (SGA) is significantly associated with perinatal morbidity and mortality and it is known that there are significant differences in birth weight and fetal size among different populations. The aim of our study was to assess the impact on outcomes of the diagnosis of SGA according to Bangladeshi and European antenatal growth charts in Sri Lankan population. The estimated fetal weight before delivery was retrospectively reviewed according to Bangladeshi and European growth references. Three groups were identified: Group 1-SGA according to Bangladeshi growth chart; Group 2-SGA according to European growth chart but not having SGA according to Bangladeshi growth chart; Group 3-No SGA according to both charts. There was a difference in prevalence of SGA between Bangladeshi and European growth charts: 12.7\% and 51.7\%, respectively. There were statistically significant higher rates in emergency cesarean section, fetal distress in labour, and intrauterine death (P < 0.001) in Group 1 compared with Group, 2 and 3. No differences of outcomes occurred between Groups 2 and 3. Our study demonstrated that only cases diagnosed as SGA according to population-based growth charts are at risk of adverse outcome. The use of inappropriate prenatal growth charts might lead to misdiagnosis and potential unnecessary interventions.

}, keywords = {Asian Continental Ancestry Group, Bangladesh, Birth Weight, Europe, European Continental Ancestry Group, Female, Fetal Growth Retardation, Growth Charts, Humans, Infant, Newborn, Infant, Small for Gestational Age, Pregnancy, Prognosis, Sri Lanka}, issn = {1537-744X}, doi = {10.1155/2014/474809}, author = {Maso, Gianpaolo and Jayawardane, Mathota A M M and Alberico, Salvatore and Piccoli, Monica and Senanayake, Hemantha M} } @article {3488, title = {The role of gestational diabetes, pre-pregnancy body mass index and gestational weight gain on the risk of newborn macrosomia: results from a prospective multicentre study.}, journal = {BMC Pregnancy Childbirth}, volume = {14}, year = {2014}, month = {2014}, pages = {23}, abstract = {

BACKGROUND: It is crucial to identify in large population samples the most important determinants of excessive fetal growth. The aim of the study was to evaluate the independent role of pre-pregnancy body mass index (BMI), gestational weight gain and gestational diabetes on the risk of macrosomia.

METHODS: A prospective study collected data on mode of delivery and maternal/neonatal outcomes in eleven Hospitals in Italy. Multiple pregnancies and preterm deliveries were excluded. The sample included 14109 women with complete records. Associations between exposure variables and newborn macrosomia were analyzed using Pearson{\textquoteright}s chi squared test. Multiple logistic regression models were built to assess the independent association between potential predictors and macrosomia.

RESULTS: Maternal obesity (adjusted OR 1.7, 95\% CI 1.4-2.2), excessive gestational weight gain (adjusted OR 1.9, 95\% CI 1.6-2.2) and diabetes (adjusted OR 2.1, 95\% CI 1.5-3.0 for gestational; adjusted OR 3.0, 95\% CI 1.2-7.6 for pre-gestational) resulted to be independent predictors of macrosomia, when adjusted for other recognized risk factors. Since no significant interaction was found between pre-gestational BMI and gestational weight gain, excessive weight gain should be considered an independent risk factor for macrosomia. In the sub-group of women affected by gestational or pre-gestational diabetes, pre-gestational BMI was not significantly associated to macrosomia, while excessive pregnancy weight gain, maternal height and gestational age at delivery were significantly associated. In this sub-population, pregnancy weight gain less than recommended was not significantly associated to a reduction in macrosomia.

CONCLUSIONS: Our findings indicate that maternal obesity, gestational weight gain excess and diabetes should be considered as independent risk factors for newborn macrosomia. To adequately evaluate the clinical evolution of pregnancy all three variables need to be carefully assessed and monitored.

}, keywords = {Adolescent, Adult, Birth Weight, Body Height, Body Mass Index, Diabetes, Gestational, Female, Fetal Macrosomia, Gestational Age, Humans, Infant, Newborn, Italy, Middle Aged, Obesity, Pregnancy, Pregnancy in Diabetics, Prospective Studies, Risk Factors, Weight Gain, Young Adult}, issn = {1471-2393}, doi = {10.1186/1471-2393-14-23}, author = {Alberico, Salvatore and Montico, Marcella and Barresi, Valentina and Monasta, Lorenzo and Businelli, Caterina and Soini, Valentina and Erenbourg, Anna and Ronfani, Luca and Maso, Gianpaolo} } @article {1946, title = {The clinical interpretation and significance of electronic fetal heart rate patterns 2 h before delivery: an institutional observational study.}, journal = {Arch Gynecol Obstet}, volume = {286}, year = {2012}, month = {2012 Nov}, pages = {1153-9}, abstract = {

PURPOSE: To evaluate the clinical significance of intrapartum fetal heart rate (FHR) monitoring in low-risk pregnancies according to guidelines and specific patterns.

METHODS: An obstetrician, blinded to neonatal outcome, retrospectively reviewed 198 low-risk cases that underwent continuous electronic fetal monitoring (EFM) during the last 2 h before delivery. The tracings were interpreted as normal, suspicious or pathological, according to specific guidelines of EFM and by grouping the different FHR patterns considering baseline, variability, presence of decelerations and bradycardia. The EFM groups and the different FHR-subgroups were associated with neonatal acid base status at birth, as well as the short-term neonatal composite outcome. Comparisons between groups were performed with Kruskal-Wallis test. Differences among categorical variables were evaluated using Fisher{\textquoteright}s exact test. Significance was set at p < 0.05 level.

RESULTS: Significant differences were found for mean pH values in the three EFM groups, with a significant trend from "normal" [pH 7.25, 95 \% confidence interval (CI) 7.28-7.32] to "pathological" tracings (pH 7.20, 95 \% CI 7.17-7.13). Also the rates of adverse composite neonatal outcome were statistically different between the two groups (p < 0.005). Among the different FHR patterns, tracings with atypical variable decelerations and severe bradycardia were more frequently associated with adverse neonatal composite outcome (11.1 and 26.7 \%, respectively). However, statistically significant differences were only observed between the subgroups with normal tracings and bradycardia.

CONCLUSIONS: In low-risk pregnancies, there is a significant association between neonatal outcome and EFM classification. However, within abnormal tracings, neonatal outcome might differ according to specific FHR pattern.

}, keywords = {Acidosis, Bradycardia, Female, Fetal Blood, Fetal Monitoring, Heart Rate, Fetal, Humans, Hydrogen-Ion Concentration, Infant, Newborn, Labor, Obstetric, Predictive Value of Tests, Pregnancy, Pregnancy Outcome, Retrospective Studies, Single-Blind Method, Statistics, Nonparametric, Time Factors}, issn = {1432-0711}, doi = {10.1007/s00404-012-2446-8}, author = {Maso, Gianpaolo and Businelli, Caterina and Piccoli, Monica and Montico, Marcella and De Seta, Francesco and Sartore, Andrea and Alberico, Salvatore} } @article {1945, title = {The effects of uterine fundal pressure (Kristeller maneuver) on pelvic floor function after vaginal delivery.}, journal = {Arch Gynecol Obstet}, volume = {286}, year = {2012}, month = {2012 Nov}, pages = {1135-9}, abstract = {

PURPOSE: To evaluate the role of uterine fundal pressure during the second stage of labor (Kristeller maneuver) on pelvic floor dysfunction (urinary and anal incontinence, genital prolapse, pelvic floor strength).

METHODS: 522 primiparous women, enrolled 3 months after vaginal delivery, were divided in two groups: group A (297 women) identifies the women who received Kristeller maneuvers with different indications (e.g. fetal distress, failure to progress, mother exhaustion), group B (225 women) the women without maneuver. Participants were questioned about urogynecological symptoms and examined by Q-tip test, digital test, vaginal perineometry and uroflowmetric stop test score.

RESULTS: Mediolateral episiotomies, dyspareunia and perineal pain were significantly higher in Kristeller group, whereas urinary and anal incontinence, genital prolapse and pelvic floor strength were not significantly different between the groups.

CONCLUSIONS: Kristeller maneuver does not modify puerperal pelvic floor function but increases the rate of episiotomies.

}, keywords = {Delivery, Obstetric, Dyspareunia, Dystocia, Episiotomy, Fatigue, Fecal Incontinence, Female, Fetal Distress, Humans, Labor Stage, Second, Pain, Postoperative, Pelvic Floor, Pelvic Organ Prolapse, Perineum, Pregnancy, Pressure, Puerperal Disorders, Urinary Incontinence, Uterus}, issn = {1432-0711}, doi = {10.1007/s00404-012-2444-x}, author = {Sartore, Andrea and De Seta, Francesco and Maso, Gianpaolo and Ricci, Giuseppe and Alberico, Salvatore and Borelli, Massimo and Guaschino, Secondo} } @article {1765, title = {"GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies".}, journal = {BMC Pregnancy Childbirth}, volume = {11}, year = {2011}, month = {2011}, pages = {31}, abstract = {

BACKGROUND: Gestational diabetes (GDM) is one of the most common complications of pregnancies affecting around 7\% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.

METHODS/DESIGN: Pregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurements are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20\% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.

DISCUSSION: The present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms. .

}, keywords = {Adolescent, Adult, Cesarean Section, Diabetes, Gestational, Female, Gestational Age, Humans, Intention to Treat Analysis, Labor, Induced, Patient Selection, Pregnancy, Pregnancy Outcome, Research Design, Watchful Waiting, Young Adult}, issn = {1471-2393}, doi = {10.1186/1471-2393-11-31}, author = {Maso, Gianpaolo and Alberico, Salvatore and Wiesenfeld, Uri and Ronfani, Luca and Erenbourg, Anna and Hadar, Eran and Yogev, Yariv and Hod, Moshe} }