Gianpaolo Maso

The effects of mediolateral episiotomy on pelvic floor function after vaginal delivery.

OBJECTIVE: To evaluate the effect of mediolateral episiotomy on puerperal pelvic floor strength and dysfunction (urinary and anal incontinence, genital prolapse). METHODS: Five hundred nineteen primiparous women were enrolled 3 months after vaginal delivery. Puerperae were divided in 2 groups: group A (254 women) comprised the women who received mediolateral episiotomy and group B (265 women) the women with intact perineum and first- and second-degree spontaneous perineal lacerations. Each woman was questioned about urogynecological symptoms and examined by digital test, vaginal perineometry, and uroflowmetric stop test score. Data were subjected to Student t test and Fisher exact test to assess, respectively, the difference between the mean values and the proportions within the subpopulations. Using a simple logistic regression model to test an estimate of relative risk, we expressed the odds ratios of the variables considered with respect to the control population (group B). RESULTS: No significant difference was found with regard to the incidence of urinary and anal incontinence and genital prolapse, whereas dyspareunia and perineal pain were significantly higher in the episiotomy group (7.9% versus 3.4%, P = .026; 6.7% versus 2.3%, P = .014, respectively). Episiotomy was associated with significantly lower values, both in digital test (2.2 versus 2.6; P < .001) and in vaginal manometry (12.2 versus 13.8 cm water; P < .001), but not in uroflowmetric stop test. CONCLUSION: Mediolateral episiotomy does not protect against urinary and anal incontinence and genital prolapse and is associated with a lower pelvic floor muscle strength compared with spontaneous perineal lacerations and with more dyspareunia and perineal pain. LEVEL OF EVIDENCE: II-2

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

BackgroundIt 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.MethodsA 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’s chi squared test. Multiple logistic regression models were built to assess the independent association between potential predictors and macrosomia.ResultsMaternal 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.ConclusionsOur 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.

Aetiology of preterm labour: bacterial vaginosis

Bacterial vaginosis (BV) is a common condition characterised by a polymicrobial disorder, with an overgrowth of several anaerobic or facultative bacteria and with a reduction or absence of lactobacillus colonisation. The prevalence of BV ranges from 4 to 64%, depending on the racial, geographic and clinical characteristics of the study population. In asymptomatic women, the prevalence varies from 12 to 25%, and similar percentages are observed in pregnant women. Although BV is associated with several adverse outcomes, such as upper genital tract infections, pelvic inflammatory disease, endometritis, preterm birth and low birthweight, many basic questions regarding the pathogenesis of BV remain unanswered. Mucosal immune system activation may represent a critical determinant of adverse consequences associated with BV. An unequal risk for BV acquisition and\or recurrence could derive from different mucosal immune host abilities and\or capability of invading microbes to produce factors that inactivate the local immune response. BV is associated with a two‐fold increased risk of preterm birth, with the greatest risk when BV is present before 16 weeks of gestation (odds ratio = 7.55). This may indicate a critical period during early gestation when BV‐related organisms can gain access to the upper genital tract and set the stage for spontaneous preterm labour later in gestation. The results of treatment trials for pregnant women with BV have been heterogeneous, with anywhere from an 80% reduction to a two‐fold increase in preterm birth among women who received treatment. For this reason, in current clinical practice significant controversy surrounds determining not only who and when to screen but also who and how to treat. Recent evidence shows that individual genetic backgrounds can affect chemokine production. This is an interesting area for future research and could lead to trials of treatment only for women genetically predisposed to preterm birth.

Does cervical length at 13-15 weeks' gestation predict preterm delivery in an unselected population?

To assess the role of early mid‐trimester cervical length measurement as a predictor of spontaneous preterm birth in an unselected population.

First-trimester intrauterine hematoma and outcome of pregnancy.

OBJECTIVE: To evaluate the outcome of pregnancies complicated by first-trimester intrauterine hematoma. METHODS: An analysis was performed on 248 cases. The pregnancy outcome was correlated with hematoma volume, gestational age (weeks), and maternal age (years). RESULTS: One hundred eighty-two cases were eligible for the study. Clinical complications occurred in 38.5% of the cases (adverse outcome group). Spontaneous abortion (14.3%), fetal growth restriction (7.7%), and preterm delivery (6.6%) were the most frequent clinical conditions observed. Considering the hematoma variables in adverse and favorable outcome groups, we found a significant difference only for gestational age at diagnosis. The median gestational age was significantly lower (P < .02) in the adverse outcome group (7.27, I and III quartiles 6.22–8.78) than in the favorable outcome cases (8.62, I and III quartiles 6.70–9.98). Among clinical conditions, the median gestational age was significantly lower (P = .02) in pregnancies complicated by spontaneous abortion (6.60, I and III quartiles 5.95–8.36) than in cases not ending in a miscarriage (8.50, I and III quartiles 6.70–9.91). The overall risk of adverse outcome was 2.4 times higher when the hematoma was diagnosed before 9 weeks (odds ratio 2.37, 95% confidence interval 1.20–4.70). In particular, intrauterine hematoma observed before 9 weeks significantly increases the risk of spontaneous abortion (odds ratio 14.79, 95% confidence interval 1.95–112.09) CONCLUSION: Intrauterine hematoma can affect the outcome of pregnancy. The risk of spontaneous abortion is related to gestational age and is significantly increased if diagnosed before 9 weeks. LEVEL OF EVIDENCE: III

The Application of the Ten Group Classification System (TGCS) in Caesarean Delivery Case Mix Adjustment. A Multicenter Prospective Study

Background Caesarean delivery (CD) rates are commonly used as an indicator of quality in obstetric care and risk adjustment evaluation is recommended to assess inter-institutional variations. The aim of this study was to evaluate whether the Ten Group classification system (TGCS) can be used in case-mix adjustment. Methods Standardized data on 15,255 deliveries from 11 different regional centers were prospectively collected. Crude Risk Ratios of CDs were calculated for each center. Two multiple logistic regression models were herein considered by using: Model 1- maternal (age, Body Mass Index), obstetric variables (gestational age, fetal presentation, single or multiple, previous scar, parity, neonatal birth weight) and presence of risk factors; Model 2- TGCS either with or without maternal characteristics and presence of risk factors. Receiver Operating Characteristic (ROC) curves of the multivariate logistic regression analyses were used to assess the diagnostic accuracy of each model. The null hypothesis that Areas under ROC Curve (AUC) were not different from each other was verified with a Chi Square test and post hoc pairwise comparisons by using a Bonferroni correction. Results Crude evaluation of CD rates showed all centers had significantly higher Risk Ratios than the referent. Both multiple logistic regression models reduced these variations. However the two methods ranked institutions differently: model 1 and model 2 (adjusted for TGCS) identified respectively nine and eight centers with significantly higher CD rates than the referent with slightly different AUCs (0.8758 and 0.8929 respectively). In the adjusted model for TGCS and maternal characteristics/presence of risk factors, three centers had CD rates similar to the referent with the best AUC (0.9024). Conclusions The TGCS might be considered as a reliable variable to adjust CD rates. The addition of maternal characteristics and risk factors to TGCS substantially increase the predictive discrimination of the risk adjusted model.

GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies.

BackgroundGestational 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/DesignPregnant 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 measurement4s 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.DiscussionThe 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.Trial RegistrationThe study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number NCT01058772.

Diabetes in Pregnancy: Timing and Mode of Delivery

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’s consent and informed decisions.

Interinstitutional variation of caesarean delivery rates according to indications in selected obstetric populations: a prospective multicenter study.

The aim of the study was to identify which groups of women contribute to interinstitutional variation of caesarean delivery (CD) rates and which are the reasons for this variation. In this regard, 15,726 deliveries from 11 regional centers were evaluated using the 10-group classification system. Standardized indications for CD in each group were used. Spearmans correlation coefficient was used to calculate (1) relationship between institutional CD rates and relative sizes/CD rates in each of the ten groups/centers; (2) correlation between institutional CD rates and indications for CD in each of the ten groups/centers. Overall CD rates correlated with both CD rates in spontaneous and induced labouring nulliparous women with a single cephalic pregnancy at term (P = 0.005). Variation of CD rates was also dependent on relative size and CD rates in multiparous women with previous CD, single cephalic pregnancy at term (P < 0.001). As for the indications, “cardiotocographic anomalies” and “failure to progress” in the group of nulliparous women in spontaneous labour and “one previous CD” in multiparous women previous CD correlated significantly with institutional CD rates (P = 0.021, P = 0.005, and P < 0.001, resp.). These results supported the conclusion that only selected indications in specific obstetric groups accounted for interinstitutional variation of CD rates.

Does Amniotic Fluid Alpha-Fetoprotein Have Diagnostic or Prognostic Value at the Time of Second Midtrimester Genetic Amniocentesis?

In order to assess the usefulness of amniotic fluid α-fetoprotein (AFP) levels at the time of midtrimester genetic amniocentesis, 4,430 cases were retrospectively studied to compare the high, normal or low AFP values with the karyotype characteristics and fetal anatomy using ultrasound (US) scanning and confirmed by postnatal evaluation or necroscopy in the case of termination of pregnancy. All the cases presenting malformations were correctly diagnosed by US examinations. AFP levels over the 2nd standard deviation (SD) were found in 112 cases (2.52%) and below the 2nd SD in 11 cases (0.24%). The characteristics of these cases are presented and discussed. According to our results, it is concluded that routine assessment of AFP at the time of midtrimester genetic amniocentesis, if coupled with optimal US scanning, is no longer justified.