Mode of birth in women with low-lying placenta: protocol for a prospective multicentre 1:3 matched case-control study in Italy (the MODEL-PLACENTA study).

INTRODUCTION: The term placenta praevia defines a placenta that lies over the internal os, whereas the term low-lying placenta identifies a placenta that is partially implanted in the lower uterine segment with the inferior placental edge located at 1-20 mm from the internal cervical os (internal-os-distance). The most appropriate mode of birth in women with low-lying placenta is still controversial, with the majority of them undergoing caesarean section. The current project aims to evaluate the rate of vaginal birth and caesarean section in labour due to bleeding by offering a trial of labour to all women with an internal-os-distance >5 mm as assessed by transvaginal sonography in the late third trimester. METHODS AND ANALYSIS: The MODEL-PLACENTA is a prospective, multicentre, 1:3 matched case-control study involving 17 Maternity Units across Lombardy and Emilia-Romagna regions, Italy. The study includes women with a placenta located in the lower uterine segment at the second trimester scan. Women with a normally located placenta will be enrolled as controls. A sample size of 30 women with an internal-os-distance >5 mm at the late third trimester scan is needed at each participating Unit. Since the incidence of low-lying placenta decreases from 2% in the second trimester to 0.4% at the end of pregnancy, 150 women should be recruited at each centre at the second trimester scan. A vaginal birth rate ≥60% in women with an internal-os-distance >5 mm will be considered appropriate to start routinely admitting to labour these women. ETHICS AND DISSEMINATION: Ethical approval for the study was given by the Brianza Ethics Committee (No 3157, 2019). Written informed consent will be obtained from study participants. Results will be disseminated by publication in peer-reviewed journals and presentation in international conferences. TRIAL REGISTRATION NUMBER: NCT04827433 (pre-results stage).

Adherence to the Mediterranean Diet and Serum Adiponectin Levels in Pregnancy: Results from a Cohort Study in Normal Weight Caucasian Women.

The Mediterranean Diet (MedDiet) is significantly associated with anti-inflammatory effects and a favorable health outcome. During pregnancy, both inflammatory changes and oxidative balance are essential for a successful outcome, while an unbalanced inflammatory response can be a key mediator of obstetrical syndromes. The aim of this study is to investigate the adherence to MedDiet during pregnancy in the 1st and in the 3rd trimester, and to test whether the adherence was associated with serum adiponectin levels. The study was carried out on 99 normal weight Caucasian women. The adherence to MedDiet was measured by a 13-point Mediterranean scale. The whole sample scored 7.2 ± 1.5, with no difference between first and third trimester (p = 0.7). Critical points were: fruit < 3 servings/day in 77% of the sample, beans < 3 times/week in 89%, fish < 2 times/week in 69%, and nut weekly intake < 30 g in 75%. The serum adiponectin levels significantly decreased from the first to the third trimester (-16% ± 4%, p = 0.008), which confirms a low-grade inflammatory condition associated with advancing gestational age. The women who were in the highest tertile of the adherence to MedDiet had a lower percentage decrease, as compared with those in the lowest tertile (10% ± 11% vs. -34% ± 3%, p = 0.01). Even if in pregnancy the adiponectin levels are strongly influenced by the low-grade inflammation, the adherence to MedDiet may modulate this state.

Neonatal respiratory distress syndrome: are risk factors the same in preterm and term infants?

OBJECTIVE: To analyze respiratory distress syndrome (RDS) incidence and risk factors at different gestational age. METHODS: We considered data from 321 327 infants born in Lombardy, a Northern Italian Region. We computed multivariate analysis to identify risk factors for RDS by dividing infants in early- and moderate-preterm, late-preterm and term infants. RESULTS: Low-birth weight is the main risk factor for RDS, with higher odds ratio in term births. The risk was higher in infants delivered by cesarean section and in male, for all gestational age. Pathological course of pregnancy resulted in increased risk only in late-preterm and term infants. Maternal age and multiple birth were not associated with increased risk in any group. Babies born at term after assisted conception were at higher risk of RDS. CONCLUSION: Our analysis suggests as some risk factors do not influence RDS incidence in the same way at different gestational age.

Longitudinal changes and correlations of bioimpedance and anthropometric measurements in pregnancy: Simple possible bed-side tools to assess pregnancy evolution.

PURPOSE: The aim of this study was to assess longitudinal changes of bioimpedance analysis compared with anthropometric measurements in low-risk pregnant woman recruited in the first trimester and to observe possible differences in these indices in women who developed high-risk pregnancies. MATERIALS AND METHODS: Bioimpedance indices for the three trimesters of pregnancies were calculated separately for uneventful pregnancies delivered of newborns > the 10th centile. These findings were compared with anthropometric measurements. Data of women who developed hypertensive disorders of pregnancy (HDP) or delivered SGA newborns were calculated and compared. RESULTS: Significantly longitudinal increases were observed in these pregnancies for total body water (TBW), free fat mass, fat mass, and extra-cellular water. These increases were paralleled body mass index (BMI), skinfolds, and waist measurements. The correlations between these two sets of findings were poor. Women who developed HDP with AGA fetuses showed significantly different bioimpedance from normal cases. TBW indices were highly significantly different since the first trimester. In pregnancies delivered of SGA newborns, these indices were opposite of the values observed in patients with HDP-AGA, TBW in these patients was significantly reduced compared with normal pregnancies. CONCLUSIONS: The bioelectrical impedance is a fast, simple, noninvasive way to assess the TBW content in pregnancy. Our findings are in agreement with the hypothesis that bioimpedance might help to identify early in gestation patients at risk of developing different clinical phenotypes of hypertensive disease of pregnancy and SGA fetuses.

Risk of Monozygotic Twins After Assisted Reproduction: A Population-Based Approach.

BACKGROUND: Recent studies have suggested that ovarian stimulation and assisted reproductive techniques (ART) may increase the frequency of monozygotic twins. In this article, we present the analysis of the estimated frequency of twin deliveries following in vitro fertilization (IVF) in Lombardy during the period 2010-2014 for a total of 450,949 pregnancies. METHOD: This is a population-based study using data from the regional data base of Lombardy, a northern Italian region with a population of about 10 million inhabitants. During the considered period, a total of 461,424 single or multiple births were registered in Lombardy. After exclusion of triplets or more pregnancies, the total number of twin deliveries, in separate strata of like and unlike sex pregnancies twin deliveries, were obtained and the rate of twin deliveries was computed according to spontaneous and non-spontaneous conception and type of ART. Further, estimates of dizygotic or monozygotic twin births were calculated using Weinberg's methods. RESULTS: The frequency of twins deliveries was 1.24/100 deliveries after natural conception and 20.05 after assisted conception. The estimated rates of monozygotic twins was 0.45 and 0.72/100 (95% CI: 0.58-0.91) deliveries after natural and assisted conception, respectively. This difference was statistically significant (p < .05). CONCLUSION: the present population based study suggests that the risk of monozygotic twin is about 60% higher among assisted than after natural conception.

Mode of delivery and level of neonatal care in Lombardy: a descriptive analysis according to volume of care.

BACKGROUND: Using data from the Hospital Discharge data-base (SDO) and from the Certificate of Delivery Assistance data-base (CedAP) we analysed mode of delivery and neonatal care in public and private hospitals in Lombardy Region during 2012. METHODS: In Lombardy a standard form is used to register all discharges from public or private hospitals (the SDO data-base which contained information on inpatient activity provided to each patient by any hospital or clinic included in the Regional Health System. Further, information on maternal characteristics and pregnancy outcome are available for all deliveries in CedAP data-base. We obtained data regarding all deliveries (mother discharge data-base M-SDO)and newborns discharge (N-SDO) and the CedAP data-base over the period January-December 2012 by the Lombardy Health Directorate. After linkage (using an anonymous key) of the three data-base using anonymized codes we obtained a data-base by the linkage of CedAP and N-SDO records, which includes, after elimination of incorrect codes, information on 90863 neonates and a data-base obtained by the linkage of CedAP and M-SDO records, which includes information on 90868 mother and deliveries. Using these data-base we have analysed mode of delivery and neonatal care in Lombardy according to the volume of care (VoC = number of delivery per year in the care unit). RESULTS: In 2012, in Lombardy, less than 3% of newborns were born in hospitals reporting less than 500 deliveries/year and less than 30% in hospitals reporting < 1000 deliveries per year. Cesarean section rate was higher in units reporting less than 1000 deliveries/year (28.7% versus 27.5% in hospitals with more than 1000 deliveries/year). In hospitals reporting 500, 500-799, 800-999 deliveries/year the percentage of preterm births with gestational age <33 weeks ranged from 0.1% to 0.2%, but was 3.4% in hospitals reporting 2500 deliveries per year or more. A total of 0.6% of newborns weighing less than 1000 grams and 3.2% of newborns with birth weight between 1000 and 1499 grams was born in hospitals which reported 1000 deliveries or more. CONCLUSIONS: This article provides an overview of delivery and neonatal care in the Lombardy Region with a focus on volume of care.

The risk of birth defects after assisted reproduction.

PURPOSE: Aim of this study was to investigate the association between congenital malformations and type of conception (spontaneous or medically assisted). METHODS: This is a population based study using data from the regional data base of Lombardy, a Northern Italian Region with a population of about 10 million inhabitants. Included in the study were 277,043 neonates born in Lombardy during the study period 2010-2012. Adjusted and unadjusted odds ratios (OR), and corresponding 95% confidence intervals (CI), of congenital abnormalities were calculated using unconditional multiple logistic regression. RESULTS: A total of 7057 births (2.5%) were reported after non spontaneous conception. Overall, the frequency of birth defects was 4.4% among births after spontaneous conception and 6.7% among births after non spontaneous ones (OR = 1.67, 95%CI = 1.5-1.9). The association disappeared after taking into account the confounding effect of maternal age and factors associated with non spontaneous conception. The crude OR of abnormalities was higher than unity for any defect (OR = 1.67, 95%CI = 1.5-1.9), multiple defects (OR = 1.76, 95%CI = 1.3-2.3), cardiovascular (OR = 2.05, 95%CI = 1.8-2.4), musculoskeletal (OR = 2.05, 95%CI = 1.7-2.5) and metabolic system abnormalities (OR = 1.97, 95%CI = 1.1-3.5). Almost all these associations, however, disappeared after taking into account potential confounding with the exception of musculoskeletal defects (adjusted OR = 1.31, 95%CI = 1.1-1.6). In this case also, if adjustment for multiple comparison is taking into account, results did not reach statistical significance. CONCLUSIONS: The results of this analysis confirm the recently emerging view that the increased frequency of birth defects observed after ART/medically induced ovulation only is largely due to confounders.

An imbalance of COX level is not related to placental abruption.

AIMS: Muscularised basal plate arteries (MA) or chorioamnionitis (CA) are often present in placental abruption. The aim of this study was to evaluate the placental expression of COX 1 and COX 2 in cases of placental abruption with MA or CA hypothesising that an imbalance in COX placental expression might be implicated in its pathogenesis. METHODS: COX 1 and COX 2 placental immunostaining was analysed in 16 placentas with abruption (nine with MA, seven with CA), in 26 normal placentas and in 10 gestational age-matched MA or CA cases without abruption. RESULTS: COX 1 and COX 2 protein expression was observed in all cases, both in placental abruption and in normal placentas. No differences in distribution of immunoreactivity were observed either between cases and controls or between MA and CA. The mean COX 1 ratio between COX-positive cells and all stromal cells was significantly lower in placental abruption with MA (0.14±0.05) when compared with cases with CA (0.35±0.06) and normal placenta (0.23±0.02; p<0.001). The mean COX 2 ratio was lower in placental abruption with MA than in normal placenta (0.09±0.06 vs 0.18±0.05: p<0.001). In contrast, no difference in COX 1 and COX 2 ratio was observed between MA cases with or without abruption and between CA cases with or without abruption. CONCLUSIONS: It is hypothesised that an imbalance of normal COX level may be present in cases with MA and CA but it is not related to placental abruption.