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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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 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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p>The study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number <a href="http://www.clinicaltrials.gov/ct2/show/NCT01058772">NCT01058772</a>.</p

Maternal outcomes and risk factors for COVID-19 severity among pregnant women.

Pregnant women may be at higher risk of severe complications associated with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which may lead to obstetrical complications. We performed a case control study comparing pregnant women with severe coronavirus disease 19 (cases) to pregnant women with a milder form (controls) enrolled in the COVI-Preg international registry cohort between March 24 and July 26, 2020. Risk factors for severity, obstetrical and immediate neonatal outcomes were assessed. A total of 926 pregnant women with a positive test for SARS-CoV-2 were included, among which 92 (9.9%) presented with severe COVID-19 disease. Risk factors for severe maternal outcomes were pulmonary comorbidities [aOR 4.3, 95% CI 1.9-9.5], hypertensive disorders [aOR 2.7, 95% CI 1.0-7.0] and diabetes [aOR2.2, 95% CI 1.1-4.5]. Pregnant women with severe maternal outcomes were at higher risk of caesarean section [70.7% (n = 53/75)], preterm delivery [62.7% (n = 32/51)] and newborns requiring admission to the neonatal intensive care unit [41.3% (n = 31/75)]. In this study, several risk factors for developing severe complications of SARS-CoV-2 infection among pregnant women were identified including pulmonary comorbidities, hypertensive disorders and diabetes. Obstetrical and neonatal outcomes appear to be influenced by the severity of maternal disease

Cervical Assessment for Predicting Preterm Birth—Cervical Length and Beyond

Preterm birth is considered one of the main etiologies of neonatal death, as well as short- and long-term disability worldwide. A number of pathophysiological processes take place in the final unifying factor of cervical modifications that leads to preterm birth. In women at high risk for preterm birth, cervical assessment is commonly used for prediction and further risk stratification. This review outlines the rationale for cervical length screening for preterm birth prediction in different clinical settings within existing and evolving new technologies to assess cervical remodeling

Cervical Assessment for Predicting Preterm Birth—Cervical Length and Beyond

Preterm birth is considered one of the main etiologies of neonatal death, as well as short- and long-term disability worldwide. A number of pathophysiological processes take place in the final unifying factor of cervical modifications that leads to preterm birth. In women at high risk for preterm birth, cervical assessment is commonly used for prediction and further risk stratification. This review outlines the rationale for cervical length screening for preterm birth prediction in different clinical settings within existing and evolving new technologies to assess cervical remodeling

Substantial Obstetric Anal Sphincter Injury during Vacuum Assisted Delivery: An Obstetrical Issue or Device Related?

Background: Obstetric anal sphincter injuries (OASIS) might be associated with long-term urinary and anorectal morbidities. The aim of the study was to investigate the risk factors and clinical implications of OASIS associated with vacuum-assisted deliveries versus normal vaginal deliveries. Methods: A series of 413 consecutive OASIS cases were retrospectively analyzed. A comparison was made between OASIS cases diagnosed following vacuum-assisted deliveries versus OASIS cases diagnosed following normal vaginal deliveries. Multivariable analysis was used to study the association between vacuum-assisted deliveries and superficial (3A and 3B) versus deep (3C and 4) perineal tears. Results: The study population comprised 88,123 singleton vaginal deliveries. Diagnosis of OASIS was made in 413 women (0.47% of the total cohort), 379 (91.8%) of whom had third-degree tears and 34 (8.2%) of whom had fourth-degree tears. Among the 7410 vacuum-assisted deliveries, 102 (1.37%) had OASIS, whereas, among the 80,713 normal vaginal deliveries, only 311 (0.39%) had OASIS. In a multivariate analysis, only vacuum-assisted delivery was found to be associated with a significant risk of deeper (3C or 4) perineal tears (OR = 1.72; 95% CI 1.02–2.91; p = 0.043). Conclusions: Vacuum-assisted instrumental intervention is a significant risk factor for OASIS and especially for deeper tears, independent of other maternal and obstetric risk factors