Effect of listening music on nulliparous singleton pregnancies who underwent induction of labor: a randomized clinical trial.

BACKGROUND: A recent randomized clinical trial showed that listening music reduces the pain level, and the anxiety level in women with spontaneous labor at term. Effect on pregnant women undergoing induction of labor is still unclear. OBJECTIVE: To test the hypothesis that in nulliparous women with singleton pregnancies, undergoing induction of labor at term, listening music would reduce the pain level during labor. STUDY DESIGN: Parallel group non-blinded randomized clinical trial conducted at a single center in Italy. Nulliparous women with singleton pregnancies and vertex presentation, admitted for induction of labor with either oral or vaginal prostaglandins, between 37 0/7 - 42 0/7 weeks, were randomized in a 1:1 ratio to receive music during induction of labor or no music during induction. The endpoints of the trials were the pain level during induction, and in the active phase of labor, recorded using the visual analogue scale (VAS) for pain, ranging from 0 (no pain) to 10 (unbearable pain). The effect of music use on each outcome was quantified as the mean difference (MD) with 95% confidence interval (CI). RESULTS: During the study period, 30 women agree to take part in the study, underwent randomization, and were enrolled and followed up. 15 women were randomized in the music group, and 15 in the control group. No patients were lost to follow up for the primary outcome. Pain level during the induction procedure was scored 8.8±0.9 in the music group, and 9.8±0.3 in the control group (MD -2.60 points, 95% CI -3.94 to -1.26; p<0.01). Music during labor and delivery was also associated with a decreased anxiety during the induction procedure (MD -3.80 points, 95% CI -5.53 to -2.07; p<0.01) Conclusions: In nulliparous women, listening music during induction of labor, reduces the pain and anxiety level. TRIAL REGISTRATION: Clinicaltrials.gov NCT04662424.

Obstetric violence in a group of Italian women: socio-demographic predictors and effects on mental health.

This study had two aims: (1) to explore the types and incidence of obstetric violence (OV) in a group of Italian women, as well as associated socio-demographic factors; and (2) to assess whether OV affects women's mental health (e.g. psychological distress and post-traumatic stress). A web-based cross-sectional study was conducted with 282 Italian women. Women answered questions on socio-demographic factors, childbirth characteristics, OV and mental health. Multiple linear regression analyses assessing the predictive role of socio-demographic and childbirth characteristics on OV were conducted. Additionally, hierarchical multiple linear regression analyses assessing whether OV affected women's mental health were also carried out. More than three quarters of the sample (78.4%) had experienced at least one type of OV (55.5% of non-consented care and 66.4% of abuse and violence). The factors most associated with OV were younger age, low educational level, not having attended a prenatal childbirth preparedness course, and having given birth naturally. The form of OV that most affected women's mental health was that linked to abuse and violence rather than non-consented care. Study findings shed light into addressing OV from a multidimensional perspective.

Obstetric A&E unit admission and hospitalization for obstetrical management during COVID-19 pandemic in a third-level hospital of southern Italy.

BACKGROUND: The COronaVIrus Disease 2019 (COVID-19) has spread in Italy since February 2020, inducing the government to call for lockdown of any activity, apart primary needs, during the months March-May 2020. During the lockdown, a reduction of admissions and hospitalizations for ischemic diseases was noticed. Purpose of this study was to observe if there has been the same reduction trend in Accident & Emergency (A&E) unit admissions also for obstetric-gynecological conditions. METHODS: Medical records and electronic clinical databases were searched for all patients who were admitted to the obstetric A&E department or hospitalized at the Gynecology and Obstetrics Unit of University hospital of Naples Federico II, during the quarter March-May in the years 2019 and 2020. The mean ± standard deviation (SD) of monthly admission to the obstetric A&E department and hospitalization of the year 2020 was compared with that of the year 2019, using the unpaired T test with α error set to 0.05 and 95% confidence intervals (95% CI). RESULTS: Admissions were 1483 in the year 2020 and 1786 in 2019. Of total, 1225 (37.5%) women were hospitalized: 583 in the year 2020, 642 in 2019. Mean ± SD of patients monthly admitted to our obstetric A&E department was 494 ± 33.7 in the year 2020, and 595.3 ± 30.9 in 2019, with a mean difference of - 101.3 (95% CI - 103.5 to - 99.1; p < 0.0001). Mean ± SD of patients monthly hospitalized to our department was 194 ± 19.1 in the year 2020, 213.7 ± 4.7 in 2019, with a mean difference of - 19.7 (95% CI - 23.8 to - 15.6; p < 0.0001). CONCLUSION: A significant decrease in the mean of monthly admissions and hospitalizations during the COVID-19 pandemic when compared to the previous year was found also for obstetric-gynecological conditions. Further studies are necessary to assess COVID-19 impact and to take the most appropriate countermeasures.

Fractional Microablative CO2 Laser-Related Histological Changes on Vulvar Tissue in Patients With Genitourinary Syndrome of Menopause.

BACKGROUND AND OBJECTIVES: Fractional CO2 laser has been proposed as an effective treatment for the genitourinary syndrome of menopause (GSM). However, the effects of laser treatment on vulvar tissue have never been assessed. We aimed to assess histological changes related to fractional CO2 laser in vulvar tissue from GSM patients. STUDY DESIGN/MATERIALS AND METHODS: A single-center observational prospective cohort study was performed enrolling all GSM patients from July 2017 to October 2018. Patients underwent three outpatient vulvovaginal applications of fractional CO2 laser and vulvar biopsy before and after treatment. Rates of histological changes in vulvar tissue, the difference in means of Vulva Health Index (VuHI), Vaginal Health Index (VHI), Visual Analogue Scale scores for GSM symptoms, and procedure-related pain, and rate of patient's overall satisfaction with treatment were assessed. Univariate comparisons between continuous variables were performed by using the paired t-test (α error = 0.05). RESULTS: Of 20 enrolled patients, 18 underwent all laser applications, and 15 underwent both vulvar biopsies. 93.3% of patients showed remodeling of vulvar connective tissue; 80% showed improvement in vulvar epithelium trophism and 86.7% showed neovascularization. Differences in means between before and after treatment were significant for VuHI, VHI, and all GSM symptoms. Means ± standard deviation of the degree of pain at each laser application were 4.4 ± 0.9, 3.7 ± 1.6, and 2.9 ± 1.9. The rate of overall satisfaction with the treatment was 72.2%. CONCLUSIONS: Fractional CO2 laser leads to a restoration of the normal architecture of vulvar tissue, with significant improvement in GSM-related signs and symptoms, and overall satisfaction with the treatment in most GSM patients. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Early amniotomy after cervical ripening for induction of labor: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE DATA: Timing of artificial rupture of membranes (ie, amniotomy) in induction of labor is controversial, because it has been associated not only with shorter labors, but also with fetal nonreassuring testing, at times necessitating cesarean delivery. The aim of this systematic review and metaanalysis of randomized trials was to evaluate the effectiveness of early amniotomy vs late amniotomy or spontaneous rupture of membranes after cervical ripening. STUDY: The search was conducted with the use of electronic databases from inception of each database through February 2019. Review of articles included the abstracts of all references that were retrieved from the search. STUDY APPRAISAL AND SYNTHESIS METHODS: Selection criteria included randomized clinical trials that compared early amniotomy vs control (ie, late amniotomy or spontaneous rupture of membranes) after cervical ripening with either Foley catheter or prostaglandins at any dose. The primary outcome was the incidence of cesarean delivery. The summary measures were reported as summary relative risk with 95% of confidence interval with the use of the random effects model of DerSimonian and Laird. RESULTS: Four trials that included 1273 women who underwent cervical ripening with either Foley catheter or prostaglandins and then were assigned randomly to either early amniotomy, late amniotomy, or spontaneous rupture of membranes (control subjects) were included in the review. Women who were assigned randomly to early amniotomy had a similar risk of cesarean delivery (31.1% vs 30.9%; relative risk, 1.05; 95% confidence interval, 0.71-1.56) compared with control subjects and had a shorter interval from induction to delivery of approximately 5 hours (mean difference, -4.95 hours; 95% confidence interval, -8.12 to -1.78). Spontaneous vaginal delivery was also reduced in the early amniotomy group, but only 1 of the included trials reported this outcome (67.5% vs 69.1%; relative risk, 0.78; 95% confidence interval, 0.66-0.93). No between-group differences were reported in the other obstetrics or perinatal outcomes. CONCLUSION: After cervical ripening, routine early amniotomy does not increase the risk of cesarean delivery and reduces the interval from induction to delivery.

First-trimester screening based on cell-free DNA vs combined screening: A randomized clinical trial on women's experience.

OBJECTIVE: To compare women's experience of first-trimester combined screening (FTCS), with women's experience of an approach that uses the combination of a detailed early anatomy scan and cell-free DNA (cfDNA) analysis. METHODS: This was single-center, open label, parallel group, randomized clinical trial. Pregnant women were randomized at the time of their first prenatal visit to either a policy of first-trimester risk assessment based on FTCS, or to a policy of first-trimester risk assessment based on ultrasound findings and cfDNA. FTCS included ultrasound evaluation with crown-rump length, nuchal translucency (NT) measurement, and a detailed ultrasound scan, along with biochemistry (PAPP-A and free beta hCG). In this group, invasive diagnostic testing was offered to patients with risk >1 in 100, or NT >3.5 mm, or any fetal abnormalities on ultrasound. Women randomized in the intervention group received an approach of first-trimester risk assessment based on ultrasound findings and cfDNA. cfDNA analysis included a simultaneous microarray-based assay of non-polymorphic (chromosomes 13, 18, 21, X and Y) and polymorphic loci to estimate chromosome proportion and fetal fraction. In the intervention group, invasive diagnostic testing was offered to patients with abnormal cfDNA screening results, or NT >3.5 mm, or any fetal abnormalities on ultrasound. Participants received pre-test and post-test questionnaires regarding to measure reassurance, satisfaction, and anxiety. The primary outcome was the post-test reassurance, defined as mean score of reassurance post-test questionnaire. The effect of the assigned screening test on the mean of each outcome was quantified as mean difference (MD) with 95% confidence interval (CI). RESULTS: Forty women with singleton gestations were enrolled in the trial. Mean score for reassurance was significantly higher in the cfDNA group compared to the FTCS group in the pre-test questionnaire (MD 0.80 points, 95% CI 0.27 to 1.33) and in the post-test questionnaire (MD 16.50 points, 95% CI 2.18 to 30.82). Women randomized to the cfDNA group had higher satisfaction and lower mean anxiety score as assessed in the STAI pre-test questionnaire. CONCLUSIONS: First-trimester risk assessment for fetal aneuploidy with a combination of a detailed ultrasound examination and cfDNA is associated with better maternal reassurance and better maternal satisfaction compared to the standard first-trimester combined screening with nuchal translucency, and biochemistry. TRIAL REGISTRATION: Clinicaltrials.gov NCT04077060.

Effect of music on labor and delivery in nulliparous singleton pregnancies: a randomized clinical trial.

BACKGROUND: Women's experience of pain during labor varies greatly, and pain control is a major concern for obstetricians. Several methods have been studied for pain management for women in labor, including drug and non-drug interventions. OBJECTIVE: To test the hypothesis that in nulliparous women with singleton pregnancies at term, listening to music would reduce the pain level during labor. METHODS: Parallel group non-blinded randomized clinical trial conducted at a single center in Italy. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted in labor and delivery room between 37 0/7 and 42 0/7 weeks of gestation for active phase of labor were eligible, and were randomized in a 1:1 ratio to receive music during labor or no music during labor. Music in labor was defined listening to music from the randomization until the delivery of the baby. The primary endpoint was the pain level during the active phase of labor, recorded using the visual analogue scale (VAS) for pain, ranging from 0 (no pain) to 10 (unbearable pain). The effect of music use during labor on each outcome was quantified as the mean difference (MD) with 95% confidence interval (CI). RESULTS: During the study period, 30 women agree to take part in the study, underwent randomization, and were enrolled and followed up. 15 women were randomized in the music group, and 15 in the control group. No patients were lost to follow up for the primary outcome. Pain level during the active phase of labor was scored 8.8 ± 0.9 in the music group, and 9.8 ± 0.3 in the control group (MD - 1.00 point, 95% CI - 1.48 to - 0.52; P < 0.01). Music during labor and delivery was also associated with a decreased pain at 1 h postpartum (MD - 2.40 points, 95% CI - 4.30 to - 0.50), and decreased anxiety level during active phase of labor (MD - 19.90 points, 95% CI - 38.72 to - 1.08), second stage of labor (MD - 49.40 points, 95% CI - 69.44 to - 29.36), and at 1 h postpartum (MD - 27.00 points, 95% CI - 47.37 to - 6.63). CONCLUSION: In nulliparous women with singleton pregnancies at term, listening to music reduces the pain level, and the anxiety level during labor. TRIAL REGISTRATION: Clinicaltrials.gov NCT03779386.

Prenatal ultrasound diagnosis of duplication gallbladder: a multicenter study.

BACKGROUND: Gallbladder duplication is a rare anatomic anomaly characterized by the presence of an accessory gallbladder. OBJECTIVE: To appraise the prevalence and significance of prenatal diagnosis of duplication of gallbladder in a multicenter study. METHODS: This was a multicenter case series with literature review. Clinical records of all consecutive pregnant women with a prenatal diagnosis of duplication of gallbladder, who were referred to our Centers were included in this study. The diagnosis of duplication of gallbladder was based on the evidence of double gallbladder in the standard abdominal circumference plane using grey scale. Postnatal magnetic resonance cholangiopancreatography (MRCP) 3D and postnatal neonatal abdominal ultrasound scan were offered soon after birth to confirm the diagnosis of double gallbladder. The systematic review was conducted using electronic databases from inception of each database through December 2019. RESULTS: Five studies, including a total of seven cases, were identified as relevant and included in the systematic review. Gestational age at diagnosis ranged from 20 to 32 weeks of gestation. Associated findings were reported in only one case, where the fetus presented with a left-sided gallbladder, and bilateral renal agenesis with Potter sequence. None of the included cases reported abnormal karyotype. Our cases series included nine cases (0.03%) of double gallbladder with postnatal confirmation, with an overall incidence of this anomaly of 0.03%.Associated findings were reported in only two cases, one with IUGR and omphalocele, that opted for I-TOP, and one with single umbilical artery. Except for the I-TOP, neonatal outcome was favorable in all cases. CONCLUSIONS: Duplication of the gallbladder is a very rare malformation with only seven cases reported in the literature diagnosed prenatally. This anomaly is not associated with abnormal karyotype, and the neonatal outcome is favorable if there are no other associated abnormalities.

Differentiating between septate and bicornuate uterus: bi-dimensional and 3-dimensional power Doppler findings.

STUDY OBJECTIVE: To assess if any difference could be found in uterine vascularization between septate and bicornuate uterus. DESIGN: Pilot study (Canadian Task Force classification II-2). SETTING: University hospital infertility clinic. PATIENTS: One hundred nine women with complete duplication of the uterine cavity. All had already received the final diagnosis of the type of uterine malformation, either septate uterus or bicornuate uterus, via diagnostic hysteroscopy and laparoscopy. Another group of 10 patients with uterine anomalies and affected by ovarian mass were also evaluated via intravenous contrast medium-enhanced ultrasound examination. INTERVENTIONS: Patients were evaluated using 2-dimensional and 3-dimensional power Doppler imaging of the uterus. MEASUREMENTS AND MAIN RESULTS: Seventy-three patients with septate uterus, with or without cervical and vaginal duplication, and 36 patients with bicornuate uterus were selected for inclusion in the study. Irregular vascular networks were detected between the 2 hemicavities in the patients with septate uterus. All bicornuate uteri showed a peculiar vascular network between the 2 hemicavities: the main recognizable vessels formed a network depicting the Greek letter γ at the level of the uterine midline. Detection of the γ sign can be used to differentiate septate from bicornuate uterus. This finding was also confirmed in patients who underwent intravenous contrast medium-enhanced ultrasound examination. CONCLUSIONS: power Doppler provides a new and uninvasive tool for differentiation of septate from bicornuate uterus.

Cervical elastography using E-Cervix™ for prediction of preterm birth in twin pregnancies with threatened preterm labor.

OBJECTIVE: To evaluate the prediction performance of E-Cervix™ for preterm birth in twin pregnancies with threatened preterm labor. METHODS: This was a single-center retrospective cohort study of twin pregnancies presenting to obstetrics triage for threatened preterm labor (PTL) between 23 0/7 - 33 6/7 weeks who received screening for PTL with transvaginal ultrasound cervical length (TVU CL) and cervical elastography with E-Cervix™ at the time of triage. Cervical elastography parameters were examined and compared between women who delivered preterm and those who did not. The quantification of cervical strain was calculated by a data analysis system that directly analyzes raw data from the region of interest (ROI) and described as hardness ratio (HR), mean strain level within 1 cm from internal (IOS) and external (EOS) os. RESULTS: 63 twin gestations without prior preterm birth and with threatened PTL between 23 0/7 - 33 6/7 weeks of gestation were included in the study. 27 (42.9 %) had cervical length < 25 mm, and were admitted for true PLT. Out of the 36 women with cervical length ≥ 25 mm, 6 (16.7 %) were admitted. Women with threatened PTL had significantly higher HR compared to those with true PTL (p < 0.01), and significantly lower IOS and EOS. Women who delivered preterm had significantly higher HR compared to those who did not delivery preterm and significantly lower IOS and EOS, in overall cohort, and in the subset of women with true PTL. Incidences of HR < 50 % and < 35 % were statistically significantly higher in women who delivered preterm compared to those who did not (p < 0.01). CONCLUSION: Cervical elastography with E-Cervix™ may be useful for assessment of twin gestations presenting to obstetrics triage for threatened PTL.

Progression of adenomyosis: Rate and associated factors.

OBJECTIVE: To evaluate the rate of disease progression and the factors associated with such progression in patients with an ultrasound diagnosis of adenomyosis. METHODS: This was a single center, prospective, observational, cohort study performed at a tertiary referral center. Patients who obtained an ultrasound diagnosis of adenomyosis from May 2022 to August 2022 were recruited. Demographic, clinical and ultrasound data were recorded at the first visit (T0) and after 12 months (T1) for enrolled patients and compared between T0 and T1. The study population was divided in two groups according to progression (increase in uterine volume >20%) or stability/regression (decrease or increase in uterine volume ≤20%) of adenomyosis at T1. Primary study outcome was the rate of adenomyosis progression, while secondary study outcome was the association of adenomyosis progression with demographic and clinical factors. Post hoc subgroups analyses for primary and secondary study outcomes were performed based on hormonal therapy (untreated and treated). RESULTS: A total of 221 patients were enrolled in the study, with no significant difference in terms of baseline data among the two study groups and no patients were lost to follow-up. The overall rate of adenomyosis progression was 21.3% (47/221 patients). The rate was 30.77% in hormonally untreated women, and 18.34% in hormonally treated women. Progression was associated with the presence of focal adenomyosis of the outer myometrium (P = 0.037), moderate to severe dysmenorrhea (P = 0.001), chronic pelvic pain (P = 0.05), dyschezia (P = 0.05), and worsening of chronic pelvic pain (P = 0.04) at T1. CONCLUSION: Adenomyosis showed a rate of disease progression of 21.3% at the 12-month follow-up (30.77% in hormonally untreated women, and 18.34% in hormonally treated women). The presence and/or worsening of painful symptoms, such as severe dysmenorrhea, dyschezia and chronic pelvic pain, as well as the presence focal adenomyosis of the outer myometrium, might help identify patients at higher risk of disease progression and tailor their follow-up.

Prenatal identification of invasive placentation using ultrasound in women with placenta previa and prior cesarean delivery.

OBJECTIVE: To evaluate the performance of ultrasound for antenatal identification of invasive placentation in women with placenta previa in the setting of prior cesarean delivery. STUDY DESIGN: This was a multicenter, retrospective, cohort study. Singleton pregnancies at risk of placenta accreta because of persistent placenta previa in the setting of prior cesarean delivery who delivered at four centers, from January 2010 to May 2020, were included in the study. For this study, pregnancies with diagnosis of accreta, increta, or percreta were considered under the umbrella term of placenta accreta. All women with placenta previa identified in the second trimester had a follow-up ultrasound at 32-34 weeks. Only those with prior cesarean delivery were considered at risk of placenta accreta. Women were considered with suspected accreta in case of suspected prenatal ultrasound. Women with suspected placenta accreta had delivery planned via cesarean hysterectomy at 34+0 - 35+6 weeks, without any attempt to remove the placenta. The primary endpoint of the study was the performance of ultrasound for antenatal identification of invasive placentation. The following ultrasound signs were evaluated: placenta lacunae; loss of clear space; increased vascularity between myometrium and placenta; intracervical lake; rail sign; uterovesical hypervascularity; increased vascularity in the inferior part of the lower uterine segment potentially extending into the parametrial region; and disruption of bladder-myometrial interface. RESULTS: 180 singleton pregnancies with placenta previa in the setting of prior cesarean delivery were identified. Of them, 155 (86.1%) had antenatal suspected placenta accreta based on ultrasound, having at least one sign of invasive placentation. Of the 155 suspected cases, 99 had confirmed placenta accreta at the time of delivery. Among the 99 cases of confirmed placenta accreta, all of them had at least one sign of invasive placentation at ultrasound. Among the 81 cases with placenta previa, prior cesarean delivery, without placenta accreta, 25/81 (30.9%) had ultrasound scan negative for sign of invasive placentation, and 56/81 (69.1%) had at least one sign of invasive placentation). In particular, 12/81 (14.8%) had placenta lacunae, 16/81 (19.8%) had loss of clear space, 20/81 (24.7%) had increased vascularity between myometrium and placenta, 9/81 (11.1%) had intracervical lake, 14/81 (17.3%) had rail sign, 14 (17.3%) had uterovesical hypervascularity, 5/81 (6.2%) had increased vascularity in the inferior part of the lower uterine segment potentially extending into the parametrial region, 8/81 (9.9%) had disruption of bladder-myometrial interface. In the group of women with confirmed placenta accreta, the most common sign recorded was the disruption of bladder-myometrial interface, being recorded in 88/99 women. Disruption of bladder-myometrial interface had the highest sensitivity in detection placenta accreta. Women with disruption of bladder-myometrial interface at ultrasound had 73-fold increase in the risk of placenta accreta compared to those who did not. CONCLUSION: Prenatal ultrasound has an excellent diagnostic accuracy in identifying invasive placentation in women with placenta previa and prior cesarean delivery.

Randomized trial of screening for preterm birth in low-risk women - the preterm birth screening study.

BACKGROUND: Preterm birth is a major cause of perinatal morbidity and mortality. It is unclear whether the introduction of a universal transvaginal ultrasound cervical length screening program in women at low risk for preterm delivery is associated with a reduction in the frequency of preterm birth. OBJECTIVE: To test the hypothesis that the introduction of a midtrimester universal transvaginal ultrasound cervical length screening program in asymptomatic singleton pregnancies without prior preterm delivery would reduce the rate of preterm birth at <37 weeks of gestation. STUDY DESIGN: This study was a multicenter nonblinded randomized trial of screening of asymptomatic singleton pregnancies without prior spontaneous preterm birth, who were randomized to either cervical length screening program (ie, intervention group) or no screening (ie, control group). Participants were randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks of gestation. Women randomized in the screening group received cervical length measurement. Those who were found to have cervical length ≤25 mm were offered 200 mg vaginal progesterone daily along with cervical pessary. The primary outcome was preterm birth at <37 weeks. The risk of primary outcome was quantified by the relative risk with 95% confidence interval, and was based on the intention-to-screen principle. RESULTS: A total of 1334 asymptomatic women with singleton pregnancies and without prior preterm birth, were included in the trial. Out of the 675 women randomized in the transvaginal ultrasound cervical length screening group, 13 (1.9%) were found to have transvaginal ultrasound cervical length ≤25 mm during the screening. Preterm birth at <37 weeks of gestation occurred in 48 women in the transvaginal ultrasound cervical length screening group (7.5%), and 54 women in the control group (8.7%) (relative risk, 0.86; 95% confidence interval, 0.59-1.25). Women randomized in the transvaginal ultrasound cervical length screening group had no significant differences in the incidence of preterm birth at less than 34, 32, 30, 28, and 24 weeks of gestation. CONCLUSION: The introduction of a universal transvaginal ultrasound cervical length screening program at 18 0/6 to 23 6/7 weeks of gestation in singleton pregnancies without prior spontaneous preterm birth, with treatment for those with cervical length ≤25 mm, did not result in significant lower incidence of preterm delivery than the incidence without the screening program.

Activity restriction for women with arrested preterm labor: a randomized controlled trial.

BACKGROUND: In the past, some pregnant women have been recommended to be in activity restriction because of the presumed increased risk of preterm birth due to the increased release of catecholamines, which might stimulate myometrial activity, during exercise and aerobic activity. OBJECTIVE: This study aimed to test the hypothesis that in women with singleton pregnancy and arrested preterm labor, activity restriction would reduce the rate of preterm birth at <37 weeks of gestation. STUDY DESIGN: This was a parallel-group nonblinded randomized trial conducted at a single center in Italy. Eligible patients were those with a diagnosis of arrested preterm labor, defined as not delivering after 48 hours of hospitalization for threatened preterm labor, with transvaginal ultrasound cervical length ≤25 mm, no other symptoms of possible uterine contractions, and cervical dilatation <3 cm at pelvic examination. Inclusion criteria were singleton pregnancies between 24 0/7 and 33 6/7 weeks of gestation. Participants were randomized in a 1:1 ratio to either activity restriction at the time of discharge or no activity restriction. Women in the intervention group were recommended activity restriction, defined as the following: pelvic rest, prohibition of sexual activity, and reduction of work and/or nonwork activity. The primary endpoint was preterm birth at <37 weeks of gestation. RESULTS: A total of 120 participants were included in the trial; 60 patients were enrolled in the activity restriction group and 60 in the control group. Preterm birth at <37 weeks of gestation occurred in 15 of 60 women (25.0%) in the activity restriction group and 23 of 60 women (38.3%) in the control group (relative risk, 0.65; 95% confidence interval, 0.38-1.12). There was no significant between-group difference in the incidence of preterm birth at <32 weeks and in neonatal outcomes, but the trial was not powered for these outcomes. CONCLUSION: In singleton gestations with arrested preterm labor, activity restriction, including pelvic rest, prohibition of sexual activity, and reduction of work and/or nonwork activity, does not result in a lower rate of preterm birth at <37 weeks. Given the evidence on the lack of benefits, use of activity restriction in this population should be discouraged.

Prevalence and burden of nausea and vomiting in pregnant women: Interim analysis of the PURITY survey.

OBJECTIVES: Nausea and vomiting in pregnancy is a common and invalidating condition in early pregnancy. However, no data are available on its prevalence in Italy. This survey aims to evaluate the prevalence and impact of nausea and vomiting during pregnancy on the quality of life of Italian women. STUDY DESIGN: The survey was performed in three Italian public University Hospitals in two distinct periods: a first interview took place between the 18th and 22nd week of pregnancy, using the Questionnaire for Pregnancy Period (14 questions regarding demographic data and 30 questions about nausea and vomiting in pregnancy, including Pregnancy-Unique Quantification of Emesis questionnaire), and a follow-up interview, by telephone call, took place immediately after giving birth and in any case within 14 days of delivery, using the Questionnaire for Post-Pregnancy (9 questions). Included women were Caucasian, in physiological pregnancy and between the 18th and 22nd week (time of morphological ultrasound), able to communicate adequately with the interviewer, understand the questionnaires and able to provide valid informed consent. Twin pregnancies and women who recurred to medically assisted procreation were excluded. This is an interim report on data collected from 232 of the planned 600 women. RESULTS: Mean age of the recruited subjects was 32.6 ± 4.6 years, with approximately 60% primiparous. The prevalence of nausea and vomiting in pregnancy in the sample examined was 65.5% overall (152 out of 232 subjects). Of these 152 women, 63 (41.4%) experienced only nausea, 6 (3.9%) only vomiting, and 83 (54.6%) reported both. Symptoms were reported to begin at 7.2 ± 2.7 weeks, lasted 10.2 ± 5.6 weeks, and persisted at the time of the interview in 32.2% of cases. Overall, over 50% of the women interviewed experienced a negative impact of nausea and vomiting in pregnancy on social relationships and work activity. CONCLUSIONS: A high prevalence of nausea and vomiting in pregnancy, 65.5% overall, was found in this interim analysis. These symptoms appeared capable of negatively influencing women quality of life. Screening procedures should be offered during pregnancy and measures that address nausea and vomiting in pregnancy impact warranted.

Perinatal depression during the fourth wave of the COVID-19 outbreak in a single prenatal clinic in Southern Italy: The role of loneliness, anxiety, and maternal support.

Background: The current study aimed at assessing the levels of perinatal depression (i.e., both antenatal and postnatal) during the fourth wave of the COVID-19 outbreak in a group of Italian women, as well as to evaluate the role of loneliness, anxiety, and lack of maternal support in cumulatively predicting perinatal depression. Methods: A cross-sectional study was conducted with 200 Italian women recruited during a peak of the COVID-19 pandemic in Italy (i.e., from September to December 2021) from a single prenatal clinic in Southern Italy. A non-parametric binomial test was conducted to assess whether the perinatal depression frequencies of the current sample differed from those found in a pre-Covid reference group. Additionally, hierarchical multiple linear regression analyses assessing whether loneliness, anxiety, and maternal support affected women's perinatal depression were also conducted. Results: The general prevalence of perinatal depression was significantly higher in participants recruited during the fourth wave of the COVID-19 pandemic compared to the pre-Covid reference group (29% vs. 9.2%). However, results showed that, contrary to postnatal depression (18.2% vs. 19.9%), only the prevalence of antenatal depression was significantly higher compared to the pre-Covid reference group (39.6% vs. 6.4%). Furthermore, loneliness and anxiety, but not maternal support, were associated with higher levels of PD. Limitations: Limitations concerned the cross-sectional nature of the study and the relatively small sample size. Conclusions: This study sheds light on the need to address perinatal mental health of women during major stressful events, such as the COVID-19 pandemic.

Computational reactive-diffusive modeling for stratification and prognosis determination of patients with breast cancer receiving Olaparib.

Mathematical models based on partial differential equations (PDEs) can be exploited to handle clinical data with space/time dimensions, e.g. tumor growth challenged by neoadjuvant therapy. A model based on simplified assessment of tumor malignancy and pharmacodynamics efficiency was exercised to discover new metrics of patient prognosis in the OLTRE trial. We tested in a 17-patients cohort affected by early-stage triple negative breast cancer (TNBC) treated with 3 weeks of olaparib, the capability of a PDEs-based reactive-diffusive model of tumor growth to efficiently predict the response to olaparib in terms of SUVmax detected at 18FDG-PET/CT scan, by using specific terms to characterize tumor diffusion and proliferation. Computations were performed with COMSOL Multiphysics. Driving parameters governing the mathematical model were selected with Pearson's correlations. Discrepancies between actual and computed SUVmax values were assessed with Student's t test and Wilcoxon rank sum test. The correlation between post-olaparib true and computed SUVmax was assessed with Pearson's r and Spearman's rho. After defining the proper mathematical assumptions, the nominal drug efficiency (εPD) and tumor malignancy (rc) were computationally evaluated. The former parameter reflected the activity of olaparib on the tumor, while the latter represented the growth rate of metabolic activity as detected by SUVmax. εPD was found to be directly dependent on basal tumor-infiltrating lymphocytes (TILs) and Ki67% and was detectable through proper linear regression functions according to TILs values, while rc was represented by the baseline Ki67-to-TILs ratio. Predicted post-olaparib SUV*max did not significantly differ from original post-olaparib SUVmax in the overall, gBRCA-mutant and gBRCA-wild-type subpopulations (p > 0.05 in all cases), showing strong positive correlation (r = 0.9 and rho = 0.9, p < 0.0001 both). A model of simplified tumor dynamics was exercised to effectively produce an upfront prediction of efficacy of 3-week neoadjuvant olaparib in terms of SUVmax. Prospective evaluation in independent cohorts and correlation of these outcomes with more recognized efficacy endpoints is now warranted for model confirmation and tailoring of escalated/de-escalated therapeutic strategies for early-TNBC patients.

Vaginal progesterone compared with intramuscular 17-alpha-hydroxyprogesterone caproate for prevention of recurrent preterm birth in singleton gestations: a systematic review and meta-analysis.

OBJECTIVE: Randomized trials have found benefits of both vaginal progesterone and 17-alpha-hydroxyprogesterone caproate in the prevention of recurrent preterm birth. A previous meta-analysis directly comparing the two was limited by low-quality evidence, and national and international society guidelines remain conflicting regarding progestin formulation recommended for prevention of recurrent preterm birth. The aim of this updated systematic review with meta-analysis was to evaluate the efficacy of vaginal progesterone compared with 17-alpha-hydroxyprogesterone caproate in the prevention of spontaneous preterm birth in patients with singleton gestations and previous spontaneous preterm birth. DATA SOURCES: Searches were performed in MEDLINE, Ovid, Scopus, ClinicalTrials.gov, the International Prospective Register of Systematic Reviews (PROSPERO), SciELO, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) with the use of a combination of keywords and text words related to "preterm birth," "preterm delivery," "singleton," "cervical length," "progesterone," "progestogens," "vaginal," "17-alpha-hydroxy-progesterone caproate," and "intramuscular" from inception of each database to September 2021. No restrictions for language or geographic location were applied. STUDY ELIGIBILITY CRITERIA: We included all randomized controlled trials of asymptomatic singleton gestations with previous spontaneous preterm birth that were randomized to prophylactic treatment with either vaginal progesterone (ie, intervention group) or intramuscular 17-alpha-hydroxyprogesterone caproate (ie, comparison group). Post hoc sensitivity analysis was performed for studies with low risk of bias and studies with protocol registration. METHODS: The primary outcome was preterm birth <34 weeks' gestation. The summary measures were reported as relative risks with 95% confidence intervals. RESULTS: Seven randomized controlled trials including 1910 patients were included in the meta-analysis. Patients who received vaginal progesterone had a significantly lower rate of preterm birth at <34 weeks (14.7% vs 19.9%; relative risk, 0.74; 95% confidence interval, 0.57-0.96), preterm birth at <37 weeks (36.0% vs 46.6%; relative risk, 0.76; 95% confidence interval, 0.69-0.85), and preterm birth at <32 weeks of gestation (7.9% vs 13.6%; relative risk, 0.58; 95% confidence interval, 0.39-0.86), compared with women who received intramuscular 17-alpha-hydroxyprogesterone caproate. There were no significant differences in the rate of preterm birth at <28 weeks' gestation. Adverse drug reactions were significantly lower in the vaginal progesterone group than in the 17-alpha-hydroxyprogesterone caproate group (15.6% vs 22.2%; relative risk, 0.71; 95% confidence interval, 0.54-0.92). Perinatal mortality was lower in the vaginal progesterone group than in the 17-alpha-hydroxyprogesterone caproate group (2.2% vs 4.4%; relative risk, 0.51; 95% confidence interval, 0.25-1.01). In sensitivity analysis including trials rated with at least 4 Cochrane tools as of "low risk of bias," 4 trials were included (N=575), and there was no longer a significant difference in preterm birth at <34 weeks' gestation between vaginal progesterone and 17-alpha-hydroxyprogesterone caproate (12.2% vs 13.9%; relative risk, 0.87; 95% confidence interval, 0.57-1.32). CONCLUSION: Overall, vaginal progesterone was superior to 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth at <34 weeks' gestation in singleton pregnancies with previous spontaneous preterm birth. Although sensitivity analysis of high-fidelity studies showed the same trend, findings were no longer statistically significant.