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.

Role of Ovarian Suspension in Preventing Postsurgical Ovarian Adhesions in Patients with Stage III-IV Pelvic Endometriosis: A Systematic Review.

Endometriosis is a benign complex gynecologic condition with high morbidity that affects women of reproductive age. Pelvic adhesion formation represents a serious clinical challenge in the management of patients with endometriosis. Several interventions aimed at reducing postoperative ovarian adhesion formation have been proposed in recent years. Here we summarize the published evidence on the efficacy of ovarian suspension in preventing postoperative ovarian adhesion formation in women undergoing laparoscopic surgery for stage III-IV endometriosis. The research was conducted using electronic databases. A review of the abstracts of all references retrieved from the search was conducted. Selection criteria for the systematic review included all randomized controlled trials (RCTs) and nonrandomized studies (NRSs) of premenopausal women diagnosed with stage III-IV pelvic endometriosis who underwent ovarian suspension or no ovarian suspension (control group). The RCTs were eligible for meta-analysis. Eight studies, 2 RCTs and 6 NRSs, were included in the systematic review. In all 8 studies, ovarian suspension was performed during surgery for stage III-IV endometriosis. The site of the suspension was the anterior abdominal wall in 76.8% of the cases. Five studies reported the use of polypropylene as suture for the suspension. Removal of the suspension suture in the postoperative period was reported in 6 studies. Pooled data from a meta-analysis of the RCTs show that women who underwent ovarian suspension had a significantly lower incidence of postoperative adhesion formation, particularly of moderate to severe adhesions. Ovarian suspension may reduce the rate and severity of postoperative adhesions formation in women undergoing laparoscopy for the treatment of stage III-IV endometriosis; however, RCTs with larger sample sizes are needed.

Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta-analysis.

OBJECTIVES: To evaluate the effectiveness of cervical pessary for preventing spontaneous preterm birth (SPTB) in singleton gestations with a second trimester short cervix. METHODS: Electronic databases were searched from their inception until February 2016. We included randomized clinical trials (RCTs) comparing the use of the cervical pessary with expectant management in singletons pregnancies with transvaginal ultrasound cervical length (TVU CL) ≤25 mm. The primary outcome was incidence of SPTB <34 weeks. The summary measures were reported as relative risk (RR) with 95% confidence interval (CI). RESULTS: Three RCTs (n = 1,420) were included. The mean gestational age (GA) at randomization was approximately 22 weeks. The Arabin pessary was used as intervention in all three trials, and was removed by vaginal examination at approximately 37 weeks. Cervical pessary was not associated with prevention of SPTB <37 (20.2% vs 50.2%; RR 0.50, 95% CI 0.23 to 1.09), <34, <32, and <28 weeks, compared to no pessary. No differences were found in the mean of GA at, interval from randomization to delivery, incidence of preterm premature rupture of membranes and of cesarean delivery, and in neonatal outcomes. The Arabin pessary was associated with a significantly higher risk of vaginal discharge. CONCLUSIONS: In singleton pregnancies with a TVU CL ≤25mm at 200 -246 weeks, the Arabin pessary does not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. Individual patient data meta-analysis may clarify whether cervical pessary may be beneficial in subgroups, such as only singleton gestations without prior SPTB or by different CL cutoffs.

COVID-19 vaccine and pregnancy outcomes: A systematic review and meta-analysis.

OBJECTIVES: To explore perinatal outcomes in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-vaccinated pregnant women compared with unvaccinated counterparts. METHODS: Search was conducted using Web of Science, Scopus, ClinicalTrial.gov, MEDLINE, Embase, OVID, and Cochrane Library as electronic databases. We included observational studies evaluating pregnant women undergoing SARS-CoV-2 vaccination and compared pregnancy and perinatal outcomes with those in unvaccinated women. Categorical variables were assessed using odds ratio (OR) with 95% confidence interval (CI), whereas for continuous variables, the results were expressed as mean difference with their 95% CI. All analyses were performed by adopting the random effect model of DerSimonian and Laird. RESULTS: There was no difference in the probability of having a small-for-gestational-age fetus (OR 0.97, 95% CI 0.85-1.09; P = 0.570), but we observed a reduced probability of a non-reassuring fetal monitoring, a reduced gestational age at delivery, and a reduced probability of premature delivery in vaccinated pregnant women versus unvaccinated ones. CONCLUSION: The probability of small for gestational age is similar between vaccinated and unvaccinated pregnant women, and the former also had a slightly reduced rate of premature delivery.

Monofilament vs multifilament suture for uterine closure at the time of cesarean delivery: a randomized clinical trial.

BACKGROUND: Different factors may influence the closure of the uterine wall, including suture material. Suture materials may indeed influence tissue healing and therefore the development of scar defects. OBJECTIVE: To test whether uterine closure using synthetic absorbable monofilament sutures at the time of cesarean delivery would reduce the rate of cesarean scar defects compared with uterine closure using synthetic absorbable multifilament sutures. STUDY DESIGN: Parallel-group, nonblinded, randomized clinical trial of women with singleton pregnancies undergoing cesarean delivery at term in a single center in Italy. The inclusion criteria were singleton pregnancy, first or second cesarean delivery, scheduled and emergent or urgent cesarean deliveries, and gestational age between 37 0/7 and 42 0/7 weeks. Eligible participants were randomly allocated in a 1:1 ratio to either the monofilament group (polyglytone 6211 [Caprosyn]; Covidien, Dublin, Ireland) or the multifilament suture group (coated polyglactin 910 suture with Triclosan [Vicryl Plus]; Ethicon, Inc, Raritan, NJ). The primary outcome was the incidence of cesarean scar defect at ultrasound at the 6-month follow-up visit. The secondary outcomes were residual myometrial thickness and symptoms. RESULTS: Overall, 300 women were included in the trial. Of the randomized women, 151 were randomized to the monofilament group and 149 to the multifilament group. However, 27 women were lost to follow-up: 15 in the monofilament group and 12 in the multifilament group. Of note, 6 months after delivery, the incidence rates of cesarean scar defect were 18.4% (25 of 136 patients) in the monofilament group and 23.4% (32 of 137 patients) in the multifilament group (relative risk, 0.79; 95% confidence interval, 0.41-1.25; P=.31). The mean residual myometrial thicknesses were 7.6 mm in the monofilament group and 7.2 mm in the multifilament group (mean difference, +0.40 mm; 95% confidence interval, -0.23 to 1.03). There was no between-group substantial difference found in the incidence of symptoms, including pelvic pain, painful periods, and dyspareunia. CONCLUSION: In singleton pregnancies undergoing primary or second cesarean delivery, the use of synthetic absorbable monofilament sutures at the time of uterine wall closure was not associated with a reduction in the rate of cesarean scar defect 6 months after delivery compared with the use of synthetic absorbable multifilament sutures.

Worldwide beliefs among pregnant women on SARS-CoV-2 vaccine: a systematic review.

BACKGROUND: SARS-CoV-2 vaccine has been recommended to pregnant women, but survey studies showed contrasting findings worldwide in relation to the willingness to accept vaccination during pregnancy. OBJECTIVE: To evaluate the evidence from the literature regarding the acceptance rate of the SARS-CoV-2 vaccine in pregnant and breastfeeding women. STUDY DESIGN: We performed a systematic review on the main databases (MEDLINE (PubMed), Scopus, ISI Web of Science) searching for all the peer-reviewed survey studies analyzing the eventual acceptance rate of the SARS-CoV-2 vaccine among pregnant and breastfeeding women. To combine data meta-analyses of proportions and pooled proportions with their 95% confidence intervals (CI) were calculated. RESULTS: 15 studies including 25,839 women were included in the analysis. The proportion of women actually willing to be vaccinated during pregnancy is 49.1% (95% CI, 42.3-56.0), and the proportion of breastfeeding women is 61.6% (95% CI, 50.0-75.0). CONCLUSION: The cumulative SARS-CoV-2 vaccine acceptance rate among pregnant women appears still low. Vaccinal campaign are urgently needed to drive more confidence into the vaccine to help reducing the spread of the infection and the possible consequences during pregnancy.

Being an obstetrics and gynaecology resident during the COVID-19: Impact of the pandemic on the residency training program.

OBJECTIVE: to evaluate the impact of the COVID-19 pandemic on the obstetrics and gynecology residency training program in Italy. STUDY DESIGN: This was a cross-sectional survey study aimed to assess the impact of the COVID-19 pandemic on the obstetrics and gynecology residency training program in Italy. An online survey with 45 questions was sent and completed anonymously by residents after accepting an informed consent. The invitation to the online survey was sent to all the Italian residents in obstetrics and gynecology. Those on maternity leave at the time of the study were excluded. Residents were asked about their routinely activity before the COVID-19 pandemic, and to report the reduction in their clinical practice. They were also asked about psychological impact of COVID-19 on their clinical practice. RESULTS: 933 Italian residents in obstetrics and gynecology, were invited for this survey study. Four-hundred and seventy-six (51 %) completed the survey and were included in the study. Three-hundred and eighty-seven (81.3 %) were female, and 89 (18.7 %) were male. Residents age ranged from 25 to 42. In 71,8 % (342/476) of the cases residents work in a COVID-19 reference Hospitals. One-hundred and eighty-four out of 76 residents (38.6 %) were tested on RT-PCR assay of nasal and pharyngeal swab specimens, and of them 12/184 (6.5 %) were positive to SARS-COV-2. Regarding the use of personal protective equipment (PPE), 267 (56.1 %) reported to receive adequate device, and 379 (79.6 %) felt to be well informed about prevention and management protocols. Three-hundred and thirty-one residents (69.5 %) reported to have managed COVID-19 positive patients. For 54,7 % of respondent residents, training activity in general decreased significantly during the COVID-19 epidemic. A one-third reduction was reported in 31,4 % of the cases, whereas a total suspension of the training in 9,9 % of the cases. In 89,3 % of cases the reduction was caused by the reorganization of work. Anxiety about the professional future was reported in 84 % of the residents, and 59 % of them had the perception that their training was irreversibly compromised. CONCLUSIONS: Among Italian residents in obstetrics and gynecology, COVID-19 pandemic was associated with a significant training impairment.

Warm perineal compresses during the second stage of labor for reducing perineal trauma: A meta-analysis.

OBJECTIVE: Perineal trauma may have a negative impact on women's lives as it has been associated with perineal pain, urinary incontinence and sexual dysfunction. The aim of this systematic review and meta-analysis of randomized controlled trials was to evaluate the effectiveness of warm compresses during the second stage of labor in reducing perineal trauma. METHODS: Electronic databases were searched from inception of each database to May 2019. Inclusion criteria were randomized trials comparing warm compresses (i.e. intervention group) with no warm compresses (i.e. control group) during the second stage of labor. Types of participants included pregnant women planning to have a spontaneous vaginal birth at term with a singleton in a cephalic presentation. The primary outcome was the incidence of intact perineum. Meta-analysis was performed using the Cochrane Collaboration methodology with results being reported as relative risk (RR) with 95% confidence interval (CI). RESULTS: Seven trials, including 2103 participants, were included in this meta-analysis. Women assigned to the intervention group received warm compresses made from clean washcloths or perineal pads immersed in warm tap water. These were held against the woman's perineum during and in between pushes in second stage. Warm compresses usually started when the baby's head began to distend the perineum or when there was active fetal descent in the second stage of labor. We found a higher rate of intact perineum in the intervention group compared to the control group (22.4% vs 15.4%; RR 1.46, 95% CI 1.22 to 1.74); a lower rate of third degree tears (1.9% vs 5.0%; RR 0.38, 95% CI 0.22 to 0.64), fourth degree tears (0.0% vs 0.9%; RR 0.11, 95% CI 0.01 to 0.86) third and fourth degree tears combined (1.9% vs 5.8%; RR 0.34, 95% CI 0.20 to 0.56) and episiotomy (10.4% vs 17.1%; RR 0.61, 95% CI 0.51 to 0.74). CONCLUSION: Warm compresses applied during the second stage of labor increase the incidence of intact perineum and lower the risk of episiotomy and severe perineal trauma.

Effects of exercise during pregnancy in women with short cervix: Secondary analysis from the Italian Pessary Trial in singletons.

OBJECTIVE: To evaluate effects of exercise during pregnancy in asymptomatic singleton pregnancies without prior spontaneous preterm birth (SPTB) but with short transvaginal ultrasound cervical length (TVU CL). STUDY DESIGN: This is a secondary analysis of the Italian Pessary Trial for the Italian Preterm Birth Prevention (IPP) Working Group. In the original prospective randomized controlled trial asymptomatic singleton pregnancies without prior SPTB but with TVU CL ≤ 25 mm at 18 0/6-23 6/7 weeks were randomized into 1:1 ratio to either cervical pessary or no pessary. During their follow-up visits, women were asked about their activity. For the purpose of this secondary analysis, women were classified in the following groups, using the information obtained in the follow-up visit one month after randomization: 1) Exercise group, defined as women performing exercise ≥2 days a week for ≥20 min each day. 2) No exercise group, defined as women performing exercise <2 days a week for ≥20 min each day. The primary outcome of this secondary analysis was PTB < 37 weeks. RESULTS: 300 women were included in this analysis. 99 (33.0%) were included in the exercise group. 201 (67.0%) were included in the no exercise group. Of the 201 women in the no exercise group, 90 (44.8%) affirmed that they had reduced their activity after the diagnosis of short cervix despite the research staff recommendations, while the other 111 (55.2%) women performed a sedentary life style even before the diagnosis of short cervix. PTB < 37 weeks occurred in 22 women (22.2%) in the exercise group, and 66 women (32.8%) in the no exercise group (aOR 0.65, 95% CI 0.33-1.03). CONCLUSION: In asymptomatic singleton pregnancies with short cervix, performing exercise ≥2 days a week for ≥20 min each day does not increase the risk of PTB but is indeed associated with a non-significant reduction in PTB < 37 weeks by 32%.

Antenatal corticosteroids for maturity of term or near term fetuses: systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE:  To evaluate the effectiveness of antenatal corticosteroids given at ≥34 weeks' gestation. DESIGN:  Systematic review with meta-analysis. DATA SOURCES:  Electronic databases were searched from their inception to February 2016. ELIGIBILITY CRITERIA FOR STUDY SELECTION:  Randomized clinical trials comparing antenatal corticosteroids with placebo or no treatment in women with a singleton pregnancy at ≥34 weeks' gestation. Trials on antenatal steroids in women expected to deliver late preterm (340-366 weeks) and trials given before planned cesarean delivery at term (≥37 weeks) were included. DATA SYNTHESIS:  The primary outcome was the incidence of severe respiratory distress syndrome (RDS). The summary measures were reported as relative risks or mean differences with 95% confidence intervals. RESULTS:  Six trials, including 5698 singleton pregnancies, were analyzed. Three included 3200 women at 340-366 weeks' gestation and at risk of imminent premature delivery at the time of hospital admission. The three other trials included 2498 women undergoing planned cesarean delivery at ≥37 weeks. Overall, infants of mothers who received antenatal corticosteroids at ≥34 weeks had a significantly lower risk of RDS (relative risk 0.74, 95% confidence interval 0.61 to 0.91), mild RDS (0.67, 0.46 to 0.96), moderate RDS (0.39, 0.18 to 0.89), transient tachypnea of the newborn (0.56, 0.37 to 0.86), severe RDS (0.55, 0.33 to 0.91), use of surfactant, and mechanical ventilation, and a significantly lower time receiving oxygen (mean difference -2.06 hours, 95% confidence interval -2.17 to -1.95), lower maximum inspired oxygen concentration (-0.66%, -0.69% to -0.63%), shorter stay on a neonatal intensive care unit (-7.64 days, -7.65 to -7.64), and higher APGAR scores compared with controls. Infants of mothers who received antenatal betamethasone at 340-366 weeks' gestation had a significantly lower incidence of transient tachypnea of the newborn (relative risk 0.72, 95% confidence interval 0.56 to 0.92), severe RDS (0.60, 0.33 to 0.94), and use of surfactant (0.61, 0.38 to 0.99). Infants of mothers undergoing planned cesarean delivery at ≥37 weeks' gestation who received prophylactic antenatal corticosteroids 48 hours before delivery had a significantly lower risk of RDS (0.40, 0.27 to 0.59), mild RDS (0.43, 0.26 to 0.72), moderate RDS (0.40, 0.18 to 0.88), transient tachypnea of the newborn (0.38, 0.25 to 0.57), and mechanical ventilation (0.19, 0.08 to 0.43), and significantly less time receiving oxygen (mean difference -2.06 hours, 95% confidence interval -2.17 to -1.95), lower percentage of maximum inspired oxygen concentration (-0.66%, -0.69% to -0.63%), shorter stay in neonatal intensive care (-7.44 days, -7.44 to -7.43), and a higher APGAR score at one and at five minutes. CONCLUSIONS:  Antenatal steroids at ≥34 weeks' gestation reduce neonatal respiratory morbidity. A single course of corticosteroids can be considered for women at risk of imminent late premature delivery 340-366 weeks' gestation, as well as for women undergoing planned cesarean delivery at ≥37 weeks' gestation. SYSTEMATIC REVIEW REGISTRATION:  PROSPERO CRD42016035234.

Omega-3 long chain polyunsaturated fatty acids to prevent preterm birth: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the efficacy of omega-3 in reducing the incidence of preterm birth. DATA SOURCES: Searches were performed in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, EMBASE, and the Cochrane Central Register of Controlled Trials with the use of a combination of keywords related to "fish oil," "pregnancy," and "omega-3." METHODS OF STUDY SELECTION: We included all randomized controlled trials of asymptomatic women with singleton gestations who were randomized to prophylactic treatment with either omega-3 supplementation or control (either placebo or no treatment). Exclusion criteria included trials in women with multiple gestations, intrauterine growth restriction, gestational hypertension or preeclampsia at randomization, prior preterm birth, and trials with polyunsaturated fatty acids as control. TABULATION, INTEGRATION, AND RESULTS: Nine randomized trials including 3,854 eligible women were identified. Women who received omega-3 had a similar rate of preterm birth before 37 weeks of gestation compared with women in the control group (7.7% compared with 9.1%, respectively; relative risk 0.90, 95% confidence interval [CI] 0.72-1.11). There were no significant differences in birth weight, neonatal intensive care unit admission, necrotizing enterocolitis, sepsis, or perinatal death in the omega-3 compared with control groups, respectively. There were no significant differences in the subgroup analyses, except for the rate of perinatal death, which was lower (0.3% compared with 1.2%; relative risk 0.27, 95% CI 0.09-0.80) in the women who received omega-3 before 21 weeks of gestation and in trials with low risk of bias (0.3% compared with 1.0%; relative risk 0.28, 95% CI 0.09-0.89) compared with women in the control group. However, in no randomized controlled trial was perinatal death the primary outcome. CONCLUSION: Omega-3 supplementation during pregnancy does not reduce the incidence of preterm birth or improve neonatal outcome.

Physical Examination-Indicated Cerclage: A Systematic Review and Meta-analysis.

OBJECTIVE: To estimate the effectiveness of physical examination-indicated cerclage in the setting of second-trimester cervical dilatation by systematic review and meta-analysis of published studies. DATA SOURCES: We searched MEDLINE, EMBASE, Scopus, ClinicalTrials.gov, Web of Science, and the Cochrane Library for studies published between 1966 and 2014 that evaluated cervical cerclage for the treatment of cervical insufficiency. METHODS OF STUDY SELECTION: The search yielded 6,314 citations. We included cohort studies and randomized controlled trials comparing cerclage placement with expectant management of women with cervical dilatation between 14 and 27 weeks of gestation. Two investigators independently reviewed each citation for inclusion or exclusion and discordant decisions were arbitrated by a third reviewer. Summary estimates were reported as the mean difference and 95% confidence interval (CI) for continuous variables or relative risk and with 95% CI for dichotomous outcomes. Fixed- and random-effects meta-analysis was used, depending on heterogeneity. TABULATION, INTEGRATION, AND RESULTS: Ten studies met inclusion criteria and were included in the final analysis. One was a randomized controlled trial, two were prospective cohort studies, and the remaining seven were retrospective cohort studies. Of the 757 women, 485 (64%) underwent physical examination-indicated cerclage placement and 272 (36%) were expectantly managed. Cerclage was associated with increased neonatal survival (71% compared with 43%; relative risk 1.65, 95% CI 1.19-2.28) and prolongation of pregnancy (mean difference 33.98 days, 95% CI 17.88-50.08). CONCLUSION: Physical examination-indicated cerclage is associated with a significant increase in neonatal survival and prolongation of pregnancy of approximately 1 month when compared with no such cerclage. The strength of this conclusion is limited by the potential for bias in the included studies.