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.

Hands-on vs hands-off technique for the prevention of perineal injury: a randomized clinical trial.

BACKGROUND: Perineal trauma after vaginal delivery is common and is associated with severe morbidity, including incontinence, pelvic pain, and sexual dysfunction. Morbidity is mainly related to third- or fourthdegree lacerations. OBJECTIVE: This study aimed to test the hypothesis that in nulliparous women with singleton pregnancies at term, hands-off technique during spontaneous vaginal delivery could reduce the rate of perineal laceration. STUDY DESIGN: This was a parallel-group, nonblinded, randomized clinical trial. Nulliparous women in spontaneous labor with singleton pregnancies and vertex presentation admitted to the labor and delivery room between 37 0/7 and 42 0/7 weeks of gestation were eligible, and were randomized in a 1:1 ratio to receive hands-off technique (intervention group) or hands-on technique during pushing in the second stage of labor. The primary outcome was perineal laceration (any degree). The effect of hands-off technique on each outcome was quantified as relative risk with 95% confidence interval. RESULTS: A total of 70 women were enrolled in the trial. Perineal lacerations (any degree) occurred in 15 of 35 (42.9%) women in the intervention group and 33 of 35 (94.3%) women in the control group (relative risk, 0.45; 95% confidence interval, 0.31-0.67). Hands-off technique was also associated with significantly decreased incidence of episiotomy (relative risk, 0.36; 95% confidence interval, 0.14-0.88), first-degree lacerations (relative risk, 0.41; 95% confidence interval, 0.20-0.87), and second-degree lacerations (relative risk, 0.43; 95% confidence interval, 0.19-0.99). There was no significant between-group difference in third- and fourth-degree lacerations, but the trial was not powered for these outcomes. CONCLUSION: In nulliparous women with singleton pregnancies at term, hands-off technique reduces the rate of perineal lacerations.

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.

Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial.

OBJECTIVE: To compare maternal blood loss with immediate cord clamping versus delayed cord clamping in women undergoing spontaneous vaginal delivery at term. METHODS: Parallel group non-blinded randomized trial conducted at a single center in Italy. Women with singleton gestations who underwent spontaneous vaginal delivery at term were eligible and were randomized in a 1:1 ratio to either immediate or delayed cord clamping. In the immediate cord clamping group, cord clamping was within 15 s after birth. In the delayed cord clamping group, cord clamping was after more than 60 s, or when the cord had stopped pulsing. The primary outcome was change in maternal hemoglobin level from the day of delivery to day one after delivery. RESULTS: A total of 122 participants were enrolled in the trial. There were no significant differences in maternal blood loss as assessed by comparing the decrease in maternal hemoglobin level (mean difference - 0.10 g/dl, 95% confidence interval - 0.28 to 0.08) between the two groups. The mean hemoglobin level at postdelivery day 1 was 11.0 ± 1.5 g/dl in the delayed group and 11.3 ± 1.6 g/dl in the immediate group. CONCLUSIONS: Delayed umbilical cord clamping, compared with immediate umbilical cord clamping, resulted in no significant change in maternal hemoglobin level 1 day after delivery. TRIAL REGISTRATION: Clinicaltrials.gov NCT04353544.

Oil-based vitamin E oral spray for oral health in pregnancy.

Aim: To assess the efficacy of vitamin E oral spray in pregnancy. Materials & methods: This was a retrospective study aimed to evaluate efficacy of vitamin E oral spray (vitamin E acetate in a medium chain tryglicerides vehicle - patented formulation) starting from the first trimester of pregnancy, with a control group. Results: A total of 100 women were included in the study and were compared with a matched control group. Only 25/200 women reported to have at least one teeth cleaning during pregnancy. Women who received the oral spray had a significantly lower risk of preterm birth compared with the control group, and lower risk of periodontal diseases. Conclusion: Use of oil-based vitamin E oral spray in pregnancy is associated with a decreased risk of periodontal diseases and therefore preterm birth.

Labor Analgesia: A Systematic Review and Meta-Analysis of Non-Pharmacological Complementary and Alternative Approaches to Pain during First Stage of Labor.

the aim of the study was to conduct a meta-analysis to evaluate the efficacy of non-invasive and non-pharmacological techniques on labor first-stage pain intensity. Literature databases were searched from inception to May 2021, and research was expanded through the screening of previous systematic reviews. Inclusion criteria were: (1) population: women in first stage of labor; (2) intervention: non-pharmacological, non-invasive, or minimally invasive intrapartum analgesic techniques alternative and/or complementary to pharmacological analgesia; (3) comparison: routine intrapartum care or placebos; (4) outcomes: subjective pain intensity; and (5) study design: randomized controlled trial. Risk of bias of included studies was investigated, data analysis was performed using R version 3.5.1. Effect size was calculated as difference between the control and experimental groups at posttreatment in terms of mean pain score. A total of 63 studies were included, for a total of 6146 patients (3468 in the experimental groups and 2678 in the control groups). Techniques included were massage (n = 11), birth balls (n = 5) mind-body interventions (n = 8), heat application (n = 12), music therapy (n = 9), dance therapy (n = 2), acupressure (n = 16), and transcutaneous electrical nerve stimulation (TENS) (n = 8). The present review found significant evidence in support of the use of complementary and alternative medicine for labor analgesia, and different methods showed different impact. However, more high-quality trials are needed.

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.

Maternal and perinatal complications according to maternal age: A systematic review and meta-analysis.

OBJECTIVE: To evaluate the risk levels for maternal and perinatal complications at > 40, > 45 and > 50 years old compared with younger controls. METHODS: Electronic databases were searched from their inception until March 2021. We included studies reporting pregnancy outcome in pregnant women aged 40, 45, and 50 years or older compared with controls at the time of delivery. Case reports and case series were excluded. The primary outcome was the incidence of stillbirth. Meta-analysis was performed using the random effects model of DerSimonian and Laird, to produce summary treatment effects in terms of relative risk (RR) with 95% confidence interval (CI). Heterogeneity was measured using I2 (Higgins I2 ). Subgroup analyses in women older than 45 years and in those older than 50 years were performed. RESULTS: Twenty-seven studies, including 31 090 631 women, were included in the meta-analysis. The overall quality of the included studies was moderate to high. Most of the included studies were retrospective cohort studies (21/27), four were population-based studies, and two were cross-sectional studies. Women aged ≥40 years had significantly higher risk of stillbirth (RR 2.16, 95% CI 1.86-2.51), perinatal mortality, intrauterine growth restriction, neonatal death, admission to neonatal intensive care unit, pre-eclampsia, preterm delivery, cesarean delivery, and maternal mortality compared with women younger than 40 years old (RR 3.18, 95% CI 1.68-5.98). The increased risks for maternal mortality were 42.76 and 11.60 for women older than 50 years and for those older than 45 years, respectively, whereas those for stillbirth were 3.72 and 2.32. The risk of stillbirth and cesarean delivery was significantly higher in women >45 years compared with those aged 40-45 years, and in those aged >50 years compared with those aged 45-50 years. The risk of maternal mortality was significantly higher in women aged >50 years compared with those aged 40-45 (RR 60.40, 95% CI 13.28-274.74). CONCLUSION: The risk of stillbirth, cesarean delivery, and maternal mortality increases with advancing maternal age. The risk ratios for maternal mortality were 3.18, 11.60, and 42.76 in women older than 40, older than 45, and older than 50 years, respectively. These data should be used when women with advanced maternal age are counseled regarding their risk in pregnancy. SYSTEMATIC REVIEW REGISTRATION: The review was registered with the PROSPERO International Prospective Register of Systematic Reviews (registration No.: CRD42020208788).

Computerized cardiotocography in singleton gestations with diabetes mellitus: a retrospective study.

BACKGROUND: The aim of this study was to evaluate the use of computerized cardiotocography (C-CTG) in women with diabetes mellitus. METHODS: This was a retrospective cohort study of women with diabetes mellitus referred to University of Naples Federico II from January 2018 to January 2020 for antenatal monitoring. Only women who underwent antenatal monitoring with C-CTG were included in the study. For the purpose of this study only the C-CTG recorded at the time of outpatient admission were analyzed. Women were divided into four groups: 1) women with diabetes mellitus type 1; 2) women with diabetes mellitus type 2; 3) women with gestational diabetes mellitus (GDM); 4) control group without diabetes mellitus. The primary outcome of the study was the C-CTG short term variability (STV). RESULTS: A total of 298 patients were included in the study, 89 with type 1 diabetes (group 1), 27 with type 2 diabetes (group 2), 77 with GDM (group 3) and 105 controls (group 4). Fetal heart rate was statistically higher in pregnant women with pre-pregnancy diabetes both Type 1 and 2 compared to gestational diabetes and physiological pregnancies. The parameters of STV, APRS and DPRS were statistically lower in the pregnant group with pre-pregnancy type 1 diabetes than in type 2 and compared to group 3 and 4. CONCLUSIONS: Fetal heart rate was statistically higher in pregnant women with pre-pregnancy diabetes, both Type 1 and 2, compared to gestational diabetes and controls. STV, APRS and DPRS were statistically lower in the pregnant group with pre-pregnancy type 1 diabetes than in type 2 and compared to group 3 and 4.

Urinary Incontinence after Planned Cesarean Hysterectomy for Placenta Accreta.

INTRODUCTION: Data regarding the risk of incontinence after cesarean hysterectomy are lacking. We aimed to assess the risk of urinary incontinence in women who underwent planned cesarean hysterectomy for placenta accreta. METHODS: This was a retrospective study of women who underwent planned cesarean hysterectomy for placenta accreta. The primary outcome was the incidence of post-cesarean hysterectomy urinary incontinence, defined as involuntary loss of urine between 3 and 12 months after cesarean hysterectomy. Outcomes were compared in a cohort of women who underwent planned cesarean hysterectomy for placenta accreta with a control group of women who underwent scheduled cesarean section without hysterectomy. RESULTS: Forty-seven singleton gestations who underwent planned cesarean hysterectomy for placenta accrete were included in the study and were compared with 100 controls. Eight cases of bladder injuries were reported, 7 in the planned cesarean hysterectomy group and one in the planned cesarean delivery group. Overall, urinary incontinence was reported in 10 women of the planned cesarean hysterectomy group and in 8 women of the planned cesarean section group (21.3% vs. 8.0%; p = 0.03). CONCLUSION: Planned cesarean hysterectomy for placenta accreta is a risk factor for urinary incontinence.

Prenatal diagnosis and postnatal management of congenital unilateral hydrocephalus for stenosis of the foramen of Monro.

Congenital hydrocephalus and ventriculomegaly can be diagnosed reliably with prenatal ultrasound and Magnetic Resonance Imaging (MRI). Unilateral hydrocephalus is uncommon, and the prognosis depends on etiology and postnatal management. Here, we present a case of a 32-years-old woman with prenatal diagnosis of unilateral hydrocephalus associated with stenosis of the foramen of Monro. Unilateral hydrocephalus is an uncommon feature that can be detected prenatally on ultrasound and MRI. In case of isolated stenosis of the foramen of Monro prognosis is good.

Cervical pessary in singleton gestations with arrested preterm labor: a randomized clinical trial.

BACKGROUND: Cervical pessary has been proven to be effective in reducing the rate of preterm birth in asymptomatic women with singleton gestations and short cervical length in the midtrimester of pregnancy; however, the efficacy of this device in women with arrested preterm labor is still a subject of debate. OBJECTIVE: This study aimed to test the hypothesis that the use of a cervical pessary in women with singleton pregnancy and arrested preterm labor would reduce the risk of preterm birth at <37 weeks of gestation. STUDY DESIGN: This study is a parallel group, nonblinded, randomized trial. Participants included in the study were women with a diagnosis of arrested preterm labor between 24 0/7 and 33 6/7 weeks of gestations. The participants were randomized to either the cervical pessary group or no pessary group in a 1:1 ratio. The primary endpoint was preterm birth at <37 weeks of gestation. A sample size of 120 participants was determined, but the trial was concluded before the completion of enrollment. RESULTS: A total of 61 women with singleton pregnancies and arrested preterm labor at 24 0/7 to 33 6/7 weeks of gestation were enrolled in the trial. Of the 61 women, 32 were randomized to the cervical pessary group and 29 to the control group. Preterm birth at <37 weeks of gestation occurred in 14 women (43.8%) in the pessary group and 6 women (20.7%) in the control group (relative risk, 2.98; 95% confidence interval, 0.96-9.30). CONCLUSION: In this underpowered trial, among women with singleton pregnancies and arrested preterm labor, compared with no pessary use, the use of a cervical pessary does not result in a lower rate of preterm birth at <37 weeks of gestation.

Antenatal cardiotocography with and without computer analysis in high-risk pregnancy: a randomized clinical trial.

BACKGROUND: Cardiotocography or nonstress test is a technical means of recording the fetal heartbeat and uterine contractions for antenatal monitoring. OBJECTIVE: This study aimed to evaluate whether antepartum cardiotocography with computer analysis (computerized cardiotocography) increases the incidence of cesarean delivery in women with high-risk pregnancies but without intrauterine growth restriction. STUDY DESIGN: This was a parallel group nonblinded randomized clinical trial of singletons with high-risk pregnancies admitted for inpatient monitoring between 24 0/7 and 37 6/7 weeks' gestation. Eligible participants were randomly allocated in a 1:1 ratio to antenatal monitoring with either standard cardiotocography or computerized cardiotocography. Women randomized to the computerized cardiotocography arm received cardiotocographic monitoring with computerized analysis in a central monitoring station. The primary outcome was the incidence of cesarean delivery. RESULTS: Overall, 28 women were enrolled in this trial. In addition, 14 women were randomized to the computerized cardiotocography group and 14 women to the control group. No woman was excluded after randomization or lost to follow-up. Cesarean delivery occurred in 9 women (64.3%) in the computerized cardiotocography group and 9 women (64.3%) in the control group (relative risk, 1.00; 95% confidence interval, 0.21-4.69).There was no significant between-group difference in preterm birth, gestational age at delivery, Apgar score, and birthweight. CONCLUSION: Among women with high-risk pregnancies, use of computerized cardiotocography for antenatal monitoring did not result in a significant increase in cesarean delivery compared with standard cardiotocography. The results of this single-center randomized trial require confirmation in multicenter studies.