Randomized clinical trials behind level A recommendations in obstetric practice bulletins: compliance with CONSORT statement

We appraised the compliance of randomized clinical trials (RCTs) cited for level A recommendations in obstetric practice bulletins (OPBs) and published after the CONSORT (Consolidated Standards of Reporting Trials, published 1996) statement. From the CONSORT checklist, we identified 50 separate items the RCTs should describe in the article and assigned 1 point if present; 0, if absent. The CONSORT score was the total points, expressed as a percentage. From 1998 to 2006, American College of Obstetricians and Gynecologists published 68 level A obstetric recommendations, and 20 (29%) are supported by > or = 1 RCT published after 1997. The median CONSORT score for the 32 RCTs published after the statement was 73% (range 30 to 100%). Only four RCTs complied with 90% of the CONSORT statement. RCTs supporting level A recommendations in OPB have variable compliance with CONSORT. Recommendations that lack quality RCTs should prompt further studies into the topic.     

Intrahepatic cholestasis of pregnancy as a risk factor for preeclampsia

Intrahepatic cholestasis of pregnancy and preeclampsia are two major pregnancy complications. We aimed to investigate the association between intrahepatic cholestasis of pregnancy (ICP) and preeclampsia. Single-center retrospective study. Study group included 180 women (162 singletons and 18 twin gestations) who were diagnosed with ICP based on clinical presentation, elevated liver enzymes and bile acids. The reference group included 1618 women (1507 singletons and 111 twin gestations) who delivered during the study period, and were matched according to age, gravidity, parity and singleton or twin gestation. The incidence of ICP was 0.36%. The incidence of preeclampsia was higher in women with ICP compared to reference group (7.78% vs 2.41%, aOR, 3.74 95% CI 12.0–7.02, p < 0.0001), for either without—(3.89% vs 1.61%, aOR 2.83, 95% CI 1.23–6.5, p = 0.145) or with severe features (3.89% vs 0.80%, aOR 5.17 95% CI 2.14–12.50, p = 0.0003). For both singleton and twin pregnancies, overall preeclampsia rates were higher in the ICP group (5.56% vs 2.19%, aOR 2.91 95% CI 1.39–6.07 p = 0.0045; and 27.78% vs 5.41%, aOR 10.9 95% CI 2.16–47.19, p = 0.0033, respectively). Earlier diagnosis of ICP was associated with higher incidence of preeclampsia (31.1 ± 3.8 vs 34.86 ± 6.2 gestational weeks, p = 0.0259). The average time between ICP diagnosis and to the onset of preeclampsia was 29.7 ± 24 days. ICP is associated with an increased risk for preeclampsia. We suggest intensified follow-up for preeclampsia in women with ICP, especially among those with early ICP presentation and twins’ gestations.     

Theatre sending: how long does it take and what is the cost of late starts?

This study seeks to identify areas of poor utilisation of theatre time and estimate the cost of late starts. Retrospective study of elective gynaecological operations from September to November 2008 in a district general hospital was conducted. Primary outcome measures were time to send, time for anaesthesia and procedure time. Secondary outcome measures were time to send for the first patient and cost of late starts (N = 164). The mean time to send was 19 ± 8.10 min (95% CI: 18–20). The mean time for anaesthesia was 9 ± 6.40 min (95% CI: 7.91–9.86). The mean procedure time was 60 ± 35 (95% CI: 55–65). On average time to send for the first patient on the morning list took 20 ± 9.83 min (95% CI: 17–23) and resulted in 93% of lists starting late. The surgical team waited a mean of 22 ± 19 min (95% CI: 17–27) for the first patient to arrive after the list was due to start. Total time wasted on late starts was 910 min (15 h), costing an estimated ￡3,640 over the 3-month period. This figure is based on local theatre staff wages of ￡236.30 per hour. Sending for patients 30 min before the list is due to start is an auditable standard that could increase theatre efficiency and enable 15 h of currently wasted resources to be used to shorten waiting lists and enhance staff training opportunities.     

A pragmatic evaluation of sleep patterns before gynecologic surgery

The aim of this study was to evaluate preoperative sleep patterns in-patients scheduled for elective endoscopic surgery and to compare sleep characteristics before different types of endoscopic procedures. A prospective survey cohort study (Canadian Task Force classification II-2) was designed to evaluate quantitative and qualitative (score 1–7) sleep parameters. Patients completed sleep-monitoring forms on the baseline (6 weeks before surgery), two nights (night-2), and the night before surgery (night-1). Of a total 119 women, 73 (61%) underwent laparoscopies and 46 (39%) hysteroscopies. Forty-seven (40%) operations involved organ removal and 72 (60%) were reconstructive surgery. The mean overall sleep-quality score on night-1 (3.29 ± 0.15) was higher (worse) than on baseline (2.09 ± 0.10, P < 0.0001) and night-2 (2.45 ± 0.11, P < 0.001, respectively). Patients reported more difficulty falling asleep on night-1 (2.53 ± 0.15) than on baseline (1.61 ± 0.09, P < 0.0001) and night-2 (1.84 ± 0.12, P = 0.001, respectively). The mean number of nocturnal awaking events was also highest on night-1 (1.52 ± 0.17) than on baseline (0.69 ± 0.09, P < 0.001) and night-2 (0.87 ± 0.09, P < 0.05 respectively). Using logistic regression, we found that age, stress level, and time before surgery (baseline, night-2, night-1), were significant predictors of poor sleep. The type of planned surgery did not influence the quality of sleep. Falling asleep on night-1 took longer than on baseline and night-2. There was no difference in the sleep quality measures between the baseline and night-2. Poor sleep quality is common mainly in the night before surgery. The nature and extent of planned surgery do not affect sleep quality variables.     

Intrapartum PRSA: a new method to predict fetal acidosis?—a case-control study

Phase-rectified signal averaging method (PRSA) represents an analysis method which applied on fetal cardiotocography (CTG) allows the quantification of the speed of fetal heart rate changes. By calculating the average deceleration capacity (ADC) an assessment of the fetal autonomic nervous system (ANS) is possible. The objective of this study was to test its ability to predict perinatal acidosis. A case–control study was performed at a University Hospital in Munich. All intrapartum CTG heart rate tracings saved during a 7-year period were considered for analysis. All neonates born with an umbilical arterial blood pH ≤ 7.10 were considered as cases. Controls were defined as healthy fetuses born with a pH ≥ 7.25. The main matching criteria were gestational age at delivery, parity, birth mode, and birth weight percentile. Exclusion criteria were a planned caesarean section, fetal malformations, and multiple pregnancies. ADC and STV were then calculated during the last 60, the last 45, and the last 30 min intervals prior to delivery. Of all stored birth CTG recordings, 227 cases met the inclusion criteria and were studied. ADC was significantly higher in fetuses born with acidemia (4.85 bpm ± 3.0) compared to controls (3.36 bpm ± 2.2). The area under ROC curve was 0.659 (95% CI 0.608–0.710) for ADC and 0.566 (0.512–0.620) for STV (p = 0.013). This study confirms that the assessment of ADC using PRSA represents a good additional tool for the prediction of acute fetal acidosis during delivery.     

Da Vinci S robotic surgery in the treatment of benign and malignant gynecologic tumors

The objective of this work is to present and analyze our da Vinci S robotic surgery results in the treatment of gynecologic tumors for a 1-year period. Fifty-one patients underwent da Vinci S (Intuitive Surgical, USA) robotic surgery at the Medical University—Pleven Gynecologic Oncology Clinic from January 2008 to January 2009. Robot-assisted radical hysterectomy with total pelvic lymph node dissection was performed in 28 (54.9%) of them, robot-assisted total hysterectomy in 21 (41.2%), and robot-assisted pelvic lymph node dissection in two (3.9%). The average length of the operative intervention, from the beginning of the CO₂ insufflation of the abdomen to closing trocar skin incision was 119.89 min (± 43.441) and mean console time was 76.56 min (± 32.904). The average patient body weight was 70.56 kg (± 18.272; range, 41–114) with mean body mass index (BMI) of 27.30 (± 6.938). No significant difference was observed between the BMI and operative time (p = 0.49). No significant intra-operative complications were registered. An ureterovaginal fistula was diagnosed on the 10th postoperative day in one of the patients (2%). Robot-assisted endoscopic gynecologic surgery is a modern and advanced method for operative treatment of benign and malignant gynecological tumors. It is appropriate for obese patients as the obesity is not related to a prolonged operative time.     

The clinical analysis of poor ovarian response in in-vitro-fertilization embryo-transfer among Chinese couples

Purpose To explore the prevalence, predictor of clinical pregnancy and possible aetiology of poor ovarian response (POR) in in vitro fertilization–embryo transfer (IVF–ET) in Chinese. Methods A total of 4,600 retrieval oocyte cycles were finished between July 1, 2004 and April 30, 2006. Poor ovarian responses were observed in 426 patients of 472 cycles undergoing IVF, which were selected on the same retrieve oocyte day as the control group. The outcome of IVF–ET and the common markers of ovarian reserve were compared. Results The patients had previous ovarian surgery in 64 cycles of 472 poor ovarian response cycles. The group with poor ovarian response has significant differences in comparison with the control group in age (36.6 ± 4.2 vs 33.3 ± 4.04), ovarian surgeries (13.6 vs 2.8%), dose of gonadotrophin (58.5 ± 15.8 vs 40.6 ± 17.0), fertilization rate (71.5 vs 86%) and pregnancy rate (14.8 vs 36.7%). In the group with poor ovarian responses, clinical pregnancy rate declined significantly in women aged >40 years than in those aged ≤40 years (2.8 vs 18.5%, P < 0.001). The age, basal serum follicle stimulating hormone (FSH), basal serum luteinizing hormone (LH), basal oestradiol (E2) concentrations, FSH to LH ratio and the antral follicle count (AFC) are the common markers of ovarian reserve in our center. We found that there were significant differences in age, basal FSH, FSH-to-LH ratio and the antral follicle count. But no statistical significant differences were observed in basal oestradiol concentration and basal serum LH when comparing the two groups. Binary logistic regression analysis was used to study the relation among age, FSH, LH, E2, AFC and clinical pregnancy, and the age (odds ratio, 0.863; 95% confidence interval, 0.805–0.925; p = 0.000) was the only variable selected. Conclusion Our data show that the prevalence of poor ovarian response in Chinese is 11.9%. Previous ovarian surgery is associated with poor ovarian responses. The pregnancy rate of women with poor ovarian response is low in IVF–ET, especially the decline in clinical pregnancy rate of women aged >40 years became accelerated. Correct identification of those who are at risk for POR prior to stimulation is helpful in tailoring the best stimulation protocol to individual patients. Chronological age significantly improved the prediction of clinical pregnancy of poor ovarian responders.     

Retention of membrane charge attributes by cryopreserved-thawed sperm and zeta selection

Purpose Mature sperm can be selected based on their negative zeta electrokinetic potential. The zeta selection of cryopreserved sperm is unknown. The objective was to study the effect of zeta processing on the morphology and kinematic parameters of cryopreserved-thawed sperm. Methods Colloid-washed sperm (N = 9 cases) were cryopreserved for 24 h, thawed and diluted in serum-free medium in positive-charged tubes. After centrifugation, the tubes were decanted, serum-supplemented medium was added and the resuspended sperm were analyzed. Untreated sperm and fresh sperm served as the controls. Results There were improvements in strict normal morphology in fresh (11.8 ± 0.3 versus control 8.8 ± 0.3 %, mean ± SEM) and thawed (8.7 ± 0.2 versus control 5.4 ± 0.2%) sperm after zeta processing. Percent sperm necrosis was reduced after zeta processing (66.0 ± 0.6 versus unprocessed 74.6 ± 0.3%). Progression decreased by 50% but not total motility after zeta processing of thawed sperm. Conclusions The results suggested that the cryopreservation process did not impact the sperm membrane net zeta potential and higher percentages of sperm with normal strict morphology, acrosome integrity and reduced necrosis were recovered. The zeta method was simple and improved the selection of quality sperm after cryopreservation but more studies would be needed before routine clinical application. Cryopreserved-thawed sperm processed using the zeta membrane-charge method showed improvements in strict normal morphology, acrosome and reduced necrosis.     

Minimally invasive surgical management of symptomatic uterine cysts

This study aims to evaluate the feasibility of a minimally invasive access-integrated protocol for aspiration or drainage of symptomatic uterine cysts. The design of the study is a prospective cohort study. The study setting is a tertiary care referral facility and university hospital. Twenty seven women with objective evidence of uterine cysts diagnosed by ultrasonography. The patients underwent transvaginal sonographic diagnosis of uterine cysts at different sites. Cyst aspiration was performed using interventional 2D ultrasonography, hysteroscopy and/or laparoscopy. Follow-up was performed for a maximum of 1 year to assess relief of symptoms and the recurrence rate. The main outcome measures of the study are success of aspiration tool, relief of symptoms, and persistence or recurrence rates. Cervical and corporeal uterine cysts were diagnosed in 19 and eight cases respectively. The mean size of the cervical cyst was 2.9 ± 1.21 (1.8–3.7) cm, while that of the uterine cysts was 4.8 ± 1.89 (3.4–-6.1) cm. Improved health-related quality of life in the form of relief of deep dyspareunia and excessive vaginal discharge were reported in eight of 12 (66.6%) and 11/14 (78.5%) cases, respectively. Aspiration of symptomatic uterine cysts is technically feasible and achieves acceptable results. Uterine cysts may not be ignored as a potential cause of gynecologic symptoms, however, their precise pathogenesis and related co morbidities including impact on fertility should be substantiated by an adequately powered prospective randomized controlled study.     

Does parity affect pregnancy outcomes in the elderly gravida?

To identify whether older primiparas have more complications than do women who continue to deliver children into their late reproductive age. Patients of at least 35 years of age at delivery were included. Within this cohort, data from primiparous and multiparous women were compared. This retrospective study was based on electronic medical records from a single academic center, with more than 7000 deliveries annually. The impact of parity on maternal complications was assessed using a multivariate logistic regression model that adjusted for baseline maternal characteristics and medical history. During the study period, there were 54 283 deliveries in our medical center. A total of 13,982 (25.7%) patients were at least 35 years old at delivery. The rate of twin pregnancy was higher in the primiparous group (1.9%) as compared to the multiparous group (0.8%, 95% CI 0.30–0.64, P < 0.001), as was the incidence of delivery prior to 34 weeks (6.1% of the primiparas versus 2.9% of the multiparas, P < 0.001, OR 2.16, 95% CI 1.75–2.68); hypertensive disorders (3.9% versus 1.7%, P < 0.001, 95% CI 0.33–0.57); diabetes (4.6% versus 3.2%, P = 0.003, 95% CI 0.55–0.88); and IUGR (10.5% versus 4.7%, P < 0.001, 95% CI 0.35–049), respectively. The increased risk for pre-term delivery, hypertensive disorders, diabetes, and IUGR was maintained after logistic regression analysis. We found that pregnancy complications typical to older parous women are significantly more common among primiparas, indicating that not only older age, but also having a first child relatively late in the reproductive period contributes to adverse pregnancy outcomes.     

Can glyburide be advocated over subcutaneous insulin for perinatal outcomes of women with gestational diabetes? A systematic review and meta-analysis

To obtain precise findings from published studies about the efficacy and safety of glyburide versus subcutaneous insulin in patients with gestational diabetes mellitus (GDM). We searched PubMed, Cochrane Library, Web of Science, and Scopus, up to January 2019, for relevant studies that compared glyburide with subcutaneous insulin for patients with GDM. We extracted maternal and neonatal outcomes from included studies, performed meta-analysis, evaluated heterogeneity, assessed the risk of bias of included studies, and conducted subgroup and sensitivity analyses. A total of 24 studies (11 randomized controlled trials (RCTs) and 13 observational cohort studies) with a total of 24,517 women were included in the present study. The pooled estimate showed that glyburide significantly decreased the need for cesarean section (OR = 0.87, 95% CI [0.82, 0.92], p < 0.0001), fasting blood glucose (MD − 5.63 mg/dL, 95% CI [− 10.97, − 0.28], p = 0.04), and Apgar score at 5 min (MD − 0.30, 95% CI [− 0.36, − 0.23], p < 0.001) than insulin. However, glyburide significantly increased the risk of neonatal hypoglycemia (OR = 1.42, 95% CI [1.03, 1.95], p = 0.03) and neonatal intensive care unit admission duration (NICU) (MD 4.26 days, 95% CI [2.65, 5.86], p < 0.01) compared to insulin. The overall results did not favor either group in terms of macrosomia (OR = 1.14, 95% CI [0.92, 1.41], p = 0.25) and large for gestational age (LGA) (OR = 1.38, 95% CI [0.99, 1.92], p = 0.06). While subgroup analysis of RCTs showed that maternal hypoglycemia and LGA rates were significantly higher in glyburide than insulin and cesarean section rates were comparable between both compared groups. Our study suggests that glyburide is an effective and well-tolerated drug compared to insulin in the management of women with GDM, provided neonates are monitored for hypoglycemia and Apgar score. In addition, glyburide was associated with lower cesarean sections, which may add to the potential clinically benefits of glyburide compared to insulin.     

Sperm chromatin stability and its relationship with fertilization rate after Intracytoplasmic Sperm Injection (ICSI) in an assisted reproduction program

Objective Evaluate sperm chromatin stability and its relationship with the rate of fertilization after procedures of intracytoplasmic sperm injection (ICSI) in a program of assisted reproduction. Design Prospective study. Setting Institute of Gynecology and Reproduction. Patients Thirty-three women with their respective partners (12 couples in the study group and 21 couples in the control group) participating in a program of assisted reproduction. The study group was defined as men with >30% of non-decondensed spermatozoa (high sperm chromatin stability). Interventions A part of each seminal sample was used to evaluate sperm chromatin stability under SDS and EDTA treatment and the second aliquot was used for the ICSI procedure. Fertilization was evaluated 16–18 h post sperm injection at a pronuclear stage. The fertilized oocytes were further cultured for 24–48 h before transfer to the patient. Main outcome measures Fertilization rate. Results Thirty-five oocytes (35.7%) in the group of study and 109 oocytes (78.9%) in the control group showed two pronuclei (P < 0.001). The coefficient of determination between the SDS + EDTA (Grade 2) and rate of fertilization was r ² = 0.85 (P < 0.001) and the coefficient of regression was 1.72 ± 0.19 (β ± ES) (P < 0.001). Conclusions High sperm chromatin stability is a factor which reduces the rate of fertilization after ICSI procedure.     

Effects of luteinizing hormone and follicle stimulating hormone on the developmental competence of porcine preantral follicle oocytes grown in vitro

Background There has been controversy over the role of FSH in the regulation of preantral follicle development. LH is a survival and differentiation factor that increases oocyte maturation in FSH-supplemented cultures of mouse preantral follicles. However, little information exists on the action of LH and FSH in the developmental competence of porcine preantral follicle oocytes in vitro. Materials and methods Porcine preantral follicles were cultured for 3 days in the presence or absence of FSH or LH. Oocytes from these follicles were then matured, fertilized in vitro, and embryos were cultured. Estradiol secretion and histological analysis of cultured follicles were also carried out. Results FSH or combined LH and FSH significantly enhanced follicular growth compared to LH alone or the controls. Combined LH and FSH treatment of preantral follicles significantly increased the percentage (59 ± 5%) of oocytes competent to undergo cleavage to the two-cell stage after fertilization. A significant effect was seen on oocyte competence to develop from the two-cell to the blastocyst stage (30 ± 6%) compared to FSH alone treatment (45 ± 7 and 14 ± 5%, respectively). The amount of estradiol on days 2 and 3 of culture was significantly higher in follicles cultured with FSH (48.75 ± 17, 70.5 ± 14 pg/ml) or combined LH and FSH (63.25 ± 16, 72.5 ± 12 pg/ml) than that cultured with the untreated controls (16 ± 10, 5.66 ± 4 pg/ml). Conclusions The results indicated that FSH is essential for the in vitro growth of porcine preantral follicles, estradiol secretion, and for oocytes to acquire competence to resume meiosis and undergo fertilization and embryonic development. LH with FSH treatment of porcine preantral follicles can improve the quality of oocytes by promoting growth and a higher frequency of embryonic development.     

Adnexal masses in adolescent girls with pelvic pain: Report on 63 cases

To improve clinical appreciation of these lesions, we reviewed the presentation, evaluation, outcome, and therapeutic aspects of painful adnexal masses in adolescent females. During the period January 2005–September 2006, 63 adolescent females with painful adnexal masses were recruited. The patient management and outcomes were documented. The mean age was 15.36 ± 1.6 years, and the mean diameter of the masses was 54.5 ± 1.3 mm. Forty-nine patients (77.7%) underwent surgical management, and 45 of the 49 surgeries were achieved by laparoscopic surgery (91.8%). Two converting laparotomies (4%) were performed. Fourteen patients with a presumed functional cyst were followed up without surgery. Postoperative histopathologic evaluation revealed a benign epithelial ovarian cyst rate of 26.5%, a mature cystic teratoma rate of 22.4%, and a borderline ovarian tumor rate of 4.08%. Non-neoplastic adnexal lesions were encountered in surgeries of 22 cases. The incidence of acute ovarian torsion and true ovarian neoplasm was 9.52% and 55.1%, respectively, and none was malignant. True ovarian neoplasia remains a common indication for surgery in the majority of adolescents. Because most cases are benign, minimal access surgery should be performed whenever feasible.     

Male age influences oocyte-donor program results

Background The purpose of our research was to examine the relationship between male age and semen parameters in a range of ages (from 20s to 60s) in Egg Donation Program (EDP) cycles. EDP provides a pool of high quality oocytes, thus allowing better analysis of the sperm efficacy. Discussion The retrospective study population consisted of 484 male partners of patients undergoing EDP in in-vitro fertilization (IVF) treatments. A comparison was made of male age and sperm parameters within two groups: cycles resulting in a pregnancy (pregnant group) and cycles which failed to achieve a pregnancy (non-pregnant group). The men involved in the pregnant group were found to be significantly younger 43.2 ± 8.1 than those of the non-pregnant group 46.8 ± 7.8 (p = 0.003). Analysis of sperm morphology revealed a significant prevalence of teratozoospermia in males of the non-pregnant group, as compared to the males of the pregnant group (29% vs. 11%, respectively). The results also demonstrate that sperm parameters are apparently not diminished until men reach the age of 40. However, between 40–50 years old semen parameters deteriorate. Male age was found to be related to a reduction in sperm strict criteria: 44.8 in normozoospermia, 47.9 (p = 0.02), 48.4 (p = 0.04) and 51.9 (p = 0.001) years old in mild teratozoospermia, moderate teratozoospermia and severe teratozoospermia, respectively. Additionally, the results showed that the percentage of “healthy” embryos on day 3 of embryo culture was lower in the non-pregnant group (26%), as compared with the pregnant group (34%; p = 0.01). Conclusion Our study confirms that sperm parameters are reduced by age and suggests that this age-dependent effect could be a reason for failures in IVF cycles even in EDP couples.     

Elevated basal FSH and embryo quality: lessons from extended culture embryos

Background  The relationship between elevated basal FSH and embryo quality remains a topic of heated discussion among practitioners of ART. Some authors suggest a negative effect of raised FSH on the quality of embryos and therefore on IVF treatment outcome. We postulate that women with elevated FSH who respond well to ovarian stimulation and have embryos to transfer, have the same chance of conceiving like women of a similar age with normal FSH. To test this hypothesis, we studied women with elevated basal FSH who made enough embryos to qualify for blastocyst culture and day 5 embryo transfer. Methods  Analysis of data collected prospectively, on women age 25–43 years, who underwent IVF between January 2005 and December 2006. The women were divided into: those with high FSH (≥10 IU/L) and women with normal FSH (<10 IU/L). We analysed data to show treatment outcome in the two groups, following embryo transfer on day 3 and after transfer on day 5. Outcome measures include number of oocytes retrieved, number of embryos available, implantation rate, pregnancy and live birth rate. Results  Among the 1,858 women who under-went a day 3 transfer, 1,368 had basal FSH ≤ 10 IU/L, and in 492 basal FSH was above 10 IU/L. The average number of oocytes retrieved was lower among women with elevated FSH (10.12 ± 5.6 Vs 6.16 ± 3.9). Women with a normal FSH, had a higher pregnant and live birth rate than those with elevated FSH (43.3% vs 27.9% p = 0.021) and (30.8% vs 17.6% p = 0.028) respectively. 398 women made enough embryos to qualify for extended embryo culture to blastocysts. Of these 366 had an FSH ≤ 10 IU/L and 32 had FSH > 10 IU/L. In this group, there was no significant difference in the pregnancy and live birth rates between women with elevated and those with normal FSH, (67.2% vs 65.6%) and (51.9% vs 43.8%) respectively. In this selected group of women where quantity is not an issue, the quality of embryos was same irrespective of whether the basal FSH was low or high. Conclusion  Women with elevated basal FSH who respond well to stimulation and generate a good number of oocytes / embryos have a chance of becoming pregnant and having a live birth similar to that of women of their age. Women should therefore not be denied the benefits of IVF based solely on the basal FSH level as a subset may respond well and therefore have a good chance of taking home a baby.     

Outcomes of ultrasound and physical-exam based cerclage: assessment of risk factors and the role of adjunctive progesterone in preventing preterm birth—a retrospective cohort study

To assess outcomes of ultrasound and physical examination-based cerclage performed at mid to late second trimester and to assess the potential added value of progesterone treatment combined with cerclage for preventing preterm birth. A retrospective cohort study of women who underwent cerclage in a university-affiliated tertiary medical center (2012–2018). Inclusion criteria included only ultrasound-based cerclage and physical examination-based cerclage. Women who underwent history-based cerclage or multiple gestations were excluded. Study groups were stratified by previous PTB < 37 weeks and other risk factors for PTB. Primary outcome was the incidence of preterm birth < 35 weeks of gestation. Secondary outcomes included the potential added value of progesterone treatment and neonatal outcome. Sixty-nine women underwent cervical cerclage placement between 16–23 weeks of gestation. All women had short cervix (cervical length of < 25 mm) at presentation. Indications for cerclage placement included: 29% previous PTB, 32% prior cervical interventions (history of at least one D&C, hysteroscopy or cold-knife conization in the past), 22% had cervical dilatation > 1 cm at presentation, 12% due to failure of progesterone treatment defined as continued cervical shortening after 14 days of progesterone treatment, and 5% had other indications. Overall, 42 women (61%) gave birth at term. 27 women (39%) delivered prior to 37 weeks of gestation, of them, 20 women (29%) gave birth prior to 35 weeks. Overall median gestational age at delivery was 35 + 5 ± 4.7 weeks. Cervical dilatation at presentation of > 1 cm was associated with an increased risk for PTB < 35 weeks (OR 3.57, CI 1.43–30.81, p = 0.036). Previous PTB, prior cervical interventions and extent of cervical shortening at presentation did not increase the risk of PTB. Progesterone treatment in addition to cerclage did not result in a decreased risk for PTB < 35 weeks of gestation (OR 2.83, CI 0.58–13.89, p = 0.199). Late second trimester cerclage is a practical measure for preventing PTB in cases of asymptomatic cervical shortening. Our study did not find adjunctive benefit for progesterone treatment with physical or ultrasound-based cerclage in reducing the rate PTB.     

Does birthweight have a role in the effect of episiotomy on anal sphincter injury?

Most professional guidelines advise against routine episiotomy during vaginal delivery, although mounting evidence supports its protective role regarding obstetric anal sphincter injury (OASI). We aimed to study the effect of lateral and mediolateral episiotomies on the rate of OASI in relation to birthweight among nulliparous women undergoing vaginal delivery. A historical cohort study was conducted of all nulliparous women who delivered vaginally at term between 2011 and 2019 at a tertiary university hospital. Women were allocated into two groups: (1) with OASI and (2) without OASI. Episiotomy performance and birthweight groups were analyzed. Overall, 22,250 deliveries were analyzed for inclusion: 18,533 (83.3%) spontaneous vaginal deliveries (SVD), 3222 (14.5%) vacuum-assisted deliveries (VAD) and 495 (2.2%) forceps deliveries. Total episiotomy and OASI rate was 48.2% and 1.7%, respectively. Episiotomy rate was lower in the OASI group as compared to the no OASI group (158 (41.3%) vs. 10,568 (48.3%), OR 0.75, 0.61–0.92, p = 0.006). Median birthweight was higher for OASI group neonates (3355 vs. 3160, p < 0.001). In SVDs, episiotomy decreased the rate of OASI in neonatal birthweight groups of 3000–3499, 3500–3999 and > 4000 g (OR 0.56, 0.38–0.82, p = 0.003; 0.66, 0.45–0.99, p = 0.04 and 0.24, 0.07–0.78, p = 0.01, respectively). In VADs, episiotomy decreased the rate of OASI in the neonatal weight groups of 2500–2999 and 3000–3499 g (OR 0.36, 0.14–0.89, p = 0.02 and OR 0.38, 0.19–0.75, p = 0.004, respectively). Lateral and mediolateral episiotomies are independent modifiable predictors of OASI, protective against OASI in SVDs when neonates weigh > 3000 g and 2500–3499 g in VADs.     

Which way is better to deliver the very heavy baby: mode of delivery,maternal and neonatal outcome

Currently there are no existing data regarding the maternal and neonatal outcomes for nulliparous women delivering neonates with birthweight above 4500 g. We aim to evaluate birth outcome among these subset of parturients. A retrospective study of nulliparous delivering a singleton fetus weighing  ≥ 4500 g in two tertiary medical centers between 2007 and 2018. Women who chose to undergo a trial of labor (TOL) were compared to those who underwent elective cesarean delivery (CD). Overall, 121 women were included. Seventy eight (65.4%) women elected a TOL while 43 (34.6%) had elective CD. Of women who chose TOL, 46 (59%) delivered with unassisted vaginal delivery, 28 (36%) by intrapartum CD, and 4 (5%) by assisted vaginal delivery, reaching TOL success rate of 64% (50/78). The rates of shoulder dystocia and anal sphincter injury in vaginal deliveries were 5/50 (10%) and 2/50 (4%) respectively. Successful TOL was negatively associated with the presence of gestational diabetes [5 (18%) vs. 0 (0%), OR 0.8 (95% CI 0.7–0.9), p = 0.005], and was positively associated with maternal height (median 170 cm vs. 165 cm, p = 0.002), epidural analgesia [42 (84%) vs. 16 (57%), OR 3.5 (95% CI 1.2–9.8), p = 0.009] and spontaneous onset of labor (38 (76%) vs. 10 (36%), OR 5.7 (95% CI 2.1–15.6), p = 0.001. Neonates born after TOL were more commonly complicated by meconium aspiration syndrome as compared to no TOL (9 (11%) vs. 0 (0%), OR 1.1 (95% CI 1.04–1.22, p = 0.02). Only maternal height was independently associated with successful TOL (aOR 6.9 (95% CI 1.03–46.3, p = 0.04). Maternal and neonatal adverse composite outcomes were associated with gestational hypertensive disorders (10 (50%) vs. 5 (5%). OR 19.2 (5.5–67.4), p < 0.001) and with delivery before 40 weeks (9 (57%) vs, 86 (82%), OR 3.5 (95% CI 1.2–10.6, p = 0.02), respectively. Trial of vaginal delivery in nulliparous with fetuses ≥ 4500 g was associated with a high failure rate, with only two thirds of parturients achieving successful vaginal delivery. Nevertheless, neonatal outcomes mostly did not differ according to the mode of delivery. Maternal height was the only factor associated with successful vaginal delivery.     

Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate System: safety, tolerability, and ablation results in a closed abdomen setting

This was a single-site cohort study to evaluate the safety of a new transcervical device (VizAblate™) combining real-time intrauterine sonography with radiofrequency (RF) ablation for the treatment of fibroids. Nineteen women with uterine fibroids received treatment with the VizAblate System in a closed abdomen setting prior to hysterectomy. Twelve of these subjects underwent an immediate abdominal hysterectomy after radiofrequency ablation (acute group), while the remaining seven underwent hysterectomy on post-ablation days 16 and 17 (subacute group). Uteri were sectioned and stained with the viability stain triphenyltetrazolium chloride (TTC) to quantify fibroid ablation dimensions and assess the serosa for thermal injury. Subjects in the subacute group were treated with the VizAblate System under conscious sedation; they provided pain and tolerability data for the interval from ablation through hysterectomy, and indicated overall procedural satisfaction. Twenty-two ablations ranging from 1.8 to 36.2 cm³ were created among 19 subjects within 20 fibroids and one region of adenomyosis. There were no complications or thermal serosal injury. For subjects in the subacute group receiving one ablation, the mean total procedure time was 25.8 ± 6.0 min (range 18–32 min). All subjects in the subacute group were discharged within 2 h of the VizAblate procedure. For fibroids ≤ 5 cm, 67.2% ± 27.0% of the fibroid volume was ablated (range 15–100%; median 75%). Transcervical RF ablation of fibroids under intrauterine sonographic guidance with the VizAblate system can be accomplished with a high degree of reliability and without adverse events.