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Objectives: To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. Design: Multicenter, open‐label, phase 3 trial. Setting: Sixty‐nine sites in Europe and Russia. Population: Sexually active women aged 18–50 years with regular menstrual cycles and body mass index ≤35 kg/m2. Methods: E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary. Main outcome measures: Pearl Index (PI) for women 18–35 years (overall and method‐failure), bleeding pattern and AEs. Results: A total of 1553 women aged 18–50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman‐years (95% CI 0.15–1.11); method failure PI was 0.29 pregnancies/100 woman‐years (95% CI 0.06–0.83). Scheduled bleeding/spotting occurred in 91.9–94.4% of women over Cycles 1 to 12 and lasted a median of 4–5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment‐related serious AE was reported, a lower extremity venous thromboembolism. One‐hundred and forty‐one (9.1%) women discontinued study participation because of treatment‐related adverse events. Conclusion: E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile. A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile. This article includes Author Insights, a video abstract available at: https://vimeo.com/bjog/authorinsights16840 [ABSTRACT FROM AUTHOR]

Objective: To compare adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy. Design: Parallel group, 1:1 single‐centre single‐blinded randomised trial, designed as non‐inferiority study with a margin of 15%. Setting: Belgian teaching hospital. Population: Non‐pregnant non‐virgin women with an intact uterus and without obliteration of the pouch of Douglas scheduled to undergo removal of an adnexal mass assessed to be benign on ultrasound by IOTA criteria. Methods: Randomisation to laparoscopy (control group) or vNOTES (experimental group). Stratification according to adnexal size. Blinding of participants and outcome assessors by sham incisions. Main outcome measures: The primary outcome measure was adnexectomy by the allocated technique. Secondary outcomes included duration of surgery, pain scores and analgesics used, quality of life and adverse events. Results: We randomly assigned 67 participants (34 to the vNOTES group and 33 to the laparoscopy group). The primary end point was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the laparoscopy group: the one‐sided 95% upper limit for the differences in proportions of conversion was estimated as 13%, which is below the predefined non‐inferiority margin of 15%. The secondary outcomes demonstrated a shorter duration of surgery, lower pain scores, lower total dose of analgesics and a trend for more adverse events in the vNOTES group. Conclusions: vNOTES is non‐inferior to laparoscopy for a successful adnexectomy without conversion. vNOTES allowed shorter operating times and less postoperative pain but there was a trend for more adverse events. This article includes Author Insights, a video abstract available at: https://vimeo.com/bjog/authorinsights16838 [ABSTRACT FROM AUTHOR]

There is increased awareness of transgender physical and mental health widely and in academic research. A significant proportion of transgender men will retain their cervix with an increased risk of cervical cancer. In this review of cervical cancer screening among transgender men, we try to estimate how many transgender men still have a cervix, understand to identify challenges and barriers to cervical screening and propose possible solutions. Organised cervical screening programmes need to consider the needs of this population, in particular the provision of HPV self‐sampling. Transgender men need access to cervical screening. Transgender men need access to cervical screening. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the mode of delivery and stillbirth rates over time among women with obstetric fistula.Design: Retrospective record review.Setting: Tanzania, Uganda, Kenya, Malawi, Rwanda, Somalia, South Sudan, Zambia and Ethiopia.Population: A total of 4396 women presenting with obstetric fistulas for repair who delivered previously in facilities between 1990 and 2014.Methods: Retrospective review of trends and associations between mode of delivery and stillbirth, focusing on caesarean section (CS), assisted vaginal deliveries and spontaneous vaginal deliveries.Main Outcome Measures: Mode of delivery, stillbirth.Results: Out of 4396 women with fistula, 3695 (84.1%) delivered a stillborn baby. Among mothers with fistula giving birth to a stillborn baby, the CS rate (overall 54.8%, 2027/3695) rose from 45% (162/361) in 1990-94 to 64% (331/514) in 2010-14. This increase occurred at the expense of assisted vaginal delivery (overall 18.3%, 676/3695), which declined from 32% (115/361) to 6% (31/514).Conclusions: In Eastern and Central Africa, CS is increasingly performed on women with obstructed labour whose babies have already died in utero. Contrary to international recommendations, alternatives such as vacuum extraction, forceps and destructive delivery are decreasingly used. Unless uterine rupture is suspected, CS should be avoided in obstructed labour with intrauterine fetal death to avoid complications related to CS scars in subsequent pregnancies. Increasingly, women with obstetric fistula add a history of unnecessary CS to their already grim experiences of prolonged, obstructed labour and stillbirth.Tweetable Abstract: Caesarean section is increasingly performed in African women with stillbirth treated for obstetric fistula. [ABSTRACT FROM AUTHOR]

Objective: To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure.Design: Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%.Setting: Belgian teaching hospital.Population: Women aged 18-70 years scheduled to undergo hysterectomy for benign indications.Methods: Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors.Main Outcome Measures: The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes.Results: We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004.Conclusions: vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting.Tweetable Abstract: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery. [ABSTRACT FROM AUTHOR]

Abstract: The continuing pollinator crisis is due, in part, to the lack of year‐round floral resources. In intensive farming regions, such as the Upper Midwest (UMW) of the USA, natural and pastoral vegetation largely has been replaced by annual crops such as maize (Zea mays L.), soyabean (Glycine max L.) and wheat (Triticum spp.). Neither the energy (nectar) nor protein (pollen) needs of pollinating and other beneficial insects are being met sufficiently by the new, high‐intensity, agricultural landscape. Several potentially useful oilseed crops can be grown in the UMW, and many of these oilseeds are highly attractive to beneficial insects. Prior research showed that some of these oilseeds produced abundant nectar, but their corresponding values for pollen production are unknown. Accordingly, the aim of our research was to document pollen (and protein) production per unit area of twelve oilseed crops grown in Minnesota and associate these values with levels of beneficial insect visitation during anthesis. Our results show that oilseed crops such as camelina (Camelina sativa L.), flax (Linum usitatissimum L.) and pennycress (Thlaspi arvense L.) produce relatively little pollen (≤40 kg/ha); borage (Borago officinalis L.), calendula (Calendula officinalis L.), canola (Brassica napus L.), crambe (Crambe abyssianica Hochst) and cuphea (Cuphea viscosissima Jacq. × Cuphea lanceolata W. T. Aiton) produce bountiful pollen resources (50–150 kg/ha); and oilseed echium (Echium plantagineum L.) generates massive amounts of pollen (>400 kg/ha), about 50% of which is protein. Our study is unique in presenting a season‐long perspective of pollen production in alternative oilseed crops, a resource valuable to pollen‐feeding insects such as managed and wild bees. Diversification of UMW landscapes that includes alternative oilseed crops such as oilseed echium and cuphea can potentially provide a ready source of pollen and protein to help combat pollinator decline. [ABSTRACT FROM AUTHOR]

S. Weyers, K. Lambein, Y. Sturtewagen, H. Verstraelen, J. Gerris and M. Praet Cytology of the ‘penile’ neovagina in transsexual women Objective: The primary objective was to describe the neovaginal cytology in transsexual patients ( n = 50) treated with the inverted penile skin technique. Secondary objectives were to compare our cytological findings with patient characteristics including use of oestrogens, sexual orientation and penetrative intercourse. Methods: The medical and surgical history, sexual orientation and whether there was a current relationship were ascertained. A speculum examination was followed by microscopy of a Pap smear of the neovaginal vault. Results: Well-preserved nucleated squamous cells were found in 72%. The correlation between their presence and sexual orientation was highly significant ( P = 0.016), with those not sexually interested and homosexually oriented all having nucleated cells on the Pap smear. However, the correlation between these cells and penetrative intercourse failed to reach significance. Four samples showed atypical squamous cells of undetermined significance, all were negative for high-risk human papillomavirus (HR-HPV) types. One patient showed a low-grade squamous intraepithelial lesion that was HR-HPV positive. There was a significant correlation between the presence of cytological lesions and sexual orientation ( P = 0.006). Four percentage of the specimens showed Döderlein bacilli. Inflammation was found in 30.6% of samples with squamous cells. Conclusions: The penile skin-lined neovagina of transsexual women can reflect the cytological findings present in biological women. However ‘normal’ cervical cytology, with superficial, intermediate and parabasal cells as well as Döderlein bacilli, was found in only 4% of transsexual women. Although one patient’s Pap test showed koilocytes and was HR-HPV positive, no high-grade squamous intraepithelial lesions were identified. [ABSTRACT FROM AUTHOR]

Objective: To assess the role of human papillomavirus (HPV) testing and cytology as predictors of residual/recurrent disease after treatment of high-grade cervical intraepithelial lesions. Methods: One hundred and thirty-eight women with cervical intraepithelial neoplasia (CIN) grade 2/3 lesion on biopsy were included in a prospective follow-up study in Belgium and Nicaragua. All women were treated with loop electrosurgical excision procedure (LEEP) and follow-up visits took place at 6 weeks, 6 months, 1 year and 2 years. During these visits, a Papanicolaou (Pap) smear test was taken, colposcopy was performed and specimens were collected for HPV testing. Cytology, high-risk (HR) HPV presence, persistent HR HPV infection and combinations of these tests at different time points during follow-up were correlated with histologically confirmed residual/recurrent disease. Results: Thirteen patients (9%) developed residual/recurrent disease during follow-up. Abnormal cytology at 6 weeks after treatment was significantly correlated with residual/recurrent disease. Nine of thirty-seven patients with abnormal cytology at 6 weeks had recurrent disease versus three of seventy with a normal cytology [odds ratio (OR): 7.2; 95% confidence interval (CI): 1.8–28.5; P = 0.003). Sensitivity of this test was 75.0%, specificity 70.5%. Combining abnormal cytology and the presence of HR HPV within the first 6 months after treatment gave the best correlation with residual/recurrent disease: of the 54 women with abnormal cytology and/or HR HPV presence within the first 6 months, 11 developed residual/recurrent disease (OR 10.2; 95% CI: 2.2–48.3). Sensitivity of this combination was 84.6% and specificity 65.0%. Conclusion: Cytology remains the cornerstone in the early follow-up after LEEP for CIN lesions of the cervix. HPV testing can add value as it increases the sensitivity of cytology in concomitant testing within the first 6 months. [ABSTRACT FROM AUTHOR]

Nursing staff are exposed to stressful work load which in turn is associated with poor physical and psychological health, sickness absence and job exit. The effort-reward imbalance (ERI) model is a validated approach to measure chronic psychosocial work stress by identifying nonreciprocity between occupational efforts spent and rewards received, and has been found to predict poor health. The aim of this cross-sectional study (n = 367 nurses and nurses aides) was first to test the psychometric properties of the Danish questionnaire measuring ERI, and secondly to analyse whether psychosocial work stress is associated with six indicators of poor self-rated health. Results derived from confirmatory factor analysis indicate satisfying psychometric properties. Elevated risks of poor self-rated health (odds ratios varying from 1.92 to 4.76) are observed in nursing staff characterized by high effort in combination with low reward. Effects are enhanced in those respondents who additionally exhibit a high level of work-related overcommitment. In conclusion, despite methodological limitations, this study contributes to the validation of the ERI questionnaire in Danish language. Furthermore, by documenting associations with poor self-rated health, it supports efforts of theory-guided prevention of work stress in health care professions. [ABSTRACT FROM AUTHOR]

E. Beerens, L. Van Renterghem, M. Praet, Y. Sturtewagen, S. Weyers, M. Temmerman, H. Depypere, P. Claeys and C. A. Cuvelier Human papillomavirus DNA detection in women with primary abnormal cytology of the cervix: prevalence and distribution of HPV genotypes In this study, we focus on the prevalence and occurrence of different anogenital human papillomavirus (HPV) genotypes in a first abnormal cervical screening test, and correlate HPV genotyping with the cytological diagnosis on thin-layer liquid-based preparations in routine gynaecological screening. Out of 780 abnormal smears, 513 tested positive for HPV. All 25 different HPV types were identified by Line Probe Assay. The prevalence of high-risk HPV types increased from 72% in atypical squamous cell of undetermined significance to 94.5% in high-grade intra-epithelial lesion (HSIL). Co-infection with multiple HPV types was predominantly found in HSIL (35.8%). In the HSIL group the most common HPV types were 16, 52, 51 and 31; type 18 was rarely present. The role of types 31, 51 and 52 should be considered in future studies on vaccine development. [ABSTRACT FROM AUTHOR]

The problem of urinary retention after hysterectomy for benign disease is extensively evaluated by authors from Ghent. Their interesting results show that it is associated with the de-afferentiation of the bladder wall and with Fowler's syndrome. These findings help our understanding of a troublesome condition. Further work is reported into the use of the tension-free vaginal tape procedure, particularly into its positive effect on quality of life. Another study reported here found that in patients with BOO associated with BPH, there is a focal compromise of the blood-urine permeability barrier, with an increase in expression of inducible nitric oxide synthase. Objective To detect prospectively neurogenic damage in patients with urinary retention responding to sacral nerve stimulation (SNS) after hysterectomy for benign disease. Patients and methods From August 1995 to February 2002, 13 of 15 patients (mean age 43 years, sd 7) with urine retention for a mean (sd, range) of 25 (22, 6–240) months after hysterectomy for benign disease, were prospectively evaluated and treated with SNS. They were assessed using urodynamics at baseline and during the test stimulation. Sensory evoked potentials (SEPs), electrical sensory threshold (EST) measurements of the pudendal nerve, bladder neck and the bladder (2 Hz, 0–300 V), and needle electromyography of the external urethral sphincter (EUS) were undertaken in all patients. Results De-afferentiation (EST ≥ 200 V) was limited to the bladder in four of the 13 patients and extended to the bladder neck in one other, and was matched by no response at the SEP. Relative ESTs of the bladder neck correlated inversely with residual urine (r = - 0.76, P = 0.01, x = 546, fx = 1.22) and bladder capacity (r = - 0.77, P = 0.01, x = 611, fx = 1.26) at diagnosis. Complex repetitive discharges and decelerating bursts of the EUS were seen in these five patients. Unilateral SNS was applied in 10 patients (bilateral in... [ABSTRACT FROM AUTHOR]

Objectives: To assess the contraceptive efficacy, bleeding pattern and safety of a combined oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg., Design: Multicenter, open-label, phase 3 trial., Setting: Sixty-nine sites in Europe and Russia., Population: Sexually active women aged 18-50 years with regular menstrual cycles and body mass index ≤35 kg/m 2 ., Methods: E4/DRSP was administered in a 24 active/4 placebo regimen for up to 13 cycles. Visits were scheduled during Cycles 2, 4, 7 and 10 and after completing treatment during which adverse events (AEs) were collected. Participants recorded medication intake, vaginal bleeding/spotting, use of other contraceptive methods and sexual intercourse on a daily diary., Main Outcome Measures: Pearl Index (PI) for women 18-35 years (overall and method-failure), bleeding pattern and AEs., Results: A total of 1553 women aged 18-50 years, including 1353 from 18 to 35 years old, received the study medication. PI was 0.47 pregnancies/100 woman-years (95% CI 0.15-1.11); method failure PI was 0.29 pregnancies/100 woman-years (95% CI 0.06-0.83). Scheduled bleeding/spotting occurred in 91.9-94.4% of women over Cycles 1 to 12 and lasted a median of 4-5 days per cycle. The percentage of women with unscheduled bleeding/spotting episodes decreased from 23.5% in Cycle 1 to <16% from Cycle 6 onwards. The most common AEs were headache (7.7%), metrorrhagia (5.5%), vaginal haemorrhage (4.8%) and acne (4.2%). One treatment-related serious AE was reported, a lower extremity venous thromboembolism. One-hundred and forty-one (9.1%) women discontinued study participation because of treatment-related adverse events., Conclusion: E4/DRSP provides effective contraception, a predictable bleeding pattern and a favourable safety profile., Tweetable Abstract: A phase 3 trial with E4/DRSP shows high contraceptive efficacy, a predictable bleeding pattern and favourable safety profile., (© 2021 Estetra SRL. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Objective: To compare adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy., Design: Parallel group, 1:1 single-centre single-blinded randomised trial, designed as non-inferiority study with a margin of 15%., Setting: Belgian teaching hospital., Population: Non-pregnant non-virgin women with an intact uterus and without obliteration of the pouch of Douglas scheduled to undergo removal of an adnexal mass assessed to be benign on ultrasound by IOTA criteria., Methods: Randomisation to laparoscopy (control group) or vNOTES (experimental group). Stratification according to adnexal size. Blinding of participants and outcome assessors by sham incisions., Main Outcome Measures: The primary outcome measure was adnexectomy by the allocated technique. Secondary outcomes included duration of surgery, pain scores and analgesics used, quality of life and adverse events., Results: We randomly assigned 67 participants (34 to the vNOTES group and 33 to the laparoscopy group). The primary end point was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the laparoscopy group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 13%, which is below the predefined non-inferiority margin of 15%. The secondary outcomes demonstrated a shorter duration of surgery, lower pain scores, lower total dose of analgesics and a trend for more adverse events in the vNOTES group., Conclusions: vNOTES is non-inferior to laparoscopy for a successful adnexectomy without conversion. vNOTES allowed shorter operating times and less postoperative pain but there was a trend for more adverse events., (© 2021 John Wiley & Sons Ltd.)

Objective: To evaluate the mode of delivery and stillbirth rates over time among women with obstetric fistula., Design: Retrospective record review., Setting: Tanzania, Uganda, Kenya, Malawi, Rwanda, Somalia, South Sudan, Zambia and Ethiopia., Population: A total of 4396 women presenting with obstetric fistulas for repair who delivered previously in facilities between 1990 and 2014., Methods: Retrospective review of trends and associations between mode of delivery and stillbirth, focusing on caesarean section (CS), assisted vaginal deliveries and spontaneous vaginal deliveries., Main Outcome Measures: Mode of delivery, stillbirth., Results: Out of 4396 women with fistula, 3695 (84.1%) delivered a stillborn baby. Among mothers with fistula giving birth to a stillborn baby, the CS rate (overall 54.8%, 2027/3695) rose from 45% (162/361) in 1990-94 to 64% (331/514) in 2010-14. This increase occurred at the expense of assisted vaginal delivery (overall 18.3%, 676/3695), which declined from 32% (115/361) to 6% (31/514)., Conclusions: In Eastern and Central Africa, CS is increasingly performed on women with obstructed labour whose babies have already died in utero. Contrary to international recommendations, alternatives such as vacuum extraction, forceps and destructive delivery are decreasingly used. Unless uterine rupture is suspected, CS should be avoided in obstructed labour with intrauterine fetal death to avoid complications related to CS scars in subsequent pregnancies. Increasingly, women with obstetric fistula add a history of unnecessary CS to their already grim experiences of prolonged, obstructed labour and stillbirth., Tweetable Abstract: Caesarean section is increasingly performed in African women with stillbirth treated for obstetric fistula., (© 2019 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd on behalf of 1 Royal College of Obstetricians and Gynaecologists.)

Objective: To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure., Design: Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%., Setting: Belgian teaching hospital., Population: Women aged 18-70 years scheduled to undergo hysterectomy for benign indications., Methods: Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors., Main Outcome Measures: The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes., Results: We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the one-sided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference -0.5 days, (95% CI -0.98 to -0.02), P = 0.004., Conclusions: vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting., Tweetable Abstract: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery., (© 2018 Royal College of Obstetricians and Gynaecologists.)