Uri Wiesenfeld

GINEXMAL RCT: Induction of labour versus expectant management in gestational diabetes pregnancies.

BackgroundGestational Diabetes (GDM) is one of the most common complications of pregnancies affecting around 7% of women. This clinical condition is associated with an increased risk of developing fetal macrosomia and is related to a higher incidence of caesarean section in comparison to the general population. Strong evidence indicating the best management between induction of labour at term and expectant monitoring are missing.Methods/DesignPregnant women with singleton pregnancy in vertex presentation previously diagnosed with gestational diabetes will be asked to participate in a multicenter open-label randomized controlled trial between 38+0 and 39+0 gestational weeks. Women will be recruited in the third trimester in the Outpatient clinic or in the Day Assessment Unit according to local protocols. Women who opt to take part will be randomized according to induction of labour or expectant management for spontaneous delivery. Patients allocated to the induction group will be admitted to the obstetric ward and offered induction of labour via use of prostaglandins, Foley catheter or oxytocin (depending on clinical conditions). Women assigned to the expectant arm will be sent to their domicile where they will be followed up until delivery, through maternal and fetal wellbeing monitoring twice weekly. The primary study outcome is the Caesarean section (C-section) rate, whilst secondary measurement4s are maternal and neonatal outcomes. A total sample of 1760 women (880 each arm) will be recruited to identify a relative difference between the two arms equal to 20% in favour of induction, with concerns to C-section rate. Data will be collected until mothers and newborns discharge from the hospital. Analysis of the outcome measures will be carried out by intention to treat.DiscussionThe present trial will provide evidence as to whether or not, in women affected by gestational diabetes, induction of labour between 38+0 and 39+0 weeks is an effective management to ameliorate maternal and neonatal outcomes. The primary objective is to determine whether caesarean section rate could be reduced among women undergoing induction of labour, in comparison to patients allocated to expectant monitoring. The secondary objective consists of the assessment and comparison of maternal and neonatal outcomes in the two study arms.Trial RegistrationThe study protocol has been registered in the ClinicalTrials.gov Protocol Registration System, identification number NCT01058772.

Tubercular endometritis visualized as endometrial micropolyps during hysteroscopic procedure

Female genital tuberculosis is a rare disease in developed countries but it is a frequent cause of chronic pelvic inflammatory disease and infertility in undeveloped countries. A rare case of tubercular endometritis diagnosed at hysteroscopy and successfully treated in a woman with secondary infertility, is presented. As far as we know this is the first case that shows the association between endometrial micropolyps and tubercular endometritis.

STUDY OF THE PARTNERS OF WOMEN WITH HUMAN PAPILLOMAVIRUS INFECTION

Background. Genital human papillomavirus (HPV) infection is one of the most common sexually transmitted diseases, and it has been identified as a significant risk factor for the development of dysplasia and cancer of the uterine cervix. The possible influence of male HPV lesions on female cervix oncogenesis has not been elucidated so far. In the present study we evaluate the male partners of women with clinical or subclinical HPV infection with particular interest in the clinical features of this infection in both partners.

Resectoscopic treatment of atypical endometrial polyps in fertile women.

OBJECTIVE The purpose of this study was to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in fertile women with or without progestin suppression. STUDY DESIGN We conducted a quasi-randomized trial in which conservative treatment was offered to 21 patients who had endometrial polyps with focal atypia and a surrounding normal endometrium. The polyps were analyzed separately from their bases. Random biopsy specimens were taken from 4 standard places of the endometrium. RESULTS Eighteen women (10 women with an intrauterine device and 8 women with no intrauterine device) completed the follow-up procedure. After 5 years, we found no difference in the 2 groups regarding recurrence of atypical polyps. CONCLUSION Conservative resectoscopic treatment may be considered in fertile women with atypical polyps if polyp base and surrounding endometrium are benign. If women want to become pregnant at short term, the use of progestins can be delayed, with a strict follow-up procedure. Larger studies should be encouraged.

Overtreatment in a see-and-treat approach to cervical intraepithelial lesions.

To the Editor: We read with interest the report by Bosgraaf et al on the see-and-treat approach to cervical intraepithelial lesions. Our concern regards the possibly misleading conclusion that this approach is justifiable in some cases with only high-grade impression on colposcopy. The large loop excision of the transformation zone, called loop electrosurgical excision procedure (LEEP) in North America, is very efficient and not difficult to learn for treating cervical lesions. A LEEP can be performed on an outpatient basis, and the size of the loop can be adjusted depending on the lesion. It is easier to become a good LEEP performer than a good colposcopist. Therefore a colposcopic impression alone, especially in times of defensive medicine, could cause an excessive use of LEEP, with the consequent risks reported also in a recent Finnish study. The two-step approach, requiring a colposcopically directed biopsy, as recently recommended by the Society of Obstetricians and Gynecologists of Canada, is, in our opinion, preferable because it allows a tailored treatment and favors better training for colposcopists. The key for improving the standard of care for patients with cervical intraepithelial lesions is the skill of the colposcopist, who also has the responsibility of facilitating shared decision making through patient information before, during, and after the examination, as recommended by European Guidelines.

Meconium-stained amniotic fluid: a risk factor for postpartum hemorrhage

Background/aim Clinical data with respect to the impact of meconium on the risk of maternal hemorrhage are scarce. Therefore, in this study, we aimed to determine whether meconium-stained amniotic fluid (MSAF) represents a risk factor for postpartum hemorrhage (PPH) after vaginal delivery in a large unselected population. Patients and methods A retrospective cohort study evaluated 78,542 consecutive women who had a vaginal delivery between 24th and 44th weeks of gestation. The women who had undergone cesarean section were excluded to avoid possible bias. Postpartum blood loss was measured with graduated blood sack. Postpartum blood loss between 1,000 and 2,000 mL and >2,000 mL were classified as moderate and severe PPH, respectively. Results A total of 74,144 patients were available for analysis. According to the color of amniotic fluid (AF), two groups of patients were identified: MSAF (n=10,997) and clear AF (n=63,147). The rates of severe and massive PPH were found to be significantly higher in the MSAF group than that of clear AF group (OR=1.3, 95% CI: 1.2–1.5, p<0.001 and OR=2.5, 95% CI: 1.5–4.2, p<0.001). Operative vaginal delivery rate was found to be higher in the MSAF group than that of clear AF group, but the difference was only borderline significant (OR=1.5, 95% CI: 1.0–2.2, p=0.05). There were no significant differences between the MSAF and the clear AF groups with respect to episiotomies, second- or third-degree perineal tears, vaginal–perineal thrombus, cervical lacerations, vaginal births after cesarean section, twin deliveries, and placental retention rates. Conclusion To the best of our knowledge, this is the first clinical study that has investigated the role of MSAF as a risk factor for PPH after vaginal delivery in an unselected population. Our results suggest that MSAF is significantly associated with higher risk of moderate and severe PPH than clear AF.

Relevance of random biopsy at the transformation zone when colposcopy is negative.

To the Editor:We read with interest the article by Huh et al1 on random biopsy in women with negative colposcopy results. We completely agree that colposcopic practice is not perfect, and the colposcopist is not a perfect doctor. But the colposcopist remains a very important doctor. As recommended b

Re: Management of women with low‐grade cytology: how reassuring is a normal colposcopy examination?

Sir, Miscarriage is one of the most common clinical problems that gynaecologists encounter every day, worldwide. Despite multiple studies on first-trimester miscarriage, there has been no significant change in management, in terms of both medical and psychological treatment, in the past two decades. Besides, there is a lack of high-quality study on the effectiveness of psychological intervention for women suffering pregnancy loss. Therefore, we believed our study, a randomised controlled trial to assess the effectiveness of a supportive counselling programme compared with ‘standard’ care upon psychological wellbeing following miscarriage, can be applied to current practice. Although our results do not justify the routine counselling of all women following miscarriage, a supportive counselling programme for selected women with high levels of psychological distress may be more promising. We do believe that these results can be generalised to women of different ethnicity, or merits further investigation. Gestational age at the time of pregnancy loss could affect the psychological impact. Previous studies on this issue are heterogeneous on patient recruitment, including miscarriage, late-pregnancy loss or even perinatal deaths. Thus, the results from these studies are not suitable to be applied in the management of women with miscarriages, the majority of which occur in the first trimester. Our study specifically targeted women with first-trimester miscarriage, aiming to formulate better post-miscarriage psychological care of women. The stratification of gestational age in firsttrimester miscarriage may further identify risk factors for psychological distress, and further research is required to identify the ‘high risk’ group of women who would benefit from supportive counselling, apart from those with high levels of psychological distress reported from questionnaires. For the treatment modalities in firsttrimester miscarriage, our previous study did not demonstrate substantial differences in the psychological impact, women’s preference and satisfaction for different treatment modalities. Thus, we believe that the treatment modalities will not significantly alter the risk of psychological distress after miscarriage. Healthcare professionals should pay attention to psychological morbidity after miscarriage and offer adequate support to these women; however, it is difficult to recognise women whom are in psychological distress after miscarriage. We suggest the use of the 12–item General Health Questionnaire (GHQ– 12) and the 21–item Beck Depression Inventory (BDI) psychological questionnaires to assess the level of psychological distress, and to provide supportive counselling to women who have high levels of psychological distress.n