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Objective To assess fertility and obstetric outcomes in women treated with curettage or undergoing expectant management for an incomplete miscarriage after misoprostol treatment. Study Design Between June 2012 and July 2014, we conducted a multicentre randomised clinical trial (RCT) with a parallel cohort study for non-randomised women, treated according to their preference. In the RCT 30 women were allocated curettage and 29 expectant management. In the cohort 197 women participated; 65 underwent curettage and 132 women underwent expectant management. Primary outcome was curation, defined as either an empty uterus on sonography at six weeks or an uneventful clinical follow-up. We used questionnaires to assess fertility and obstetric outcome of the first new pregnancy subsequent to study enrolment. Results Curation was seen in 91/95 women treated with curettage (95.8%) versus 134/161 women managed expectantly (83.2%) (p = 0.003). The response rate was 211/255 (82%). In 198 women pursuing a new pregnancy, conception rates were 92% (67/73) in the curettage group versus 96% (120/125) in the expectant management group (OR 0.96, 95% CI 0.89;1.03, p = 0.34), with ongoing pregnancy rates of 87% (58/67) versus 78% (94/120), respectively (OR 1.12, 95% CI 0.99;1.28, p = 0.226). Preterm birth rates were 1/46 in the curettage group versus 8/81 in the expectant management group (OR 0.22, 95% CI 0.03;1.71 P = 0.15). Caesarean section rates were 23% and 24% for women in the curettage group and expectant management group respectively. Conclusion In women with an incomplete evacuation of the uterus after misoprostol treatment, curettage and expectant management does not lead to different fertility and pregnancy outcomes, as compared to expectant management.

Item does not contain fulltext Objective We assessed experience and preferences among term women undergoing induction of labor with oral misoprostol or Foley catheter. Study Design In 18 of the 29 participating hospitals in the PROBAAT-II trial, women were asked to complete a questionnaire within 24 hours after delivery. We adapted a validated questionnaire about expectancy and experience of labor and asked women whether they would prefer the same method again in a future pregnancy. Results The questionnaire was completed by 502 (72%) of 695 eligible women; 273 (54%) had been randomly allocated to oral misoprostol and 229 (46%) to Foley catheter. Experience of the duration of labor, pain during labor, general satisfaction with labor, and feelings of control and fear related to their expectation were comparable between both the groups. In the oral misoprostol group, 6% of the women would prefer the other method if induction is necessary in future pregnancy, versus 12% in the Foley catheter group (risk ratio: 0.70; 95% confidence interval: 0.55-0.90; p = 0.02). Conclusion Women's experiences of labor after induction with oral misoprostol or Foley catheter are comparable. However, women in the Foley catheter group prefer more often to choose a different method for future inductions.

STUDY QUESTION: What is the treatment success rate of systemic methotrexate (MTX) compared with expectant management in women with an ectopic pregnancy or a pregnancy of unknown location (PUL) with low and plateauing serum hCG concentrations?SUMMARY ANSWER: In women with an ectopic pregnancy or a PUL and low and plateauing serum hCG concentrations, expectant management is an alternative to medical treatment with single-dose systemic MTX.WHAT IS KNOWN AND WHAT THIS PAPER ADDS: MTX is often used in asymptomatic women with an ectopic pregnancy or a PUL with low and plateauing serum hCG concentrations. These pregnancies may be self-limiting and watchful waiting is suggested as an alternative, but evidence from RCTs is lacking. The results of this RCT show that expectant management is an alternative to treatment with systemic MTX in a single-dose regimen in these women.STUDY DESIGN, SIZE, DURATION: A multicentre RCT women were assigned to systemic MTX (single dose) treatment or expectant management, using a web-based randomization program, block randomization with stratification for hospital and serum hCG concentration (PARTICIPANTS, SETTING, METHODS: From April 2007 to January 2012, we performed a multicentre study in The Netherlands. All haemodynamically stable women >18 years old with both an ectopic pregnancy visible on transvaginal sonography and a plateauing serum hCG concentration MAIN RESULTS: We included 73 women of whom 41 were allocated to single-dose MTX and 32 to expectant management. There was no difference in primary treatment success rate of single-dose MTX versus expectant management, 31/41 (76%) and 19/32 (59%), respectively [relative risk (RR) 1.3 95% confidence interval (CI) 0.9-1.8]. In nine women (22%), additional MTX injections were needed, compared with nine women (28%) in whom systemic MTX was administered after initial expectant management (RR 0.8; 95% CI 0.4-1.7). One woman (2%) from the MTX group underwent surgery compared with four women (13%) in the expectant management group (RR 0.2; 95% CI 0.02-1.7), all after experiencing abdominal pain within the first week of follow-up. In the MTX group, nine women reported side effects versus none in the expectant management group. No serious adverse events were reported. Single-dose systemic MTX does not have a larger treatment effect compared with expectant management in women with an ectopic pregnancy or a PUL and low and plateauing serum hCG concentrations.WIDER IMPLICATIONS OF THE FINDINGS: Sixty percent of women after expectant management had an uneventful clinical course with steadily declining serum hCG levels without any intervention, which means that MTX, a potentially harmful drug, can be withheld in these women. BIAS, LIMITATION AND GENERALISABILITY: A limitation of this RCT is that it was an open (not placebo controlled) trial. Nevertheless, introduction of bias was probably limited by the strict criteria to be fulfilled for treatment with MTX.STUDY FUNDING: This trial is supported by a grant of the Netherlands Organization for Health Research and Development (ZonMw Clinical fellow grant 90700154).TRIAL REGISTRATION: ISRCTN 48210491.

INTRODUCTION AND HYPOTHESIS: The objective of the study was to establish the effects of additional diagnostic tests compared to a consensus outcome on treatment selection in primary pelvic organ prolapse. METHODS: Three expert gynecologists individually defined a management plan in 53 patients after magnetic resonance imaging, defecography, urodynamic, and anorectal function test information was provided. These management plans were compared with basic treatment advices in the absence of any test and with consensus advices (opinion-based references). The experts assigned a subjective score (assigned diagnostic value [ADV], 0-100%) to rate the test's relative importance. RESULTS: On average, additional diagnostic testing resulted in a revised initial management plan in 38% of the cases; 24% of the individual management plans did not meet the consensus reference. Overall defecography was regarded most valuable (ADV range 19-65%) vs. magnetic resonance imaging rated least (ADV range 0-37%). CONCLUSIONS: Although additional diagnostic tests frequently led to adaptations of basic treatment proposals, consensus was not reached in a fourth of the cases

(1) To describe the epidemiology of neonatal group B streptococcal (GBS) disease over five years (1997-2001) in the Netherlands, stratified for proven and probable sepsis and for very early (12 h), late early (12 h -7 days) and late (7-90 days) onset sepsis. (2) To evaluate the effect of the introduction in January 1999 of guidelines for prevention of early onset GBS disease based on risk factors.Data on cases were collected in collaboration with the Dutch Paediatric Surveillance Unit and corrected for under-reporting by the capture-recapture technique.Total incidence of proven very early onset, late early onset and late onset GBS sepsis was 0.32, 0.11 and 0.14 per 1000 live births, respectively, and of probable very early onset, late early onset and late onset GBS sepsis was 1.10, 0.18 and 0.02 per 1000 live births, respectively. Maternal risk factors were absent in 46% of the proven early onset cases. Considerably more infants with proven GBS sepsis were boys. 64% of the infants with proven very early onset GBS sepsis were first born compared with 47% in the general population. After the introduction of guidelines the incidence of proven early onset sepsis decreased considerably from 0.54 per 1000 live births in 1997-8 to 0.36 per 1000 live births in 1999-2001. However, there was no decrease in the incidence of meningitis and the case fatality rate in the first week of life. The incidence of late onset sepsis also remained unchanged.After the introduction prevention guidelines based on risk factors there has been a limited decrease in the incidence of proven early onset GBS sepsis in the Netherlands. This study therefore recommends changing the Dutch GBS prevention guidelines.

Item does not contain fulltext Group B streptococcal (GBS) infection is still an important cause of morbidity and mortality in newborn infants. In The Netherlands, there are no published data on the incidence of neonatal GBS infection. We collected data of all infants with GBS disease during the first 3 months of life, as reported to the Dutch Paediatric Surveillance Unit (DPSU) during a period of 2 years (1997-98). Neonates with early-onset GBS disease (both sepsis and probable sepsis) were included for further analysis. The level of completeness of the DPSU data was determined by capture-recapture techniques. The incidence of early-onset GBS disease in The Netherlands in 1997-98, as calculated from the DPSU data, was 0.9 per 1000 live births. After correction for under-reporting, the incidence was estimated to be 1.9 per 1000 live births. The case fatality rate of early-onset GBS disease was only 5%. Despite the decrease in the mortality rate during the last decades, it remains a serious condition with potential irreversible brain damage. Therefore, formal guidelines for the prevention of neonatal early-onset GBS disease in The Netherlands were introduced in 1999. The data collected in this study may serve as baseline data for evaluation of the effect of these guidelines.

The prevalence of human papillomavirus (HPV) rises with increasing histological severity of neoplasia, more cigarettes smoked per day and higher lifetime number of sexual partners in women with cervical dyskaryosis. Recently, the highly sensitive SPF10 primers and Inno-LiPA (line probe assay) HPV prototype research assay became available for the detection and typing of HPV. Background : using this system, we challenged the previously reported findings. Study design : the study group comprised 304 women referred because of abnormal pap smears in whom a histological diagnosis was made. Data on the lifetime number of sexual partners and smoking behaviour were obtained by questionnaire. HPV analysis was performed on cervical scrapes obtained at the enrolment visit. Results : oncogenic HPV was found in 288 (95%) women. A total of 86 (30%) out of these 288 women disclosed multiple types. HPV 16 occurred significantly less often in multiple infections than was expected on the basis of chance alone. The grade of neoplasia was significantly associated with the presence of oncogenic HPV, and this association depended on the presence of HPV type 16. No association was found between grade of neoplasia and the presence of multiple HPV types. Neither the lifetime number of sexual partners nor smoking were associated with oncogenic HPV, the five most frequent HPV types separately or the presence of multiple types. Conclusion : we conclude that the association between the detection of HPV and the epidemiological risk factors, as found with the GP5/6 PCR in the past, could not be confirmed when using SPF10 PCR primers and LiPA HPV genotyping. We suggest that the number of sexual partners and smoking may be determinants of high HPV viral load rather than determinants of the presence of HPV per se.

Item does not contain fulltext BACKGROUND: Physiotherapy involving pelvic-floor muscle training is advocated as first-line treatment for stress urinary incontinence; midurethral-sling surgery is generally recommended when physiotherapy is unsuccessful. Data are lacking from randomized trials comparing these two options as initial therapy. METHODS: We performed a multicenter, randomized trial to compare physiotherapy and midurethral-sling surgery in women with stress urinary incontinence. Crossover between groups was allowed. The primary outcome was subjective improvement, measured by means of the Patient Global Impression of Improvement at 12 months. RESULTS: We randomly assigned 230 women to the surgery group and 230 women to the physiotherapy group. A total of 49.0% of women in the physiotherapy group and 11.2% of women in the surgery group crossed over to the alternative treatment. In an intention-to-treat analysis, subjective improvement was reported by 90.8% of women in the surgery group and 64.4% of women in the physiotherapy group (absolute difference, 26.4 percentage points; 95% confidence interval [CI], 18.1 to 34.5). The rates of subjective cure were 85.2% in the surgery group and 53.4% in the physiotherapy group (absolute difference, 31.8 percentage points; 95% CI, 22.6 to 40.3); rates of objective cure were 76.5% and 58.8%, respectively (absolute difference, 17.8 percentage points; 95% CI, 7.9 to 27.3). A post hoc per-protocol analysis showed that women who crossed over to the surgery group had outcomes similar to those of women initially assigned to surgery and that both these groups had outcomes superior to those of women who did not cross over to surgery. CONCLUSIONS: For women with stress urinary incontinence, initial midurethral-sling surgery, as compared with initial physiotherapy, results in higher rates of subjective improvement and subjective and objective cure at 1 year. (Funded by ZonMw, the Netherlands Organization for Health Research and Development; Dutch Trial Register number, NTR1248.).

Group B streptococcus is the leading cause of neonatal septicaemia. Major risk factors for early-onset disease are heavy maternal GBS colonization preterm delivery (and related low birthweight), preterm rupture of membranes, prelabour rupture of membranes, intrapartum fever, GBS urinary infection and low levels of maternal serum anti-GBS antibodies. Screening for maternal GBS colonization, a part of most current preventive strategies, can be targeted on all pregnant women or only on those with recognizable risk factors, and can be implemented antepartum or intrapartum. A culture in a selective broth is the 'gold standard' for detection of GBS colonization. The lower vagina (introitus) is the most suitable site for culturing, with the optional addition of an anorectal sample. The sensitivity of the available rapid GBS antigen tests for vagina samples seems too low to advocate their general use. Intrapartum prophylaxis with ampicillin, preferably targeted on GBS-colonized parturients with risk factors is, at present, the only strategy with established efficacy and safety to prevent early-onset infection. Vaginal chlorhexidine disinfection during labour in all women may, in addition offer a minor contribution to prevention. Late-onset GBS disease is unlikely to be reduced by these strategies. In the future, immunoprophylaxis may well prove to be the most safe and efficacious alternative to prevent GBS septicaemia, irrespective of age of onset, although protection of (very) preterm infants is unlikely.

Objective:Group B streptococcus (GBS,Streptococcus agalactiae) is an important cause of neonatal sepsis. Prevention is possible by intrapartum screening for maternal GBS carriership and antimicrobial treatment of colonized women with risk factors during labor. The conflicting results of diagnostic performance are reported both for the newly developed rapid GBS antigen tests and Gram's stain.Methods:The value of Gram's stain in GBS screening was investigated prospectively in 1,020 women. Intrapartum Gram's stains of the cervix from these women and of the introitus from 510 of them were compared with cultures of the cervix, introitus, and anorectum in a semiquantitative way.Results:The sensitivities of the cervical and introital Gram's stains were 25% and 31%, respectively, and the specificities 99% and 98%, respectively. Higher sensitivities (52% and 44%, respectively) were found in heavily colonized parturients. No significant influence of rupture of the membranes was detected. There was a poor correlation between the number of gram-positive cocci in the Gram's stain and the growth density.Conclusions:We do not recommend the routine use of the Gram's stain for intrapartum GBS detection because of both the limited sensitivity and positive predictive value.

Objectives: To evaluate the sensitivity of intrapartum screening for group B streptococcal (GBS) colonization and to compare 4 rapid GBS antigen tests in vitro. Design: Two swabs of the lower vagina of 769 parturients were taken; one swab was cultured, the other was frozen at −70 °C until antigen testing with the Group B Strep Test (Quidel) of the culture positive samples was performed. The Quidel test was then compared with 3 other rapid GBS antigen tests in vitro: Wellcogen Strep B (Wellcome Diagnostics), Slidex meningite Strepto B (bioMerieux) and ICON Strep B (Hybritech). The supernatant of 29 GBS cultures in Todd-Hewitt broth was tested in bacterial concentrations of 106, 107, and 108 Colony-Forming Units (CFU)/ml, respectively. Results: Lower vagina GBS carrier rate was 13.4% (103769) and heavy colonization (growth density 3 and 4 on blood agar plates) was found in 5.2% (40769). The Group B Strep Test detected 11% (11103) of GBS carriers, with a sensitivity for heavy colonization of 25% (1040). In vitro none of the tests scored positively with a concentration of 106 CFU/ml, while with 107 CFU/ml the enzyme immunoassay tests (Quidel, Hybritech) were more sensitive (McNemar test, P < 0.05) than the latex agglutination tests (Wellcome Diagnostics, bioMerieux). Conclusions: Although in vitro the enzyme immunoassay tests are more sensitive than the latex agglutination tests, sensitivity in vivo is too low to recommend the use of rapid antigen tests for general screening.

Background Patients with ectopic pregnancy (EP) and low serum hCG concentrations and women with a pregnancy of unknown location (PUL) and plateauing serum hCG levels are commonly treated with systemic methotrexate (MTX). However, there is no evidence that treatment in these particular subgroups of women is necessary as many of these early EPs may resolve spontaneously. The aim of this study is whether expectant management in women with EP or PUL and with low but plateauing serum hCG concentrations is an alternative to MTX treatment in terms of treatment success, future pregnancy, health related quality of life and costs. Methods/Design A multicentre randomised controlled trial in The Netherlands. Hemodynamically stable patients with an EP visible on transvaginal ultrasound and a plateauing serum hCG concentration < 1,500 IU/L or with a persisting PUL with plateauing serum hCG concentrations < 2,000 IU/L are eligible for the trial. Patients with a viable EP, signs of tubal rupture/abdominal bleeding, or a contra-indication for MTX will not be included. Expectant management is compared with systemic MTX in a single dose intramuscular regimen (1 mg/kg) in an outpatient setting. Serum hCG levels are monitored weekly; in case of inadequately declining, systemic MTX is installed or continued. In case of hemodynamic instability and/or signs of tubal rupture, surgery is performed. The primary outcome measure is an uneventful decline of serum hCG to an undetectable level by the initial intervention. Secondary outcomes are (re)interventions (additional systemic MTX injections and/or surgery), treatment complications, health related quality of life, financial costs, and future fertility. Analysis is performed according to the intention to treat principle. Quality of life is assessed by questionnaires before and at three time points after randomisation. Costs are expressed as direct costs with data on costs and used resources in the participating centres. Fertility is assessed by questionnaires after 6, 12, 18 and 24 months. Patients' preferences will be assessed using a discrete choice experiment. Discussion This trial will provide guidance on the present management dilemmas in women with EPs and PULs with low and plateauing serum hCG concentrations. Trial registration Current Controlled Trials ISRCTN 48210491

Groups A and B streptococci are of great significance in the history of obstetrics. Group A streptococci were a great threat to the puerperium, especially in the 19th century, when homebirth was replaced by institutional birth in lying-in hospitals. The history of the rise and fall of puerperal fever is indeed a tragedy. Some people, like Semmelweis, who brought new and important evidence based findings were not believed by their fellow obstetricians, an attitude that spoilt thousands of innocent lives. Even today group A streptococci, though seldom, may be the cause of puerperal sepsis. Group B streptococci are widespread and may cause sepsis and important lifelong morbidity or mortality of the newborn. Obstetricians today try to establish cost-effective prophylactic measures during labor to prevent these neonatal infections.

Risk indicators play an important role in the active prevention of neonatal Early-Onset GBS-related Disease (EOD). We studied the associations between potential risk indicators and the occurrence of EOD by means of a case-control study. All cases of EOD delivered in the Academic Medical Centre in Amsterdam between January 1988 and December 1995 were included. For each case we selected 3 controls, matched for date and time of birth. The association between continuous risk indicators and the occurrence of EOD was assessed using spline functions. Multivariable logistic regression analysis was performed to determine which risk indicators contributed independently. Forty-one cases were compared with 123 controls. In the multivariable analysis, gestational age < 37 weeks and intrapartum temperature > or = 37.4 degrees C showed to be statistically significant risk indicators for EOD, with odds ratios of 2.5 per week gestation and 1.6 per 0.1 degree C, respectively. After cesarean section the risk of EOD was significantly decreased (OR 0.13). Of the other potential risk indicators only prelabor rupture of membranes showed an increased risk, although the association was not statistically significant. Prolonged duration of ruptured membranes had no additional merit. Risk indicators that should be taken into account in strategies to prevent EOD are increased maternal temperature and decreased gestational age

On a passe en revue retrospectivement tous les cas prouves de septicemie a streptocoque du groupe B (GBS) precoce dans une unite de soins intensifs neonatals entre 1985 et 1993 pour determiner la morbidite et mortalite. En outre, nous avons evalue les facteurs de risque de meme que les facteurs prognostiques. Les donnees supplementaires ont ete obtenues par des dossiers medicaux ou par une questionnaire rempli par les parents. Soixante-dix-huit patients souffrants de GBS precoce ont ete identifie. Le taux de mortalite total etait de 23%. Tous les 5 patients (6,5%) souffrants de meningite sont morts. En 60 cas sur 73 (82%) au moins un des facteurs de risque examines a ete present: prematurite, des symptomes d'infection pendant la grossesse et une rupture prolongee des membranes (tableau I). Le faible poids a la naissance n'etait pas un facteur de risque independant (fig. 2). Nous avons obtenu des donnees supplementaires sur 44 des 60 survivants (73%) apres au moins un an (tableau Il). A peu pres 30% d'entre-eux souffrait de suites: les plus importantes etaient des spasticites et developpement psychomoteur retarde. Dans 42% des patients qui montraient des symptomes d'infection GBS dans les premiers 6 heures apres la naissance, se sont presentes des suites. Il n'y avait pas de suites parmi les patients ou se sont presentes des symptomes apres 6 heures. Tous les 9 enfants avec endommagement cerebral severe montraient des symptomes peu apres la naissance. La mortalite et le taux des sequels etaient superieurs parmi les enfants nes prematurement ou avec un score d'Apgar a 5 minutes moins de 7. Le traitement prompt a fait baisser la mortalite, mais n'a pas reduit les sequels. La septicemie GBS provoque toujours une mortalite significative. En meme temps, parmi les survivants un nombre substantiel reste endommage. Il est crucial de rester vigilant a l'infection GBS pour assurer le traitement prompt et pour avoir des bons resultats.

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Objective: To evaluate the effect of vaginal disinfection with chlorhexidine gel during labor on vertical transmission of group B streptococcus, as a method to prevent vertical transmission and subsequent neonatal early onset group B streptococcal disease. Study Design: A prospective study with randomization of 1020 parturients to one of three groups as soon as labor started. In all parturients, anus, introitus and cervix were cultured semiquantitatively. Two groups were treated double-blindly with 10 ml of either a 0.3% chlorhexidine gel or a placebo gel, applicated around the portio and into the fomices. If labor still continued, a second application was given after 10 h. The third group received no treatment. Ear, pharynx and umbilicus of all newborns were also cultured semiquantitatively. Results: Nine hundred and eighty one women were evaluated. The overall incidence of group B strep­ tococcal carriership was 19.4%. Vertical transmission was 52.4% in the chlorhexidine group, 71.4% in the placebo group and 66.7% in the control group (P = 0.069). When testing the transmission rates for the chlorhexidine versus the combined placebo plus control group (69.3%), the difference was 16.9% (P ~ 0.026). Conclusion: Vaginal disinfection with a chlorhexidine gel during labor modest­ ly reduces group B streptococcal vertical transmission. Because the method is cheap, simple and safe, it should be considered for routine use. Our results indicate that it may reduce the incidence of early onset group B streptococcal sepsis by 2-32%.