'She convinced me'- partner involvement in choosing a high risk birth setting against medical advice in the Netherlands: A qualitative analysis.

Home births in high risk pregnancies and unassisted childbirth seem to be increasing in the Netherlands. There is a lack of qualitative data on women's partners' involvement in these choices in the Dutch maternity care system, where integrated midwifery care and home birth are regular options in low risk pregnancies. The majority of available literature focuses on the women's motivations, while the partner's influence on these decisions is much less well understood. We aimed to examine partners' involvement in the decision to birth outside the system, in order to provide medical professionals with insight and recommendations regarding their interactions with these partners in the outpatient clinic. An exploratory qualitative research design with a constructivist approach and a grounded theory method were used. In-depth interviews were performed with twenty-one partners on their involvement in the decision to go against medical advice in choosing a high risk childbirth setting. Open, axial and selective coding of the interview data was done in order to generate themes. Four main themes were found: 1) Talking it through, 2) A shared vision, 3) Defending our views, and 4) Doing it together. One overarching theme emerged that covered all other themes: 'She convinced me'. These data show that the idea to choose a high risk birth setting almost invariably originated with the women, who did most of the research online, filtered the information and convinced the partners of the merit of their plans. Once the partners were convinced, they took a very active and supportive role in defending the plan to the outside world, as well as in preparing for the birth. Maternity care providers can use these findings in cases where there is a discrepancy between the wishes of the woman and the advice of the professional, so they can attempt to involve partners actively during consultations in pregnancy. That will ensure that partners also receive information on all options, risks and benefits of possible birth choices, and that they are truly in support of a final plan.

External quality assessment schemes for inorganic elements in the clinical laboratory: Lessons from the OELM scheme.

Measurements of inorganic elements in clinical laboratories produce results used for the diagnosis, the treatment and the monitoring of deficiencies or overloads. The main objective of External Quality Assessment Schemes is to verify, on a regular frequency, that clinical laboratory results correspond to the quality requirement for patient care. Therefore, External Quality Assessment Schemes represent an essential component of a laboratory's quality management system. However, External Quality Assessment Schemes within the same analytical field remain heterogeneous for different reasons such as samples, determination of assigned value, acceptable limits, content of the reports. The aim of this review was to describe and illustrate some major critical aspects of External Quality Assessment Schemes based on Occupational and Environmental Laboratory Medicine external quality assessment scheme experience.

Discontinuation of intravenous oxytocin in the active phase of induced labour.

BACKGROUND: In most Western countries, obstetricians and midwives induce labour in about 25% of pregnant women. Oxytocin is an effective drug for this purpose, but associated with serious adverse effects of which uterine tachysystole, fetal distress and the need for immediate delivery are the most common. Various administration regimens such as reduced or pulsatile dosing have been suggested to minimise these. Discontinuation in the active phase of labour, i.e. when contractions are well-established and the cervix is dilated at least 5 cm is another method which may reduce adverse effects. OBJECTIVES: To assess whether birth outcomes can be improved by discontinuation of intravenous (IV) oxytocin, initiated in the latent phase of induced labour, once active phase of labour is established. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2018), Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) (23 January 2018) together with reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing discontinued IV with continuous IV oxytocin in the active phase of induced labour.No exclusion criteria were applied in terms of parity, maternal age, ethnicity, co-morbidity status, labour setting, gestational age, and prior caesarean delivery.Studies comparing different dosage regimens are outside the scope of this review. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. MAIN RESULTS: We found 10 completed RCTs involving 1888 women. One additional trial is ongoing. The included trials were conducted in hospital settings between February 1998 and January 2016, two in Europe (Denmark, and Greece), two in Turkey, and one each in Israel, Iran, USA, Bangladesh, India, and Thailand. Most trials included full-term singleton pregnancies with a fetus in vertex presentation. Some excluded women with cervical priming prior to induction and some excluded women with a history of prior caesarean delivery. When reported, the average age of the women ranged from 22 to 31 years, nulliparity from 45% to 68%, and pre-pregnancy body mass index from 22 to 32.Many of the included trials had design limitations and were judged to be at either high or unclear risk of bias across a number of 'Risk of bias' domains.Four trials included a Consort flow diagram. In three, this gave details of participants delivered before the active phase of labour, and treatment compliance for those who reached that stage. One Consort diagram only provided the latter information. The data in many of the trials without such a flow diagram were implausibly compliant with treatment allocation, suggesting that there had been silent post randomisation exclusions of women delivered before the active phase of labour. We therefore conducted a secondary analysis (not in our protocol) of caesarean section among women who reached the active phase of labour and were therefore eligible for the intervention.Our analysis by 'intention-to-treat' found that, compared with continuation of IV oxytocin stimulation, discontinuation of IV oxytocin may reduce the caesarean delivery rate, risk ratio (RR) 0.69, 95% confidence interval (CI) 0.56 to 0.86, 9 trials, 1784 women, low-level certainty. However, restricting our analysis to women who reached the active phase of labour (using 'reached active phase' as our denominator) suggests there is probably little or no difference between groups (RR 0.92, 95% CI 0.65 to 1.29, 4 trials, 787 women, moderate-certainty evidence).Discontinuation of IV oxytocin probably reduces the risk ofuterine tachysystole combined with abnormal fetal heart rate (FHR) compared with continued IV oxytocin (RR 0.15, 95% CI 0.05 to 0.46, 3 trials, 486 women, moderate-level certainty). We are uncertain about whether or not discontinuation increases the risk of chorioamnionitis (average RR 2.32, 95% CI 0.99 to 5.45, 1 trial, 252 women, very low-level certainty). Discontinuation of IV oxytocin may have little or no impact on the use of analgesia and epidural during labour compared to the use of continued IV oxytocin (RR 1.04 95% CI 0.95 to 1.14, 3 trials, 556 women, low-level certainty). Intrapartum cardiotocography (CTG) abnormalities (suspicious/pathological CTGs) are probably reduced by discontinuing IV oxytocin (RR 0.65, 95% CI 0.51 to 0.83, 7 trials, 1390 women, moderate-level certainty). Compared to continuing IV oxytocin, discontinuing IV oxytocin probably has little or no impact on the incidence of Apgar < 7 at five minutes (RR 0.78, 95% CI 0.27 to 2.21, 4 trials, 893 women, low-level certainty), or and acidotic cord gasses at birth (arterial umbilical pH < 7.10), (RR 1.03, 95% CI 0.50 to 2.13, 4 trials, 873 women, low-level certainty).Many of this review's maternal and infant secondary outcomes (including maternal and neonatal mortality) were not reported in the included trials. AUTHORS' CONCLUSIONS: Discontinuing IV oxytocin stimulation after the active phase of labour has been established may reduce caesarean delivery but the evidence for this was low certainty. When restricting our analysis to those trials that separately reported participants who reached the active phase of labour, our results showed there is probably little or no difference between groups. Discontinuing IV oxytocin may reduce uterine tachysystole combined with abnormal FHR.Most of the trials had 'Risk of bias' concerns which means that these results should be interpreted with caution. Our GRADE assessments ranged from very low certainty to moderate certainty. Downgrading decisions were based on study limitations, imprecision and indirectness.Future research could account for all women randomised and, in particular, note those who delivered before the point at which they would be eligible for the intervention (i.e. those who had caesareans in the latent phase), or because labour was so rapid that the infusion could not be stopped in time.Future trials could adopt the outcomes listed in this review including maternal and neonatal mortality, maternal satisfaction, and breastfeeding.

Women's motivations for choosing a high risk birth setting against medical advice in the Netherlands: a qualitative analysis.

BACKGROUND: Home births in high risk pregnancies and unassisted childbirth seem to be increasing in the Netherlands. Until now there were no qualitative data on women's motivations for these choices in the Dutch maternity care system where integrated midwifery care and home birth are regular options in low risk pregnancies. We aimed to examine women's motivations for birthing outside the system in order to provide medical professionals with insight and recommendations regarding their interactions with women who have birth wishes that go against medical advice. METHODS: An exploratory qualitative research design with a constructivist approach and a grounded theory method were used. In-depth interviews were performed with 28 women on their motivations for going against medical advice in choosing a high risk childbirth setting. Open, axial and selective coding of the interview data was done in order to generate themes. A focus group was held for a member check of the findings. RESULTS: Four main themes were found: 1) Discrepancy in the definition of superior knowledge, 2) Need for autonomy and trust in the birth process, 3) Conflict during negotiation of the birth plan, and 4) Search for different care. One overarching theme emerged that covered all other themes: Fear. This theme refers both to the participants' fear (of interventions and negative consequences of their choices) and to the providers' fear (of a bad outcome). Where for some women it was a positive choice, for the majority of women in this study the choice for a home birth in a high risk pregnancy or an unassisted childbirth was a negative one. Negative choices were due to previous or current negative experiences with maternity care and/or conflict surrounding the birth plan. CONCLUSIONS: The main goal of working with women whose birthing choices do not align with medical advice should not be to coerce them into the framework of protocols and guidelines but to prevent negative choices. Recommendations for maternity caregivers can be summarized as: 1) Rethink risk discourse, 2) Respect a woman's trust in the birth process and her autonomous choice, 3) Have a flexible approach to negotiating the birth plan using the model of shared decision making, 4) Be aware of alternative delivery care providers and other sources of information used by women, and 5) Provide maternity care without spreading or using fear.

Experienced job autonomy among maternity care professionals in The Netherlands.

OBJECTIVE: High levels of experienced job autonomy are found to be beneficial for healthcare professionals and for the relationship with their patients. The aim of this study was to assess how maternity care professionals in the Netherlands perceive their job autonomy in the Dutch maternity care system and whether they expect a new system of integrated maternity care to affect their experienced job autonomy. DESIGN: A cross-sectional survey. The Leiden Quality of Work Life Questionnaire was used to assess experienced job autonomy among maternity care professionals. SETTING: Data were collected in the Netherlands in 2015. PARTICIPANTS: 799 professionals participated of whom 362 were primary care midwives, 240 obstetricians, 93 clinical midwives and 104 obstetric nurses. FINDINGS: The mean score for experienced job autonomy was highest for primary care midwives, followed by obstetricians, clinical midwives and obstetric nurses. Primary care midwives scored highest in expecting to lose their job autonomy in an integrated care system. KEY CONCLUSIONS: There are significant differences in experienced job autonomy between maternity care professionals. IMPLICATIONS FOR PRACTICE: When changing the maternity care system it will be a challenge to maintain a high level of experienced job autonomy for professionals. A decrease in job autonomy could lead to a reduction in job related wellbeing and in satisfaction with care among pregnant women.

Women's Experiences with and Preference for Induction of Labor with Oral Misoprostol or Foley Catheter at Term.

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.

Induction of labour at term with oral misoprostol versus a Foley catheter (PROBAAT-II): a multicentre randomised controlled non-inferiority trial.

BACKGROUND: Labour is induced in 20-30% of all pregnancies. In women with an unfavourable cervix, both oral misoprostol and Foley catheter are equally effective compared with dinoprostone in establishing vaginal birth, but each has a better safety profile. We did a trial to directly compare oral misoprostol with Foley catheter alone. METHODS: We did an open-label randomised non-inferiority trial in 29 hospitals in the Netherlands. Women with a term singleton pregnancy in cephalic presentation, an unfavourable cervix, intact membranes, and without a previous caesarean section who were scheduled for induction of labour were randomly allocated to cervical ripening with 50 µg oral misoprostol once every 4 h or to a 30 mL transcervical Foley catheter. The primary outcome was a composite of asphyxia (pH ≤7·05 or 5-min Apgar score <7) or post-partum haemorrhage (≥1000 mL). The non-inferiority margin was 5%. The trial is registered with the Netherlands Trial Register, NTR3466. FINDINGS: Between July, 2012, and October, 2013, we randomly assigned 932 women to oral misoprostol and 927 women to Foley catheter. The composite primary outcome occurred in 113 (12·2%) of 924 participants in the misoprostol group versus 106 (11·5%) of 921 in the Foley catheter group (adjusted relative risk 1·06, 90% CI 0·86-1·31). Caesarean section occurred in 155 (16·8%) women versus 185 (20·1%; relative risk 0·84, 95% CI 0·69-1·02, p=0·067). 27 adverse events were reported in the misoprostol group versus 25 in the Foley catheter group. None were directly related to the study procedure. INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with oral misoprostol and Foley catheter has similar safety and effectiveness. FUNDING: FondsNutsOhra.

Pessary placement in the prevention of preterm birth in multiple pregnancies: a propensity score analysis.

OBJECTIVE: In asymptomatic women with a multiple pregnancy and short cervix prophylactic use of a cervical pessary might reduce preterm birth. We assessed the possible treatment effects of pessary use in pregnancy duration and for poor perinatal outcome. STUDY DESIGN: This cohort study was performed between December 2012 and September 2014 in 44 hospitals in the Netherlands. Women with multiple pregnancy had a cervical length measurement between 16 and 22 weeks of gestation. When cervical length was below 38 mm, women were offered a cervical pessary. The course of pregnancy, including perinatal outcome in these women was compared to the outcome of women from the placebo group of the AMPHIA trial (ISRCTN40512715) (historical cohort). Propensity-score matching with replacement was used to create comparable baseline characteristics between both populations. RESULTS: We studied 63 women in the pessary group and 56 women as controls. Propensity-score matching generated 57 women in the intervention group matched to 57 women (31 unique) in the control group. Gestational age at delivery was comparable between both groups (HR 0.96, 95%-CI 0.46-1.46) as well as their delivery rates before 28, 32 and 37 weeks, RR 0.68 (95%-CI 0.21-2.18), RR 0.54 (95%-CI 0.21-1.41), and RR 1.22 (95%-CI 0.47-3.15), respectively. There was no difference in composite perinatal outcome (RR 1.36, 95%-CI 0.53-3.51) and perinatal mortality (RR 0.89, 95%-CI 0.24-3.38) either. CONCLUSION: In this cohort study with propensity score analysis, pessary use did not prevent preterm birth in asymptomatic women with a multiple pregnancy and short cervix.

Incidence and recurrence rate of placental abruption: a longitudinal linked national cohort study in the Netherlands.

OBJECTIVE: Women who have experienced a placental abruption have a risk of recurrence, but exact information to quantify this risk is currently not available. We studied the incidence and recurrence rate of placental abruption in a subsequent pregnancy and the influence of hypertensive disorders. STUDY DESIGN: We conducted a retrospective national cohort study of all singleton pregnancies that ended from 1999-2007 in the Netherlands. A longitudinal linked national cohort of these women with information on a subsequent singleton delivery was used. We calculated and compared incidence and recurrence rates of placental abruption for women in total, stratified by gestational age of first placental abruption and by the presence of a hypertensive disorder in their first pregnancy. RESULTS: We studied 1,570,635 women of which 3496 (0.22%) experienced a placental abruption. Information was available on a subsequent singleton delivery for 264,424 deliveries. Of these, 521 women (0.20%) had a placental abruption in the first pregnancy vs 214 women (0.08%) in the second pregnancy. The risk of placental abruption in a subsequent pregnancy was significantly higher in women with a previous placental abruption compared with women without (5.8% vs 0.06%; adjusted odds ratio [aOR], 93; 95% confidence interval [CI], 62-139). Women with a placental abruption that occurred at term in their first pregnancy were more at risk for recurrence (aOR, 188; 95% CI, 116-306) than women with a preterm (aOR, 52; 95% CI, 25-111) or early preterm (<32 weeks of gestation) placental abruption in their first pregnancy (aOR, 39; 95% CI, 13-116). Placental abruption was more frequent among women with a hypertensive disorder compared with normotensive women (0.44% vs 0.16%; odds ratio, 2.7; 95% CI, 2.3-3.3). Women with a hypertensive disorder were less at risk for recurrence than were normotensive women (aOR, 0.68; 95% CI, 0.27-1.6). No interaction between a hypertensive disorder in the first pregnancy and the recurrence risk was found. CONCLUSION: Women with a placental abruption in their first pregnancy have a greatly increased risk of placental abruption in a subsequent pregnancy. Hypertensive disorders increase the risk of placental abruption but do not increase the recurrence rate in a subsequent pregnancy. We suggest elective induction from 37 weeks of gestation for women with a history of placental abruption at term in a previous pregnancy.

Prediction of postpartum hemorrhage in women with gestational hypertension or mild preeclampsia at term.

OBJECTIVE: To assess whether postpartum hemorrhage can be predicted in women with gestational hypertension or mild preeclampsia at term. DESIGN: A cohort study in which we used data from our multicentre randomized controlled trial (HYPITAT trial). SETTING: The study was conducted in 38 hospitals in the Netherlands between 2005 and 2008. POPULATION: Women with gestational hypertension or mild preeclampsia at term (n = 1132). METHODS: An antepartum model (model A) and an antepartum/intrapartum model (model B) were created using logistic regression. The predictive capacity of the models was assessed with receiver operating characteristic analysis and calibration. MAIN OUTCOME MEASURE: Postpartum hemorrhage, defined as blood loss >1000 mL within 24 h after delivery. RESULTS: Postpartum hemorrhage occurred in 118 (10.4%) women. Maternal age (odds ratio 1.03), prepregnancy body mass index (odds ratio 0.96), and women with preeclampsia (odds ratio 1.5) were independent antepartum prognostic variables of postpartum hemorrhage. Intrapartum variables incorporated in the model were gestational age at delivery (odds ratio 1.2), duration of dilatation stage (odds ratio 1.1), and episiotomy (odds ratio 1.5). Model A and model B showed moderate discrimination, with areas under the receiver operating characteristic curve of 0.59 (95% confidence interval 0.53-0.64) and 0.64 (95% confidence interval 0.59-0.70), respectively. Calibration was moderate for model A (Hosmer-Lemeshow p = 0.26) but better for model B (Hosmer-Lemeshow p = 0.36). The rates of postpartum hemorrhage ranged from 4% (lowest 10%) to 22% (highest 10%). CONCLUSION: In the assessment of performance of a prediction model, calibration is more important than discriminative capacity. Our prediction model shows that for women with gestational hypertension or mild preeclampsia at term, distinction between low and high risk of developing postpartum hemorrhage is possible when antepartum and intrapartum variables are combined.

Cervical pessaries for prevention of preterm birth in women with a multiple pregnancy (ProTWIN): a multicentre, open-label randomised controlled trial.

BACKGROUND: In women with a multiple pregnancy, spontaneous preterm delivery is the leading cause of perinatal morbidity and mortality. Interventions to reduce preterm birth in these women have not been successful. We assessed whether a cervical pessary could effectively prevent poor perinatal outcomes. METHODS: We undertook a multicentre, open-label randomised controlled trial in 40 hospitals in the Netherlands. We randomly assigned women with a multiple pregnancy between 12 and 20 weeks' gestation (1:1) to pessary or control groups, using a web-based application with a computer-generated list with random block sizes of two to four, stratified by hospital. Participants and investigators were aware of group allocation. For women in the pessary group, a midwife or obstetrician inserted a cervical pessary between 16 and 20 weeks' gestation. Women in the control group did not receive the pessary, but otherwise received similar obstetrical care to those in the pessary group. The primary outcome was a composite of poor perinatal outcome: stillbirth, periventricular leucomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular haemorrhage, necrotising enterocolitis, proven sepsis, and neonatal death. Analyses were by modified intention to treat. This trial is registered in the Dutch trial registry, number NTR1858. FINDINGS: Between Sept 21, 2009, and March 9, 2012, 813 women underwent randomisation, of whom 808 were analysed (401 in the pessary group; 407 in the control group). At least one child of 53 women (13%) in the pessary group had poor perinatal outcome, compared with 55 (14%) in the control group (relative risk 0·98, 95% CI 0·69-1·39). INTERPRETATION: In unselected women with a multiple pregnancy, prophylactic use of a cervical pessary does not reduce poor perinatal outcome. FUNDING: The Netherlands Organisation for Health Research and Development.

Foley catheter or prostaglandin E2 inserts for induction of labour at term: an open-label randomized controlled trial (PROBAAT-P trial) and systematic review of literature.

OBJECTIVE: To assess the safety and effectiveness of a transcervical Foley catheter compared to vaginal prostaglandin E2 inserts for term induction of labour. STUDY DESIGN: We conducted an open-label randomized controlled trial in five hospitals in the Netherlands. Women with a singleton term pregnancy in cephalic presentation, intact membranes, unfavourable cervix, and no prior caesarean section were enrolled. Participants were randomly allocated by a web-based randomization system to induction of labour with a 30 ml Foley catheter or 10mg slow-release vaginal prostaglandin E2 inserts in a 1:1 ratio. Due to the nature of the intervention this study was not blinded. The primary outcome was the caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. Additionally, we carried out a systematic review and meta-analysis of similar studies. RESULTS: We analyzed 226 women: 107 received a Foley catheter and 119 inserts. Caesarean section rates were comparable (20% versus 22%, RR 0.90, 95% CI 0.54-1.50). Secondary outcomes showed no differences. We observed no serious maternal or neonatal morbidity. Meta-analysis showed comparable caesarean section rates, but significantly fewer cases of hyperstimulation during the ripening phase when a Foley catheter was used. CONCLUSIONS: We found, in this relatively small study, no differences in effectiveness and safety of induction of labour with a Foley catheter and 10mg slow release vaginal prostaglandin E2 inserts. Meta-analysis confirmed a comparable caesarean section rate, and showed fewer cases of hyperstimulation when a Foley catheter was used.

Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial.

BACKGROUND: Induction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women with an unfavourable cervix. Recently, we showed that in term women with an unfavorable cervix the use of a Foley catheter in comparison with vaginal Prostaglandin E2 gel, results in a comparable vaginal delivery rate. A meta-analysis on the subject indicated lower rates of hyperstimulation, and probably as a sequel fewer cases of postpartum haemorrhage. Misoprostol (PgE1) is another type of prostaglandin frequently used for labour induction, recommended by the international federation of gynaecology and obstetrics (FIGO). Misoprostol can be administered by vaginal, rectal and oral route. There is evidence that oral administration results in less asphyxia and hyperstimulation than vaginal administration. At present, valid comparisons between oral misoprostol and Foley catheter are lacking. Therefore, we propose a randomised controlled trial comparing Foley catheter to oral misoprostol in order to assess safety and cost-effectiveness. METHODS/DESIGN: We plan a multicentre, randomised, controlled, open-label clinical trial among term pregnant women with a vital singleton in cephalic presentation, unfavorable cervix, intact membranes and an indication for induction of labour. After informed consent, women will be randomly allocated by a webbased randomisation system to transcervical Foley catheter or oral misoprostol (50 mcg every 4 hours). The primary outcome will be a composite of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are mode of delivery, maternal and neonatal morbidity, costs and women's preference. Serious adverse events such as severe maternal or neonatal morbitity or mortality will be monitored and reported to an independent data safety monitory board. With a sample size of 1860 women we will be able to demonstrate a 5% non-inferiority of the Foley catheter as compared to misoprostol for the composite outcome. DISCUSSION: Worldwide, various methods are being used for labour induction. Results of the proposed trial will contribute to the answer which method of induction of labour is most safe, cost-effective, and patient friendly and will help to construct evidence based guidelines. TRIAL REGISTRATION: The Netherlands Trial Register NTR3466.

Foley catheter versus vaginal prostaglandin E2 gel for induction of labour at term (PROBAAT trial): an open-label, randomised controlled trial.

BACKGROUND: Induction of labour is a common obstetric procedure. Both mechanical (eg, Foley catheters) and pharmacological methods (eg, prostaglandins) are used for induction of labour in women with an unfavourable cervix. We aimed to compare the effectiveness and safety of induction of labour with a Foley catheter with induction with vaginal prostaglandin E2 gel. METHODS: We did an open-label, randomised controlled trial in 12 hospitals in the Netherlands between Feb 10, 2009, and May 17, 2010. We enrolled women with a term singleton pregnancy in cephalic presentation, intact membranes, an unfavourable cervix, an indication for induction of labour, and no prior caesarean section. Participants were randomly allocated by an online randomisation system to induction of labour with a 30 mL Foley catheter or vaginal prostaglandin E2 gel (1:1 ratio). Because of the nature of the intervention this study was not blinded. The primary outcome was caesarean section rate. Secondary outcomes were maternal and neonatal morbidity and time from intervention to birth. All analyses were done on an intention-to-treat basis. We also did a meta-analysis that included our trial. The trial was registered with the Dutch trial registry, number NTR 1646. FINDINGS: 824 women were allocated to induction of labour with a Foley catheter (n=412) or vaginal prostaglandin E2 gel (n=412). Caesarean section rates were much the same between the two groups (23%vs 20%, risk ratio [RR] 1·13, 95% CI 0·87-1·47). A meta-analysis including our trial data confirmed that a Foley catheter did not reduce caesarean section rates. We recorded two serious maternal adverse events, both in the prostaglandin group: one uterine perforation and one uterine rupture. INTERPRETATION: In women with an unfavourable cervix at term, induction of labour with a Foley catheter is similar to induction of labour with prostaglandin E2 gel, with fewer maternal and neonatal side-effects. FUNDING: None.

[The many manifestations of Behçet's disease]. / De vele uitingen van de ziekte van Behçet.

A 19-year-old woman with a Syrian background complained of genital ulcers. Sexually transmitted disease was excluded. She was also suffering from oral aphthae and had been treated by a dermatologist for acne. The diagnosis of Behçet disease was made primarily on clinical grounds. Pathological examination of skin biopsies confirmed the diagnosis. The patient was successfully treated with corticosteroids. Behçet's disease is a chronic autoimmune vasculitis, often characterized by oral ulcers. The symptoms are often non-specific and the disease has exacerbations and remissions. This often makes its diagnosis difficult. Its exact cause is unknown but the immune system and genetic factors may play a role. Although diagnosis is made mainly on clinical grounds, laboratory tests and pathology examination may contribute to the establishment of the differential diagnosis.

Severe complication after termination of a second trimester cervical pregnancy.

OBJECTIVE: To report a supracervical hysterectomy performed after a life-threatening hemorrhage due to an attempted surgical termination at a gestational age of 18 weeks, which appeared to be a cervical pregnancy. DESIGN: Case report. SETTING: Teaching hospital. PATIENT(S): A 36-year-old pregnant woman, with two previous cesarean sections. INTERVENTION(S): Supracervical hysterectomy. MAIN OUTCOME MEASURE(S): Not applicable. RESULT(S): A stable patient. CONCLUSION(S): By missing a cervical pregnancy in the second trimester, a life-threatening hemorrhage occurred after an attempted surgical termination. In case of failure of the conservative therapy this rare diagnosis should be considered. A supracervical hysterectomy at this gestational age is the only therapeutic option.

Diagnosis of lumbar spinal stenosis: a systematic review of the accuracy of diagnostic tests.

STUDY DESIGN: Systematic review of diagnostic studies. OBJECTIVE: To investigate the diagnostic performance of tests used to detect lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Little is known about the diagnostic accuracy of tests in detecting lumbar spinal stenosis. A systematic review will provide more insight in this topic. METHODS: We performed a literature search in Medline (PubMed) and Embase for original diagnostic studies on lumbar spinal stenosis, in which one or more different tests were evaluated with a reference standard, and diagnostic values were reported or could be calculated. Two reviewers independently checked all abstracts and full text articles for inclusion criteria. Included articles were assessed for their quality using the Quadas tool. Study features and diagnostic values were extracted from the included studies. RESULTS: Of the 24 articles included in this review, 15 concerned imaging tests, 7 evaluated "clinical tests," and 2 reported on other diagnostic tests. The overall quality was poor; only 5 studies scored positive on more than 50% of the quality items. Estimates of the diagnostic value of the tests differed considerably. The imaging studies showed no superior accuracy for myelography compared with CT or MRI. Overall, there is considerable variation in the clinical tests; some studies show high sensitivity, whereas others show high specificity. CONCLUSIONS: Because of heterogeneity and overall poor quality, no firm conclusions about the diagnostic performance of the different tests can be drawn. Better-designed studies exploring the accuracy of diagnostic tests are needed to improve the diagnostic policy.

Womens' preference in Down syndrome screening.

OBJECTIVE: To determine the knowledge of pregnant women about prenatal tests, and what tests they would choose if offered. Also, the preference of pregnant women for second-trimester or first-trimester screening was assessed. PATIENTS AND METHODS: Pregnant women receiving antenatal care in a decentralized primary care system (n=80), and pregnant women that were offered a prenatal diagnosis at the Academic Medical Centre (n=195), were asked to complete a questionnaire. RESULTS: The response rate was over 80%. Most women in both groups preferred a screening test for Down syndrome to be performed in the first trimester of pregnancy. A combination of nuchal translucency measurement and first-trimester serum screening was the option of choice. The screening possibilities for Down syndrome were less well known to the women in the low-risk group compared with the women in the high-risk group. The offer of a prenatal screening test would have been declined by more than 30% of women at low risk for carrying a fetus with Down syndrome. CONCLUSIONS: Our results show that women prefer screening for Down syndrome to be performed in the first trimester of pregnancy, using both serum and ultrasound tests. In women at low risk for Down syndrome the knowledge of prenatal screening methods was less, as well as the acceptance of prenatal screening being lower.