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Objective: To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women., Design: Randomised multicentre double-blind placebo controlled trial., Setting: Two Dutch teaching hospitals and one Dutch university medical centre., Population: Postmenopausal and premenopausal nulliparous women undergoing office hysteroscopy., Methods: Patients were randomised to receive either 400 microgram misoprostol or placebo 12 and 24 hours before hysteroscopy. Pain was quantified by the use of real time pain measurement using the continuous pain score meter (CPSM) and VAS scores., Main Outcome Measures: Primary outcome was pain measured by the CPSM during passage of the hysteroscope through the cervical canal, quantified by the area under the curve (AUC). Secondary outcomes included VAS scores, other CPSM parameters, failures and side effects., Results: In all, 149 patients were randomly assigned to either misoprostol (n = 74) or placebo (n = 75). The AUC during introduction did not significantly differ between the intervention and the placebo group. The VAS score during introduction, however, demonstrated a significant difference in premenopausal nulliparous women favouring misoprostol: 2.9 (95% CI 1.3-4.4) versus placebo 5.5 (95% CI 3.9-7.1), P = 0.02, as well as the AUC during the entire procedure: 618 (95% CI 410-827) versus 1126 (95% CI 671-1580), P = 0.04. Failures were equally distributed between the misoprostol (16%) and placebo group (13%). Intestinal side effects occurred significantly more frequently in the misoprostol group (67%) than in the placebo group (32%) [OR 4.2 (95% CI 2.1-8.3), P < 0.01]., Conclusion: Misoprostol prior to hysteroscopy reduces pain in premenopausal nulliparous women but not in postmenopausal women. It does cause side effects., Tweetable Abstract: RCT: misoprostol versus placebo prior to hysteroscopy in 149 women significantly reduces some pain parameters., (© 2017 Royal College of Obstetricians and Gynaecologists.)

Study Question: Is salpingotomy cost effective compared with salpingectomy in women with tubal pregnancy and a healthy contralateral tube?, Summary Answer: Salpingotomy is not cost effective over salpingectomy as a surgical procedure for tubal pregnancy, as its costs are higher without a better ongoing pregnancy rate while risks of persistent trophoblast are higher., What Is Known Already: Women with a tubal pregnancy treated by salpingotomy or salpingectomy in the presence of a healthy contralateral tube have comparable ongoing pregnancy rates by natural conception. Salpingotomy bears the risk of persistent trophoblast necessitating additional medical or surgical treatment. Repeat ectopic pregnancy occurs slightly more often after salpingotomy compared with salpingectomy. Both consequences imply potentially higher costs after salpingotomy., Study Design, Size, Duration: We performed an economic evaluation of salpingotomy compared with salpingectomy in an international multicentre randomized controlled trial in women with a tubal pregnancy and a healthy contralateral tube. Between 24 September 2004 and 29 November 2011, women were allocated to salpingotomy (n = 215) or salpingectomy (n = 231). Fertility follow-up was done up to 36 months post-operatively., Participants/materials, Settings, Methods: We performed a cost-effectiveness analysis from a hospital perspective. We compared the direct medical costs of salpingotomy and salpingectomy until an ongoing pregnancy occurred by natural conception within a time horizon of 36 months. Direct medical costs included the surgical treatment of the initial tubal pregnancy, readmissions including reinterventions, treatment for persistent trophoblast and interventions for repeat ectopic pregnancy. The analysis was performed according to the intention-to-treat principle., Main Results and the Role of Chance: Mean direct medical costs per woman in the salpingotomy group and in the salpingectomy group were €3319 versus €2958, respectively, with a mean difference of €361 (95% confidence interval €217 to €515). Salpingotomy resulted in a marginally higher ongoing pregnancy rate by natural conception compared with salpingectomy leading to an incremental cost-effectiveness ratio €40 982 (95% confidence interval -€130 319 to €145 491) per ongoing pregnancy. Since salpingotomy resulted in more additional treatments for persistent trophoblast and interventions for repeat ectopic pregnancy, the incremental cost-effectiveness ratio was not informative., Limitations, Reasons for Caution: Costs of any subsequent IVF cycles were not included in this analysis. The analysis was limited to the perspective of the hospital., Wider Implications of the Findings: However, a small treatment benefit of salpingotomy might be enough to cover the costs of subsequent IVF. This uncertainty should be incorporated in shared decision-making. Whether salpingotomy should be offered depends on society's willingness to pay for an additional child., Study Funding/competing Interests: Netherlands Organisation for Health Research and Development, Region Västra Götaland Health & Medical Care Committee., Trial Registration Number: ISRCTN37002267., (© The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: Despite an extensive screening programme in The Netherlands, some cases of cervical cancer are still diagnosed in late stages of disease. The aim of the present study was to investigate which elements in the diagnostic process of cervical cancer may be improved., Methods: This is a retrospective study of 120 patients with cervical cancer diagnosed between January 1st 2008 and June 1st 2010 at the University Medical Center Utrecht. Patient charts, referral information, and pathology results were analyzed., Results: 39.1% of cancer cases were screen or interval detected; the other 60.9% of patients had not been screened, either due to non-attendance or because they fell outside the age range for screening. The final diagnosis of cervical cancer was established by biopsy in 77 (64.2%) and by excision of the cervical transformation zone in 35 (29.2%) of the patients. Fifteen (43%) of these excisions could have been avoided if biopsies would have been taken at the first examination, and had shown invasive cancer., Conclusions: Cervical cancer screening aims at early detection of precursor lesions to decrease the incidence of cancer. This in-depth analysis suggests that improvement of quality of care is to be expected from correct recognition of cervical cancer by physicians and adjustments of the screening programme to reach younger women and non-responders., (Copyright © 2015 Elsevier Inc. All rights reserved.)

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.).

Background: Heavy menstrual bleeding is an important health problem. Two frequently used therapies are the levonorgestrel intra-uterine system (LNG-IUS) and endometrial ablation. The LNG-IUS can be applied easily by the general practitioner, which saves costs, but has considerable failure rates. As an alternative, endometrial ablation is also very effective, but this treatment has to be performed by a gynaecologist. Due to lack of direct comparison of LNG-IUS with endometrial ablation, there is no evidence based preferred advice for the use of one of these treatment possibilities., Method/design: A multicenter randomised controlled trial, organised in a network infrastructure in the Netherlands in which general practitioners and gynaecologists collaborate., Discusson: This study, considering both effectiveness and cost effectiveness of LNG-IUS versus endometrial ablation may well improve care for women with heavy menstrual bleeding., Trial Registration: Dutch trial register, number NTR2984.

Background: Medical treatment with misoprostol is a non-invasive and inexpensive treatment option in first trimester miscarriage. However, about 30% of women treated with misoprostol have incomplete evacuation of the uterus. Despite being relatively asymptomatic in most cases, this finding often leads to additional surgical treatment (curettage). A comparison of effectiveness and cost-effectiveness of surgical management versus expectant management is lacking in women with incomplete miscarriage after misoprostol., Methods/design: The proposed study is a multicentre randomized controlled trial that assesses the costs and effects of curettage versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage.Eligible women will be randomized, after informed consent, within 24 hours after identification of incomplete evacuation of the uterus by ultrasound scanning. Women are randomly allocated to surgical or expectant management. Curettage is performed within three days after randomization.Primary outcome is the sonographic finding of an empty uterus (maximal diameter of any contents of the uterine cavity < 10 millimeters) six weeks after study entry. Secondary outcomes are patients' quality of life, surgical outcome parameters, the type and number of re-interventions during the first three months and pregnancy rates and outcome 12 months after study entry., Discussion: This trial will provide evidence for the (cost) effectiveness of surgical versus expectant management in women with incomplete evacuation of the uterus after misoprostol treatment for first trimester miscarriage., Trial Registration: Dutch Trial Register: NTR3110.

Objective: To evaluate whether correct adherence to clinical guidelines might have led to prevention of cases with adverse neonatal outcome., Design: Secondary analysis of cases with adverse outcome in a multicenter randomized clinical trial., Setting: Nine Dutch hospitals., Population: Pregnant women with a term singleton fetus in cephalic position., Methods: Data were obtained from a randomized trial that compared monitoring by STAN® (index group) with cardiotocography (control group). In both trial arms, three observers independently assessed the fetal surveillance results in all cases with adverse neonatal outcome, to determine whether an indication for intervention was present, based on current clinical guidelines., Main Outcome Measures: Adverse neonatal outcome cases fulfilled one or more of the following criteria: (i) metabolic acidosis in umbilical cord artery (pH < 7.05 and base deficit in extracellular fluid >12 mmol/L); (ii) umbilical cord artery pH < 7.00; (iii) perinatal death; and/or (iv) signs of moderate or severe hypoxic ischemic encephalopathy., Results: We studied 5681 women, of whom 61 (1.1%) had an adverse outcome (26 index; 35 control). In these women, the number of performed operative deliveries for fetal distress was 18 (69.2%) and 16 (45.7%), respectively. Reassessment of all 61 cases showed that there was a fetal indication to intervene in 23 (88.5%) and 19 (57.6%) cases, respectively. In 13 (50.0%) vs. 11 (33.3%) cases, respectively, this indication occurred more than 20 min before the time of delivery, meaning that these adverse outcomes could possibly have been prevented., Conclusions: In our trial, more strict adherence to clinical guidelines could have led to additional identification and prevention of adverse outcome., (© 2012 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2012 Nordic Federation of Societies of Obstetrics and Gynecology.)

Objective: To predict instrumental vaginal delivery or caesarean section for suspected fetal distress or failure to progress., Design: Secondary analysis of a randomised trial., Setting: Three academic and six non-academic teaching hospitals in the Netherlands., Population: 5667 labouring women with a singleton term pregnancy in cephalic presentation., Methods: We developed multinomial prediction models to assess the risk of operative delivery using both antepartum (model 1) and antepartum plus intrapartum characteristics (model 2). The models were validated by bootstrapping techniques and adjusted for overfitting. Predictive performance was assessed by calibration and discrimination (area under the receiver operating characteristic), and easy-to-use nomograms were developed., Main Outcome Measures: Incidence of instrumental vaginal delivery or caesarean section for fetal distress or failure to progress with respect to a spontaneous vaginal delivery (reference)., Results:   375 (6.6%) and 212 (3.6%) women had an instrumental vaginal delivery or caesarean section due to fetal distress, and 433 (7.6%) and 571 (10.1%) due to failure to progress, respectively. Predictors were age, parity, previous caesarean section, diabetes, gestational age, gender, estimated birthweight (model 1) and induction of labour, oxytocin augmentation, intrapartum fever, prolonged rupture of membranes, meconium stained amniotic fluid, epidural anaesthesia, and use of ST-analysis (model 2). Both models showed excellent calibration and the receiver operating characteristics areas were 0.70-0.78 and 0.73-0.81, respectively., Conclusion:   In Dutch women with a singleton term pregnancy in cephalic presentation, antepartum and intrapartum characteristics can assist in the prediction of the need for an instrumental vaginal delivery or caesarean section for fetal distress or failure to progress., (© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.)

Objective: To investigate the agreement between conventional colposcopic impression, dynamic spectral imaging (DSI) colposcopy and histology, for human papillomavirus type 16-positive (HPV16(+)) and non-16 high-risk (hr) HPV(+) women., Design: Prospective, comparative, multicentre clinical trial., Setting: Three colposcopy clinics in the Netherlands., Population: Women (n = 177) aged 18 years or over with an intact cervix, referred for colposcopy., Methods: The colposcopist graded the lesion by using the DSI colposcope as a regular video colposcope. Subsequently the DSI impression was displayed and biopsies were taken from all abnormal areas as well as from a random (normal) site. A cervical smear was taken for HPV typing., Main Outcome Measures: Histologically confirmed high-grade cervical intraepithelial neoplasia or cancer (CIN2(+)), positive for HPV16 or for any other hrHPV type., Results: The DSI colposcope identified more CIN2(+) cervical lesions among HPV16(+) women than in non-16 hrHPV(+) women (P = 0.032 regardless of final histology and P = 0.009 among women with CIN2(+)). Consequently, the sensitivity of the DSI colposcope for detecting CIN2(+) lesions was higher in HPV16(+) women than in non-16 hrHPV(+) women (97% versus 74%, P = 0.009). No such differences were seen for the colposcopist impression. In addition, mainly smaller cervical lesions are missed by the colposcopist., Conclusions: The sensitivity of DSI colposcopy for CIN2(+) is higher in HPV16(+) than in non-16 hrHPV(+) women. Furthermore, regardless of HPV16 status, the sensitivity of DSI for CIN2(+) is higher than that of the colposcopist, probably because colposcopists tend to miss smaller cervical lesions., (© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.)

We sought to predict neonatal metabolic acidosis at birth using antepartum obstetric characteristics (model 1) and additional characteristics available during labor (model 2). In 5667 laboring women from a multicenter randomized trial that had a high-risk singleton pregnancy in cephalic presentation beyond 36 weeks of gestation, we predicted neonatal metabolic acidosis. Based on literature and clinical reasoning, we selected both antepartum characteristics and characteristics that became available during labor. After univariable analyses, the predictors of the multivariable models were identified by backward stepwise selection in a logistic regression analysis. Model performance was assessed by discrimination and calibration. To correct for potential overfitting, we (internally) validated the models with bootstrapping techniques. Of 5667 neonates born alive, 107 (1.9%) had metabolic acidosis. Antepartum predictors of metabolic acidosis were gestational age, nulliparity, previous cesarean delivery, and maternal diabetes. Additional intrapartum predictors were spontaneous onset of labor and meconium-stained amniotic fluid. Calibration and discrimination were acceptable for both models (c-statistic 0.64 and 0.66, respectively). In women with a high-risk singleton term pregnancy in cephalic presentation, we identified antepartum and intrapartum factors that predict neonatal metabolic acidosis at birth., (Copyright © 2012 by Thieme Medical Publishers, Inc.)

Objective: To assess the cost-effectiveness of addition of ST analysis of the fetal electrocardiogram (ECG; STAN) to cardiotocography (CTG) for fetal surveillance during labor compared with CTG only., Design: Cost-effectiveness analysis based on a randomized clinical trial on ST analysis of the fetal ECG., Setting: Obstetric departments of three academic and six general hospitals in The Netherlands. Population. Laboring women with a singleton high-risk pregnancy, a fetus in cephalic presentation, a gestational age >36 weeks and an indication for internal electronic fetal monitoring., Methods: A trial-based cost-effectiveness analysis was performed from a health-care provider perspective., Main Outcome Measures: Primary health outcome was the incidence of metabolic acidosis measured in the umbilical artery. Direct medical costs were estimated from start of labor to childbirth. Cost-effectiveness was expressed as costs to prevent one case of metabolic acidosis., Results: The incidence of metabolic acidosis was 0.7% in the ST-analysis group and 1.0% in the CTG-only group (relative risk 0.70; 95% confidence interval 0.38-1.28). Per delivery, the mean costs per patient of CTG plus ST analysis (n= 2 827) were €1,345 vs. €1,316 for CTG only (n= 2 840), with a mean difference of €29 (95% confidence interval -€9 to €77) until childbirth. The incremental costs of ST analysis to prevent one case of metabolic acidosis were €9 667., Conclusions: The additional costs of monitoring by ST analysis of the fetal ECG are very limited when compared with monitoring by CTG only and very low compared with the total costs of delivery., (© 2011 The Authors Acta Obstetricia et Gynecologica Scandinavica© 2011 Nordic Federation of Societies of Obstetrics and Gynecology.)

A 46-year old multiparous woman visited a 1-stop clinic for abnormal uterine bleeding. There was a small submucosal type 2 myoma of 2 cm in her normal sized uterus. We treated her using Novasure endometrial ablation. One year later the patient suffered from sudden excessive vaginal bleeding and collapse. A myoma of 4 cm was being expelled from the uterus.

Background: For most tubal ectopic pregnancies (EP) surgery is the treatment of first choice. Whether surgical treatment should be performed conservatively (salpingostomy) or radically (salpingectomy) in women wishing to preserve their reproductive capacity, is subject to debate. Salpingostomy preserves the tube, but bears the risks of both persistent trophoblast and repeat ipsilateral tubal EP. Salpingectomy, avoids these risks, but leaves only one tube for reproductive capacity. This study aims to reveal the trade-off between both surgical options: whether the potential advantage of salpingostomy, i.e. a better fertility prognosis as compared to salpingectomy, outweighs the potential disadvantages, i.e. persistent trophoblast and an increased risk for a repeat EP., Methods/design: International multi centre randomised controlled trial comparing salpingostomy versus salpingectomy in women with a tubal EP without contra lateral tubal pathology. Hemodynamically stable women with a presumptive diagnosis of tubal EP, scheduled for surgery, are eligible for inclusion. Patients pregnant after in vitro fertilisation (IVF) and/or known documented tubal pathology are excluded. At surgery, a tubal EP must be confirmed. Only women with a tubal EP amenable to both interventions and a healthy contra lateral tube are included. Salpingostomy and salpingectomy are performed according to standard procedures of participating hospitals. Up to 36 months after surgery, women will be contacted to assess their fertility status at six months intervals starting form the day of the operation. The primary outcome measure is the occurrence of spontaneous viable intra uterine pregnancy. Secondary outcome measures are persistent trophoblast, repeat EP, all pregnancies including those resulting from IVF and financial costs. The analysis will be performed according to the intention to treat principle. A cost-effectiveness analysis will be performed within a decision analysis framework, based on costs per live birth, including IVF treatment whenever a spontaneous pregnancy does not occur. Patients' preferences will be assessed using a discrete choice experiment., Discussion: This trial will provide evidence on the trade off between salpingostomy and salpingectomy for tubal EP in view of the pros and cons of both interventions and will offer guidance to clinicians in making the right treatment choice., Trial Registration: Current Controlled Trials ISRCTN37002267.

Objective: The aim of this study was to assess the preference of women with early pregnancy failure for treatment with misoprostol as compared to curettage., Study Design: Women with early pregnancy failure were interviewed and asked whether they were motivated to trade a non-invasive but potentially less effective treatment with misoprostol at the virtually 100% guarantee of complete evacuation after curettage. All women had a structured interview, in which they were informed about both treatment options. The women were asked for a treatment preference in case the complete evacuation rate after misoprostol was set at 100%. In case the women preferred misoprostol, the complete evacuation rate was subsequently decreased to 10% using steps of 5%., Results: The study group consisted of 64 women with early pregnancy failure. Seven women (11%) did not opt for misoprostol at all, because of fear of pain or bleeding using misoprostol. Fifty percent of the women would prefer misoprostol if its complete evacuation rate exceeds 65%., Conclusion: A majority of women would prefer misoprostol over curettage if its complete evacuation rate exceeds 65%.

Background: We aimed to compare patients' health-related quality of life after a misoprostol strategy to a curettage in women with early pregnancy failure after failed expectant management., Methods: A multicentre randomized clinical trial was performed in The Netherlands. In all, 154 women with early pregnancy failure confirmed at ultrasonography who had been managed expectantly unsuccessfully for > or =1 week were randomly assigned to undergo either treatment with misoprostol (n=79) or curettage (n=75). The main outcome measures were health-related quality of life and satisfaction with treatment., Results: In the misoprostol strategy 47% of the women needed additional curettage, as compared to 4% after curettage. In both groups, health-related quality of life was impaired most severely 2 days after treatment. In the misoprostol group, health-related quality of life was more severely impaired; after 2 days this was due to more pain and after 2 and 6 weeks this was due to a worse general health perception. Health-related quality of life was temporarily significantly more impaired in women in whom misoprostol failed as compared to women in whom misoprostol treatment was successful. In both treatment groups, an equal percentage of women (58%) would choose the same treatment in the future. In women treated with misoprostol, however, this choice depended on the initial success of misoprostol: in cases where misoprostol had caused complete evacuation, 76% of the women would opt for the same treatment, whereas only 38% of women who needed curettage after unsuccessful misoprostol would do so (P<0.01)., Conclusion: Our study shows that, although both the misoprostol strategy and the curettage strategy resulted in complete evacuation in the end, women are willing to accept some disadvantages of misoprostol to avoid curettage. A treatment inconvenience using misoprostol is accepted as long as initial evacuation rate is high. This finding should be an integral part of counselling women when deciding upon management of early pregnancy failure.

Background: The increased pressure on health care expenses implies that physicians should consider economic aspects as part of the clinical decision-making process. Direct and indirect costs of a strategy starting with misoprostol in treatment of early pregnancy failure as compared to curettage is therefore performed., Methods: We performed a cost-minimization analysis alongside a multicentre randomized trial. Clinical data and data on the use of medical resources were obtained from a randomized trial comparing misoprostol and curettage, which had shown that misoprostol reduced the need for curettage in 53%. In a sensitivity analysis the percentage of women who needed curettage after misoprostol varied between 25 and 90%., Results: Direct costs per case were significantly lower in the misoprostol group (mean 433) than in the curettage group (mean 683) (mean difference 250, 95% CI 184 to 316, P < 0.001). These significant differences existed under a wide range of alternative assumptions about unit costs. The differences in direct cost in favour of misoprostol were large for women who had complete evacuation after initial misoprostol treatment as compared to those who needed additional curettage after failed misoprostol. Mean indirect costs were equal for both groups (misoprostol mean 486; curettage mean 428; mean difference 60, 95% CI -61 to 179, P = 0.51). The mean total costs for a strategy starting with misoprostol was 915 versus 1107 for curettage, with a mean difference between both groups of 192 (95% CI 33 to 351, P = 0.04). An increase of the complete evacuation rates for initial misoprostol therapy to 90% in the sensitivity analysis increased the cost difference between misoprostol and curettage to 550., Conclusion: The use of misoprostol for early pregnancy failure after failed expectant management is less costly than curettage.

Objective: Misoprostol and sulprostone are prostaglandins that can be used for the termination of second and third trimester pregnancy. The aim of the present study was to compare the effectiveness of both agents for the termination of second and third trimester pregnancy in cases of congenital or genetic abnormalities, and for the induction of labour in cases of intra-uterine foetal death., Study Design: We collected data from all women who had been treated with misoprostol in the second or third trimester of pregnancy between January 2001 and July 2002 in cases of congenital or genetic abnormalities, and for the induction of labour in cases of intra-uterine foetal death. In cases where the foetus was alive, misoprostol was usually (77%) combined with mifepristone. Women were matched to women who had been treated with sulprostone for termination of second and third trimester pregnancy before 2001. We matched for hospital, previous vaginal delivery, intra-uterine death and duration of pregnancy. The primary outcome measure was time to delivery., Results: Since the treatment effect was different in patients in whom labour was induced for intra-uterine death and patients in whom labour was induced while the foetus was alive, the analysis was stratified for this parameter. In 94 patients with intra-uterine death, there was no significant difference in time to delivery, blood loss, operative removal of the placenta and need for pain relief between misoprostol and sulprostone. In vital pregnancy (n = 96), time to delivery was significantly shorter in the misoprostol group. The relative risk for haemorrhage exceeding 1000 ml in this group was 0.40 (95% confidence interval, CI, 0.13-1.2). We observed no significant differences with respect to operative removal of the placenta or need for pain relief., Conclusion: In cases of intra-uterine death, the effectiveness of misoprostol for termination of pregnancy is comparable to that of sulprostone. In vital pregnancy, combination of mifepristone and misoprostol is more effective than sulprostone alone.

Objectives: In order to assess the available evidence on the management of early pregnancy loss, we performed a meta-analysis on the subject., Methods: MEDLINE and EMBASE were searched for randomized studies reporting on the effectiveness of expectant management, misoprostol treatment or curettage. Outcomes considered were 'complete evacuation', complications, duration of bleeding, pain resulting from the procedure, side effects and women's satisfaction with the procedure., Results: Thirteen studies were identified. Combined data in women with missed abortion managed expectantly or treated with misoprostol showed complete evacuation rates of 28% (49/173) (range 14-47%) and 81% (242/298) (range 60-83%), respectively. In women with incomplete abortion, these rates were 94% (31/33) (range 80-100%) and 99% (75/76) (range 99-100%), respectively., Conclusion: In the management of early pregnancy loss both expectant management and misoprostol treatment reduce the need for curettage, but misoprostol treatment seems to be more effective in women with missed abortion as compared to expectant management., (Copyright 2004 International Federation of Gynecology and Obstetrics)

Background: Little is known about the effectiveness of misoprostol treatment in women with early pregnancy failure who have been managed expectantly. We therefore performed a randomized trial on this subject., Methods: Women with early pregnancy failure, who had been managed expectantly for at least 1 week, were assigned randomly (using a computer-generated list) to receive either vaginal misoprostol 800 microg or curettage. If, after 24 h, there had not been complete evacuation, a further 800 microg of misoprostol was administered. In the absence of complete evacuation after > days, curettage was performed. The primary end-point was the complete evacuation of the products of conception, with secondary end-points being the occurrence of side effects, pain intensity, need for analgesics, and intensity and duration of bleeding., Results: In the misoprostol group, 47% (37/79) required curettage due to incomplete evacuation. After 1 week, evacuation was complete in 85% (67 out of 79) of the misoprostol group and 93% (70 out of 75) of the curettage group. Severity of pain, bleeding and emergency evacuation was higher in the misoprostol group. The complication rate was 0% for misoprostol and 4% for curettage., Conclusions: Curettage is superior to misoprostol in the evacuation of early pregnancy failure after failed expectant management. However, misoprostol could be clinically useful since it reduces the need for curettage by half and has a lower complication rate, at the expense of increased pain, vaginal bleeding and emergency evacuation., (Copyright 2004 European Society of Human Reproduction and Embryology)

Objective: To evaluate the effect of immersion in water on maternal haemodynamic measures and fetal heart rate patterns in healthy nulliparous women., Design: A randomised cross-over study., Participants: Twenty pregnant women were studied between 26-29 weeks and between 34-37 weeks of gestation., Methods: The women were either immersed in water for 35 minutes or rested on a bed for a similar period of time. Maternal blood pressure, thoracic electrical bioimpedance, urine and blood samples, and fetal heart rate patterns were obtained before and after immersion or bedrest., Results: Compared with bedrest and pre-immersion values, immersion resulted in a significant decrease in blood pressure, which returned to baseline values within 1.5 hour. Urine production increased for a short period after immersion, but 24 hour samples showed no difference compared with bedrest. Sodium, potassium and creatinine levels in urine remained constant. No significant changes were found for the other haemodynamic measures. There were no effects on fetal heart rate nor on its variation., Conclusion: In healthy pregnant women immersion for 35 minutes has a clear effect on blood pressure and urine production. However, these effects are short lasting.

The objectives of this study were to scrutinize surgical features and analyze local tumor parameters of early cervical cancer to identify patients at-risk for recurrent disease. Three hundred eight patients who underwent radical hysterectomy and pelvic lymphadenectomy between 1984 and 1997 were studied retrospectively. All radical hysterectomies were performed in a referral oncology center, and treatment policies and operating staff were the same during the study period. Operating time gradually decreased significantly during the study period from an average of 270 min to an average of 187 min (P < 0.0001), and blood loss during surgery also decreased continually from 1515 ml to 1071 ml (P < 0.0001). Postoperative radiation treatment was given to 119 patients (40%). The overall five-year survival rate was 83%, 91% for those with negative, and 53% for those with positive pelvic nodes. Univariate analysis showed that lymph node status, parametrial involvement, status of the surgical margins, capillary lymphatic space involvement, tumor size and depth of invasion were all significantly related to the occurrence of recurrent disease. Multivariate analysis revealed that lymph node involvement (hazard ratio 4.4), parametrial involvement, tumor size and depth of invasion were independent factors of prognostic significance for disease-free survival. It was concluded that the local control of cervical tumors infiltrating > 10 mm (hazard ratio 5.1) might be improved by adjuvant radiotherapy, even in the absence of lymph node metastasis, parametrial involvement or affected surgical margins.

Objective: To determine the frequency of neonatal respiratory morbidity following elective caesarean delivery at term and to identify prognostic factors for this morbidity., Design: Retrospective., Setting: Academic Hospital Utrecht/Wilhelmina Children's Hospital Neonatal Intensive Care Unit, Utrecht, the Netherlands., Method: All elective caesarean deliveries in the Academic Hospital Utrecht from the period 1990-1995 were studied. Also, neonates were included who were admitted for intensive neonatal care because of respiratory insufficiency following elective caesarean delivery in the region surrounding Utrecht. An elective caesarean delivery was defined as a delivery performed after 37 weeks of gestation without any complicating factor that might influence the timing of delivery. Prognostic factors for neonatal morbidity after caesarean delivery were identified by multivariate logistic regression analysis., Results: During 1990-1995, 272 elective caesarean deliveries after 37 weeks of gestation were performed that fulfilled the inclusion criteria; 5.1% of the neonates were admitted to the medium care unit because of respiratory problems. The relative risk of respiratory morbidity after delivery by caesarean section with a gestational age of 39-42 weeks compared with a gestational age of 37-38 weeks, was 0.14 (95% confidence interval: 0.03-0.64; p < 0.001). Male sex was a cofactor. Nine neonates of whom 8 (90%) had a gestational age of less than 39 weeks were admitted to the intensive care unit., Conclusion: Most of neonatal respiratory morbidity could have been avoided by postponement of the at-term elective caesarean section until a certain gestational age of at least 38 complete weeks. An elective caesarean section should not be performed before that period.

In patients undergoing coronary artery bypass surgery while under 40 years of age, prevalence of risk factors for coronary artery disease and prognostic factors for mortality were assessed. Ninety-four patients of such age were operated from 1979 until 1989. Eighty-two patients were male, 12 female. Fifty-eight patients (62%) had a history of myocardial infarction. Patients were predominantly in New York Heart Association class II or III (69%). In this study prevalence of risk factors for coronary artery disease was different compared to studies of patients undergoing coronary artery bypass grafting over 40 years of age. Smoking (83%), hypercholesterolaemia (79%), and positive family history for coronary heart disease (66%) were more prevalent in this study compared to other studies concerning patients older than 40 years of age whereas the occurrence of hypertension (25%) and diabetes (6%) was lower. Six patients (6%) had one-vessel disease, 15 patients (17%) had two-vessel disease and 73 patients (78%) showed triple-vessel disease. Similar studies of patients older than 40 years of age showed a lower prevalence of triple vessel disease than in this study. Hospital mortality amounted to 3 patients (3%). Five-year-survival rate was 93%. Multivariate survival analysis revealed left main stenosis and concomitant operations as significant prognostic factors of survival. Number of vessels diseased, sex, priority of operation, reoperation, or impaired left-ventricular function were not prognostic factors for mortality in this study.