Search

Objective: Pregnancies complicated by intrauterine growth retardation (IUGR) beyond 36 weeks of gestation are at increased risk of neonatal morbidity and mortality. Optimal treatment in IUGR at term is highly debated. Results from the multicenter DIGITAT (Disproportionate Intrauterine Growth Intervention Trial At Term) trial show that induction of labor and expectant monitoring result in equal neonatal and maternal outcomes for comparable cesarean section rates. We report the maternal health-related quality of life (HR-QoL) that was measured alongside the trial at several points in time.Methods: Both randomized and non-randomized women were asked to participate in the HR-QoL study. Women were asked to fill out written validated questionnaires, covering background characteristics, condition-specific issues and the Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90) at baseline, 6 weeks postpartum and 6 months postpartum. We compared the difference scores of all summary measures between the two management strategies by ANOVA. A repeated measures multivariate mixed model was defined to assess the effect of the management strategies on the physical (PCS) and mental (MCS) components of the SF-36. Analysis was by intention to treat.Results: We analyzed data of 361 randomized and 198 non-randomized patients. There were no clinically relevant differences between the treatments at 6 weeks or 6 months postpartum on any summary measures; e.g., on the SF-36 (PCS: P = .09; MCS: P = .48). The PCS and the MCS were below norm values at inclusion. The PCS improved over time but stayed below norm values at 6 months, while the MCS did not improve.Conclusion: In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life. [ABSTRACT FROM AUTHOR]

OBJECTIVE: We sought to study long-term (neuro)developmental and behavioral outcome of pregnancies complicated by intrauterine growth restriction at term in relation to induction of labor or an expectant management. STUDY DESIGN: Parents of 2-year-old children included in the Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) answered the Ages and Stages Questionnaire (ASQ) and Child Behavior Checklist (CBCL). RESULTS: We approached 582 (89.5%) of 650 parents. The response rate was 50%. Of these children, 27% had an abnormal score on the ASQ and 13% on the CBCL. Results of the ASQ and the CBCL for the 2 policies were comparable. Low birthweight, positive Morbidity Assessment Index score, and admission to intermediate care increased the risk of an abnormal outcome of the ASQ. This effect was not seen for the CBCL. CONCLUSION: In women with intrauterine growth restriction at term, neither a policy of induction of labor nor expectant management affect developmental and behavioral outcome when compared to expectant management. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT) compared induction of labor and expectant management in suspected intrauterine growth restriction (IUGR) at term. In this subanalysis, we report neonatal morbidity between the policies based on the Morbidity Assessment Index for Newborns (MAIN). STUDY DESIGN: We used data from the DIGITAT. For each neonate, we calculated the MAIN score, a validated outcome scale. RESULTS: There were no differences in mean MAIN scores or in MAIN morbidity categories. We found that neonatal admissions are lower after 38 weeks' gestational age compared with 36 and 37 weeks in both groups. CONCLUSION: The incidence of neonatal morbidity in IUGR at term is comparable and relatively mild either after induction or after an expectant policy. However, neonatal admissions are lower after 38 weeks of pregnancy, so if induction to preempt possible stillbirth is considered, it is reasonable to delay until 38 weeks, provided watchful monitoring. [ABSTRACT FROM AUTHOR]

Objective: To compare, in women with twin pregnancy with the first twin in cephalic position, neonatal morbidity and mortality rates after actual 1) Vaginal delivery (VD) both twins versus 2) unplanned Cesarean Delivery (CD) of both twins and 3) after VD of twin A and CD of twin B (combined delivery)., Study Design: We describe a nationwide cohort study of women pregnant with twins who planned to deliver vaginally between 32 +0 - 41 +6 weeks with the first twin in cephalic position, between 2000-2012 in the Netherlands. We used multivariate logistic regression analysis to compare neonatal morbidity and mortality according to actual mode of delivery, overall, and for preterm and term groups separately., Results: We included 19,723 women of whom 15,785 women (80.0 %) delivered both twins by VD, 2926 (14.6 %) delivered both twins by unplanned CD, and 1012 (5.1 %) women delivered by combined delivery. After unplanned CD of both twins compared to VD more perinatal mortality (1 or more twins affected) was seen (adjusted Odds Ratio (aOR) 2.23 (95 % CI 1.26-4.129)), as was 'Asphyxia related morbidity' (aOR 2.44 (95 % CI 1.80-3.31), 'other morbidity' (aOR 1.34 (95 %CI 1.17-1.54), and 'any morbidity or mortality' (aOR1.39 (95 % CI 1.22-1.58)). Less 'Trauma- related morbidity' after unplanned CD vs. VD (aOR 0.11 (95 % 0.02-0.79)) was seen. After combined delivery vs. VD, more perinatal mortality (aOR 7.75 (95 % CI 4.51-13.34)), more Asphyxia- related morbidity (aOR 6.67 (95 % CI4.91-9.06), 'prematurity related morbidity' (aOR 2.11 (95 % CI 1.59-2.79) 'other morbidity' (aOR 2.01 (95 % CI 1.65-2.46), and 'any morbidity or mortality' (aOR 2.44 (95 % CI 2.04-2.91)) were noted. All outcomes expect 'trauma-associated morbidity' were more increased for twin B as compared to twin A., Conclusion: After unplanned CD of both twins vs. VD of both twins, a twofold increase in neonatal mortality is noted. Combined delivery vs. VD of both twins is associated with a sevenfold increase in perinatal mortality and a five-fold increase in asphyxia-related outcomes. Twin A is more affected after unplanned CD of both twins, while twin B is more affected after combined delivery., Competing Interests: Declaration of Competing Interest BWM is supported by a NHMRC Investigatorgrant (GNT1176437), BWM reports consultancy for ObsEva, Merck Merck KGaA, iGenomix and Guerbet, (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: To evaluate the effect of androgen supplementation in healthy combined oral contraceptive (COC) users who experience mood disturbances during COC-use only., Methods: Six women with mood disturbances during COC-use only, received COC with co-treatment of 50 mg dehydroepiandrosterone (DHEA) during three cycles and placebo during another three cycles in an individualized random order. Daily mood rating was measured by a single item: 'In what kind of mood have you been in the past 24 h?' The results were analysed using a randomisation test for single-case experimental designs., Results: The p values for the alternation design randomisation tests on the raw data of the six healthy individuals varied between 0.21 and 1, indicating that the average daily mood ratings of the active treatment DHEA are not statistically significantly larger than the average daily mood ratings of placebo. The combined p value of the subjects using a DRSP-containing pill was 0.97, and of the subjects using an LNG-containing pill was 0.65, indicating no statistically significant treatment effect for any of the pill types., Conclusions: In this single-case alternation design study, concomitant treatment with DHEA for intermittent periods of 4 weeks did not result in improvement of mood disturbances related to COC-use, but had also no side-effects.

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., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

Objective: To assess the cost-effectiveness of routine labour epidural analgesia (EA), from a societal perspective, as compared with labour analgesia on request., Study Design: Women delivering of a singleton in cephalic presentation beyond 36+0 weeks' gestation were randomly allocated to routine labour EA or analgesia on request in one university and one non-university teaching hospital in the Netherlands. Costs included all medical, non-medical and indirect costs from randomisation to 6 weeks postpartum. Effectiveness was defined as a non-operative, spontaneous vaginal delivery without EA-related maternal adverse effects. Incremental cost-effectiveness ratio (ICER) was defined as the ratio of the difference in costs and the difference in effectiveness between both groups. Data were analysed according to intention to treat and divided into a base case analysis and a sensitivity analysis., Results: Total delivery costs in the routine EA group (n=233) were higher than in the labour on request group (n=255) (difference -€ 322, 95% CI -€ 60 to € 355) due to more medication costs (including EA), a longer stay in the labour ward, and more operations including caesarean sections. Total postpartum hospital costs in the routine EA group were lower (difference -€ 344, 95% CI -€ 1338 to € 621) mainly due to less neonatal admissions (difference -€ 472, 95% CI -€ 1297 to € 331), whereas total postpartum home and others costs were comparable (difference -€ 20, 95% CI -€ 267 to € 248, and -€ 1, 95% CI -€ 67 to € 284, respectively). As a result, the overall mean costs per woman were comparable between the routine EA group and the analgesia on request group (€ 8.708 and € 8.710, respectively, mean difference -€ 2, 95% CI -€ 1.012 to € 916). Routine labour EA resulted in more deliveries with maternal adverse effects, nevertheless the ICER remained low (€ 8; bootstrap 95% CI -€ 6.120 to € 8.659). The cost-effectiveness acceptability curve indicated a low probability that routine EA is cost-effective., Conclusion: Routine labour EA generates comparable costs as analgesia on request, but results in more operative deliveries and more EA-related maternal adverse effects. Based on cost-effectiveness, no preference can be given to routine labour EA as compared with analgesia on request., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

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., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates., Method: Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery., Results: The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adherence 46%), 2) non-progressive labour (frequency 12%, CS performed too early in over 75%), 3) continuous support during labour (frequency 88%, adherence 37%) and 4) previous CS (frequency 12%), with adequate counselling in 15%., Conclusions: We identified four concrete target groups for improvement of obstetrical care, which can be used as a starting point to reduce CS rates worldwide.

Objectives: To determine neurodevelopment at two years in twins., Methods: At two years of age, all twins ≥32 weeks, delivered in our center and not randomized in the Twin Birth Study, underwent a neurodevelopment screen using the Ages and Stages Questionnaire (ASQ). Children with ≥1 abnormal ASQ domain score were evaluated by a pediatrician. Results were documented according to a planned cesarean section (PCS) or a planned vaginal delivery (PVD)., Results: An ASQ was obtained from 185 children (67%). No significant differences in percentages of abnormal scores were found between the PCS group and the PVD group or between twins A and B. Pediatric assessment revealed three children with a neurodevelopmental delay. Five other children were already under pediatric or general practitioner care for other reasons. One child with a congenital anomaly was born by a PCS, two twins A and five twins B were born in the PVD group., Conclusion: ASQ screening revealed no significant differences in abnormal neurodevelopment in twins at two years of age according to the mode of delivery. Pediatric assessment suggested an increased incidence for abnormal neurodevelopment in twins B born by PVD.

Using orthogonal design, we created a questionnaire containing 16 cases of twin pregnancies. For each case, respondents indicated whether they would plan a vaginal delivery (VD) or a caesarean section (CS). We assessed the association between each variable (maternal age, parity, mode of conception, gestational age, chorionicity, body mass index, foetal growth, foetal presentation and wish for additional children) and the planned mode of delivery. A VD was planned mostly for vertex presentation of twin A (vertex-vertex vs. non-vertex-vertex, odds ratio [OR]: 0.002, 95% confidence interval [CI]: 0.001-0.003, p < 0.001). For vertex- non-vertex (vs. vertex-vertex) presentation, chances on planning a VD decreased threefold (OR: 0.29, 95% CI: 0.018-0.46, p < 0.001), although the majority of respondents would still plan a VD. In multiparous (vs. nulliparous) women, VD was chosen more often (OR: 3.24, 95% CI: 2.50-4.18, p < 0.001).Vertex presentation of twin A and multiparity were the main reasons for planning a VD.

Introduction: We investigated the predictive capacity of mid-trimester cervical length (CL) measurement for spontaneous and iatrogenic preterm birth., Material and Methods: We performed a prospective observational cohort study in nulliparous women and low-risk multiparous women with a singleton pregnancy between 16(+0) and 21(+6) weeks of gestation. We assessed the prognostic capacity of transvaginally measured mid-trimester CL for spontaneous and iatrogenic preterm birth (<37 weeks) using likelihood ratios (LR) and receiver-operating-characteristic analysis. We calculated numbers needed to screen to prevent one preterm birth assuming different treatment effects. Main outcome measures were preterm birth <32, <34 and <37 weeks., Results: We studied 11,943 women, of whom 666 (5.6%) delivered preterm: 464 (3.9%) spontaneous and 202 (1.7%) iatrogenic. Mean CL was 44.1 mm (SD 7.8 mm). In nulliparous women, the LRs for spontaneous preterm birth varied between 27 (95% CI 7.7-95) for a CL ≤ 20 mm, and 2.0 (95% CI 1.6-2.5) for a CL between 30 and 35 mm. For low-risk multiparous women, these LRs were 37 (95% CI 7.5-182) and 1.5 (95% CI 0.97-2.2), respectively. Using a cut-off for CL ≤ 30 mm, 28 (6.0%) of 464 women with spontaneous preterm birth were identified. The number needed to screen to prevent one case of preterm birth was 618 in nulliparous women and 1417 for low-risk multiparous women (40% treatment effect, cut-off 30 mm)., Conclusion: In women at low risk of preterm birth, CL predicts spontaneous preterm birth. However, its isolated use as a screening tool has limited value due to low sensitivity., (© 2015 Nordic Federation of Societies of Obstetrics and Gynecology.)

Objective: To assess the effect on mode of delivery of the routine use of labour epidural analgesia (EA) compared with analgesia on request., Design: Randomised non-inferiority trial., Setting: One university and one non-university teaching hospital in The Netherlands., Population: Women with a singleton pregnancy in cephalic presentation beyond 36 + 0 weeks' gestation., Methods: Participants were randomly allocated to receive either routine EA or analgesia on request. Intention-to-treat (ITT) and per-protocol (PP) analyses were performed, with confidence intervals (CI) calculated for the differences in percentages or means., Main Outcome Measures: Rate of operative delivery (instrumental vaginal or caesarean), labour characteristics, and adverse labour and neonatal outcomes., Results: A total of 488 women were randomly allocated to the routine EA (n = 233) or analgesia on request group (n = 255). In the routine EA group, 89.3% (208/233) received EA. According to ITT analysis, 34.8% (81/233) women in the routine EA group had an operative delivery, compared with 26.7% (68/255) in the analgesia on request group (difference 8.1%, 95% CI -0.1 to 16.3). The difference in rate of operative deliveries according to the PP analysis was statistically significant (difference 8.9%, 95% CI 0.4 to 17.4). Inferiority of EA could not be rejected, as in both analyses the upper bound of the confidence interval exceeded the pre-specified inferiority criterion of +10%. Women in the routine EA group had more adverse effects, including hypotension (difference 9.5%, 95% CI 4.2 to 14.9), and motor blockade (difference 6.8%, 95% CI 1.1 to 12.5)., Conclusion: Non-inferiority of routine EA could not be demonstrated in this trial. Routine EA use is likely to lead to more operative deliveries and more maternal adverse effects. The results of our study do not justify routine use of EA., (© 2014 Royal College of Obstetricians and Gynaecologists.)

Introduction. Acute myocardial infarction (AMI) in a pregnant woman is rare. When occurring, AMI is a major cause of maternal and neonatal death. By presenting the following case we describe the dilemma concerning the timing of delivery. Case. A 36-year-old, multiparous women, at 35 6/7 weeks of gestation, suffered from an AMI due to an acute blockage of the left anterior descending artery (LAD). This was treated by angiographic thrombosuction and biodegradable stent placement. Within 5 hours after this procedure, a cesarean section (CS) was performed because of a nonreassuring fetal condition. A healthy son with an Apgar score of 9/10 was born. The patient's postoperative course was complicated by a big wound hematoma, a hemoglobin drop, and heart failure. Discussion. In case of AMI during pregnancy, the cardiological management has absolute priority. The obstetrical management is not outlined. In a nonreassuring fetal condition, delivery is indicated after stabilization of the mother. However, delivery after recent AMI and angiography will bring new risks of cardiologic stress and bleeding complications. The limited literature available tends to an expectant obstetrical management, but this case emphasizes the difficulty of waiting in suspected fetal distress.

Objective: To describe trends in the use of epidural analgesia (EA) and to evaluate the association of EA with operative deliveries., Study Design: In this population-based, retrospective cohort study, women with an intention to deliver vaginally of a term, cephalic, singleton between 2000 and 2009 (n=1378458) were included. Main outcome measures were labor EA rates, unplanned caesarean section (CS), and instrumental vaginal delivery (IVD) including deliveries by either vacuum or forceps. Data were obtained from the Perinatal Registry of The Netherlands and logistic regression analyses were used., Results: Among nulliparous, EA use almost tripled over the 10-year span (from 7.7% to 21.9%), while rates of CS and IVD did not change much (+2.8% and -3.3%, respectively). Among multiparous, EA use increased from 2.4% to 6.8%, while rates of CS and IVD changed slightly (+0.8% and -0.7%, respectively). Multivariable analysis showed a positive association of EA with CS, which weakened in ten years, from an adjusted OR of 2.35 (95% CI, 2.18 to 2.54) to 1.69 (95% CI, 1.60 to 1.79; p<0.001) in nulliparous, and from an adjusted OR of 3.17 (95% CI, 2.79 to 3.61) to 2.56 (95% CI, 2.34 to 2.81; p<0.001) in multiparous women. A weak inverse association between EA and IVD was found among nulliparous (adjusted OR, 0.76; 95% CI, 0.75 to 0.78), and a positive one among multiparous women (adjusted OR, 2.08; 95% CI, 2.00 to 2.16). Both associations grew slightly weaker over time., Conclusions: A near triplication of EA use in The Netherlands in ten years was accompanied by relatively stable rates of operative deliveries. The association between EA and operative delivery became weaker. This supports the idea that EA is not an important causal factor of operative deliveries., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Women delivering with EA (EA group) were matched on parity with 453 women with deliveries without EA (non-EA group). Significantly more neonates born in the EA-group had fever ≥ 38.0°C (11.6% vs 1.8%, p < 0.001) at birth. The overall incidence of neonatal sepsis, based on clinical symptoms and defined as proven (by a positive blood culture) or suspected (no positive blood culture), was significantly higher in the EA group (6.0% vs 2.2%; p = 0.002), but the incidence of proven neonatal sepsis alone was not (0.4% vs 0%; p = 0.250). EA turned out to be an independent risk factor for neonatal sepsis (adjusted OR 2.43, 95% CI 1.15-5.13; p = 0.020). However, in the EA group as well as the non-EA group, the incidence of neonatal sepsis was significantly higher in mothers with intrapartum fever compared with afebrile mothers (11.0% vs 2.9% in the EA group; p = 0.004; 8.2% vs 1.3% in the non-EA group; p = 0.006). Therefore we conclude, that the positive association between neonatal sepsis and labour EA is possibly mediated by maternal intrapartum fever.

Objective: To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage., Design: Randomised non-inferiority trial., Setting: Thirty-seven Dutch university and general hospitals., Population: Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities., Methods: Women were allocated to RBC transfusion or non-intervention., Main Outcome Measures: Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum., Results: In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable., Conclusions: Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified., (© 2014 Royal College of Obstetricians and Gynaecologists.)

OBJECTIVES To investigate the continuation rates of the etonogestrel subdermal contraceptive implant among well-informed women, and the reasons for early discontinuation. STUDY DESIGN Retrospective consecutive cohort design. METHODS Women who had the implant inserted between 1 January 2006 and 1 January 2010 at the Atrium Medical Centre, the Netherlands were followed up for at least three years. The dates of insertion and removal were recorded, as were the reasons for removal. Statistical analysis was performed using the independent samples t-test and the Pearson alpha correlation test. RESULTS The implant was inserted in 230 women. Follow-up was possible in 214 women, with an average age of 26.7 years. Most of them were nulliparous and the majority had used a combined oral contraceptive, Implanon®, or Mirena® previously. The mean overall continuation period was 23.5 months (95% confidence interval: 21.7-25.3), with a median of 25 months. The continuation rate after 12 months was 72%; after 24 months, 53%; and after 36 months, 25%, with all women concerned having a new implant placed. The previously used contraceptive method Implanon® was associated with the highest continuation rates. An erratic bleeding pattern was the main reason for early removal. CONCLUSIONS Despite adequate counselling before insertion, the continuation rate of the etonogestrel implant was rather low compared to those reported by other investigators. The main reason for discontinuation was an irregular bleeding pattern.

Objective: To develop a patient decision aid (PtDA) for mode of delivery after caesarean section that integrates personalised prediction of vaginal birth after caesarean (VBAC) with the elicitation of patient preferences and evidence-based information., Design: A PtDA was developed and pilot tested using the International Patients Decision Aid Standards (IPDAS) criteria., Setting: Obstetric health care in the Netherlands., Population: A multidisciplinary steering group, an expert panel, and 25 future users of the PtDA, i.e. women with a previous caesarean section., Methods: The development consisted of a construction phase (definition of scope and purpose, and selection of content, framework, and format) and a pilot testing phase by interview. The process was supervised by a multidisciplinary steering group., Main Outcome Measures: Usability, clarity, and relevance., Results: The construction phase resulted in a booklet including unbiased balanced information on mode of birth after caesarean section, a preference elicitation exercise, and tailored risk information, including a prediction model for successful VBAC. During pilot testing, visualisation of risks and clarity formed the main basis for revisions. Pilot testing showed the availability of tailored structured information to be the main factor involving women in decision-making. The PtDA meets 39 out of 50 IPDAS criteria (78%): 23 out of 23 criteria for content (100%) and 16 out of 20 criteria for the development process (80%). Criteria for effectiveness (n = 7) were not evaluated., Conclusions: An evidence-based PtDA was developed, with the probability of successful VBAC and the availability of structured information as key items. It is likely that the PtDA enhances the quality of decision-making on mode of birth after caesarean section., (© 2013 Royal College of Obstetricians and Gynaecologists.)

Compared with other countries, the elective caesarean section rate for twins is relatively low in the Netherlands. Worldwide, there is an increasing trend toward performing more elective caesarean sections for women with a twin pregnancy at term, be it for twins with the first child in breech or in cephalic presentation. The results of the 'Twin Birth Study' indicate that a planned caesarean section does not improve outcome as compared with planned vaginal birth for twins with the first child in cephalic position beyond 32 weeks gestation. During the study, an experienced obstetrician was present during planned vaginal delivery and there was a possibility of performing a secondary caesarean section within 30 minutes. This study provides an additional argument to guarantee the aforementioned conditions in all hospitals where women plan to deliver their twins vaginally. However, the definition of an experienced obstetrician is subject to debate.

Objective: To develop and internally validate a model that predicts the outcome of an intended vaginal birth after caesarean (VBAC) for a Western European population that can be used to personalise counselling for deliveries at term., Design: Registration-based retrospective cohort study., Setting: Five university teaching hospitals, seven non-university teaching hospitals, and five non-university non-teaching hospitals in the Netherlands., Population: A cohort of 515 women with a history of one caesarean section and a viable singleton pregnancy, without a contraindication for intended VBAC, who delivered at term., Methods: Potential predictors for a vaginal delivery after caesarean section were chosen based on literature and expert opinions. We internally validated the prediction model using bootstrapping techniques., Main Outcome Measures: Predictors for VBAC. For model validation, the area under the receiver operating characteristic curve (AUC) for discriminative capacity and calibration-per-risk-quantile for accuracy were calculated., Results: A total of 371 out of 515 women had a VBAC (72%). Variables included in the model were: estimated fetal weight greater than the 90(th) percentile in the third trimester; previous non-progressive labour; previous vaginal delivery; induction of labour; pre-pregnancy body mass index; and ethnicity. The AUC was 71% (95% confidence interval, 95% CI = 69-73%), indicating a good discriminative ability. The calibration plot shows that the predicted probabilities are well calibrated, especially from 65% up, which accounts for 77% of the total study population., Conclusion: We developed an appropriate Western European population-based prediction model that is aimed to personalise counselling for term deliveries., (© 2013 Royal College of Obstetricians and Gynaecologists.)

Objective: Pregnancies complicated by intrauterine growth restriction (IUGR) are at increased risk for neonatal morbidity and mortality. The Dutch nationwide disproportionate intrauterine growth intervention trial at term (DIGITAT trial) showed that induction of labour and expectant monitoring were comparable with respect to composite adverse neonatal outcome and operative delivery. In this study we compare the costs of both strategies., Study Design: A cost analysis was performed alongside the DIGITAT trial, which was a randomized controlled trial in which 650 women with a singleton pregnancy with suspected IUGR beyond 36 weeks of pregnancy were allocated to induction or expectant management. Resource utilization was documented by specific items in the case report forms. Unit costs for clinical resources were calculated from the financial reports of participating hospitals. For primary care costs Dutch standardized prices were used. All costs are presented in Euros converted to the year 2009., Results: Antepartum expectant monitoring generated more costs, mainly due to longer antepartum maternal stays in hospital. During delivery and the postpartum stage, induction generated more direct medical costs, due to longer stay in the labour room and longer duration of neonatal high care/medium care admissions. From a health care perspective, both strategies generated comparable costs: on average €7106 per patient for the induction group (N=321) and €6995 for the expectant management group (N=329) with a cost difference of €111 (95%CI: €-1296 to 1641)., Conclusion: Induction of labour and expectant monitoring in IUGR at term have comparable outcomes immediately after birth in terms of obstetrical outcomes, maternal quality of life and costs. Costs are lower, however, in the expectant monitoring group before 38 weeks of gestation and costs are lower in the induction of labour group after 38 weeks of gestation. So if induction of labour is considered to pre-empt possible stillbirth in suspected IUGR, it is reasonable to delay until 38 weeks, with watchful monitoring., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Background: Acne is a common problem that is increasingly being effectively treated with isotretinoin, a highly teratogenic agent. According to the pregnancy prevention program, contraception should be used until at least one month after discontinuing the medication., Case Description: A 29-year-old woman became pregnant shortly after discontinuing isotretinoin. She was referred to the gynaecologist for an abortion. However, since she wished to continue the pregnancy, she received personal advice on the risk of bearing a child with congenital abnormalities. After an uneventful pregnancy she gave birth to a healthy son., Conclusion: Given the teratogenicity of isotretinoin, every woman in the fertile phase of life should use contraception while taking the medication. If she becomes pregnant, however, the individual risk of having a child with congenital abnormalities can be carefully and reliably estimated by determining the precise date of conception through ultrasound and the date that isotretinoin was stopped.

Objectives: To review the clinical experience with the contraceptive vaginal ring (CVR, NuvaRing(®)) since its introduction over ten years ago., Methods: The literature was searched on efficacy, cycle control, safety, user preference and satisfaction of the CVR in comparison with combined oral contraceptives (COCs) and the patch, with special attention to recent developments., Results: The ring has the same working mechanism and contraindications as COCs. Serum levels of steroids are steadier, whereas oestrogenic exposure is lower. Contraceptive efficacy is similar, as are metabolic changes. Cycle control is better, and compliance and continuation rates are equal or higher. Oestrogen-related adverse symptoms appear to be fewer, but reports on the incidence of venous thrombosis are conflicting. Expulsion of the ring is reported by 4% to 20% of women. Local adverse events are the main reason for discontinuation. Acceptability is as high as with COCs and, after structured counselling, the ring is preferred by many women to the pill or the patch., Conclusions: Efficacy of the CVR, and the metabolic changes and adverse events it elicits, are generally comparable to those of COCs, yet oestrogenic exposure is lower and cycle control superior. After counselling, the ring is preferred to the pill by many women.

To assess neonatal and maternal morbidity in twins ≥ 32 weeks' gestation, related to the changes in planned mode of delivery, a retrospective cohort study was performed, including 185 twin births delivered in the Atrium Medical Centre, Heerlen, during the years 2003-2008. The results were compared with those of an earlier study from our department during the period 1999-2002. Compared with the 1999-2002 cohort, the elective caesarean section rate significantly increased from 17.7% to 36.8%. The secondary caesarean rate significantly decreased from 15.9% to 8.8%, but increased from 1.2% to 3.3% for only twin B. No significant differences in serious neonatal morbidity rates for twins A and B were found between both study periods, neither in the elective caesarean group, nor in the planned vaginal birth group. Serious maternal morbidity was not significantly increased in both groups compared with the 1999-2002 cohort.

Introduction and Hypothesis: This study aimed to determine the relationship of recurrent cystocele with avulsion of puborectalis muscle and other risk factors., Methods: In this prospective observational cohort study, 245 women undergoing anterior colporrhaphy were invited for a 2-year follow-up visit consisting of a questionnaire, physical examination, and translabial 3D ultrasonography. Women with and without recurrent cystocele were compared to identify recurrence risk factors., Results: Of the 245 women, 156 agreed to the follow-up visit (63.7%). Objective recurrence rate was 80 of 156 (51.3%). Seventeen of the 156 (10.9%) reported subjective recurrence. Risk factors for anatomical recurrence were complete avulsion of puborectalis muscle (OR, 2.4; 95% CI, 1.3, 4.7), advanced preoperative stage (OR, 2.0; 95% CI, 1.0, 4.1), family history of prolapse (OR, 2.4; 95% CI, 1.2, 4.9), and sacrospinous fixation (OR, 6.5; 95% CI, 2.0, 21.2)., Conclusions: Risk factors for anatomical cystocele recurrence after anterior colporrhaphy were complete avulsion of puborectalis muscle, advanced preoperative stage, family history of prolapse, and sacrospinous fixation.

A 87-year-old woman presented with vaginal blood loss. A tumor protruded through the anterior vaginal wall. Biopsy revealed transitional epithelium without atypia. In 1975 the urethra was dilated because of ischuria after a midline cystocele repair resulted in trauma. A post-traumatic transvaginal diverticulum of the urethra was diagnosed and closed.

Objective: Review of the literature regarding the relation between the timing of epidural analgesia and the rate of caesarean or instrumental vaginal deliveries., Search Strategy: Pubmed, Embase and the Cochrane Library were searched for articles published until 31 July 2010., Selection Criteria: Studies were selected in which the effects of early latent phase (defined as a cervical dilatation of 3 cm or less) epidural analgesia (including combined-spinal epidural) and late active phase epidural analgesia on the mode of delivery in nulliparous women at 36 weeks of gestation or more were evaluated., Data Collection and Analysis: Data extraction was completed by using a data-extraction form. Risk ratio and its 95% confidence intervals were calculated for caesarean delivery and instrumental vaginal delivery. Pooled data were calculated., Main Results: The search retrieved 20 relevant articles, of which six fulfilled the selection criteria of inclusion. These six studies reported on 15,399 nulliparous women in spontaneous or induced labour with a request for analgesia. Risk of caesarean delivery (pooled risk ratio 1.02, 95% CI 0.96-1.08) or instrumental vaginal delivery (pooled risk ratio 0.96, 95% CI 0.89-1.05) was not significantly different between groups., Authors' Conclusions: This systematic review showed no increased risk of caesarean delivery or instrumental vaginal delivery for women receiving early epidural analgesia at cervical dilatation of 3 m or less in comparison with late epidural analgesia., (© 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.)

Introduction and Hypothesis: The aim of this study was to compare the number of temporary catheter replacements and urinary tract infections after indwelling catheterization for 2 versus 5 days following an anterior colporrhaphy., Methods: Two hundred forty-six patients were randomly assigned to 2 or 5 days of indwelling catheterization. Outcome measures were temporary catheter replacements because of post-voiding residual >200 mL after removal of the indwelling catheter, urinary tract infections, and hospital stay. All patients were analyzed according to the intention to treat principle., Results: Compared to the 5-day protocol group, in the 2-day protocol group more patients needed temporary catheter replacement (9% versus 28%, odds ratio (OR) 4.0, confidence interval (CI) 1.9-8.3, p < 0.01), whereas less patients had a urinary tract infection (37% versus 22%, OR 0.5, CI 0.3-0.9, p = 0.02) and median hospital stay was lower., Conclusions: Removal of an indwelling catheter after 2 versus 5 days following anterior colporrhaphy is associated with more temporary catheter replacements, but less urinary tract infections and a shorter hospital stay.

Objective: To compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term., Design: Multicentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT))., Setting: Eight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008., Participants: Pregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction., Interventions: Induction of labour or expectant monitoring., Main Outcome Measures: The primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means., Results: 321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference -9.9 days, 95% CI -11.3 to -8.6) and weighed 130 g less (mean difference -130 g, 95% CI -188 g to -71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference -0.8%, 95% CI -4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%)., Conclusions: In women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth., Trial Registration: International Standard Randomised Controlled Trial number ISRCTN10363217.

Background: Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands., Methods/design: The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%)., Discussion: This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs.

Objective: To assess the economic consequences of labour induction compared with expectant monitoring in women with gestational hypertension or pre-eclampsia at term., Design: An economic analysis alongside the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT)., Setting: Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands., Population: Women diagnosed with gestational hypertension or pre-eclampsia between 36(+0) and 41(+0) weeks of gestation, randomly allocated to either induction of labour or expectant monitoring., Methods: A trial-based cost-effectiveness analysis was performed from a societal perspective during a 1-year time horizon., Main Outcome Measures: One-year costs were estimated and health outcomes were expressed as the prevalence of poor maternal outcome defined as either maternal complications or progression to severe disease., Results: The average costs of induction of labour (n = 377) were €7077 versus €7908 for expectant monitoring (n = 379), with an average difference of -€831 (95% CI -€1561 to -€144). This 11% difference predominantly originated from the antepartum period: per woman costs were €1259 for induction versus €2700 for expectant monitoring. During delivery, more costs were generated following induction (€2190) compared with expectant monitoring (€1210). No substantial differences were found in the postpartum, follow-up and for non-medical costs., Conclusion: In women with gestational hypertension or mild pre-eclampsia at term, induction of labour is less costly than expectant monitoring because of differences in resource use in the antepartum period. As the trial already demonstrated that induction of labour results in less progression to severe disease without resulting in a higher caesarean section rate, both clinical and economic consequences are in favour of induction of labour in these women., Trial Registration: The trial has been registered in the clinical trial register as ISRCTN08132825., (© 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.)

A 43-year-old female, gravida 3, para 2, who was 9 weeks pregnant, presented herself as a surrogate mother for a 33-year-old couple at our outpatient clinic in Heerlen, the Netherlands, for pregnancy follow-up. As she had not passed the selection procedure in the Netherlands (VU University Medical Center, Amsterdam), IVF using the gametes of the prospective parents and embryo transfer was performed in Belgium. We discussed the management of possible problems and complications during pregnancy and delivery. After an uneventful pregnancy and delivery a healthy boy was taken home by the donor couple. In the Netherlands, high-tech surrogate motherhood under strict non-commercial conditions has been accepted by law since 1997. Since the inclusion criteria are very strict, some couples seem to find a way to have their wish fulfilled abroad. Uniformity of the IVF surrogacy legislation in Europe is necessary to discourage this practice. When this situation occurs nevertheless, it is important that doctors involved know how to handle the (often unknown) medical, ethical, legal, emotional and psychosocial aspects associated with high-tech IVF-surrogacy.

Objective: To investigate which clinical factors are important in management decisions that clinicians make in the process of labour induction, and which clinical factors they estimate as predictive of labour outcome after induction., Study Design: A written interview was conducted among obstetricians, residents and clinical midwives in five teaching hospitals in the south of the Netherlands. Sixteen fictive vignettes were constructed of pregnant nulliparous women who were candidates for induction of labour. The vignettes differed on eight clinical variables: maternal age, BMI, gestational age, indication for induction (maternal request vs mild pre-eclampsia), dilation, position, consistency and effacement of the cervix. For each case presentation, the inclination to induce labour was calculated for the three groups, and their estimates of the probability of a spontaneous vaginal delivery or a caesarean delivery were analyzed., Results: Of the 80 questionnaires sent, 60 (75%) were completed. Mild pre-eclampsia and post-term pregnancy were the most important clinical factors for the decision to induce or not in all three groups. Gestational age, effacement and dilation of the cervix were considered as the most important predictors of labour outcome after induction., Conclusions: In this interview, obstetricians, residents and clinical midwives based their decision-making whether or not to induce labour predominantly on medical indications. Outcome of labour after induction was estimated to depend on gestational age and cervical status at the start of induction.

Background: Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity., Methods: We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks' gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome--maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 mL blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825., Findings: 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, p<0.0001). No cases of maternal or neonatal death or eclampsia were recorded., Interpretation: Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation., Funding: ZonMw.

The basic principle of the practice guideline 'Pharmaceutical pain treatment during labour' is that during labour every woman can have adequate pain treatment at her request. Most women experience severe pain during labour, but retrospective satisfaction also depends on the support of care-givers and on the extent to which the woman was involved in decisions relating to her situation. A number of medical indications require good pain management. Epidural analgesia is the safest and most effective method, preferably as patient-controlled analgesia (PCA). PCA with remifentanil appears promising, but remains to be adequately investigated. Pethidine is far less effective. Recommended organisational changes include structured provision of information on pharmaceutical pain management in the 30th week of pregnancy, to be developed by midwives, obstetricians and anaesthetists. Other recommended changes include referral to another hospital for the treatment of choice, development of local protocols across primary and secondary care with agreements about out-patient referral to the anaesthetist, structured daily contact between obstetricians and anaesthetists, the time lapse between the request for pain treatment and the administration of the treatment, and the site of administration and monitoring.

The objective is to assess the ability of preoperative serum CA125 levels to identify patients at high risk of suboptimal cytoreductive surgery for epithelial ovarian cancer (EOC). One hundred and thirty-two women diagnosed with EOC between 1998 and 2004, who had serum CA125 levels measured preoperatively and received primary cytoreductive surgery, were retrospectively evaluated. The value of CA125 and patient and disease characteristics to predict suboptimal cytoreduction were determined, and a prognostic scoring system, based on statistically significant variables, was created. Optimal cytoreduction was achieved in 42.7% of the women with FIGO stage III/IV EOC. The optimal cutoff point of preoperative CA125 to predict surgical outcome in this group was 330 U/mL (sensitivity 80.0%; specificity 41.5%). The area under the receiver-operating characteristic curve (AUC) for preoperative CA125 predicting suboptimal surgery in FIGO stage III/IV was 0.576 (P = 0.617). Preoperative radiologic amount of ascites and weight loss (ie, >or=10% in the last 6 months before diagnosis) were independent prognostic factors for suboptimal cytoreduction, showing an AUC of 0.76 (P < 0.001) in women with FIGO stage III/IV. A prognostic scoring system showed that the chance of suboptimal surgery was 84.6% in FIGO stage III/IV when both these factors are present preoperatively. The role of CA125 levels predicting suboptimal cytoreduction seems questionable. Instead, women with considerable weight loss and a gross amount of ascites have a higher risk of suboptimal cytoreduction. These patients may be candidates for neoadjuvant chemotherapy.

The purpose of this review was to test contraceptive efficacy, cycle control, tolerability, and acceptability as found in the non-comparative studies with NuvaRing((R)) by those found in the randomized trials comparing NuvaRing and combined oral contraceptives (COCs). All large non-comparative studies and all relevant randomized controlled trials (RCTs) between NuvaRing and a COC up to and including December 2006 were analyzed. Two large multi-center registration studies, 1 large daily clinical practice study, and 6 RCTs comparing NuvaRing and a COC were identified. The findings in the non-comparative studies were confirmed in the RCTs. Contraceptive efficacy was high showing no significant differences in comparison with the COC; cycle control was good and consistently better than that of the COC; compliance was high and comparable with that of the pill; the incidence of adverse events such as breast tenderness, headache, and nausea was low, but not lower than with the COC despite a halving of the systemic exposure to ethinyl estradiol (EE) with NuvaRing compared with a 30-mug EE-containing COC; the incidence of local and ring-related events was low but higher than with the COC, leading to higher discontinuation rates among NuvaRing users; acceptability was high and comparable between both contraceptives, resulting in a global improvement of sexual function with both methods. After study completion, women using NuvaRing were more likely to continue with their method than women using a COC. The good results with respect to contraceptive efficacy, cycle control, tolerability, and acceptability as achieved with NuvaRing in the large non-comparative registration studies were confirmed in the RCTs comparing NuvaRing with different COCs.

A 28-year-old nulliparous Moroccan woman presented at an outpatient gynaecology clinic because she had been unable to conceive for the last 2 years. She had an enlarged right adnexus. Histopathological examination of the resected right adnexus was suspicious for tuberculosis. After isolating Mycobacterium bovis from a psoas abscess 3 months later, a 6-month regimen with anti-tuberculosis drugs was started, and the clinical response was good. Female genital tuberculosis is rare in developed countries. Symptoms are few and non-specific. The disease can be suspected incidentally during the subfertility work-up. The fallopian tubes are the most commonly affected site. A definitive diagnosis is difficult to make, even when tuberculosis is strongly suspected. Histopathological findings can support a diagnosis of tuberculosis, and molecular PCR techniques that detect DNA are promising. Treatment of genital tuberculosis is similar to that of pulmonary tuberculosis, although it is difficult to monitor treatment response. The chance of spontaneous conception after treatment is very small, and IVF is often the only treatment option.

Introduction: This study was performed to evaluate mothers' views of their childbirth experience two years after term breech delivery., Methods: Two years after delivery mothers were asked to fill out a questionnaire concerning their breech birth experience and their view about the care provided to them while giving birth. Outcomes of the planned cesarean section (CS) group were compared with outcomes of the planned vaginal delivery (VD) group, whether or not a vaginal birth was realized or an emergency cesarean section was performed. Any differences were further analyzed by use of logistic regression, controlling for potential confounders., Results: Significantly more women in the planned CS group were reassured about their baby's health (67.4% vs. 37.9%, p=0.0006) at the time of delivery, whereas more women in the planned VD group recalled having been worried about their baby's health at the time of delivery (45.0% vs. 25.6%, p=0.02). Also, more women in the planned VD group experienced more pain during labor and delivery than expected (46.9% vs. 18.5%, p=0.008). In the planned VD group fewer women indicated they had an active say in decision-making (59.1% vs. 85.3%, p=0.001)., Conclusions: Evaluation of the mothers' views of their childbirth experience two years after term breech delivery showed that more women in the planned VD group recalled having been worried about their child's health at the time of delivery, experienced more pain than expected, and reported less involvement in decision-making.

Objective: To compare the difference in neonatal mortality and morbidity between breech and cephalic presentations at term., Methods: This was a retrospective matched cohort study in two centers between July 1998 and April 2000, including all breech deliveries between 37(+0) and 41(+6) weeks, except cases with multiple gestations and antepartum intrauterine deaths. All breech presentations were matched with two cephalic presentations. Onset of labor and route of delivery were recorded, and neonatal data were categorized into variables belonging to serious morbidity or moderate morbidity., Results: One thousand one hundred and nineteen deliveries were included. Three hundred and seventy-three babies were in breech position and 746 in cephalic position. The gestational age and birth weight of the babies in the breech group were lower than in the cephalic group (p < 0.001). Congenital abnormalities occurred more often in the breech group (p < 0.005). An elective cesarean section was performed in 23.3% of breech presentations versus 3.5% of cephalic presentations (p < 0.001). Emergency cesarean sections were done in 29.2% of breech presentations versus 8.8% of cephalic presentations (p < 0.001). Children born in breech presentation had lower Apgar scores after 1 minute (p < 0.0001), but 5-minute Apgar scores were the same in both groups (p = 0.22). Children born in breech presentation received significantly more resuscitation than children born in cephalic presentation (p < 0.001). In both groups no perinatal mortality occurred. No differences were observed in percentages of children with serious or moderate neonatal morbidity between the breech and cephalic lies., Conclusions: Although the numbers are small, this study shows that the conservative (vaginal) approach in selected fetuses in breech position can be safely pursued with neonatal results similar to fetuses in cephalic presentation.

Background: Hypertensive disorders, i.e. pregnancy induced hypertension and preeclampsia, complicate 10 to 15% of all pregnancies at term and are a major cause of maternal and perinatal morbidity and mortality. The only causal treatment is delivery. In case of preterm pregnancies conservative management is advocated if the risks for mother and child remain acceptable. In contrast, there is no consensus on how to manage mild hypertensive disease in pregnancies at term. Induction of labour might prevent maternal and neonatal complications at the expense of increased instrumental vaginal delivery rates and caesarean section rates., Methods/design: Women with a pregnancy complicated by pregnancy induced hypertension or mild preeclampsia at a gestational age between 36+0 and 41+0 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant management for spontaneous delivery. The primary outcome of this study is severe maternal morbidity, which can be complicated by maternal mortality in rare cases. Secondary outcome measures are neonatal mortality and morbidity, caesarean and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be by intention to treat. In total, 720 pregnant women have to be randomised to show a reduction in severe maternal complications of hypertensive disease from 12 to 6%., Discussion: This trial will provide evidence as to whether or not induction of labour in women with pregnancy induced hypertension or mild preeclampsia (nearly) at term is an effective treatment to prevent severe maternal complications., Trial Registration: The protocol is registered in the clinical trial register number ISRCTN08132825.

Background: Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term., Methods/design: The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm., Discussion: This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term., Trial Registration: Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.

Background: The purpose of this review was to compare pharmacology, contraceptive efficacy, cycle control, side effects and acceptability with the combined contraceptive vaginal ring (CCVR) and combined oral contraceptives (COCs)., Study Design: All randomized controlled trials (RCTs) between the CCVR and a COC up to and including December 2006 were analyzed., Results: Twelve RCTs comparing the CCVR and a COC were identified. Systemic exposure to ethinyl estradiol (EE) with the CCVR was half of that with a 30-microg EE-containing COC with less variation in serum levels. During CCVR use, sex hormone-binding globulin and cortisol-binding globulin concentrations were significantly less increased than during COC use. Both methods showed adequate ovarian suppression and equal contraceptive efficacy. Uterine concentrations of EE and etonogestrel were not elevated with the CCVR. Cycle control achieved with the CCVR was better than that of the COC. Compliance with both methods was high. Mean blood pressure and body weight did not change in either group. Incidence of adverse events such as breast tenderness, headache and nausea was comparable, but a higher incidence of local and ring-related events led to higher discontinuation rates in the CCVR group. Both contraceptives were highly acceptable and resulted in a global improvement of sexual function. Ring users were more likely to continue with their method after study completion than COC users., Conclusions: The vaginal ring has the same contraceptive efficacy as COCs with lower systemic EE exposure, more consistent serum EE levels and better cycle control, but more local adverse events resulting in higher discontinuation rates.

Objective: To evaluate maternal health outcomes two years after term breech delivery., Design: This was a non-randomized single-center prospective cohort study. Mothers were asked to fill out questionnaires at two years postpartum to judge their health in the previous three to six months. Outcomes of the planned cesarean section group were compared with outcomes of the planned vaginal delivery group, whether or not a vaginal birth was realized or an emergency cesarean section was performed., Results: One hundred and eighty-three women completed a follow-up questionnaire at two years postpartum. Outcomes of the planned cesarean section group were compared with outcomes of the planned vaginal delivery group, whether or not a vaginal birth was realized or an emergency cesarean section was performed. No differences in maternal experiences concerning breastfeeding, taking care of her child and the relationship with her partner were found between the two groups. Also, no differences were found in all investigated maternal health items, or in sexual activity and fertility., Conclusion: Maternal health outcomes two years after term breech delivery were similar after planned cesarean section and planned vaginal delivery.

Objective: To test the hypothesis that in pregnancies with a clinically suspected growth restricted foetus at term, induction of labour is as safe as expectant management, and does not lead to increased obstetrical interventions or perinatal morbidity., Study Design: In one obstetric centre, 33 women with a clinically suspected growth restricted foetus at term were randomly allocated after stratification for parity to either induction or to expectant management. Obstetric and neonatal outcome variables were compared., Results: There was a lower gestational age at labour (median 38(0) weeks versus 40(1) weeks) with a corresponding tendency to lower birth weight (mean 2428 g versus 2651 g), and a reduced need for ante partum medical surveillance, in the induction group. No significant differences in obstetrical interventions (25% versus 24%) and neonatal morbidity rates (50% versus 35%) were found., Conclusion: A larger multicenter study with a sufficient power and long-term follow-up to decide the best policy for the term growth restricted foetus is feasible.