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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]

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.

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 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.

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.

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.

Objective: To compare uterine tissue concentrations of ethinyl estradiol (EE) and etonogestrel (ENG) after one cycle of use of a contraceptive vaginal ring (NuvaRing; NV Organon, Oss, The Netherlands) or a combined oral contraceptive (COC)., Design: Randomized, open-label, pharmacokinetic study., Setting: Obstetrics and gynecology unit., Patient(s): Eight premenopausal women about to undergo hysterectomy but otherwise healthy., Intervention(s): One cycle (17-21 days) of NuvaRing or COC treatment that ended with surgical hysterectomy., Main Outcome Measure(s): Tissue concentrations of EE and ENG in uterine tissue samples taken from the upper myometrium and mid-myometrium, the cervical region, and the endometrium., Result(s): In both groups, concentrations of EE and ENG were similar in uterine tissue taken from the upper myometrium and mid-myometrium and the cervical region. However, compared with the COC group, concentrations of both hormones were markedly lower in tissue samples from the endometrium of women who had been treated with NuvaRing., Conclusion(s): Vaginal administration of hormones with NuvaRing did not produce elevated uterine concentrations of EE and ENG, compared with an oral contraceptive.

A novel contraceptive vaginal ring releasing etonogestrel 120 microg and ethinyl oestradiol 15 microg daily over a period of 3 weeks was tested. Each ring was used for one cycle, comprising 3 weeks of ring use followed by a 1 week ring-free period. This 1 year, multicentre study assessed the contraceptive efficacy, cycle control, tolerability and acceptability of the contraceptive. Altogether, 1145 women were exposed to the vaginal ring for 12,109 cycles (928 woman-years). Six pregnancies occurred during treatment, giving a Pearl Index of 0.65 (95% confidence interval 0.24--1.41). Cycle control was very good, since irregular bleeding was rare (2.6--6.4% of evaluable cycles) and withdrawal bleeding (mean duration 4.7--5.3 days) occurred in 97.9--99.4% of evaluable cycles. Compliance to the prescribed regimen was high with criteria being fulfilled in 90.8% of cycles. The ring was well tolerated. The majority of women considered this new contraceptive method easy to use, and it offers an effective, convenient, well-accepted and novel method for hormonal contraception.

The aim of the study was to evaluate the influence of a combined contraceptive vaginal ring (CCVR) made of Silastic on the cervico-vaginal epithelium during 20 cycles of use. A total of 76 volunteers used the CCVR releasing 0.120 mg etonogestrel and 0.015 mg ethinyloestradiol daily. Cytological samples were taken of the vaginal epithelium, the ectocervix and the endocervix before the start, at 4 and 12 months, and at the end of the study. Cytology, hormonal profiles, human papilloma virus (HPV) status, DNA-flow cytometry, bacterial flora, and morphometry was performed on these samples. Colposcopy and histopathology of biopsy specimens were performed at the end. No cytological changes of the squamous epithelium or the columnar epithelium were found. HPV was detected in three samples of three different women. At least two of them reverted to HPV negative during the rest of the study period. Aneuploidy was diagnosed in 11 women before the study. Seven of them changed to diploid during the study. No changes from diploid to aneuploid were seen. Aneuploidy was not seen in any of the HPV positive samples. Although bacterial flora showed considerable variation during the study, no significant influence of the CCVR could be established. Morphometrical analysis showed an increasing nucleus:cytoplasm ratio of the squamous cells during the study. Mild dysplasia was detected in one woman at the end of the study. It was concluded that no unfavourable cytological or bacteriological changes of the cervico-vaginal epithelium were demonstrated during 20 cycles of CCVR use. The vaginal epithelium became more progestogenic during the study.

Twenty-two infertile women with repeated deficient results in the postcoital test received clomiphene citrate or tamoxifen. The patterns of luteinizing hormone, follicle-stimulating hormone, prolactin, 17 beta-estradiol (E2), and progesterone were examined during the follicular and periovulatory phases of the menstrual cycle, as were the cervical mucus characteristics. Under clomiphene treatment, an overproduction of E2 was observed (P less than 0.01), which did not result in an improvement of the cervical mucus characteristics. The pH of the endocervical mucus was lower (P less than 0.01). Under tamoxifen treatment, the serum E2 levels were higher (P less than 0.05) and normalized. Higher spermatozoa penetration meter scores were observed during the preovulatory and periovulatory periods, whereas the pH of the endocervical mucus was not lowered. These data support that tamoxifen may be preferential to clomiphene in treating this kind of infertile woman.

Twenty-two women in whom a routine infertility workup had shown no abnormality except for repeated deficient results in the postcoital test (PCT), the patterns of luteinizing hormone (LH), follicle-stimulating hormone (FSH), prolactin (PRL), 17 beta-estradiol (E2), and progesterone (P) were examined during the follicular and periovulatory phases of the menstrual cycle. Cervical mucus (CM) characteristics were also investigated during the pre- and periovulatory phases and scored using a CM score and a sperm penetration meter (SPM) score. The results were compared with those of a control group of seven women with proven fertility. No differences were found between the CM scores of both groups, whereas the SPM score was lower (P less than 0.1) in the infertile group. The preovulatory serum levels of E2 were lower (P less than 0.1) in the infertile group, while the serum levels of PRL (P less than 0.1) and FSH (P less than 0.1) were constantly higher in this group. The mean serum levels of LH and P were almost equal in the two groups. It is concluded that a deficient result in the PCT can be indicative of deviated hormonal patterns in an infertile woman even when the routine fertility investigation is suggestive of a normal ovulatory cycle.