The METEX study: Methotrexate versus expectant management in women with ectopic pregnancy: A randomised controlled trial

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

HOE NORMATIEF IS NORMATIEF?

HOE NORMATIEF IS NORMATIEF

A cytophotometric and electron-microscopical study on catalase activity in serial cryostat sections of rat liver

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Non-commercial surrogacy: an account of patient management in the first Dutch Centre for IVF Surrogacy, from 1997 to 2004

Surrogacy was prohibited in the Netherlands until 1994, at which time the Dutch law was changed from the general prohibition of surrogacy to the prohibition of commercial surrogacy. This paper describes the results from the first and only Dutch Centre for Non-commercial IVF Surrogacy between 1997 and 2004. A prospective study was conducted of all intended parents, and surrogate mothers and their partners (if present), in which medical, psychological and legal aspects of patient selection were assessed by questionnaires and interviews developed for this study. More than 500 couples enquired about surrogacy by telephone or e-mail. More than 200 couples applied for surrogacy in the Centre, of which, after extensive screening, 35 couples actually entered the IVF programme and 24 completed the treatment, resulting in 16 children being born to 13 women. Recommendations for non-commercial surrogacy are given, including abandoning the 1-year waiting period before adoption, currently dictated by law, avoiding a period of unnecessary psychological distress. Our study has shown that non-commercial IVF surrogacy is feasible, with good results in terms of pregnancy outcome and psychological outcome for all parents, and with no legal problems relating to the adoption procedures arising. The extensive screening of medical, psychological and legal aspects was a key element in helping to ensure the safety and success of the procedure

Management of early pregnancy loss

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

Clinical-decision taking in primary pelvic organ prolapse; the effects of diagnostic tests on treatment selection in comparison with a consensus meeting

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