ObjectiveTo evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks. DesignMulticentre, open label, randomised controlled superiority trial. setting 14 hospitals in Sweden, 2016-18.ParticiPants 2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group. interventiOnsInduction of labour at 41 weeks and expectant management and induction of labour at 42 weeks. Main OutcOMe MeasuresThe primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat. resultsThe study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups. cOnclusiOnsThis study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths. trial registratiOnCurrent Controlled Trials ISRCTN26113652.

Sir, I was interested to read the paper by Tsiartas and colleagues 1 published in the June 2012 issue of BJOG. The authors reported the prediction of preterm labour by building a model using a cohort data set. As the authors point out in their conclusion, such a model needs to be tested in a new cohort in order to confirm its predictive ability. Why did the authors not divide their cohort into two and develop the model on one half and test it on the other? Or use other methods such as bootstrapping to test the reliability of their model?They have reported a sensitivity of 74%, a specificity of 87%, a positive predictive value (PPV) of 76%, a negative predictive value (NPV) of 86%, a likelihood ratio of 5.8 and an area under the receiver operating characteristic (AUC) curve of 0.88, concluding that serum proteins and cervical length constituted the best prediction model for the mentioned outcome. 1 Sensitivity, specificity, PPV, NPV, positive likelihood ratio (true positive/false negative) and negative likelihood ratio (false positive/true negative), as well as odds ratio (true results/false results, preferably with a value of more than 50), are among the tests to evaluate the validity (i.e. accuracy) of a single test compared with a gold standard. [2][3][4] Considering the range of values for the positive likelihood ratio (LR + = 1-infinity) and negative likelihood ratio (LR ) = 0-1), knowing that both LR + and LR ) equal 1 is the worst situation for the test. An LR + of 5.8 says nothing about the predictive value, because this should be compared with another LR + . Moreover, considering the range of possible LR + values, an LR + of 5.8 seems unimpressive. In such a situation, it is better to at least report the LR ) as well. 2,4 The area under the ROC curve is usually reported for diagnostic rather prognostic values of a model. The ROC for models may be comparable with LR + for a test because both of them actually use sensitivity and 1 -specificity; however, in LR + they are divided, and in the ROC we should plot sensitivity to 1 -specificity. 4 Prediction of spontaneous preterm delivery in women with threatened preterm labour: a prospective cohort study of multiple proteins in maternal serum Authors' ReplySir, First, we would like to thank Dr Sabour 1 for his interest in our paper. 2 He has raised important questions regarding the data analyses, which we appreciate taking the opportunity to clarify. We agree, and have pointed out in our Conclusions, that the predictive model needs to be validated in a new cohort in order to confirm its predictive ability. When we performed the analyses, we decided not to divide our data set into two parts to develop the model in one half and test it in the other. This division would have resulted in a substantial reduction of the predictive power of this study, with its limited number of patients. Our results must thus be replicated in another cohort.

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ICSI is a highly efficient treatment of male factor infertility and therefore increasingly used to treat infertile men successfully. However, when used to treat patients with a genetic cause for their infertility, there may be an increased risk for the offspring. Chromosome aberrations, Y chromosome microdeletions and CFTR (cystic fibrosis transmembrane conductance regulator) mutations alone may explain up to 25% of azoospermia and severe oligozoospermia. These genetic defects could be identified before treatment, in which case informed decisions could be made by the couple to be treated concerning the treatment, prenatal testing or preimplantation genetic diagnosis. Therefore, we propose that men with very low sperm counts (<5 x 10(6)/ml) considering ICSI should always be informed of the possibility of genetic testing. The information should include a precise statement of the implications of the results for the patient, his family and his offspring, and reassurance that a decision to test or not to test, or the subsequent test results will not be used as a reason for withholding treatment. Testing should always remain voluntary, and the couples themselves should decide whether or not they choose to be tested. If an abnormality is identified, patients should be referred to specialist genetic counselling.

Intracytoplasmic sperm injection (ICSI) has been studied in this animal research programme since 1990. In 1993, the technique was first applied clinically and up to the present time (September 1994), a total of 456 couples have been studied in 538 cycles. The principal indication for the use of ICSI has been severe male sub-fertility as judged by a semen analysis. In addition, men with high titres of antisperm antibodies, blockage of the vas deferens and neurological disorders such as spinal cord lesions have been included in the programme. Men with genetic disorders such as cystic fibrosis and acrosome-deficient spermatozoa have also been treated successfully. The overall fertilization rate using ICSI was 59%, which is similar to the conventional in vitro fertilization (IVF) programme in Göteborg, however, the pregnancy rate per embryo transfer (29%) and the ongoing pregnancy rate per transfer (22%) were slightly lower. The total number of pregnancies was 144 with 111 of the pregnancies either ongoing or already delivered. To date, 36 healthy children have been born following 29 deliveries and no major malformations have been diagnosed. Being the first programme in Scandinavia to perform ICSI, this unit has experienced long waiting lists which indicates that severe male sub-fertility will be one of the major groups for treatment with assisted reproductive technologies in the future.