Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial.

BACKGROUND: Induction of labour is a common obstetric procedure. At present, different methods are used for induction of labour in women with an unfavourable cervix. Recently, we showed that in term women with an unfavorable cervix the use of a Foley catheter in comparison with vaginal Prostaglandin E2 gel, results in a comparable vaginal delivery rate. A meta-analysis on the subject indicated lower rates of hyperstimulation, and probably as a sequel fewer cases of postpartum haemorrhage. Misoprostol (PgE1) is another type of prostaglandin frequently used for labour induction, recommended by the international federation of gynaecology and obstetrics (FIGO). Misoprostol can be administered by vaginal, rectal and oral route. There is evidence that oral administration results in less asphyxia and hyperstimulation than vaginal administration. At present, valid comparisons between oral misoprostol and Foley catheter are lacking. Therefore, we propose a randomised controlled trial comparing Foley catheter to oral misoprostol in order to assess safety and cost-effectiveness. METHODS/DESIGN: We plan a multicentre, randomised, controlled, open-label clinical trial among term pregnant women with a vital singleton in cephalic presentation, unfavorable cervix, intact membranes and an indication for induction of labour. After informed consent, women will be randomly allocated by a webbased randomisation system to transcervical Foley catheter or oral misoprostol (50 mcg every 4 hours). The primary outcome will be a composite of complications of uterine hyperstimulation, i.e. post partum haemorrhage and asphyxia. Secondary outcomes are mode of delivery, maternal and neonatal morbidity, costs and women's preference. Serious adverse events such as severe maternal or neonatal morbitity or mortality will be monitored and reported to an independent data safety monitory board. With a sample size of 1860 women we will be able to demonstrate a 5% non-inferiority of the Foley catheter as compared to misoprostol for the composite outcome. DISCUSSION: Worldwide, various methods are being used for labour induction. Results of the proposed trial will contribute to the answer which method of induction of labour is most safe, cost-effective, and patient friendly and will help to construct evidence based guidelines. TRIAL REGISTRATION: The Netherlands Trial Register NTR3466.

Effect of a school feeding programme on nutritional status and anaemia in an urban slum: a preliminary evaluation in Kenya.

To reduce malnutrition and improve child survival, school feeding programmes have been established in many parts of Africa, although prevalence of child malnutrition and anaemia remains high, especially in urban slums. The objective of this study is to evaluate the effect of a school feeding programme in the slums of Nairobi (Kenya) on anaemia and nutritional status, together with an investigation for socioeconomic determinants that may overrule this effect. Sixty-seven children at the St. George primary school in Kibera participated in the school feeding programme for 1 year and data concerning anaemia rate, nutritional status and socioeconomic status were collected during a medical health check. Data were compared with a control group of children attending the same school, of the same age and with the same gender distribution without participation in a feeding programme. Data were analyzed with statistical software (SPSS 17.0). Children participating in the school feeding programme were less stunted (p = 0.02) and wasted (p = 0.02) than children in the control group, and levels of anaemia were lower (p = 0.01). Having no father (p = 0.01) and living in small families (p = 0.003) overruled the effect of the feeding programme. Also, the higher the mother's education, the more wasting was seen (p = 0.04) despite participation in the programme. The programme reduced anaemia and malnutrition and has improved child growth in our study group greatly, but we found that education level of the mother, family size and absence of a father overruled the effect of the school feeding programme. Because sample size of our study is small, we encourage further large-scaled research on reviewing programmatic interventions to develop optimal feeding strategies and improve nutritional status of children.