ObjectiveTo evaluate the feasibility of continuous telemetric trans-abdominal fetal electrocardiogram (a-fECG) in women undergoing labour induction at home.Study DesignLow risk women with singleton term pregnancy undergoing labour induction with retrievable, slow-release dinoprostone pessaries (n = 70) were allowed home for up to 24 hours, while a-fECG and uterine activity were monitored in hospital via wireless technology. Semi-structured diaries were analysed using a combined descriptive and interpretive approach.Results62/70 women (89%) had successful home monitoring; 8 women (11%) were recalled because of signal loss. Home monitoring lasted between 2–22 hours (median 10 hours). Good quality signal was achieved most of the time (86%, SD 10%). 3 women were recalled back to hospital for suspicious a-fECG. In 2 cases suspicious a-fECG persisted, requiring Caesarean section after recall to hospital. 48/51 women who returned the diary coped well (94%); 46/51 were satisfied with home monitoring (90%).ConclusionsContinuous telemetric trans-abdominal fetal ECG monitoring of ambulatory women undergoing labour induction is feasible and acceptable to women.
BackgroundThe vulnerability of newborn babies' skin creates the potential for a number of skin problems. Despite this, there remains a dearth of good quality evidence to inform practice. Published studies comparing water with a skin-cleansing product have not provided adequate data to inform an adequately powered trial. Nor have they distinguished between babies with and without a predisposition to atopic eczema. We conducted a pilot study as a prequel to designing an optimum trial to investigate whether bathing with a specific cleansing product is superior to bathing with water alone. The aims were to produce baseline data which would inform decisions for the main trial design (i.e. population, primary outcome, sample size calculation) and to optimize the robustness of trial processes within the study setting.Methods100 healthy, full term neonates aged <24 hours were randomly assigned to bathing with water and cotton wool (W) or with a cleaning product (CP). A minimum of bathing 3 times per week was advocated. Groups were stratified according to family history of atopic eczema. Transepidermal water loss (TEWL), stratum corneum hydration and skin surface pH were measured within 24 hours of birth and at 4 and 8 weeks post birth. Measurements were taken on the thigh, forearm and abdomen. Women also completed questionnaires and diaries to record bathing practices and medical treatments.ResultsForty nine babies were randomized to cleansing product, 51 to water. The 95% confidence intervals (CI) for the average TEWL measurement at each time point were: whole sample at baseline: 10.8 g/m2/h to 11.7 g/m2/h; CP group 4 weeks: 10.9 g/m2/h to 13.3 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h; W group 4 weeks:10.9 g/m2/h to 12.2 g/m2/h; 8 weeks: 11.4 g/m2/h to 12.9 g/m2/h.ConclusionThis pilot study provided valuable baseline data and important information on trial processes. The decision to proceed with a superiority trial, for example, was inconsistent with our data; therefore a non-inferiority trial is recommended.Trial registrationISRCTN72285670
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