Hypnosis Antenatal Training for Childbirth (HATCh): a randomised controlled trial [NCT00282204]

BACKGROUND: Although medical interventions play an important role in preserving lives and maternal comfort they have become increasingly routine in normal childbirth. This may increase the risk of associated complications and a less satisfactory birth experience. Antenatal hypnosis is associated with a reduced need for pharmacological interventions during childbirth. This trial seeks to determine the efficacy or otherwise of antenatal group hypnosis preparation for childbirth in late pregnancy. METHODS/DESIGN: A single centre, randomised controlled trial using a 3 arm parallel group design in the largest tertiary maternity unit in South Australia. Group 1 participants receive antenatal hypnosis training in preparation for childbirth administered by a qualified hypnotherapist with the use of an audio compact disc on hypnosis for re-enforcement; Group 2 consists of antenatal hypnosis training in preparation for childbirth using an audio compact disc on hypnosis administered by a nurse with no training in hypnotherapy; Group 3 participants continue with their usual preparation for childbirth with no additional intervention. Women > 34 and < 39 weeks gestation, planning a vaginal birth, not in active labour, with a singleton, viable fetus of vertex presentation, are eligible to participate. Allocation concealment is achieved using telephone randomisation. Participants assigned to hypnosis groups commence hypnosis training as near as possible to 37 weeks gestation. Treatment allocations are concealed from treating obstetricians, anaesthetists, midwives and those personnel collecting and analysing data. Our sample size of 135 women/group gives the study 80% power to detect a clinically relevant fall of 20% in the number of women requiring pharmacological analgesia – the primary endpoint. We estimate that approximately 5–10% of women will deliver prior to receiving their allocated intervention. We plan to recruit 150 women/group and perform sequential interim analyses when 150 and 300 participants have been recruited. All participant data will be analysed, by a researcher blinded to treatment allocation, according to the "Intention to treat" principle with comprehensive pre-planned cost- benefit and subgroup analyses. DISCUSSION: If effective, hypnosis would be a simple, inexpensive way to improve the childbirth experience, reduce complications associated with pharmacological interventions, yield cost savings in maternity care, and this trial will provide evidence to guide clinical practice

Advance directives from haematology departments: the patient’s freedom of choice and communication with families. A qualitative analysis of 35 written documents

Abstract Background In France, advance directives are favourably perceived by most of the population, although the drafting rate is low. This ambivalence is challenging because advance directives are meant to promote the autonomy and freedom of choice of patients. The purpose of this study was to analyse the content of advance directives written by patients suffering from malignant haemopathies to better understand how patients put them into practice. These could be relevant as early as the initial diagnosis of haematological malignancies because of the uncertain course of the disease. Methods This was a multicentre, qualitative, descriptive study. The advance directives written by patients with malignant haemopathies treated in one of the six French hospital departments were included in the study from 01/06/2008 to 15/04/2016. A thematic analysis of the advance directives was performed by two researchers: a senior haematologist and a research assistant. Results The median age of the patients was 69. Most were women (sex ratio: 0.59), living as a couple (57%), with lymphoid pathologies (66%), who were still alive two years after the instructions were written (63%) and had nominated a health care proxy (88.6%). Free texts (62.9%) were richer in content than pre-defined forms. The advance directives were used in three ways: for a purely legal purpose, to focus on medical treatments or actions, or to communicate a message to the family. Three main themes emerged: (1) refusal of medical treatment (100%), in which patients express refusal of life-sustaining care (97.1%). The actual treatments or the moment when they should be limited or stopped were not always mentioned in detail. (2) A desire for effective pain relief to avoid suffering (57.1%) and (3) messages for their family (34.3%), such as funeral arrangements (17.1%) and messages of love or trust (14.3%). Conclusions Patients who write advance directives are not necessarily at the end of their lives. Their content mainly conveys treatment wishes, although patients also use them to pass on personal messages to their close family. This emerging role of advance directives to communicate messages within the family should be valued, even if it is not their original purpose

Factors associated with lamotrigine concentration/dose ratio in individuals with bipolar disorders

International audienceMonitoring of lamotrigine levels is recommended in epilepsy. However, in bipolar disorders (BD), no study has described the therapeutic range in daily practice and factors being associated to it. We used retrospective data of individuals with BD, treated with lamotrigine, and included in the FondaMental Advanced Centers of Expertise for Bipolar Disorders cohort. We extracted clinical and biological data and explored associations between these variables and lamotrigine concentration/dose (C/D) ratio. The database included 675 individuals who received lamotrigine at inclusion, whose main characteristics were female sex (68.3%) and BD type 2 (52.1%). Data about lamotrigine C/D ratio were available for 205 individuals. Lamotrigine C/D ratio was significantly associated with: Body Mass Index (BMI) (r=-0.159), estimated GFR (glomerular filtration rate) (r=-0.228), total bilirubin (r = 0.241) and at a trend level, antidepressant co-prescription (U = 3169). The model obtained was: lamotrigine C/D ratio = 1.736 - 0.013*BMI + 0.095*total bilirubin (UI/L) - 0.007*eGFR (ml/min) + 0.210*AST/ALT – 0.004*GGT (UI/L) + 0.014*age (year) + 0.303*currently smoking (yes or no) – 0.588*antidepressant co-prescription (yes or no) – 0.357*gender (F = 1.899, p = 0.057, adjusted R2 = 0.11) Information about plasma lamotrigine C/D ratio were available for only 205 out of the 675 individuals in the database and has been obtained from different laboratories. The representativeness of the included sample may be questionable. This is the first study providing information on a large sample of individuals with BD regarding factors associated with lamotrigine C/D ratio. This study allows to propose a model of lamotrigine C/D ratio that would deserve further replication