Parents report positive experiences about enrolling babies in a cord-related clinical trial before birth

Aim The aim of this study was to evaluate parents' perceptions when they were asked to enrol their unborn preterm infant in a randomised trial involving delayed cord clamping or cord milking. Methods The parents of 58 infants were asked to take part in a qualitative study using semi-structured interviews to provide feedback about how they felt about their infants being included in the research project. A total of 37 parents – 15 fathers and 22 mothers – agreed to take part. Results Parents were generally positive about their experiences of their baby taking part in the trial, but the findings raised some concerns about the validity of the consent obtained before delivery, as it was given in a hurry, and some participants had difficulty remembering that they had agreed to take part. Four themes were identified from the interviews: implications of taking part, reasons for enrolling infants, experiences of recruitment and suggestions for improvement. Conclusion Overall, the parents were positive about their baby taking part in the trial, but the consent process could be improved, by providing information about relevant trials earlier in the pregnancy or implementing continuous consent at key points in the trial

Issues of informed consent for intrapartum trials: a suggested consent pathway from the experience of the Release trial [ISRCTN13204258]

Service users within the NHS are increasingly being asked to participate in clinical research. In Liverpool Women's NHS Foundation Trust, approximately 35% of women take part in research during their pregnancy. For many studies the consent process is simple; information is provided and signed consent is given. There is a difficulty, however, with obtaining informed consent from women in pregnancy who become eligible only when they develop unforeseen complications, especially when they occur acutely. The problem is compounded with women in labour who may be frightened, vulnerable, in pain, under the effect of opiate analgesia, or all of the above. If research to improve the care of these women is to continue, then special consent procedures are needed. These procedures must ensure that the woman's autonomy is protected whilst recognising that women under these circumstances vary enormously, both in their desire for information and their ability to comprehend it. This paper will discuss the obtaining of consent in this situation, and describe an information and consent pathway for intrapartum research which has been developed in collaboration with consumer groups as a way in which these issues can be tackled

Denial of parents' rights in maternity care

1.00SIGLEAvailable from British Library Lending Division - LD:85/10773(Denial) / BLDSC - British Library Document Supply CentreGBUnited Kingdo

Childbirth care users' views Submission to the House of Commons Health Committee 1991

SIGLEAvailable from British Library Document Supply Centre- DSC:q92/17820(Childbirth) / BLDSC - British Library Document Supply CentreGBUnited Kingdo

Ultrasound? Unsound

Updated edition of AIMS Journal vol 5(1) Spring 1993SIGLEAvailable from British Library Document Supply Centre- DSC:q96/07973 / BLDSC - British Library Document Supply CentreGBUnited Kingdo

Standard- or high-dose oxytocin for nulliparous women with confirmed delay in labour:quantitative and qualitative results from a pilot randomised controlled trial

Objective Evidence suggests that a high dose of oxytocin for nulliparous women at 37-42 weeks of gestation with confirmed delay in labour increases spontaneous vaginal birth. We undertook a pilot study to test the feasibility of this treatment. Design Pilot double-blind randomised controlled trial. Setting Three teaching hospitals in the UK. Population A total of 94 consenting nulliparous women at term with confirmed delay in labour were recruited, and 18 were interviewed. Methods Women were assigned to either a standard (2 mU/min, increasing every 30 minutes to 32 mU/minute) or a high-dose regimen (4 mU/minute, increasing every 30 minutes to 64 mU/minutes) oxytocin by computer-generated randomisation. Simple descriptive statistics were used, as the sample size was insufficient to evaluate clinical outcomes. The constant comparative method was used to analyse the interviews. Main outcome measures The main outcome measures: number of women eligible; maternal and neonatal birth; safety; maternal psychological outcomes and experiences; health-related quality of life outcomes using validated tools and data on health service resource use; incidence of suspected delay of labour (cervical dilatation of <2 cm after 4 hours, once labour is established); and incidence of confirmed delay of labour (progress of <1 cm on repeat vaginal examination after a period of 2 hours). Results We successfully developed systems to recruit eligible women in labour and to collect data. Rates of spontaneous vaginal birth (10/47 versus 12/47, RR 1.2, 95% CI 0.6-2.5) and caesarean section (15/47 versus 17/47, RR 1.1, 95% CI 0.6-2.0) were increased, and rates of instrumental birth were reduced (21/47 versus 17/47, RR 0.8, 95% CI 0.5-1.3). No evidence of increased harm for either mother or baby was found. The incidences of suspected delay (14%) and confirmed delay (11%) in labour were less than anticipated. Of those who did not go on to have delayed labour confirmed, all except one woman gave birth vaginally. Conclusions A pilot trial assessing the efficacy of high-dose oxytocin was feasible, but uncertainty remains, highlighting the need for a large definitive trial. The implementation of national guidance of suspected and confirmed delay in labour is likely to reduce intervention