ObjectiveEvidence suggests that a high dose of oxytocin for nulliparous women at 37-42weeks of gestation with confirmed delay in labour increases spontaneous vaginal birth. We undertook a pilot study to test the feasibility of this treatment.DesignPilot double-blind randomised controlled trial.SettingThree teaching hospitals in the UK.PopulationA total of 94 consenting nulliparous women at term with confirmed delay in labour were recruited, and 18 were interviewed.MethodsWomen were assigned to either a standard (2mU/min, increasing every 30minutes to 32mU/minute) or a high-dose regimen (4mU/minute, increasing every 30minutes to 64mU/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 outcomes measuresThe 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 <2cm after 4hours, once labour is established); and incidence of confirmed delay of labour (progress of <1cm on repeat vaginal examination after a period of 2hours).ResultsWe 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.ConclusionsA 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.

Background Recruitment when eligibility can only be confirmed during labour is challenging, particularly for indications that occur infrequently. Currently the Royal College of Obstetricians and Gynaecologists advises that in such situations all potentially eligible women should receive antenatal information, and consent be taken when the woman becomes eligible for inclusion.1 Methods The HOLDS pilot ran in three centres between November 2010 and May 2011 and recruited 94 women to a pilot trial of standard versus high dose oxytocin for nulliparous women with confirmed delay in labour. The RCOG model was adopted and this paper reports qualitative data from semi-structured interviews with a diverse sample of 18 women approximately six weeks after birth, who were recruited to the pilot in labour. Data was analysed using the constant comparative method. Results Only four of the eighteen women remembered receiving the information antenatally, and those that did remember said it did not seem relevant to them. Fourteen of the eighteen women interviewed had at least a basic understanding of what was involved and felt able to give informed consent at the time. Two women could not recall details but trusted clinical staff. All were happy they had participated. Verbal information from clinicians to support that provided was important to participants9 decision, as was support from partner present. Conclusions The current RCOG advice regarding information to all potentially eligible women in the antenatal period may not be seen as relevant by women, nor influence their ability to give informed consent in situations that occur infrequently.

Background Relatively little is known about the experiences of women who become delayed in labour, and the evidence that does exist presents a mixed picture. For example, two UK-based studies using questionnaires found that intervention for delay was not necessarily viewed as negative by women,1 2 while two more recent small-scale interview studies from Scandinavia have shown delay can be problematic and lead women to need particular support from health professionals.3 4 Methods We undertook individual semi-structured interviews with a diverse sample of 18 women with confirmed delay in labour. Data were analysed using the constant comparative method. Results While all women reported feeling that they understood what was happening to them most of the time they were in labour, and felt well supported by staff, there were some periods for the majority when this had not been the case and they had struggled to keep up with what was going on. Factors that contributed to this included: pain; the effects of pain relief; tiredness; and being in an unfamiliar environment. On the whole, women were accepting of the fact that the delay they were experiencing meant that they had fewer choices available to them during labour and birth than perhaps they would have liked. Conclusions Women generally felt well-supported but there were ‘crunch points’ for many when explanations by health professionals about what was happening and why were not as forthcoming or as helpful as women would have liked.