Standard‐ or high‐dose oxytocin for nulliparous women with confirmed delay in labour: quantitative and qualitative results from a pilot randomised controlled trial. Issue 11 (21st June 2013)

• Record Type: Journal Article
• Authors: Kenyon, S; Armstrong, N; Johnston, T; Walkinshaw, S; Petrou, S; Howman, A; Cheed, V; Markham, C; McNicol, S; Willars, J; Waugh, J
• Is Part Of: BJOG. Volume 120:Issue 11(2013:Nov.)
• Page Start: 1403
• Page End: 1412
• Publication Date: 2013-06-21
• Subjects: Obstetrics -- Periodicals; Gynecology -- Periodicals; 618
• DOI: 10.1111/1471-0528.12331
• Languages: English
• ISSNs: 1470-0328

Abstract

<abstract abstract-type="main" id="bjo12331-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="bjo12331-sec-0001" sec-type="section"> <title>Objective</title> <p>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.</p> </sec> <sec id="bjo12331-sec-0002" sec-type="section"> <title>Design</title> <p>Pilot double‐blind randomised controlled trial.</p> </sec> <sec id="bjo12331-sec-0003" sec-type="section"> <title>Setting</title> <p>Three teaching hospitals in the UK.</p> </sec> <sec id="bjo12331-sec-0004" sec-type="section"> <title>Population</title> <p>A total of 94 consenting nulliparous women at term with confirmed delay in labour were recruited, and 18 were interviewed.</p> </sec> <sec id="bjo12331-sec-0005" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="bjo12331-sec-0006" sec-type="section"> <title>Main outcomes measures</title> <p>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).</p> </sec> <sec id="bjo12331-sec-0007" sec-type="section"> <title>Results</title> <p>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.</p> </sec> <sec id="bjo12331-sec-0008" sec-type="section"> <title>Conclusions</title> <p>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.</p> </sec> </abstract>