Details of HTA project in progress
Last updated: 1 February 2012 - Next update due: 8 February 2012
Research type: |
Primary Research (e.g. trial) |
Project title: |
A study of position during the late stages of labour in women with an epidural |
Project ref: |
08/22/02 |
Cost: |
£2,622,157 |
Chief Investigator : |
Professor Peter Brocklehurst, Professor of Women's Health, Director of the Institute for Women's Health, Institute for Women's Health UCL |
Start Date: |
January 2010 |
Estimated date of publication in HTA journal series: |
Late 2015. This date takes account of time for report preparation and printing based on current average times for these activities. |
Plain English Summary |
Epidurals are the most effective method of relieving pain in labour. About 150,000 women have epidurals during childbirth in the UK each year and they consistently report high levels of satisfaction. However, epidurals do have some disadvantages. Studies have shown that they increase the chance of women needing help to delivery their baby using forceps or vacuum suction. During an instrumental delivery a woman may need to have an episiotomy or my find it causes a tear in her birth canal as her baby is born. Instrumental deliveries also increase the risk of subsequently developing loss of bowel control (incontinence), leaking urine and suffering sexual problems after childbirth. There is debate about whether adopting an upright position during the late stage of labour, when the neck of the womb is fully open, gives a greater chance of having a normal vaginal birth. It is thought that an upright position may help by several different mechanisms: gravity may help align the baby more correctly in the birth canal and may increase the blood supply to the womb; it may also result in stronger contractions of the womb and assist a woman to push more effectively at delivery. At present few women who have an epidural are encouraged to be upright in the late stage of labour. Most adopt a position lying down or half-sitting in bed. However, advances in epidural pain relief over the last two decades have resulted in the widespread use of a technique that allows women to move around rather than to be immobile. This approach uses low doses of local anaesthetic, the drug which was responsible for leg weakness in old-style epidurals, together with another pain killer called fentanyl. With these 'mobile' epidurals, most women are able to move around safely whilst in labour, including the late stages of labour, and remain comfortable. Furthermore, the chance of needing an instrumental delivery is much less, although still greater than with no epidural. Around 3,000 women giving birth in large obstetric centres will be needed to answer this question. In the participating hospitals women will be given written information about the study during pregnancy by their midwife. All women who are in labour for the first time and who have an effective epidural, and for whom no complications are expected, with then be asked to give their consent to take part. If a woman agrees, she will be randomly allocated to one of two groups; one group will be will be encouraged by the midwife to adopt as upright a posture as possible (this would include walking, standing, sitting out of bed or sitting bolt upright in bed) for as much as possible of the late stage of labour, right up to their baby's birth, and the other group will be asked to adopt a lying down position in bed. The health of participating mothers and babies will be measured up to 1 year after birth with a postal or telephone questionnaire. The study will last for 57 months in total. The team carrying out this study represents the range of skills and expertise necessary to ensure the trial is conducted to the highest standards and within the timetable and resources proposed. Members of the study group were responsible for carrying out the COMET trial(1) which demonstrated that mobile epidurals increase a woman's chance of a normal delivery. The practical aspects of running the trial will be managed by the Clinical Trials Unit at the National Perinatal Epidemiology Unit which has over 25 years experience of running large multicentre randomised controlled trials in maternity care. |
Project Abstract: |
As the most effective form of pain relief in labour, epidural analgesia (an injection into the spine) is chosen by up to 30% of women in the UK each year. Its uptake is greater in women having their first baby, and the rate of uptake is up to 40% in large obstetric centres. Despite high maternal satisfaction with pain relief, epidurals do have unwanted side effects. For example, a systematic review of epidural versus non-epidural or no analgesia in labour found that epidural pain relief was associated with an increased risk of instrumental vaginal delivery (IVD) such as births where forceps or where a vacuum pump is used, or a C-section. If the rate of IVD could be reduced this would have a beneficial effect for both women and their babies. IVD is associated with increased risks of perineal trauma (the area between the vagina and the anus) and the consequent effects of surgical repair. Other problems that are associated with IVD include urinary and faecal incontinence, pain during intercourse and other problems with general physical and psychological health. A review of position in the part of labour where the cervix is fully open (known as the second stage of labour) has shown that women who gave birth in an upright position, such as sitting up in bed or standing, when compared to those who were lying down there was a reduced incidence in IVD in the upright group. However this study was undertaken in women who did not have an epidural in place. This trial aims to study if position has the same effect in reducing the incidence of IVD occurs in women that have an epidural in place. The trial will randomise 50% of participants to give birth in an 'upright' position, and the other 50% to give birth 'lying down'. |
ISRCTN* number: | ISRCTN 35706297 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN35706297 |
Project Protocol: |
Project protocol (pdf format, 2258 kbytes) |
URL of this page: |
http://www.hta.ac.uk/2084 |
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