Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SDO/40/2003
Study information
Scientific title
Acronym
ELSA (Early Labour Support and Assessment)
Study hypothesis
In some parts of the UK, women having their first baby have a 40-50% chance of having a caesarean section or instrumental (forceps or ventouse) delivery. These increasing rates are of concern to childbearing women, their families, and to the health services as they are associated with more ill health in women and their babies.
Some existing studies (which are small, or not very rigourous) have suggested that women who attend hospital very early in their labour are more likely to have a range of interventions including artificial rupture of membranes, epidurals, and caesarean and instrumental births. Some 10-33% of women admitted to delivery suite are not in labour, and do not need to be in hospital. This study will test these observations using a large randomised controlled trial. The aim is to examine whether or not a home visit by a community midwife when a pregnant woman thinks she may be in labour will have any impact on the rates of caesarean and other instrumental births, and other outcomes such as use of pain relief, the woman's views, and the health service resources used, compared with normal care. Women expecting their first baby, and whose pregnancy is progressing normally, will be told about the study during their pregnancy, by their own community midwife. If they are interested in participating, and after giving formal consent at around 32 weeks, they will be randomly allocated to one of two groups.
Women in the intervention group will be offered a home visit by a community midwife when they think they are in labour, while women in the control group will be asked to telephone the hospital for advice and to go into delivery suite if advised, as is normal practice across the UK. The midwife doing the home visit will offer support to the woman including breathing and relaxation techniques, carry out an assessment to see how labour is progressing, and offer advice about the appropriate time to go to hospital. Information about the two groups will be gathered directly from the women themselves, in pregnancy and 6 weeks after birth, from hospital notes, and from the midwives involved in the study. This information will be used to compare the outcomes for women in the two groups, to examine their views, to calculate the costs to the health services, and to the families. It is already known that caesarean section costs the health services more than twice the cost of a normal birth.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Pregnancy, labour
Intervention
1. Intervention: support and assessment for nulliparous women at home in early labour by community midwives
2. Control: standard care which usually comprises telephone advice to attend the hospital delivery suite to determine whether labour has established
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Labour
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2005
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy nulliparous women
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2005
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Mother and Infant Research Unit
Leeds
LS2 9LN
United Kingdom
Funders
Funder type
Government
Funder name
NHS Service Delivery and Organisation R&D Programme (UK), Ref: SDO/40/2003
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary