Condition category
Pregnancy and Childbirth
Date applied
05/11/2004
Date assigned
31/03/2005
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Helen Spiby

ORCID ID

Contact details

Mother and Infant Research Unit
22 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

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

Sponsor information

Organisation

NHS Service Delivery and Organisation Programme (SDO) (UK)

Sponsor details

NCCSDO
London School of Hygiene and Tropical Medicine
99 Gower Street
London
WC1E 6AZ
United Kingdom

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes