Improving care at the primary/secondary interface: a trial of community-based support in early labour

ISRCTN ISRCTN11168521
DOI https://doi.org/10.1186/ISRCTN11168521
Secondary identifying numbers SDO/40/2003
Submission date
05/11/2004
Registration date
31/03/2005
Last edited
10/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Helen Spiby
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Scientific title
Study acronymELSA (Early Labour Support and Assessment)
Study objectivesIn 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPregnancy, labour
Intervention1. 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 typeOther
Primary outcome measureLabour
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2005
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaHealthy nulliparous women
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2005
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Mother and Infant Research Unit
Leeds
LS2 9LN
United Kingdom

Sponsor information

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

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

ROR logo "ROR" https://ror.org/02wnqcb97

Funders

Funder type

Government

NHS Service Delivery and Organisation R&D Programme (UK), Ref: SDO/40/2003

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan