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
Scientific
Mother and Infant Research Unit
22 Hyde Terrace
Leeds
LS2 9LN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | |
| Study acronym | ELSA (Early Labour Support and Assessment) |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Labour |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Healthy nulliparous women |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Mother and Infant Research Unit
Leeds
LS2 9LN
United Kingdom
LS2 9LN
United Kingdom
Sponsor information
NHS Service Delivery and Organisation Programme (SDO) (UK)
Government
Government
NCCSDO
London School of Hygiene and Tropical Medicine
99 Gower Street
London
WC1E 6AZ
United Kingdom
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
