Contact information
Type
Scientific
Primary contact
Mrs Katie Mitchell
ORCID ID
Contact details
Obstetrics and Gynaecology Department
Stoke Mandeville Hospital
Mandeville Road
Stoke Mandeville
Aylesbury
HP21 8AL
United Kingdom
+44 (0)1296 216142
katiemitch@btinternet.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0245109928
Study information
Scientific title
Acronym
Study hypothesis
What is the relationship between the labour Electronic Fetal Monitoring (EFM) admission test and obstetric intervention for low-risk mothers?
Ethics approval
Mid and South Bucks Local Research Ethics Committee, approved on 30/12/1999 (ref: NC947), last amendment approved on 07/09/2005. Following a pilot study, approval for the change to the target number of participants obtained on 16/09/2003
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Pregnancy and Childbirth: Labour electronic fetal monitoring (EFM)
Intervention
This study will be of experimental design and will consist of a randomised, controlled trial. The trial is designed to answer the main question.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Primary outcome measure amended as of 05/03/2008:
Rate of operative delivery.
Primary outcome measures provided at time of registration:
Four indicators of obstetric intervention:
1. Rate of operative delivery
2. Rate of augmentation using an oxytocin infusion
3. Rate of episiotomy in normal deliveries
4. Rate of siting of an intravenous infusion
Secondary outcome measures
Secondary outcome measures added as of 05/03/2008:
1. Rate of augmentation using an oxytocin infusion
2. Rate of siting of an intravenous infusion
Overall trial start date
01/11/2002
Overall trial end date
10/03/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Inclusion criteria amended as of 03/09/2007:
Labouring women who attend the delivery suite involved in the study, who upon admission to hospital are considered to be of low risk of fetal or maternal complications. Low risk being defined as mothers who lack all of the criteria for exclusion. Around 1200 clients fulfilling this criteria were admitted to the unit to be studied in the period Jun 98-Jun 99.
Treatment arm (admission test) - 750 women
Control arm (no admission test) - 750 women
Inclusion criteria provided at time of registration:
Labouring women who attend the delivery suite involved in the study, who upon admission to hospital are considered to be of low risk of fetal or maternal complications. Low risk being defined as mothers who lack all of the criteria for exclusion. Around 1200 clients fulfilling this criteria were admitted to the unit to be studied in the period Jun 98-Jun 99.
Treatment arm (admission test) - 375 women
Control arm (no admission test) - 375 women
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Target number amended as of 03/09/2007: 1500. Target number provided at time of registration: 750.
Participant exclusion criteria
Added as of 07/03/2008:
Any woman having any of the following indicators of high risk upon admission in labour were excluded from the study:
1. Any major maternal medical complication e.g., diabetes, or essential hypertension
2. Previous caesarean section
3. Pre-term labour (less than 37 completed weeks)
4. Multiple pregnancy
5. Prolonged pregnancy (over 42 completed weeks)
6. Prolonged membrane rupture (over 24 hours)
7. Induction of labour
8. Meconium stained liquor
9. Maternal pyrexia
10. Rhesus sensitisation
11. Polyhydramnios
12. Oligohydramnios
13. Pre-eclampsia or blood pressure over 140/90 mmHg
14. Abnormal presentation or lie (e.g., breech or transverse)
15. High head (5/5ths palpable per abdomen)
16. Antepartum or intrapartum haemorrhage
17. Known or suspected intrauterine growth retardation
18. Any known or suspected fetal medical complication
19. Abnormal doppler artery velocimetry
20. Known fetal malformation
21. Poor obstetric history (e.g., history of stillbirth)
22. Unbooked cases
Recruitment start date
01/11/2002
Recruitment end date
10/03/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Obstetrics and Gynaecology Department
Aylesbury
HP21 8AL
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stoke Mandeville Hospital NHS Trust (UK)
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
1. 2008 results in http://www.rcm.org.uk/ebm/ebm-2008/mar-2008/the-effect-of-the-labour-electronic-fetal-monitoring-admission-test-on-operative-delivery-in-low-risk-women-a-randomised-control/