Effect of a labour electronic fetal monitoring admission test on operative delivery in low-risk women: a randomised controlled trial

ISRCTN ISRCTN28370122
DOI https://doi.org/10.1186/ISRCTN28370122
Secondary identifying numbers N0245109928
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
13/10/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Katie Mitchell
Scientific

Obstetrics and Gynaecology Department
Stoke Mandeville Hospital
Mandeville Road
Stoke Mandeville
Aylesbury
HP21 8AL
United Kingdom

Phone +44 (0)1296 216142
Email katiemitch@btinternet.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study objectivesWhat is the relationship between the labour Electronic Fetal Monitoring (EFM) admission test and obstetric intervention for low-risk mothers?
Ethics approval(s)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
Health condition(s) or problem(s) studiedPregnancy and Childbirth: Labour electronic fetal monitoring (EFM)
InterventionThis study will be of experimental design and will consist of a randomised, controlled trial. The trial is designed to answer the main question.
Intervention typeOther
Primary outcome measurePrimary 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 measuresSecondary 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 study start date01/11/2002
Completion date10/03/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsTarget number amended as of 03/09/2007: 1500. Target number provided at time of registration: 750.
Key inclusion criteriaInclusion 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
Key exclusion criteriaAdded 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
Date of first enrolment01/11/2002
Date of final enrolment10/03/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Obstetrics and Gynaecology Department
Aylesbury
HP21 8AL
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Stoke Mandeville Hospital NHS Trust (UK)

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2008 Yes No