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
Protocol serial number	N0245109928
Sponsor	Department of Health (UK)
Funder	Stoke Mandeville Hospital NHS Trust (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	What 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) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	10/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1500
Key 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
Key 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
Date of first enrolment	01/11/2002
Date of final enrolment	10/03/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Obstetrics and Gynaecology Department

Aylesbury
HP21 8AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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