Condition category
Pregnancy and Childbirth
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
13/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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/

Publication citations

Additional files

Editorial Notes