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
Scientific
Obstetrics and Gynaecology Department
Stoke Mandeville Hospital
Mandeville Road
Stoke Mandeville
Aylesbury
HP21 8AL
United Kingdom
| Phone | +44 (0)1296 216142 |
|---|---|
| katiemitch@btinternet.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| 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 | 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 study start date | 01/11/2002 |
| Completion date | 10/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Target number amended as of 03/09/2007: 1500. Target number provided at time of registration: 750. |
| 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
- England
- United Kingdom
Study participating centre
Obstetrics and Gynaecology Department
Aylesbury
HP21 8AL
United Kingdom
HP21 8AL
United Kingdom
Sponsor information
Department of Health (UK)
Government
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 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2008 | Yes | No |
