Pregnancy and Childbirth: Labour electronic fetal monitoring (EFM) Pregnancy and Childbirth
Conditions
Interventions
This study will be of experimental design and will consist of a randomised, controlled trial. The trial is designed to answer the main question.
Sponsors
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed