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

Completed

Conditions: Pregnancy and Childbirth: Labour electronic fetal monitoring (EFM)
Pregnancy and Childbirth

Registration Number: ISRCTN28370122

Lead Sponsor: Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 1500

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

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