ISRCTN28370122已完成不适用

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

Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)0 个研究点目标入组 1,500 人开始时间: 2003年9月12日最近更新: 2015年1月13日

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•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

•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

发起方

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