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 sites1,500 target enrollmentSeptember 12, 2003

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Enrollment: 1500
Status: Completed
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

September 12, 2003

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

Female

Sponsor

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

•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