A randomised trial to determine whether CTG monitoring with a computerised decision aide can improve pregnancy outcomes
Not Applicable
Completed
- Conditions
- CTG monitoring with a decision aide to reduce Caesarean deliveryPregnancy and Childbirth
- Registration Number
- ISRCTN46449237
- Lead Sponsor
- Second Municipal Hospital for Obstetrics and Gynaecology Sheynovo / Bulgarian Christmas 2007-2011 Charity Initiative (Bulgaria)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 720
Inclusion Criteria
Women admitted to labour ward who:
1. Were aged 18 years and older
2. Had a singleton pregnancy
3. Had an baby in cephalic position
4. Presented with no ultrasound/laboratory evidence of structural abnormalities of the baby
Exclusion Criteria
Women admitted to labour ward who:
1. Were aged <18 years
2. Had multiple gestations
3. Had a baby with an abnormal lie
4. Had a baby with known structural abnormalities as confirmed through ultrasound of laboratory testing
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Occurrence of hypoxia (pH <7.20)<br>2. Occurrence of acidaemia (pH <7.05)<br>3. Caesarean delivery<br>4. Forceps extraction
- Secondary Outcome Measures
Name Time Method 1. Apgar score <7 at 5 minutes<br>2. Neonatal seizures<br>3. Admission to NICU<br><br>All outcomes are immediately after birth with the exception of neonatal seizures and NICU admission. Neonatal seizures and NICU admission are within the first 24 hours after delivery