The cost-effectiveness of ST-analysis of the fetal electrocardiogram as compared to fetal blood sampling for intrapartum monitoring: a randomised controlled trial.
Recruiting
- Conditions
- women in labour with a high-risk pregnancy
- Registration Number
- NL-OMON25863
- Lead Sponsor
- niversity Medical Centre Utrecht, the Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5100
Inclusion Criteria
Women in labour with a singleton fetus in vertex position and a gestational age > 35 + 6 weeks of gestation and an indication for electronic fetal monitoring (CTG).
Exclusion Criteria
1. Women with a fetus in breech position;
2. Women with twin pregnancy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Presence or absence of metabolic acidosis defined as a pH < 7.05 and a BDecf > 12 mmol/l in the umbilical cord artery.
- Secondary Outcome Measures
Name Time Method 1. Instrumental delivery rate for the following indications:<br /> fetal distress, failure to progress or a combination;<br /><br>2. Cost-effectiveness of both strategies: see below;<br /><br>3. Neonatal outcome defined by low Apgar scores, defined as < 4 after 1 minute and/or < 7 after 5 minutes;<br /><br>4. Need for admission to the neonatal medium or intensive care unit;<br /><br>5. Cost-effectiveness of both monitoring strategies across hospitals, particularly, comparing academic and non-academic hospitals.