The cost-effectiveness of ST-ANalysis of the foetal electrocardiogram as compared to Foetal Blood Sampling for intrapartum monitoring: a randomised controlled trial

Completed

Conditions: Women in labour with a high-risk pregnancy
Pregnancy and Childbirth
High-risk pregnancy

Registration Number: ISRCTN95732366

Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 5100

Inclusion Criteria

1. Women in labour
2. Singleton foetus in vertex position
3. Gestational age more than 35 + 6 weeks of gestation
4. Indication for electronic foetal monitoring (CTG)

Exclusion Criteria

1. Women with a foetus in breech position
2. Women with twin pregnancy
3. No informed consent

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 less than 7.05 and a BDecf greater than 12 mmol/l in the umbilical cord artery.<br><br>There are no interim analyses, only by the data safety monitorings committee for serious adverse events.

Secondary Outcome Measures

Name	Time	Method
1. Instrumental delivery rate for the following indications: foetal distress, failure to progress or a combination of these<br>2. Cost-effectiveness of both strategies: the ratio of incremental costs and the reduced rate of metabolic acidosis, associated with the strategies<br>3. Neonatal outcome defined by low Apgar scores, defined as less than four after one minute and/or less than seven after five minutes<br>4. Need for admission to the neonatal medium or intensive care unit<br>5. Cost-effectiveness of both monitoring strategies across hospitals, particularly, comparing academic and non-academic hospitals<br><br>There are no interim analyses, only by the data safety monitorings committee for serious adverse events.