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The cost-effectiveness of ST-analysis of the fetal electrocardiogram as compared to fetal blood sampling for intrapartum monitoring: a randomised controlled trial.

The cost-effectiveness of ST-analysis of the fetal electrocardiogram as compared to fetal blood sampling for intrapartum monitoring: a randomised controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25863
Enrollment
5100
Registered
2005-09-01
Start date
2006-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

women in labour with a high-risk pregnancy

Interventions

Women will be randomly assigned to routine care including fetal monitoring by cardiotocography with fetal blood sampling (CTG + FBS group) or to the index group including cardiotocography with ST-anal

Sponsors

University Medical Centre Utrecht, the Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Women with a fetus in breech position; 2. Women with twin pregnancy; 3. No informed consent.

Design outcomes

Primary

MeasureTime frame
Presence or absence of metabolic acidosis defined as a pH 12 mmol/l in the umbilical cord artery.

Secondary

MeasureTime frame
1. Instrumental delivery rate for the following indications: fetal distress, failure to progress or a combination; 2. Cost-effectiveness of both strategies: see below; 3. Neonatal outcome defined by low Apgar scores, defined as < 4 after 1 minute and/or < 7 after 5 minutes; 4. Need for admission to the neonatal medium or intensive care unit; 5. Cost-effectiveness of both monitoring strategies across hospitals, particularly, comparing academic and non-academic hospitals.

Contacts

Public ContactG.H.A. Visser

University Medical Center Utrecht (UMCU) Department of Obstetrics P.O. Box 85500

g.h.a.visser@umcutrecht.nl+31 (0)88 7556426

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)