Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate

Metabolic Acidosis Clinical Trial

Official title:

Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate During Labor Over 60 Minutes Without a Significant ST-event

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259202
• Other study ID #: RECHMPL22_0070
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Montpellier
• Contact: WALTZING Aude, Resident
• Phone: 663801641
• Email: a-waltzingrenault[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

ST-analysis of the foetal ECG (STAN®) is another second line technique for intrapartum foetal monitoring. Combining ST-analysis with standard CTG interpretation aims to identify hypoxic foetuses more accurately than CTG alone. The STAN® method identifies changes in the ST-interval of the foetal ECG that occur in the presence of foetalcentral hypoxia The aim of this studie is to investigate if the foetal lactate blood sampling is still useful when STAN® monitoring is already being used as a second line technique for intrapartum foetal monitoring if the fetal heart rate is abnormal without a significant ST event Nowadays in the Montpellier hospital's protocol, the investigators have to check the value of lactate sampling in case of le STAN doesn't detect an ST event. So this studie can change the Montpellier hospital's protocol and avoid useless fetal blood sampling

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• patient with labor monitoring by ST segment analysis (STAN) according to current guidelines
• patient who received a fetal lactate sample for fetal heart rate classified as pathological for more than 60 minutes

Exclusion criteria:

• STAN guidelines not respected before installation and during work
• misclassification of fetal heart rate
• obstetrical complications during labor

Related Conditions & MeSH terms

• Acidosis
• Metabolic Acidosis

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of serious metabolic acidosis	the incidence of serious metabolic acidosis (defined as pH < 7 and Bdecf > 12 mmol/L in the umbilical cord artery).	day 1
Secondary	Number of the instrumental delivery	Apgar score	day 1
Secondary	Number of the neonatal outcome	admission to a neonatal ward	day 1