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

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

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

Study Overview

• Status: Recruiting
• Conditions: Metabolic Acidosis

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: WALTZING Aude, resident; Phone Number: 33 663801641; Email: a-waltzingrenault@chu-montpellier.fr
• Study Contact Backup: Name: DUPORT-PERCIER Marie, MD

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: WALTZING Aude, resident; Phone Number: 33 663801641; Email: a-waltzingrenault@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women monitored by STAN in active labour with singleton term fetus in cephalic presentation

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of the instrumental delivery	Apgar score	day 1
Number of the neonatal outcome	admission to a neonatal ward	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: WALTZING Aude, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Apgar score; instrumental delivery; Blood samples; serious metabolic acidosis; T segment analysis; admission to a neonatal ward
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: RECHMPL22_0070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No