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

NCT05259202 | Unknown

• 1 other identifier: RECHMPL22_0070
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metabolic Acidosis

Keywords

serious metabolic acidosis; T segment analysis; Blood samples; instrumental delivery; Apgar score; admission to a neonatal ward

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of the instrumental delivery

  day 1

• Number of the neonatal outcome

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Acidosis

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• WALTZING Aude

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WALTZING Aude, Resident

CONTACT

663801641; a-waltzingrenault@chu-montpellier.fr

DUPORT-PERCIER Marie, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: February 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: October 31, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

FR (1)