Intra-uterine Fetal Brain Activity Monitoring.

NCT03930277 | Unknown

• 1 other identifier: 0354-18-RMB
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fetal cardiac monitoring is used during labor. Fetal decelerations may imply fetal hypoxia and distress. Brain activity monitoring is not used to evaluate fetal distress during labor. In this study the investigators intend to use an EEG based algorithm to evaluate and monitor fetal brain activity during the 2nd stage of labor.

Conditions

Fetal Hypoxia

Outcome Measures

Primary Outcomes (1)

• Newborn blood gases

  Correlation between the EEG index of interhemispheric synchronization, to the umbilical PH of the newborn and to the gold standard fetal heart rate monitor.

  From the beginning of the 2nd stage of labor up to 5 minutes postpartum.

Study Arms (1)

Pregnant women in labor.

Pregnant women in labor during the 2nd stage of labor.

Diagnostic Test: Electroencephalogram

Interventions

Electroencephalogram DIAGNOSTIC_TEST

Electroencephalogram for fetal brain activity monitoring.

Pregnant women in labor.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnancy.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregannt women during the 2nd stage of labor at full dilatation.

You may qualify if:

• Vaginal delivery course.
• Patient with epidural anesthesia.
• Continous fetal heart-rate monitoring.
• Singleton pregnancy.
• Term pregnancy.

You may not qualify if:

• Suspected Chorioamnionitis.
• No epidural anesthesia.
• Multiple pregnancy.
• Fetal abnormality with emphasis on brain abnormalities.
• Preeclampsia.
• Patients refusing continous fetal heart-rate monitoring.
• Patients in need of a scalp electrode for fetal monitoring.
• Patients that received Dolestine during labor.
• Patients with Hepatitis B, Hepatitis C and HIV carriers or any other vertically transmitted pathogenic agent.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Fetal Hypoxia

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Roy Lauterbach, MD

  Rambam healthcare campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roy Lauterbach, MD

CONTACT

972-52-9432416; r_lauterbach@rambam.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: December 31, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: April 20, 2022

Record last verified: 2022-04