UnknownNot Applicable

Intra-uterine Fetal Brain Activity Monitoring.

20 participantsStarted 2022-12-31

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Vaginal delivery course. * Patient with epidural anesthesia. * Continous fetal heart-rate monitoring. * Singleton pregnancy. * Term pregnancy. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Newborn blood gases

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

Trial details

NCT IDNCT03930277

SponsorRambam Health Care Campus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

Contact for this trial

Roy Lauterbach, MD

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

View on ClinicalTrials.gov More Fetal Hypoxia trials