UnknownNot Applicable

Brain Oxygenation in Newborns Due to Neuroaksial Methods

80 participantsStarted 2024-04-01

Plain-language summary

Epidural and spinal anesthesia techniques are frequently used all over the world in elective cesarean section operations. To evaluate the effects of epidural and spinal anesthesia techniques applied in cesarean section surgery on neonatal cerebral oxygenation using Near Infrared Spectroscopy (NIRS).

Who can participate

Age range

18 Years – 35 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: * Pregnant women between the ages of 18-35 and newborns after cesarean section * Newborns born \>37 weeks of gestation * ASA II pregnant women Exclusion Criteria: * Previous local anesthetic allergy * Those with bleeding diathesis disorder * Having a mental disorder * Those who are allergic to the drugs used * Patients who did not consent to participate in the study * Height \<1.55 meters. or \>1.70 meters. * Presence of infection in the block area * Body mass index \>35 kg/m² * Those with gestational hypertension and SAP\>140 mmHg or DAP\>90 mmHg in three pre-pregnancy measurements * Known presence of fetal anomaly * Those with known placenta pathology * Those with a history of fetal anomaly and abnormal birth in previous pregnancies

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

Near İnfrared Spectroscopi

Timeframe: on 10 minutes

Trial details

NCT IDNCT06316596

SponsorBursa Yuksek Ihtisas Training and Research Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-05-01

Contact for this trial

Ahsen Gür Çelik

+905071213621 gurahsen@gmail.com

View on ClinicalTrials.gov More Cesarean Section trials