Effects of Spinal Versus General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section (NCT07477093) | Clinical Trial Compass
CompletedNot Applicable
Effects of Spinal Versus General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section
Turkey (Türkiye)49 participantsStarted 2020-01-02
Plain-language summary
This prospective observational study evaluates and compares the effects of spinal and general anesthesia techniques used during elective cesarean section on neonatal cerebral regional oxygen saturation (crSO₂) during the early transition to extrauterine life. Near-infrared spectroscopy (NIRS) was used to continuously monitor neonatal cerebral oxygenation for the first 16 minutes after birth. Neonatal heart rate, peripheral oxygen saturation (SpO₂), cerebral fractional tissue oxygen extraction (cFTOE), umbilical cord blood gas parameters, birth weight, and APGAR scores were also recorded.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
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 aged 18-40 years
* ASA physical status II
* Gestational age between 36 and 41 weeks
* Undergoing elective cesarean section
* Singleton pregnancy
* Provided written and verbal informed consent
Exclusion Criteria:
* Emergency cesarean delivery
* ASA physical status ≥ III
* Smoking or alcohol use
* Presence of chronic systemic disease
* Preeclampsia, eclampsia, or other pregnancy-related complications
* Preterm (\<36 weeks) or post-term (\>41 weeks) pregnancy
* Multiple gestation
* Placental implantation or adhesion anomalies
* Neonates requiring resuscitation or supplemental oxygen after birth
* Maternal intraoperative desaturation requiring oxygen supplementation
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.