- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07861633
Cesarean Anesthesia Blood Gas
Effects of Spinal and General Anesthesia Techniques on Maternal-Fetal Blood Gas Gradients and Fetal Carboxyhemoglobin Levels in Cesarean Delivery: A Prospective Observational Cohort Study
This prospective observational cohort study will evaluate maternal and fetal blood gas parameters in women undergoing cesarean delivery under spinal or general anesthesia. Maternal venous blood samples will be obtained immediately before anesthesia induction, and umbilical arterial blood samples will be obtained after delivery and cord clamping. Blood gas parameters, including pH, pCO2, pO2, bicarbonate, base excess, lactate, and fetal carboxyhemoglobin levels, will be compared between the spinal and general anesthesia groups. The study will also evaluate maternal-fetal blood gas gradients, Apgar scores, neonatal intensive care requirements, and the relationship between smoking exposure and fetal carboxyhemoglobin levels.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Ali KAHVECİOĞLU, MD
- Telefonnummer: +90 5549134317
- E-post: ali.kahveci92@gmail.com
Studiesteder
-
-
Istanbul
-
Istanbul, Istanbul, Tyrkia (Türkiye), 59050
- Rekruttering
- Bağcılar Training and Research Hospital
-
Ta kontakt med:
- Ali KAHVECİOĞLU, MD
- Telefonnummer: +90 5549134317
- E-post: ali.kahveci92@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Pregnant women undergoing cesarean delivery at the Obstetrics and Gynecology Clinic of Bagcilar Training and Research Hospital. The study is a prospective observational cohort comparing maternal and fetal blood gas parameters and fetal carboxyhemoglobin levels according to the observed anesthesia technique (spinal or general anesthesia).
Beskrivelse
Inclusion Criteria:
- Adult women undergoing cesarean delivery at the study center.
- Patients receiving spinal or general anesthesia for cesarean delivery.
Exclusion Criteria:
- Patients who are not eligible for participation according to the study protocol.
- Patients in whom spinal anesthesia is converted to general anesthesia because of inadequate spinal block and pain during surgery.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Spinal Anesthesia
Participants undergoing cesarean delivery who receive spinal anesthesia as the anesthesia technique. |
Observed anesthesia technique in women undergoing cesarean delivery. Participants received either spinal anesthesia or general anesthesia as part of routine clinical care; the anesthesia technique was not assigned by the study. |
|
General Anesthesia
Participants undergoing cesarean delivery who receive general anesthesia as the anesthesia technique. |
Observed anesthesia technique in women undergoing cesarean delivery. Participants received either spinal anesthesia or general anesthesia as part of routine clinical care; the anesthesia technique was not assigned by the study. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Umbilical artery pH
Tidsramme: Immediately after delivery
|
Umbilical arterial pH measured after delivery and cord clamping. |
Immediately after delivery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maternal venous pH
Tidsramme: Immediately before anesthesia induction
|
Maternal venous pH measured immediately before anesthesia induction. |
Immediately before anesthesia induction
|
|
Umbilical artery pCO2
Tidsramme: Immediately after delivery
|
Umbilical arterial pCO2 measured after delivery and cord clamping. |
Immediately after delivery
|
|
Umbilical artery pO2
Tidsramme: Immediately after delivery
|
Umbilical arterial pO2 measured after delivery and cord clamping. |
Immediately after delivery
|
|
Maternal venous pCO2
Tidsramme: Immediately before anesthesia induction
|
Maternal venous pCO2 measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Maternal venous pO2
Tidsramme: Immediately before anesthesia induction
|
Maternal venous pO2 measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Umbilical artery HCO3
Tidsramme: Immediately after delivery
|
Umbilical arterial bicarbonate measured after delivery and cord clamping. |
Immediately after delivery
|
|
Maternal venous HCO3
Tidsramme: Immediately before anesthesia induction
|
Maternal venous bicarbonate measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Umbilical artery BE
Tidsramme: Immediately after delivery
|
Umbilical arterial base excess measured after delivery and cord clamping |
Immediately after delivery
|
|
Maternal venous BE
Tidsramme: Immediately before anesthesia induction
|
Maternal venous base excess measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Umbilical artery lactate
Tidsramme: Immediately after delivery
|
Umbilical arterial lactate measured after delivery and cord clamping |
Immediately after delivery
|
|
Maternal venous lactate
Tidsramme: Immediately before anesthesia induction
|
Maternal venous lactate measured immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Umbilical artery FCOHb
Tidsramme: Immediately after delivery
|
Fetal carboxyhemoglobin measured in umbilical arterial blood after delivery and cord clamping |
Immediately after delivery
|
|
Maternal venous FCOHb
Tidsramme: Immediately before anesthesia induction
|
Maternal carboxyhemoglobin measured in venous blood immediately before anesthesia induction |
Immediately before anesthesia induction
|
|
Maternal-fetal pH gradient (ΔpH)
Tidsramme: Immediately after delivery
|
Difference between maternal venous pH and umbilical arterial pH |
Immediately after delivery
|
|
Maternal-fetal pCO2 gradient (ΔpCO2)
Tidsramme: Immediately after delivery
|
Difference between maternal venous pCO2 and umbilical arterial pCO2 |
Immediately after delivery
|
|
Maternal-fetal lactate gradient (Δlactate)
Tidsramme: Immediately after delivery
|
Difference between maternal venous lactate and umbilical arterial lactate |
Immediately after delivery
|
|
Apgar score at 1 minute
Tidsramme: 1 minute after birth
|
Apgar score assessed 1 minute after birth using the Apgar score (range, 0-10), with higher scores indicating better neonatal condition. |
1 minute after birth
|
|
Apgar score at 5 minutes
Tidsramme: 5 minutes after birth
|
Apgar score assessed 5 minutes after birth using the Apgar score (range, 0-10), with higher scores indicating better neonatal condition. |
5 minutes after birth
|
|
Neonatal intensive care unit admission
Tidsramme: During the immediate neonatal period
|
Requirement for admission to the neonatal intensive care unit after birth |
During the immediate neonatal period
|
|
Neonatal intubation
Tidsramme: During the immediate neonatal period
|
Requirement for endotracheal intubation after birth |
During the immediate neonatal period
|
|
Maternal hypotension requiring treatment
Tidsramme: From anesthesia induction until the end of surgery
|
Occurrence of maternal hypotension requiring pharmacologic treatment during cesarean delivery |
From anesthesia induction until the end of surgery
|
|
Maternal vasopressor requirement
Tidsramme: From anesthesia induction until the end of surgery
|
Requirement for vasopressor administration for management of maternal hypotension during cesarean delivery |
From anesthesia induction until the end of surgery
|
|
Smoking exposure and fetal FCOHb
Tidsramme: Immediately after delivery
|
Association between maternal smoking exposure status and fetal carboxyhemoglobin level measured in umbilical arterial blood |
Immediately after delivery
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Ali KAHVECİOĞLU, MD, University of Health Sciences, Bağcılar Training and Research Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- E-10840098-50.04-4657
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .