Cesarean DeliveryNCT07861633
Cesarean Anesthesia Blood Gas
An observational study of Cesarean Delivery, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- Anesthesia Technique
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- Adult women undergoing cesarean delivery at the study center.
- Patients receiving spinal or general anesthesia for cesarean delivery.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bağcılar Training and Research Hospital
Istanbul, Istanbul, 59050
Ali KAHVECİOĞLU, MD, +90 5549134317, ali.kahveci92@gmail.com
About this study
Official title: 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.
- Conditions
- Cesarean Delivery
- Being tested
- Anesthesia Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia | Participants undergoing cesarean delivery who receive spinal anesthesia as the anesthesia technique. Receives: Other: Anesthesia Technique | |
| General Anesthesia | Participants undergoing cesarean delivery who receive general anesthesia as the anesthesia technique. Receives: Other: Anesthesia Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical artery pH
Umbilical arterial pH measured after delivery and cord clamping.
Measured: Immediately after delivery
Secondary outcomes (23)
Maternal venous pH
Maternal venous pH measured immediately before anesthesia induction.
Measured: Immediately before anesthesia induction
Umbilical artery pCO2
Umbilical arterial pCO2 measured after delivery and cord clamping.
Measured: Immediately after delivery
Umbilical artery pO2
Umbilical arterial pO2 measured after delivery and cord clamping.
Measured: Immediately after delivery
Maternal venous pCO2
Maternal venous pCO2 measured immediately before anesthesia induction
Measured: Immediately before anesthesia induction
Maternal venous pO2
Maternal venous pO2 measured immediately before anesthesia induction
Measured: Immediately before anesthesia induction
Umbilical artery HCO3
Umbilical arterial bicarbonate measured after delivery and cord clamping.
Measured: Immediately after delivery
Maternal venous HCO3
Maternal venous bicarbonate measured immediately before anesthesia induction
Measured: Immediately before anesthesia induction
Umbilical artery BE
Umbilical arterial base excess measured after delivery and cord clamping
Measured: Immediately after delivery
Maternal venous BE
Maternal venous base excess measured immediately before anesthesia induction
Measured: Immediately before anesthesia induction
Umbilical artery lactate
Umbilical arterial lactate measured after delivery and cord clamping
Measured: Immediately after delivery
Maternal venous lactate
Maternal venous lactate measured immediately before anesthesia induction
Measured: Immediately before anesthesia induction
Umbilical artery FCOHb
Fetal carboxyhemoglobin measured in umbilical arterial blood after delivery and cord clamping
Measured: Immediately after delivery
Maternal venous FCOHb
Maternal carboxyhemoglobin measured in venous blood immediately before anesthesia induction
Measured: Immediately before anesthesia induction
Maternal-fetal pH gradient (ΔpH)
Difference between maternal venous pH and umbilical arterial pH
Measured: Immediately after delivery
Maternal-fetal pCO2 gradient (ΔpCO2)
Difference between maternal venous pCO2 and umbilical arterial pCO2
Measured: Immediately after delivery
Maternal-fetal lactate gradient (Δlactate)
Difference between maternal venous lactate and umbilical arterial lactate
Measured: Immediately after delivery
Apgar score at 1 minute
Apgar score assessed 1 minute after birth using the Apgar score (range, 0-10), with higher scores indicating better neonatal condition.
Measured: 1 minute after birth
Apgar score at 5 minutes
Apgar score assessed 5 minutes after birth using the Apgar score (range, 0-10), with higher scores indicating better neonatal condition.
Measured: 5 minutes after birth
Neonatal intensive care unit admission
Requirement for admission to the neonatal intensive care unit after birth
Measured: During the immediate neonatal period
Neonatal intubation
Requirement for endotracheal intubation after birth
Measured: During the immediate neonatal period
Maternal hypotension requiring treatment
Occurrence of maternal hypotension requiring pharmacologic treatment during cesarean delivery
Measured: From anesthesia induction until the end of surgery
Maternal vasopressor requirement
Requirement for vasopressor administration for management of maternal hypotension during cesarean delivery
Measured: From anesthesia induction until the end of surgery
Smoking exposure and fetal FCOHb
Association between maternal smoking exposure status and fetal carboxyhemoglobin level measured in umbilical arterial blood
Measured: Immediately after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ali kahvecioğlu, Bagcilar Training and Research Hospital
- Investigators
- Ali KAHVECİOĞLU, MD, Principal investigator, University of Health Sciences, Bağcılar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861633
- Sponsor's protocol ID
- E-10840098-50.04-4657
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No