Umbilical Cord BloodDELTA-CSNCT07321041
Effect of Delivery Time on Umbilical Cord Blood Gas Parameters in Cesarean Sections Under General and Spinal Anesthesia
An observational study of Umbilical Cord Blood and Cesarean Section Surgery, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to evaluate the effect of neonatal delivery time on umbilical cord blood gas parameters in pregnant women undergoing elective cesarean section under general or spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Umbilical Cord Blood, Cesarean Section Surgery, General Anesthesia
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 24 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population consists of adult pregnant women aged 18-40 years with singleton term pregnancies who are scheduled for elective cesarean section under general or spinal anesthesia. All participants will be managed according to routine clinical practice, and no experimental intervention will be applied.
Who may be able to join
- Pregnant women aged 18-40 years Singleton pregnancy at ≥36+6 weeks of gestation Scheduled for elective cesarean section Planned delivery under general or spinal anesthesia Ability to provide written informed consent
- -
Who cannot join
- Emergency cesarean section Known fetal anomalies Multiple pregnancy Maternal comorbidities that may affect neonatal outcomes (e.g., diabetes mellitus, hypertension, preeclampsia) Conversion from spinal anesthesia to general anesthesia Failure to obtain umbilical artery blood gas sample or incomplete clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neonatal Delivery Time on Umbilical Cord pH and Base Excess in Patients Undergoing Cesarean Section Under General and Spinal Anesthesia
The goal of this observational study is to evaluate the effect of neonatal delivery time on umbilical cord blood gas parameters in pregnant women undergoing elective cesarean section under general or spinal anesthesia. The study population consists of adult pregnant women aged 18-40 years with singleton term pregnancies scheduled for elective cesarean delivery.
The main questions it aims to answer are:
Read more
Is neonatal delivery time associated with changes in umbilical artery pH values under general and spinal anesthesia? Is neonatal delivery time associated with changes in umbilical artery base excess under general and spinal anesthesia? Researchers will compare cesarean sections performed under general anesthesia with those performed under spinal anesthesia to determine whether the relationship between delivery time and umbilical cord blood gas parameters differs between anesthesia techniques.
Participants will:
Undergo elective cesarean delivery under general or spinal anesthesia as part of routine clinical care Have neonatal delivery time recorded intraoperatively Have umbilical artery blood gas parameters (pH and base excess) measured immediately after birth as part of standard neonatal assessment
Read the detailed description
This prospective, observational study will be conducted at a single tertiary care center and aims to investigate the relationship between neonatal delivery time and umbilical artery blood gas parameters in elective cesarean sections performed under general or spinal anesthesia. No experimental intervention will be applied, and all procedures will be carried out as part of routine clinical care.
Eligible participants will include adult pregnant women with singleton term pregnancies who are scheduled for elective cesarean delivery. The choice of anesthesia technique (general or spinal anesthesia) will be determined by standard clinical indications and patient preference, independent of study participation. No modification to anesthesia management or surgical technique will be made for the purposes of the study.
Neonatal delivery time will be defined as the interval between uterine incision and complete delivery of the neonate and will be recorded intraoperatively by the surgical team. Immediately after birth, umbilical artery blood samples will be obtained as part of routine neonatal assessment, and blood gas analysis will be performed to determine pH and base excess values.
Data will be collected using standardized case report forms and hospital electronic medical records. All data will be anonymized and coded prior to analysis to ensure participant confidentiality. The primary analyses will assess the association between neonatal delivery time and umbilical artery pH and base excess within each anesthesia group. Secondary analyses will compare blood gas parameters between general and spinal anesthesia groups after controlling for delivery time.
This study is expected to provide clinically relevant information regarding the impact of delivery time on neonatal metabolic status during cesarean delivery and to contribute to optimizing coordination between obstetric and anesthesia teams.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | This cohort includes pregnant women undergoing elective cesarean section under general anesthesia as part of routine clinical care. The anesthesia technique is selected based on standard clinical indications and patient preference, independent of study participation. No experimental intervention is applied. Neonatal delivery time and umbilical artery blood gas parameters (pH and base excess) are recorded prospectively for observational analysis. | |
| Spinal Anesthesia | This cohort includes pregnant women undergoing elective cesarean section under spinal anesthesia as part of routine clinical care. The anesthesia technique is determined according to standard clinical practice and patient preference, independent of study participation. No experimental intervention is performed. Neonatal delivery time and umbilical artery blood gas parameters (pH and base excess) are prospectively recorded for observational analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Artery pH
Umbilical artery pH will be measured from arterial cord blood samples obtained immediately after delivery as part of routine neonatal assessment. These parameters will be used to evaluate neonatal metabolic status and their association with neonatal delivery time in cesarean sections performed under general and spinal anesthesia.
Measured: Immediately after delivery
Secondary outcomes (1)
Umbilical Artery Base Excess
Base excess measured from umbilical arterial cord blood samples obtained immediately after delivery. These parameters will be used to evaluate neonatal metabolic status and their association with neonatal delivery time in cesarean sections performed under general and spinal anesthesia.
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 Jan 2026
- Study start15 Jan 2026
- Primary completion24 Apr 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Umbilical Cord BloodStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, murat sahin, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321041
- Sponsor's protocol ID
- 4934
- Acronym
- DELTA-CS
- Status last verified
- May 2026
- First submitted
- 21 Dec 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as this is a single-center observational study using routinely collected clinical data. No predefined data-sharing agreement or repository is in place, and data sharing was not included in the original study protocol or ethics approval. De-identified aggregate results will be reported in publications.
Publications
Kinoshita M, Sakai Y, Nakaji Y, Takahashi R, Matsumoto Y, Tanaka K. Factors influencing spinal anesthesia-to-delivery interval in elective cesarean sections: A retrospective analysis. Medicine (Baltimore). 2025 May 9;104(19):e42420. doi: 10.1097/MD.0000000000042420.
PubMed 40355198Hassanin AS, El-Shahawy HF, Hussain SH, Bahaa Eldin AM, Elhawary MM, Elbakery M, Elsafty MSE. Impact of interval between induction of spinal anesthesia to delivery on umbilical arterial cord ph of neonates delivered by elective cesarean section. BMC Pregnancy Childbirth. 2022 Mar 17;22(1):216. doi: 10.1186/s12884-022-04536-y.
PubMed 35300620
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neonatal Delivery Time on Umbilical Cord pH and Base Excess in Patients Undergoing Cesarean Section Under General and Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07321041
- Acronym / sponsor ID
- DELTA-CS / 4934
- Conditions
- Umbilical Cord Blood, Cesarean Section Surgery, General Anesthesia, Spinal Anesthesia, Blood Gas Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the effect of neonatal delivery time on umbilical cord blood gas parameters in pregnant women undergoing elective cesarean section under general or spinal anesthesia. The study population consists of adult pregnant women aged 18-40 years with singleton term pregnancies scheduled for elective cesarean delivery.
The main questions it aims to answer are:
Is neonatal delivery time associated with changes in umbilical artery pH values under general and spinal anesthesia? Is neonatal delivery time associated with changes in umbilical artery base excess under general and spinal anesthesia? Researchers will compare cesarean sections performed under general anesthesia with those performed under spinal anesthesia to determine whether the relationship between delivery time and umbilical cord blood gas parameters differs between anesthesia techniques.
Participants will:
Undergo elective cesarean delivery under general or spinal anesthesia as part of routine clinical care Have neonatal delivery time recorded intraoperatively Have umbilical artery blood gas parameters (pH and base excess) measured immediately after birth as part of standard neonatal assessment
Detailed description
This prospective, observational study will be conducted at a single tertiary care center and aims to investigate the relationship between neonatal delivery time and umbilical artery blood gas parameters in elective cesarean sections performed under general or spinal anesthesia. No experimental intervention will be applied, and all procedures will be carried out as part of routine clinical care.
Eligible participants will include adult pregnant women with singleton term pregnancies who are scheduled for elective cesarean delivery. The choice of anesthesia technique (general or spinal anesthesia) will be determined by standard clinical indications and patient preference, independent of study participation. No modification to anesthesia management or surgical technique will be made for the purposes of the study.
Neonatal delivery time will be defined as the interval between uterine incision and complete delivery of the neonate and will be recorded intraoperatively by the surgical team. Immediately after birth, umbilical artery blood samples will be obtained as part of routine neonatal assessment, and blood gas analysis will be performed to determine pH and base excess values.
Data will be collected using standardized case report forms and hospital electronic medical records. All data will be anonymized and coded prior to analysis to ensure participant confidentiality. The primary analyses will assess the association between neonatal delivery time and umbilical artery pH and base excess within each anesthesia group. Secondary analyses will compare blood gas parameters between general and spinal anesthesia groups after controlling for delivery time.
This study is expected to provide clinically relevant information regarding the impact of delivery time on neonatal metabolic status during cesarean delivery and to contribute to optimizing coordination between obstetric and anesthesia teams.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | –This cohort includes pregnant women undergoing elective cesarean section under general anesthesia as part of routine clinical care. The anesthesia technique is selected based on standard clinical indications and patient preference, independent of study participation. No experimental intervention is applied. Neonatal delivery time and umbilical artery blood gas parameters (pH and base excess) are recorded prospectively for observational analysis. |
| Spinal Anesthesia | – | –This cohort includes pregnant women undergoing elective cesarean section under spinal anesthesia as part of routine clinical care. The anesthesia technique is determined according to standard clinical practice and patient preference, independent of study participation. No experimental intervention is performed. Neonatal delivery time and umbilical artery blood gas parameters (pH and base excess) are prospectively recorded for observational analysis. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of adult pregnant women aged 18-40 years with singleton term pregnancies who are scheduled for elective cesarean section under general or spinal anesthesia. All participants will be managed according to routine clinical practice, and no experimental intervention will be applied.
Key inclusion criteria (2 listed)
- Pregnant women aged 18-40 years Singleton pregnancy at ≥36+6 weeks of gestation Scheduled for elective cesarean section Planned delivery under general or spinal anesthesia Ability to provide written informed consent
- -
Key exclusion criteria (1 listed)
- Emergency cesarean section Known fetal anomalies Multiple pregnancy Maternal comorbidities that may affect neonatal outcomes (e.g., diabetes mellitus, hypertension, preeclampsia) Conversion from spinal anesthesia to general anesthesia Failure to obtain umbilical artery blood gas sample or incomplete clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Umbilical Artery pH
Time frame: Immediately after delivery
Umbilical artery pH will be measured from arterial cord blood samples obtained immediately after delivery as part of routine neonatal assessment. These parameters will be used to evaluate neonatal metabolic status and their association with neonatal delivery time in cesarean sections performed under general and spinal anesthesia.
1 secondary outcome
Umbilical Artery Base Excess
Time frame: Immediately after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 40355198Kinoshita M, Sakai Y, Nakaji Y, Takahashi R, Matsumoto Y, Tanaka K. Factors influencing spinal anesthesia-to-delivery interval in elective cesarean sections: A retrospective analysis. Medicine (Baltimore). 2025 May 9;104(19):e42420. doi: 10.1097/MD.0000000000042420.
- Background: PubMed 35300620Hassanin AS, El-Shahawy HF, Hussain SH, Bahaa Eldin AM, Elhawary MM, Elbakery M, Elsafty MSE. Impact of interval between induction of spinal anesthesia to delivery on umbilical arterial cord ph of neonates delivered by elective cesarean section. BMC Pregnancy Childbirth. 2022 Mar 17;22(1):216. doi: 10.1186/s12884-022-04536-y.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as this is a single-center observational study using routinely collected clinical data. No predefined data-sharing agreement or repository is in place, and data sharing was not included in the original study protocol or ethics approval. De-identified aggregate results will be reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Umbilical Cord Blood and Cesarean Section Surgery, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical Artery pH (time frame: Immediately after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07321041, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.