Effect of Delivery Time on Umbilical Cord Blood Gas Parameters in Cesarean Sections Under General and Spinal Anesthesia (DELTA-CS)

May 14, 2026 updated by: murat sahin, Sisli Hamidiye Etfal Training and Research Hospital

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:

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

-

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical Artery Base Excess
Time Frame: Immediately after delivery
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.
Immediately after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Actual)

April 24, 2026

Study Completion (Actual)

April 24, 2026

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 4934

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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