NCT07321041

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2026

Completed
Last Updated

May 18, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

December 21, 2025

Last Update Submit

May 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately after delivery

Secondary Outcomes (1)

  • Umbilical Artery Base Excess

    Immediately after delivery

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants will be included, as the study population consists of pregnant women undergoing elective cesarean section.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mus State Hospital

Muş, Muş, 49100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 40355198BACKGROUND
  • Hassanin 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.

    PMID: 35300620BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

January 15, 2026

Primary Completion

April 24, 2026

Study Completion

April 24, 2026

Last Updated

May 18, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations