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Not yet recruitingNCT06847737Updated Feb 26, 2025

Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods

An observational study in Postspinal Hypotension, sponsored by Istinye University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Istinye University · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.

02

Conditions studied

  • Postspinal Hypotension
03

In context

Lead sponsor

Istinye University is the lead sponsor of 216 studies on the registry; 92 are open to participants now.

Browse Istinye University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Fifty pregnant women over the age of 18 who underwent elective cesarean section, were American Society of Anesthesia I and II, and agreed to participate in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Those who underwent elective cesarean section over the age of 18,
  • American Society of Anesthesia I and II,
  • Agree to participate in the study,

Exclusion criteria

Exclusion Criteria:

  • \<18 or >45 years,
  • preeclampsia,
  • cardiovascular disorders,
  • fetal abnormalities,
  • not undergoing spinal anesthesia or undergoing general anesthesia during surgery,
  • not agreeing to participate in the study
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testperfusion index

    To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.

    Also known as: pleth variability index, tissue hemoglobin index, tissue oxygen saturation

06

What researchers measure

Primary outcomes

  1. tissue oxygen saturation

    which indicates an increase in local tissue perfusion

    Time frame: 4 month

  2. tissue hemoglobin index

    indicating vasodilation

    Time frame: 4 month

07

Study locations

1 site
  • Istinye Üniversity
    Istanbul, Merkez Mahallesi 34250, Turkey (Türkiye)
08

References and documents

Publications

  • Ilies C, Kiskalt H, Siedenhans D, Meybohm P, Steinfath M, Bein B, Hanss R. Detection of hypotension during Caesarean section with continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement. Br J Anaesth. 2012 Sep;109(3):413-9. doi: 10.1093/bja/aes224. Epub 2012 Jul 12. PubMed 22798273 ↗
  • Kuwata S, Suehiro K, Juri T, Tsujimoto S, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Pleth variability index can predict spinal anaesthesia-induced hypotension in patients undergoing caesarean delivery. Acta Anaesthesiol Scand. 2018 Jan;62(1):75-84. doi: 10.1111/aas.13012. Epub 2017 Oct 16. PubMed 29034983 ↗
  • Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16. PubMed 28890560 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2025; primary completion for May 2025, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2025
First posted
Feb 26, 2025
StartEst.
Mar 1, 2025
Primary completionEst.
May 30, 2025
CompletionEst.
Jul 1, 2025
Last update
Feb 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06847737
Lead sponsor
Istinye University
Responsible party
İlke Dolgun (Assoc. prof, Istinye University) — Principal investigator
First posted
Feb 26, 2025
Start date
Mar 1, 2025 (estimated)
Primary completion
May 30, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Feb 26, 2025

Study contacts

ilke dolgun
Contact
ilkeser2004@gmail.com
+905555485632

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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