Perfusion Index vs Positional Hemodynamic Changes to Predict Hypotension After Spinal Anaesthesia in Caesarean Section
Comparative Study Between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension After Spinal Anaesthesia in Caesarean Section
1 other identifier
observational
80
1 country
2
Brief Summary
Comparative Study between the Perfusion Index and Positional Haemodynamic Changes for Prediction of Hypotension after Spinal Anaesthesia in Caesarean Section
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Shorter than P25 for all trials
2 active sites
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
March 8, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
October 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedDecember 23, 2022
December 1, 2022
6 months
March 8, 2022
December 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Prediction of post-spinal hypotension using PI
To correlate between perfusion index and hypotension after spinal anaesthesia in caesarean section
6 months
Secondary Outcomes (1)
Prediction of post-spinal hypotension using positional hemodynamic changes
6 months
Study Arms (1)
Observational study in parturient who will be recruited for the study
this study will include the eligible parturient who will be assessed by perfusion index and by positional hemodynamic changes.
Interventions
Using perfusion index and positional hemodynamic changes for the prediction of postspinal hypotension in all parturient recruited for the study
Eligibility Criteria
Pregnant women undergoing an elective caesarean section delivery.
You may qualify if:
- Parturient acceptance.
- American Society of Anesthesiologists (ASA) II
- arturient with be gestational age \>36 weeks and \<41 weeks.
- Body mass index (BMI) ≤35kg/m2
- elective caesarean section delivery
You may not qualify if:
- preeclampsia
- eclampsia,
- gestational diabetes
- Contraindication to regional anaesthesia as allergy, coagulation abnormalities or infection in site of injection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of medicine
Zagazig, 44519, Egypt
Ramy
Zagazig, Egypt
Study Officials
- STUDY DIRECTOR
Naglaa Abdelhaleem, MD
Faculty of medicine, Zagazig University Hospitals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2022
First Posted
October 19, 2022
Study Start
July 15, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
December 23, 2022
Record last verified: 2022-12