NCT03536910

Brief Summary

In this study, investigators aimed to investigate the effects of general and spinal anesthesia techniques on copeptin levels during cesarean section and their relation with fetal distress.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 1, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

May 15, 2018

Last Update Submit

February 25, 2019

Conditions

Fetal Distress

Keywords

copeptin levelsCesarean sectiongeneral anesthesiaspinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Changes in copeptin levels after general or spinal anesthesia

    Baseline and immediately after surgery from maternal blood and arterial and venous umbilical cord at birth

Study Arms (2)

General anesthesia

OTHER
Other: Copeptin

Spinal anesthesia

OTHER
Other: Copeptin

Interventions

CopeptinOTHER

Level of copeptin in maternal blood and umbilical cord blood

Also known as: Fetal distress
General anesthesiaSpinal anesthesia

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • ASA I-II
  • gestational weeks
  • BMI ≤ 40
  • Undergoing elective cesarean section

You may not qualify if:

  • Coagulopathy
  • Known central or peripheral nerve disease
  • fetal anomalies
  • birth weight less than 2000 grams and above 4500 grams,
  • infants with a risk of meconium or amniotic fluid aspiration
  • kidney failure, diabetes mellitus, hypertension, cardiac disease, antepartum hemorrhage, asthma bronchiole, Rh incompatibility, congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fetal Distress

Interventions

Arginine Vasopressin

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

VasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Ece YAMAK ALTINPULLUK, MD

    Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

May 1, 2018

Primary Completion

July 31, 2018

Study Completion

October 31, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

TU(1)