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Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.

NCT04406051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-06-15

No results posted yet for this study

Summary

This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section

Conditions

  • Cesarean Section Complications
  • Hypotensive
  • Vasoconstriction
  • Hypotension
  • Obstetric Anesthesia Problems

Interventions

PROCEDURE

norepinephrine infusion and colloid preloading (NOR-COL)

in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia

PROCEDURE

norepinephrine infusion and crystalloid co-loading (NOR-CRYST)

in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia

Sponsors & Collaborators

  • Alexandra Hospital, Athens, Greece

    collaborator OTHER

  • Aretaieion University Hospital

    lead OTHER

Principal Investigators

  • Kassiani Theodoraki, PhD, DESA · Aretaieion University Hospital

  • Emmanouil Stamatakis, PhD · Alexandra General Hospital of Athens

  • Sofia Hadzilia, MD · Alexandra General Hospital of Athens

  • Dimitrios Valsamidis, MD · Alexandra General Hospital of Athens

  • Konstantina Kalopita, MD · Alexandra General Hospital of Athens

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-26
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406051 on ClinicalTrials.gov