NCT04272632

Brief Summary

The purpose of this study is to investigate the optimal coload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

November 29, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 11, 2020

Last Update Submit

November 25, 2021

Conditions

Adverse Effect

Keywords

ColoadInferior vena cava collapsibility indexNorepinephrineCesarean sectionDose-finding

Outcome Measures

Primary Outcomes (5)

  • The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]

    Baseline (before preload)

  • The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]

    Before spinal anesthesia (after preload)

  • The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]

    5 min after spinal anesthesia

  • The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]

    5 min after fetal delivery

  • The minimum (IVC-min), maximum diameter (IVC-max) and collapsibility index (IVC-CI) of the inferior vena cava (IVC)

    IVC-CI = \[(IVC-max-IVC-min) /IVC-max\*100%\]

    Before leaving the operating room

Secondary Outcomes (12)

  • The incidence of post-spinal anesthesia hypotension.

    1-15 minutes after spinal anesthesia

  • The incidence of severe post-spinal anesthesia hypotension.

    1-15 minutes after spinal anesthesia

  • The incidence of nausea and vomiting.

    1-15 minutes after spinal anesthesia

  • The incidence of bradycardia

    1-15 minutes after spinal anesthesia

  • The incidence of hypertension

    1-15 minutes after spinal anesthesia

  • +7 more secondary outcomes

Study Arms (3)

4 ml/kg group

EXPERIMENTAL

4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Drug: 4 ml/kg group

8 ml/kg group

EXPERIMENTAL

8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Drug: 8 ml/kg group

12 ml/kg group

EXPERIMENTAL

12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Drug: 12 ml/kg group

Interventions

4 ml/kg groupDRUG

4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Also known as: Crystalloid
4 ml/kg group
8 ml/kg groupDRUG

8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Also known as: Crystalloid
8 ml/kg group
12 ml/kg groupDRUG

12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.

Also known as: Crystalloid
12 ml/kg group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for elective cesarean section under spinal anesthesia

You may not qualify if:

  • Body height \< 150 cm
  • Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
  • Hemoglobin \< 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Interventions

Population GroupsCrystalloid Solutions

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Xinli Ni, Dr.

    General Hospital of Ningxia Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 17, 2020

Study Start

April 1, 2021

Primary Completion

November 25, 2021

Study Completion

November 25, 2021

Last Updated

November 29, 2021

Record last verified: 2021-02

Locations

CN(1)