MedTrace Logo

Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance

NCT03071783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2019-03-07

No results posted yet for this study

Summary

The objective of the clinical investigation is to test whether intra-operative traction force feed back during vacuum extraction leads to a significant decrease in incidence of brain damage in neonates.

By randomization, half of the vacuum extraction patients will be assigned to delivery using a new intelligent handle for vacuum extractions, and half will be assigned to conventional method without traction force measurement.

Conditions

  • Hypoxic Ischemic Encephalopathy
  • Neonatal Convulsions
  • Subgaleal Hematoma

Interventions

DEVICE

Vacuum extraction intelligent system

Vacuum extraction intelligent system - this is the intervention

Sponsors & Collaborators

Principal Investigators

  • Magnus Westgren, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2018-06-15
Completion
2018-06-15

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

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 NCT03071783 on ClinicalTrials.gov