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

Status Completed

Clinical Trial 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.

Clinical Trial Description

The most common indications for vacuum extraction are dystocia and/or fetal asphyxia. The safety of assisted vaginal delivery with vacuum extraction has been discussed since its introduction almost fifty years ago. Serious complications such as asphyxia, intracranial hemorrhage and seizures are overrepresented at vacuum extraction compared to spontaneous vaginal delivery.

Little has been done to improve the procedure since the introduction. Safety measures recommended include restricting total time and number of pulls, a full 34 week gestation, and station of the head at the spines or below. A general advice is also to avoid excessive traction force. There is no general agreement to what a safe traction force might be. With exceeding force there seems to be an increased risk for rupture of the sagittal sinus and tearing of the falx at its attachment to the tentorium. Furthermore, when the fetal head is becoming exceedingly elongated and flattened, and as the cup pops off it might cause damage to the brain and blood vessels.

During the procedure the obstetrician is under significant stress and the subjective element of the evaluation of traction force is a concern. The difficult decision of whether to continue a heavy extraction or abort the operation is made under stressful conditions and based mostly on subjective impressions.

To provide the obstetrician with more objective information, the investigators developed a new device consisting of an intelligent handle hooked to the chain of a regular metal cup. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03071783
Study type	Interventional
Source	Karolinska Institutet
Contact
Status	Completed
Phase	N/A
Start date	April 1, 2016
Completion date	June 15, 2018

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02551003` - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy	Phase 1/Phase 2
Completed	`NCT02683915` - Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
Recruiting	`NCT01962233` - Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy	Phase 1
Completed	`NCT01471015` - Darbe Administration in Newborns Undergoing Cooling for Encephalopathy	Phase 1/Phase 2
Completed	`NCT01683383` - California Transport Cooling Trial	N/A
Completed	`NCT01649648` - Autologous Cord Blood Cells for Brain Injury in Term Newborns	Phase 1
Completed	`NCT01481207` - Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Withdrawn	`NCT00993564` - Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE)	N/A
Completed	`NCT00945789` - Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)	Phase 1/Phase 2
Completed	`NCT00097097` - Neonatal Resuscitation in Zambia	Phase 3
Recruiting	`NCT02621944` - Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia	Early Phase 1
Not yet recruiting	`NCT02605018` - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy	Phase 1/Phase 2
Withdrawn	`NCT01128673` - MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)	N/A
Completed	`NCT01732146` - Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy	Phase 3
Completed	`NCT02349672` - Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
Completed	`NCT02826941` - Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy	Phase 2
Active, not recruiting	`NCT01138176` - Whole Body Cooling Using Phase Changing Material	Phase 1/Phase 2
Recruiting	`NCT02578823` - Targeted Temperature Management After In-Hospital Cardiac Arrest	N/A
Terminated	`NCT01765218` - Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy	Phase 1/Phase 2
Completed	`NCT01241019` - Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms