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Completed

NCT Number: NCT03071783

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical or social reasons for vacuum extraction with a metal cup, gestational age ≥37+0 weeks, singleton, cephalic

Exclusion criteria

  • Multiple pregnancy, breech presentation, gestational age <37+0

Treatment and study plan

Vacuum extraction intelligent system

Device

Vacuum extraction intelligent system - this is the intervention

Primary outcomes

  1. Composite neonatal brain damage

    Time frame: From start of extraction through 28 days after delivery (or until discharge from the hospital)

    Composite consists of: Hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage (ICH), seizures, perinatal mortality and subgaleal hematoma as routinely diagnosed in patient chart

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Intra-operative Feed Back on Traction Force During Vacuum Extraction: a Randomized Control Study of Mid and Low Metal Cup Deliveries.

Acronym: SVEA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2017
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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