Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance
NCT ID: NCT03071783
Last Updated: 2019-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
800 participants
INTERVENTIONAL
2016-04-01
2018-06-15
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Vacuum extraction intelligent system
Measurement and intra-operative feed back of vacuum extraction data: notification signal based an algorithm calculation using traction force (peak and time force integral) and time.
Vacuum extraction intelligent system
Vacuum extraction intelligent system - this is the intervention
conventional
conventional handle
No interventions assigned to this group
Interventions
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Vacuum extraction intelligent system
Vacuum extraction intelligent system - this is the intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Magnus Westgren
Professor
Principal Investigators
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Magnus Westgren, Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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MALMSTROM T. The vacuum extractor, an obstetrical instrument. I. Acta Obstet Gynecol Scand Suppl. 1957;36(suppl 3):5-50. No abstract available.
Moolgaoker AS, Ahamed SO, Payne PR. A comparison of different methods of instrumental delivery based on electronic measurements of compression and traction. Obstet Gynecol. 1979 Sep;54(3):299-309.
Towner DR, Ciotti MC. Operative vaginal delivery: a cause of birth injury or is it? Clin Obstet Gynecol. 2007 Sep;50(3):563-81. doi: 10.1097/GRF.0b013e31811eaa39.
Whitby EH, Griffiths PD, Rutter S, Smith MF, Sprigg A, Ohadike P, Davies NP, Rigby AS, Paley MN. Frequency and natural history of subdural haemorrhages in babies and relation to obstetric factors. Lancet. 2004 Mar 13;363(9412):846-51. doi: 10.1016/S0140-6736(04)15730-9.
Pettersson K, Ajne J, Yousaf K, Sturm D, Westgren M, Ajne G. Traction force during vacuum extraction: a prospective observational study. BJOG. 2015 Dec;122(13):1809-16. doi: 10.1111/1471-0528.13222. Epub 2015 Jan 5.
Romero S, Pettersson K, Yousaf K, Westgren M, Ajne G. Perinatal outcome after vacuum assisted delivery with digital feedback on traction force; a randomised controlled study. BMC Pregnancy Childbirth. 2021 Feb 26;21(1):165. doi: 10.1186/s12884-021-03604-z.
Other Identifiers
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KI-Clintec-SVEA
Identifier Type: -
Identifier Source: org_study_id
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