Intra-operative Feed Back on Traction Force During Vacuum Extraction: Safe Vacuum Extraction Alliance (SVEA)
Intra-operative Feed Back on Traction Force During Vacuum Extraction: a Randomized Control Study of Mid and Low Metal Cup Deliveries.
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Stockholm, Schweden, 14186
- Karolinska University Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
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Vacuum extraction intelligent system - this is the intervention
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Kein Eingriff: conventional
conventional handle
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Composite neonatal brain damage
Zeitfenster: From start of extraction through 28 days after delivery (or until discharge from the hospital)
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Composite consists of: Hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage (ICH), seizures, perinatal mortality and subgaleal hematoma as routinely diagnosed in patient chart
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From start of extraction through 28 days after delivery (or until discharge from the hospital)
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Magnus Westgren, Professor, Karolinska Institutet
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Neurologische Manifestationen
- Blutung
- Anzeichen und Symptome, Atmung
- Hypoxie
- Hypoxie, Gehirn
- Ischämie des Gehirns
- Krampfanfälle
- Erkrankungen des Gehirns
- Hypoxie-Ischämie, Gehirn
- Hämatom
Andere Studien-ID-Nummern
- KI-Clintec-SVEA
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