to further evaluate and monitor the safety and performance of the “BasIQ-4®” in a population of women delivering in general hospitals in The Netherlands when used as intended
ID
Bron
Verkorte titel
Aandoening
women pregnant and scheduled to deliver “at term” of a fetus in cephalic presentation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
to further evaluate and monitor the safety and performance of the “BasIQ-4®” in a population of women delivering in general hospitals in The Netherlands when used as intended
Achtergrond van het onderzoek
The episiotomy is the most performed surgical intervention in the world. However, making an incision with scissors is against surgical principles, as a cut wound using BasIQ-4® theoretically results in better wound healing. We developed the “BasIQ-4®” in order to create a (medio)lateral incision of approximately 4 cm from dorsal to ventral/lateral to median towards the vaginal introitus (from the perineum towards the posterior fourchette of the vagina). From the point with the lowest tissue tension to the direction of the highest tissue tension. As a consequence of starting the incision point dorsal it is possible to make a (medio)lateral incision in one single movement.
Doel van het onderzoek
to further evaluate and monitor the safety and performance of the “BasIQ-4®” in a population of women delivering in general hospitals in The Netherlands when used as intended
Onderzoeksopzet
time of delivery
Onderzoeksproduct en/of interventie
The “BasIQ-4” is designed to perform a (medio)lateral episiotomy of approximately 4 cm
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All women aged 18 years and older who are pregnant and scheduled to deliver “at term” of a fetus in cephalic presentation and intend to deliver vaginally (for the first time) and who are willing and able to give written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Insufficient knowledge of the local language
Prior vaginal delivery in anamnesis
Coagulation disorders
Expected wound healing problems
diabetes mellitus
venous insufficiency
immune suppression (e.g. HIV infected women, women using immunosuppressive drugs)
Thrombocytopenia
pre-eclampsia/HELPP syndrome
Forceps delivery
Vulnerable people
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8601 |
| Ander register | METC Maxima Medisch Centrum : w19.044 |