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ID
Source
Brief title
Health condition
women pregnant and scheduled to deliver “at term” of a fetus in cephalic presentation
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Secondary outcome
• To confirm the acceptability of the identified residual risks associated with the use of the “BasIQ-4®”.
• To identify not yet identified risks.
• To generate results with this study that will initiate further scientific investigation especially between the BasIQ-4® and episiotomy scissors.
Background summary
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.
Study objective
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
Study design
time of delivery
Intervention
The “BasIQ-4” is designed to perform a (medio)lateral episiotomy of approximately 4 cm
Inclusion criteria
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.
Exclusion criteria
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
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8601 |
| Other | METC Maxima Medisch Centrum : w19.044 |