women pregnant and scheduled to deliver “at term” of a fetus in cephalic presentation
Conditions
Interventions
The “BasIQ-4” is designed to perform a (medio)lateral episiotomy of approximately 4 cm
Sponsors
BasIQ B.V.
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • 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. | — |
Contacts
Public ContactMariette Schrier
BasIQ B.V.
Outcome results
None listed