Primary objectives: The main objective of this Post Market Clinical Follow-Up (PMCF) study is 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…
ID
Source
Brief title
Condition
- Maternal complications of labour and delivery
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
Device Success, achieved if all three below conditions are met:
• BasIQ-4® makes an incision in one continuous movement (without
interruption).
• The length of the scar caused by BasIQ-4® as measured at the 6 week visit is
between 3 and 5 cm.
• Absence of any Serious Adverse Event related to BasIQ-4® occurring up to the
6 week visit for neonate, caregiver or for mother (other than the intended
episiotomy itself) as adjudicated by the Data Monitoring Committee.
Secondary outcome
Secondary endpoints:
• BasIQ-4® makes an incision in one continuous movement (without
interruption).
• The length of the scar caused by BasIQ-4®, as measured at the 6 week visit is
between 3 and 5 cm.
• Serious Adverse Event related to BasIQ-4® occurring up to the 6 week visit
for neonate, caregiver or for mother (other than the intended episiotomy
itself) as adjudicated by the Data Monitoring Committee.
• Angle of the scar caused by BasIQ-4®, as measured at the 6 week visit.
• Distance (mm) from the endpoint of the scar caused by BasIQ-4® incision to
the midline of the posterior fourchette, as measured at the 6 week visit.
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
Primary objectives:
The main objective of this Post Market Clinical Follow-Up (PMCF) study is 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 (solely used by professional users and in accordance with the
PMCF study protocol and the Instructions For Use).
Secondary objectives:
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.
Study design
Prospective multicenter interventional study (open label single arm)
Intervention
Episiotomy
Study burden and risks
Episiotomy is the most performed surgical intervention in obstetrics. There are
huge geographical differences in the prevalence of episiotomy both within
Europe and worldwide. Women who intend to deliver vaginally have a chance of
21-39% to receive an episiotomy in The Netherlands.
This means approximately 34.000 episiotomies are performed in The Netherlands
each year, i.e. four episiotomies every hour. The burden of participating in
this pilot study will be the novelty of the device. The results of the pre-CE
clinical investigation showed that with the device one is able to perform a
safe (safe for patient, neonate and caregiver) episiotomy. Theoretical benefit
of the device is better healing outcome (straight incision/scar with sharp
wound edges) because of a knife cut wound instead of a wound made by scissors.
Women will be informed by their research physician. Since eligible women are
informed orally and in writing extensively, they will be aware of the purpose
of this PMCF study.
World Trade Center, Beursplein, Suite 1960 37
Rotterdam 3011 AA
NL
World Trade Center, Beursplein, Suite 1960 37
Rotterdam 3011 AA
NL
Listed location countries
Age
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
Medical products/devices used
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 |
|---|---|
| CCMO | NL70216.015.19 |
| Other | NL8601 |