To assess if the *BasIQ* makes a standardized incision of 4 cm.
ID
Source
Brief title
Condition
- Maternal complications of labour and delivery
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: The main endpoint will be whether there is a standardized incision of
4 cm in women with an episiotomy performed with the *BasIQ*.
Secondary outcome
Secundary: 1.Device safety for caregiver 2.Device safety for the neonate
3.Wound infection 4.Morbidity related to episiotomy 5. Caregiver experiences 6.
wound healing
Background summary
The episiotomy is the most performed surgical intervention in the world.
However, in modern obstetrics, this old procedure needs to be optimized while
the scissors used for an episiotomy lack precision. We developed a new device
in order to create a standardized incision with better healing outcomes.
Study objective
To assess if the *BasIQ* makes a standardized incision of 4 cm.
Study design
Prospective cohort pilot study
Intervention
Incision with the BasIQ
Study burden and risks
The *BasIQ* is invented to make a precise, sharp, 4cm incision, and is easy to
use, with better healing outcomes and less complications with similar safety.
Although the device has no CE mark yet, we believe that after various animal
testing and expert opinions, a clinical pilot study can prove the feasibility
of this new device. While eligible women are counselled extensively, they will
be aware of the purpose of the pilot study. In addition participating women
will know that if necessary, the episiotomy will be performed and sutured by an
expert.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
All women aged 18 years and older who are pregnant and intend to deliver vaginally (for the first time) in the AMC
Exclusion criteria
1.Insufficient knowledge of the Dutch language
2.Coagulation disorders
3.Expected wound healing problems (diabetes, venous insufficiency, immune suppression)
4.Thrombocytopenia (pre-eclampsia, HELLP syndrome, idiopathic thrombocytopenia
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 | NL41883.018.13 |