BasIQ-4® a new approach towards performing episiotomy

BasIQ-4® a new approach towards performing episiotomy - BasIQ-4® PMCF Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49943

Enrollment

100

Registered

2019-12-20

Start date

2020-10-22

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cut episiotomy

Interventions

Episiotomy

Eligibility

Age

18 Years to 99 Years

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
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)