Standardized episiotomy with a new device: BasIQ

Standardized episiotomy with a new device: BasIQ - Pilot study BasIQ

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39695

Enrollment

Registered

2014-03-07

Start date

2015-01-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

cut Episiotomy

Interventions

Incision with the BasIQ

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)