Standardized episiotomy with a new device: BasIQ

Completed

• Conditions: cut; Episiotomy; 10026906

• Registration Number: NL-OMON39695
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: The main endpoint will be whether there is a standardized incision of<br /><br>4 cm in women with an episiotomy performed with the *BasIQ*.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary: 1.Device safety for caregiver 2.Device safety for the neonate<br /><br>3.Wound infection 4.Morbidity related to episiotomy 5. Caregiver experiences 6.<br /><br>wound healing</p><br>