Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT06044103
Eligibility Criteria:
Inclusion Criteria:
* Adult patient (≥18 years)
* Planned examination and repair of perineal laceration
* The patient has after receiving verbal and written information about the study given her signed informed consent to participate
Exclusion Criteria:
* Perineal laceration grade III-IV
* BMI \> 35 (during first visit at the maternity care centre)
* Deviation from department guidlines regarding preopartive fasting
* Preeclampsia or hypertensive disease
* Postpartum haemorrhage \> 1000 ml
* Known/suspected allergy or contraindication to any medication within the study
* Functional disability in both hands which affect the possibility to operate the PCS device
* Cognitive impairment, unwillingness or language difficulties resulting in difficulty to understand the meaning of participation in the study or to operate the PCS device
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06044103
Study Brief:
Protocol Section:
NCT06044103