CTIS2022-502292-39-00
Recruiting
Phase 1
Does adding patient-controlled sedation with propofol during repair of obstetric perineal lacerations grade I and II improve patient experiences - a randomized control trial - PROP(ofol)
Region Oestergoetland0 sites80 target enrollmentDecember 16, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Obstetric perineal lacerations
- Sponsor
- Region Oestergoetland
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patient (\=18 years), Planned examination and repair of perineal laceration grades I or II, The patient has after receiving verbal and written information about the study given her signed informed consent to participate
Exclusion Criteria
- •BMI \> 35 (during first visit at the maternity care centre), 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, Perineal laceration grade III\-IV, Deviation from department guidlines regarding preopartive fasting
Outcomes
Primary Outcomes
Not specified
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