Status:
UNKNOWN
Patient-controlled Sedation During Repair of Obstetric Perineal Lacerations
Lead Sponsor:
Marie Blomberg
Conditions:
Pain
Patient Satisfaction
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The PROP(ofol)-study (EU CT number: 2022-502292-39-00, protocol number: ) is a clinical trial phase IV single centre prospective randomized controlled trial with parallel groups. A total of 80 women w...
Detailed Description
Study design and procedure 1. Study design Clinical trial, Phase IV; therapeutic use. The study is an open prospective randomized controlled low-intervention trial with parallel groups conducted in a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06044103
Start Date
September 20 2023
End Date
October 30 2024
Last Update
September 21 2023
Active Locations (1)
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1
Vrinnevihospital
Norrköping, Sweden