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Patient-controlled sedation during repair of obstetric perineal lacerations
EU CTIS ID: 2022-502292-39-00
What this study is testing
To investigate patient pain/discomfort and complications when patient-controlled sedation with propofol is added to standard routine with pudendal nerve block during repair of obstetrical perineal lacerations grade I and II.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.