Paracervical Block During II-trimester Abortion
Not Applicable
Completed
- Conditions
- Second Trimester Medical Abortion
- Interventions
- Drug: bipuvacainOther: NaCl
- Registration Number
- NCT01617564
- Lead Sponsor
- Kristina Gemzell Danielsson
- Brief Summary
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 112
Inclusion Criteria
- Women who request second trimester medical abortion (13-22 weeks gestation according to ultrasound)
- 18 years of age or older
- able to understand and communicate in Swedish
- able to understand the study related information and willing to give her
- informed consent to participation in the study
Exclusion Criteria
- Known allergy to bupivakain or related substances
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bupivacain bipuvacain - Sodium Chloride NaCl -
- Primary Outcome Measures
Name Time Method Pain score at 24 hours Pain indicated on VAS at specific time intervals during the induction to expulsion
- Secondary Outcome Measures
Name Time Method Efficacy after 24h from induction Number of complete abortions within 24h without the need for surgery
Time to abortion at 24hours Time from induction (first dose of misoprostol) to expulsion
Number of Participants with Adverse Events as a Measure of Safety and Tolerability at 6 to 8 weeks AEs reported during the time period from mifepristone (Day 1)until follow up
Trial Locations
- Locations (2)
Dept of Obstetrics and Gynecology, Karolinska University Hospital
🇸🇪Stockholm, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden