NCT01617564CompletedNot Applicable
Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial
Kristina Gemzell Danielsson2 sites in 1 country112 target enrollmentStarted: May 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 112
- Locations
- 2
- Primary Endpoint
- Pain score
Study Overview
Brief Summary
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Bupivacain
Active Comparator
Intervention: bipuvacain (Drug)
Sodium Chloride
Sham Comparator
Intervention: NaCl (Other)
Outcomes
Primary Outcomes
Pain score
Time Frame: at 24 hours
Pain indicated on VAS at specific time intervals during the induction to expulsion
Secondary Outcomes
- Efficacy(after 24h from induction)
- Time to abortion(at 24hours)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(at 6 to 8 weeks)
Investigators
Kristina Gemzell Danielsson
Professor
Karolinska Institutet
Study Sites (2)
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