Paracervical Block During II-trimester Abortion
Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial
1 other identifier
interventional
112
1 country
2
Brief Summary
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 31, 2012
CompletedFirst Posted
Study publicly available on registry
June 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMay 18, 2015
May 1, 2015
3 years
May 31, 2012
May 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score
Pain indicated on VAS at specific time intervals during the induction to expulsion
at 24 hours
Secondary Outcomes (3)
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
Study Arms (2)
Bupivacain
ACTIVE COMPARATORSodium Chloride
SHAM COMPARATORInterventions
PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose).
Eligibility Criteria
You may qualify if:
- Women who request second trimester medical abortion (13-22 weeks gestation according to ultrasound)
- 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
You may not qualify if:
- Known allergy to bupivakain or related substances
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dept of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, SE17176, Sweden
Södersjukhuset
Stockholm, Sweden
Related Publications (1)
Andersson IM, Benson L, Christensson K, Gemzell-Danielsson K. Paracervical block as pain treatment during second-trimester medical termination of pregnancy: an RCT with bupivacaine versus sodium chloride. Hum Reprod. 2016 Jan;31(1):67-74. doi: 10.1093/humrep/dev286. Epub 2015 Nov 15.
PMID: 26573530DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristina Gemzell Danielsson, MD, PhD
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 31, 2012
First Posted
June 12, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
May 18, 2015
Record last verified: 2015-05