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Paracervical Block During II-trimester Abortion

This study is currently recruiting participants.
Verified June 2012 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01617564
First received: May 31, 2012
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

Paracervical blockage can reduce severe pain during second trimester induced medical abortion.


Condition Intervention
Second Trimester Medical Abortion
 Drug: bipuvacain
Other: NaCl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Pain score [ Time Frame: at 24 hours ] [ Designated as safety issue: No ]
    Pain indicated on VAS at specific time intervals during the induction to expulsion


Secondary Outcome Measures:
  • Efficacy [ Time Frame: after 24h from induction ] [ Designated as safety issue: No ]
    Number of complete abortions within 24h without the need for surgery

  • Time to abortion [ Time Frame: at 24hours ] [ Designated as safety issue: No ]
    Time from induction (first dose of misoprostol) to expulsion

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: at 6 to 8 weeks ] [ Designated as safety issue: Yes ]
    AEs reported during the time period from mifepristone (Day 1)until follow up


Estimated Enrollment: 140
Study Start Date: May 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacain Drug: bipuvacain
PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose).
Other Name: (Marcain® 2,5mg/ml)
Sham Comparator: Sodium Chloride Other: NaCl
PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617564

Contacts
Contact: Inga-Maj Andersson, RNM inga-maj.andersson@sodersjukhuset.se

Locations
Sweden
Dept of Obstetrics and Gynecology, Karolinska University Hospital Recruiting
Stockholm, Sweden, SE17176
Contact: Kristina Gemzell Danielsson, MD, PhD     +46851772128     kristina.gemzell@ki.se    
Principal Investigator: Kristina Gemzell Danielsson, Prof.MD.PhD            
Södersjukhuset Recruiting
Stockholm, Sweden
Contact: Inga-Maj Andersson, RNM     +46702191036     inga-maj.andersson@sodersjukhuset.se    
Principal Investigator: Inga-Maj Andersson, RNM            
Sponsors and Collaborators
Kristina Gemzell Danielsson
Investigators
Principal Investigator: Kristina Gemzell Danielsson, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01617564     History of Changes
Other Study ID Numbers: W2010IM
Study First Received: May 31, 2012
Last Updated: June 8, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
medical abortion
second trimester
para cervical blockage
pain management

ClinicalTrials.gov processed this record on May 23, 2013