Paracervical Block During II-trimester Abortion

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014