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Paracervical Block During II-trimester Abortion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01617564
First Posted: June 12, 2012
Last Update Posted: May 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet
  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: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial

Further study details as provided by Kristina Gemzell Danielsson, Karolinska Institutet:

Primary Outcome Measures:
  • Pain score [ Time Frame: at 24 hours ]
    Pain indicated on VAS at specific time intervals during the induction to expulsion


Secondary Outcome Measures:
  • Efficacy [ Time Frame: after 24h from induction ]
    Number of complete abortions within 24h without the need for surgery

  • Time to abortion [ Time Frame: at 24hours ]
    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 ]
    AEs reported during the time period from mifepristone (Day 1)until follow up


Enrollment: 112
Study Start Date: May 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01617564


Locations
Sweden
Dept of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, Sweden, SE17176
Södersjukhuset
Stockholm, Sweden
Sponsors and Collaborators
Kristina Gemzell Danielsson
Investigators
Principal Investigator: Kristina Gemzell Danielsson, MD, PhD Karolinska Institutet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01617564     History of Changes
Other Study ID Numbers: W2010IM
First Submitted: May 31, 2012
First Posted: June 12, 2012
Last Update Posted: May 18, 2015
Last Verified: May 2015

Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
medical abortion
second trimester
para cervical blockage
pain management