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Paracervical Block During II-trimester Abortion

This study has been completed.
Information provided by (Responsible Party):
Kristina Gemzell Danielsson, Karolinska Institutet Identifier:
First received: May 31, 2012
Last updated: May 15, 2015
Last verified: May 2015
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


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01617564

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kristina Gemzell Danielsson, Professor, Karolinska Institutet Identifier: NCT01617564     History of Changes
Other Study ID Numbers: W2010IM
Study First Received: May 31, 2012
Last Updated: May 15, 2015

Keywords provided by Kristina Gemzell Danielsson, Karolinska Institutet:
medical abortion
second trimester
para cervical blockage
pain management processed this record on September 21, 2017