Paracervical Block During II-trimester Abortion

May 15, 2015 updated by: Kristina Gemzell Danielsson

Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Södersjukhuset
      • Stockholm, Sweden, SE17176
        • Dept of Obstetrics and Gynecology, Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • (Marcain® 2,5mg/ml)
SHAM_COMPARATOR: Sodium Chloride
Other: NaCl
PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: at 24 hours
Pain indicated on VAS at specific time intervals during the induction to expulsion
at 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: after 24h from induction
Number of complete abortions within 24h without the need for surgery
after 24h from induction
Time to abortion
Time Frame: at 24hours
Time from induction (first dose of misoprostol) to expulsion
at 24hours
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
at 6 to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kristina Gemzell Danielsson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (ESTIMATE)

June 12, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W2010IM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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