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OpenTrials
Completed

NCT Number: NCT01617564

Paracervical Block During II-trimester Abortion

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

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Key information

Conditions

Second Trimester Medical Abortion Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bipuvacain

Drug

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)

NaCl

Other

PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator

Primary outcomes

  1. Pain score

    Time frame: at 24 hours

    Pain indicated on VAS at specific time intervals during the induction to expulsion

Secondary outcomes

  1. Efficacy

    Time frame: after 24h from induction

    Number of complete abortions within 24h without the need for surgery

  2. Time to abortion

    Time frame: at 24hours

    Time from induction (first dose of misoprostol) to expulsion

  3. 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

Sponsors and collaborators

Lead sponsor

Kristina Gemzell Danielsson

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2012
Registry last updated
May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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