An interventional study of bipuvacain and NaCl in Second Trimester Medical Abortion, sponsored by Kristina Gemzell Danielsson. Completed at 2 sites in Sweden. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-05-18.
Sponsored by Kristina Gemzell Danielsson · Not applicable, Interventional, and Treatment
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
Kristina Gemzell Danielsson is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: bipuvacain
Other: NaCl
PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose).
Also known as: (Marcain® 2,5mg/ml)
PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator
Pain score
Pain indicated on VAS at specific time intervals during the induction to expulsion
Time frame: at 24 hours
Efficacy
Number of complete abortions within 24h without the need for surgery
Time frame: after 24h from induction
Time to abortion
Time from induction (first dose of misoprostol) to expulsion
Time frame: at 24hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
AEs reported during the time period from mifepristone (Day 1)until follow up
Time frame: at 6 to 8 weeks
The record gives a start of May 2012, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Agnosia
Kristina Gemzell Danielsson