- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00540748
Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful? (oxystudien)
April 15, 2010 updated by: Asker & Baerum Hospital
Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful ?
This is a randomized, single-blind study using oxytocin 5U i.v.
during surgical abortion in one arm of the study, and no medication in the other arm of the study.
Comparison is done between the two groups measuring the following outcomes: pain, nausea and blood loss.
The investigators' hypothesis is that there will be no significant differences between the two groups.
Study Overview
Detailed Description
All women seeking surgical abortion before 12 weeks of pregnancy will be invited to participate in the study.
We will include 400 patients.
Written consent is given.
Pain is measured on a VAS-scale (1-10) 2 hours post operatively and repeated 2 days postoperatively.
Nausea is categorized in 4 groups, from 1 (no nausea) to 4 (pronounced nausea with vomiting)and is registered together with bloodloss also during the hospital stay (2 hours) and 2 days postoperatively.
The two groups will be compared.
Study Type
Interventional
Enrollment (Anticipated)
400
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
-
-
Rud
-
Baerum, Rud, Norway, 1309
- Kvinneklinikken SABHF
-
-
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 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- seeking legal abortion
- first trimester
- surgical intervention
- no current medication
- fluent in norwegian language
Exclusion Criteria:
- current medication
- medical condition with coagulopathy
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: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A1
|
5 U i.v.
during surgical abortion
|
NO_INTERVENTION: A2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood loss, pain, nausea
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Annelill Valbo, consultant, MD PhD, Kvinneklinikken SABHF
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
October 1, 2007
Primary Completion (ACTUAL)
June 1, 2009
Study Completion (ACTUAL)
December 1, 2009
Study Registration Dates
First Submitted
October 4, 2007
First Submitted That Met QC Criteria
October 4, 2007
First Posted (ESTIMATE)
October 8, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
April 16, 2010
Last Update Submitted That Met QC Criteria
April 15, 2010
Last Verified
May 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 392-06154 1.2006.1683 (REK)
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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