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Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful? (oxystudien)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540748
First Posted: October 8, 2007
Last Update Posted: April 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Asker & Baerum Hospital
  Purpose
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.

Condition Intervention
Induced Abortion Drug: oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful ?

Resource links provided by NLM:


Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • blood loss, pain, nausea [ Time Frame: 2 years ]

Estimated Enrollment: 400
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: oxytocin
5 U i.v. during surgical abortion
No Intervention: A2

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • seeking legal abortion
  • first trimester
  • surgical intervention
  • no current medication
  • fluent in norwegian language

Exclusion Criteria:

  • current medication
  • medical condition with coagulopathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540748


Locations
Norway
Kvinneklinikken SABHF
Baerum, Rud, Norway, 1309
Sponsors and Collaborators
Asker & Baerum Hospital
Investigators
Study Director: Annelill Valbo, consultant, MD PhD Kvinneklinikken SABHF
  More Information

Responsible Party: Administrator Marit Kristoffersen, Asker and Baerum Hospital
ClinicalTrials.gov Identifier: NCT00540748     History of Changes
Other Study ID Numbers: 392-06154 1.2006.1683 (REK)
First Submitted: October 4, 2007
First Posted: October 8, 2007
Last Update Posted: April 16, 2010
Last Verified: May 2009

Keywords provided by Asker & Baerum Hospital:
first trimester abortion
oxytocin

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs