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

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. Identifier: NCT00540748
Recruitment Status : Completed
First Posted : October 8, 2007
Last Update Posted : April 16, 2010
Information provided by:
Asker & Baerum Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Induced Abortion Drug: oxytocin Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 400 participants
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 ?
Study Start Date : October 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A1 Drug: oxytocin
5 U i.v. during surgical abortion
No Intervention: A2

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

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

Inclusion Criteria:

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

Exclusion Criteria:

  • current medication
  • medical condition with coagulopathy

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 identifier (NCT number): NCT00540748

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

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

Keywords provided by Asker & Baerum Hospital:
first trimester abortion

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