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

This study has been completed.
Sponsor:
Information provided by:
Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT00540748
First received: October 4, 2007
Last updated: April 15, 2010
Last verified: May 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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), 392-06154 1.2006.1683 (REK)
Study First Received: October 4, 2007
Last Updated: April 15, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014