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

Status

Completed

Conditions

Intervention / Treatment

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

  • Norway
    • 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
Drug: oxytocin
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

Asker & Baerum Hospital

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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