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

Induced Abortion Clinical Trial

— oxystudien  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00540748
• Other study ID #: 392-06154 1.2006.1683 (REK)
• Secondary ID: 392-06154 1.2006
• Status: Completed
• Phase: N/A
• First received: October 4, 2007
• Last updated: April 15, 2010
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: May 2009
• Source: Asker & Baerum Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induced Abortion

Intervention

Drug:
• oxytocin
5 U i.v. during surgical abortion

Locations

Country	Name	City	State
Norway	Kvinneklinikken SABHF	Baerum	Rud

Sponsors (1)

Lead Sponsor	Collaborator
Asker & Baerum Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss, pain, nausea		2 years	No