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

Asker & Baerum Hospital

Status: Completed

Conditions: Induced Abortion

Treatments: Drug: oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT00540748

392-06154 1.2006.1683 (REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• current medication
• medical condition with coagulopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

A1

Experimental group

Treatment:

Drug: oxytocin

A2

No Intervention group