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

NCT ID: NCT00540748

Last Updated: 2010-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Induced Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A1

Group Type EXPERIMENTAL

oxytocin

Intervention Type DRUG

5 U i.v. during surgical abortion

A2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oxytocin

5 U i.v. during surgical abortion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* current medication
* medical condition with coagulopathy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Asker & Baerum Hospital

OTHER

Sponsor Role lead

Responsible Party

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Asker and Baerum Hospital

Principal Investigators

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Annelill Valbo, consultant, MD PhD

Role: STUDY_DIRECTOR

Kvinneklinikken SABHF

Locations

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Kvinneklinikken SABHF

Baerum, Rud, Norway

Site Status

Countries

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Norway

Other Identifiers

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392-06154 1.2006.1683 (REK)

Identifier Type: -

Identifier Source: secondary_id

392-06154 1.2006.1683 (REK)

Identifier Type: -

Identifier Source: org_study_id

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