NCT00540748

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 16, 2010

Status Verified

May 1, 2009

Enrollment Period

1.7 years

First QC Date

October 4, 2007

Last Update Submit

April 15, 2010

Conditions

Induced Abortion

Keywords

first trimester abortionoxytocin

Outcome Measures

Primary Outcomes (1)

  • blood loss, pain, nausea

    2 years

Study Arms (2)

A1

EXPERIMENTAL
Drug: oxytocin

A2

NO INTERVENTION

Interventions

oxytocinDRUG

5 U i.v. during surgical abortion

A1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • current medication
  • medical condition with coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kvinneklinikken SABHF

Baerum, Rud, 1309, Norway

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Annelill Valbo, consultant, MD PhD

    Kvinneklinikken SABHF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

April 16, 2010

Record last verified: 2009-05

Locations

NO(1)