The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women

February 21, 2018 updated by: Satu P. Suhonen, MD, PhD, Helsinki University Central Hospital
As intrauterine contraception is an increasingly popular form of contraception the objective of our study is to examine if uterine size or posture affects the insertion or use of intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective observational study among nulliparous women requesting intrauterine contraception.

Study Type

Observational

Enrollment (Actual)

161

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

  • Finland
      • Helsinki, Finland
        • Contraceptive unit of city of Helsinki

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

Sampling Method

Non-Probability Sample

Study Population

The study population consists of nulliparous women attending the centralized Family planning center of the City of Helsinki requesting intrauterine contraception, either the LNG-IUS or a Cu-IUD.

Description

Inclusion Criteria:

- nulliparous women with no previous history of IUD use

Exclusion Criteria:

  • malformation of uterus
  • myomas
  • acute gynecological infection
  • malignant uterine or cervical tumor

In addition if requesting a Cu-IUD

  • heavy menstruations
  • iron deficiency
  • bleeding disorder
  • copper allergy or Wilson's disease

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LNG-IUS
Nulliparous women
Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
Cu-IUD
Nulliparous women
Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of uterine size or posture on IUD insertion.
Time Frame: Day 1
The size of the uterine cavity (cm) and the flexion angle of the uterus are determined at insertion using ultrasonography. This is compared with assessment of perception of insertion pain both by the patient and the inserting doctor is evaluated as well as the easiness if insertion (by the doctor).
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction and continuation rate with intrauterine contraception.
Time Frame: 3 months
Clinical evaluation including gynecological examination is at 3 months after insertion. Patterns of bleeding and severeness of pain are followed daily for the 90 first days after insertion.
3 months
Satisfaction and continuation rate with intrauterine contraception.
Time Frame: 12 months
A second clinical evaluation including gynecological examination is at 12 months after insertion. Patterns of bleeding and severeness of pain are followed daily for the last 90 days of the first year of use of intrauterine contraception.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 30, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 14, 2012

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1491/13/03/03/2010

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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