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Completed

NCT Number: NCT01685164

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

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.

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Key information

Conditions

Intrauterine Contraception

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Contraceptive unit of city of Helsinki

Helsinki, Finland

About this study

Prospective observational study among nulliparous women requesting intrauterine contraception.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Other

Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 14, 2012
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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