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CompletedNCT01685164Updated Feb 23, 2018

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

An observational study in Intrauterine Contraception, sponsored by Helsinki University Central Hospital. Completed at 1 site in Finland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-23.

Sponsored by Helsinki University Central Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
161
Ages
18 Years to 45 Years
Sex
Female
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Study summary

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.

Read the detailed description

Prospective observational study among nulliparous women requesting intrauterine contraception.

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Conditions studied

  • Intrauterine Contraception

Keywords

  • nulliparous
  • IUD
  • IUS
  • insertion
  • expulsion
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In context

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- nulliparous women with no previous history of IUD use

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
161 participants (actual)

Groups and cohorts

  • LNG-IUS

    Nulliparous women

    Other: 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.

Interventions

  • OtherEvaluation 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.

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What researchers measure

Primary outcomes

  1. The effect of uterine size or posture on IUD insertion.

    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).

    Time frame: Day 1

Secondary outcomes

  1. Satisfaction and continuation rate with intrauterine contraception.

    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.

    Time frame: 3 months

  2. Satisfaction and continuation rate with intrauterine contraception.

    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.

    Time frame: 12 months

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Study locations

1 site
  • Contraceptive unit of city of Helsinki
    Helsinki, Finland
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References and documents

Publications

  • Kaislasuo J, Heikinheimo O, Lahteenmaki P, Suhonen S. Menstrual characteristics and ultrasonographic uterine cavity measurements predict bleeding and pain in nulligravid women using intrauterine contraception. Hum Reprod. 2015 Jul;30(7):1580-8. doi: 10.1093/humrep/dev102. Epub 2015 May 19. PubMed 25990577 ↗
  • Kaislasuo J, Heikinheimo O, Lahteenmaki P, Suhonen S. Predicting painful or difficult intrauterine device insertion in nulligravid women. Obstet Gynecol. 2014 Aug;124(2 Pt 1):345-353. doi: 10.1097/AOG.0000000000000362. PubMed 25004340 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01685164
Responsible party
Satu P. Suhonen, MD, PhD (Physician in chief, Centralized Family Planning, City of Helsinki Health Centre, Helsinki University Central Hospital) — Principal investigator
First posted
Sep 14, 2012
Start date
Jan 2011
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Feb 23, 2018
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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