Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01685164
Enrollment
161
Registered
2012-09-14
Start date
2011-01-31
Completion date
2013-07-31
Last updated
2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Contraception

Keywords

nulliparous, IUD, IUS, insertion, expulsion

Brief 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.

Detailed description

Prospective observational study among nulliparous women requesting intrauterine contraception.

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.

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

MeasureTime frameDescription
Satisfaction and continuation rate with intrauterine contraception.3 monthsClinical 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.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026