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

Study Overview
=================
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.

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

Conditions
-----------------
Intrauterine Contraception

Intervention / Treatment
-----------------
* Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LNG-IUS<br>Nulliparous women | Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.<br>* Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.<br>|
| Cu-IUD<br>Nulliparous women | Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.<br>* Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nulliparous, IUD, IUS, insertion, expulsion