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

Completed

• Conditions: Intrauterine Contraception
• Interventions: Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

• Registration Number: NCT01685164
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-14
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 161

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The effect of uterine size or posture on IUD insertion.	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 Outcome Measures

Name	Time	Method
Satisfaction and continuation rate with intrauterine contraception.	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.

Trial Locations

Locations (1)

Contraceptive unit of city of Helsinki; 🇫🇮 Helsinki, Finland