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

Intrauterine Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685164
• Other study ID #: 1491/13/03/03/2010
• Status: Completed
• Phase: N/A
• First received: August 30, 2012
• Last updated: February 21, 2018
• Start date: January 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2018
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Prospective observational study among nulliparous women requesting intrauterine contraception.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrauterine Contraception

Intervention

Other:
• Evaluation 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.

Locations

Country	Name	City	State
Finland	Contraceptive unit of city of Helsinki	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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