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

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ClinicalTrials.gov Identifier: NCT01685164
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Intrauterine Contraception. Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.

Detailed Description:
Prospective observational study among nulliparous women requesting intrauterine contraception.

Study Design

Study Type : Observational
Actual Enrollment : 161 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women
Study Start Date : January 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

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U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
LNG-IUS
Nulliparous women
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.
Cu-IUD
Nulliparous women
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.


Outcome Measures

Primary Outcome Measures :
  1. The effect of uterine size or posture on IUD insertion. [ Time Frame: 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 :
  1. Satisfaction and continuation rate with intrauterine contraception. [ Time Frame: 3 months ]
    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.

  2. Satisfaction and continuation rate with intrauterine contraception. [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685164


Locations
Finland
Contraceptive unit of city of Helsinki
Helsinki, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Satu P. Suhonen, MD, PhD, Physician in chief, Centralized Family Planning, City of Helsinki Health Centre, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01685164     History of Changes
Other Study ID Numbers: 1491/13/03/03/2010
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by Satu P. Suhonen, MD, PhD, Helsinki University Central Hospital:
nulliparous
IUD
IUS
insertion
expulsion