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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Satu P. Suhonen, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01685164
First received: August 30, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • The effect of uterine size or posture on IUD insertion. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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:
  • Satisfaction and continuation rate with intrauterine contraception. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Satisfaction and continuation rate with intrauterine contraception. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 161
Study Start Date: January 2011
Estimated Study Completion Date: October 2013
Groups/Cohorts Assigned Interventions
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.

Detailed Description:

Prospective observational study among nulliparous women requesting intrauterine contraception.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685164

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

No publications provided

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
Study First Received: August 30, 2012
Last Updated: September 11, 2012
Health Authority: Finland: Ethics Committeé of Helsinki UCH
Finland: City of Helsinki Research Board

Keywords provided by Helsinki University Central Hospital:
nulliparous
IUD
IUS
insertion
expulsion

ClinicalTrials.gov processed this record on July 31, 2014