The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women
1 other identifier
observational
161
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 30, 2012
CompletedFirst Posted
Study publicly available on registry
September 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFebruary 23, 2018
February 1, 2018
2.5 years
August 30, 2012
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Satisfaction and continuation rate with intrauterine contraception.
3 months
Satisfaction and continuation rate with intrauterine contraception.
12 months
Study Arms (2)
LNG-IUS
Nulliparous women
Cu-IUD
Nulliparous women
Interventions
Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
Eligibility Criteria
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.
You may qualify if:
- \- nulliparous women with no previous history of IUD use
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Contraceptive unit of city of Helsinki
Helsinki, Finland
Related Publications (2)
Kaislasuo J, Heikinheimo O, Lahteenmaki P, Suhonen S. Menstrual characteristics and ultrasonographic uterine cavity measurements predict bleeding and pain in nulligravid women using intrauterine contraception. Hum Reprod. 2015 Jul;30(7):1580-8. doi: 10.1093/humrep/dev102. Epub 2015 May 19.
PMID: 25990577DERIVEDKaislasuo J, Heikinheimo O, Lahteenmaki P, Suhonen S. Predicting painful or difficult intrauterine device insertion in nulligravid women. Obstet Gynecol. 2014 Aug;124(2 Pt 1):345-353. doi: 10.1097/AOG.0000000000000362.
PMID: 25004340DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician in chief, Centralized Family Planning, City of Helsinki Health Centre
Study Record Dates
First Submitted
August 30, 2012
First Posted
September 14, 2012
Study Start
January 1, 2011
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
February 23, 2018
Record last verified: 2018-02