Intrauterine ContraceptionNCT01685164
The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women
An observational study of Intrauterine Contraception, run by Helsinki University Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Contraception
- What is being tested?
- Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
- How many people
- 161 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- nulliparous women with no previous history of IUD use
Who cannot join
- malformation of uterus
- myomas
- acute gynecological infection
- malignant uterine or cervical tumor
- In addition if requesting a Cu-IUD
- heavy menstruations
Show all 9Show fewer
- iron deficiency
- bleeding disorder
- copper allergy or Wilson's disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Prospective observational study among nulliparous women requesting intrauterine contraception.
- Conditions
- Intrauterine Contraception
- Being tested
- Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
- Keywords
- nulliparous, IUD, IUS, insertion, expulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.Other
Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| LNG-IUS | Nulliparous women Receives: Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up. | |
| Cu-IUD | Nulliparous women Receives: Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (2)
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.
Measured: 3 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intrauterine ContraceptionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satu P. Suhonen, MD, PhD, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685164
- Sponsor's protocol ID
- 1491/13/03/03/2010
- Status last verified
- Feb 2018
- First submitted
- 30 Aug 2012
- Last updated
- 23 Feb 2018
- Results posted
- No
Publications
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.
PubMed 25990577Kaislasuo 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.
PubMed 25004340
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women
- ClinicalTrials.gov ID
- NCT01685164
- Acronym / sponsor ID
- 1491/13/03/03/2010
- Conditions
- Intrauterine Contraception
- Keywords
- nulliparous, IUD, IUS, insertion, expulsion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LNG-IUS | – | Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.Nulliparous women |
| Cu-IUD | – | Other: Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.Nulliparous women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- nulliparous women with no previous history of IUD use
Key exclusion criteria (9 listed)
- malformation of uterus
- myomas
- acute gynecological infection
- malignant uterine or cervical tumor
- In addition if requesting a Cu-IUD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Cu-IUD, LNG-IUS |
Primary outcome
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).
2 secondary outcomes
Satisfaction and continuation rate with intrauterine contraception.
Time frame: 3 months
Satisfaction and continuation rate with intrauterine contraception.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Derived from this study: PubMed 25990577Kaislasuo 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.
- Derived from this study: PubMed 25004340Kaislasuo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Contraception, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of uterine size or posture on IUD insertion. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685164, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.