ContraceptionNCT01223521
Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion.
A study testing Immediate intrauterine contraception in people with Contraception, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Immediate intrauterine contraception
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 748 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2010to Mar 2018
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Duration of pregnancy < 12 weeks.
- Age ≥18 years
Who cannot join
- Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).
Trial locations and contacts
1 site in 1 country.
Finland1 site
Dept Obstetrics and Gynecology, Helsinki University Central Hospital
Helsinki, 00029 HUS
About this study
Official title: Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial.
A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life.
- Conditions
- Contraception
- Being tested
- Immediate intrauterine contraception
- Keywords
- Contraception, Abortion, First trimester, Intrauterine device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate intrauterine contraceptionDevice
A Cu-IUD or LNG-IUS is inserted after abortion.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intrauterine contraception | Experimental | IUD (either Cu-IUD or LNG-IUS) inserted immediately after abortion. Receives: Device: Immediate intrauterine contraception |
| Control group | No intervention | Post-abortal contraception is prescribed by the hospital but on the responsibility of the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of repeat abortions
Number of subsequent abortions during five years follow-up time.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 748 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- City of Helsinki
- Responsible party
- Principal investigator, Elina Pohjoranta, Helsinki University Central Hospital
- Investigators
- Oskari Heikinheimo, MD, PhD, Principal investigator, Helsinki University Central HospitalSatu P Suhonen, MD, PhD, Study director, City of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223521
- Sponsor's protocol ID
- TYH2010224
- Status last verified
- Aug 2018
- First submitted
- 18 Oct 2010
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pohjoranta E, Mentula M, Gissler M, Suhonen S, Heikinheimo O. Provision of intrauterine contraception in association with first trimester induced abortion reduces the need of repeat abortion: first-year results of a randomized controlled trial. Hum Reprod. 2015 Nov;30(11):2539-46. doi: 10.1093/humrep/dev233. Epub 2015 Sep 14.
PubMed 26370664Toffol E, Pohjoranta E, Suhonen S, Hurskainen R, Partonen T, Mentula M, Heikinheimo O. Anxiety and quality of life after first-trimester termination of pregnancy: a prospective study. Acta Obstet Gynecol Scand. 2016 Oct;95(10):1171-80. doi: 10.1111/aogs.12959.
PubMed 27500660Pohjoranta E, Suhonen S, Mentula M, Heikinheimo O. Intrauterine contraception after medical abortion: factors affecting success of early insertion. Contraception. 2017 Mar;95(3):257-262. doi: 10.1016/j.contraception.2016.10.012. Epub 2016 Nov 9.
PubMed 27836586Pohjoranta E, Suhonen S, Gissler M, Ikonen P, Mentula M, Heikinheimo O. Early provision of intrauterine contraception as part of abortion care-5-year results of a randomised controlled trial. Hum Reprod. 2020 Apr 28;35(4):796-804. doi: 10.1093/humrep/deaa031.
PubMed 32266392Pohjoranta E, Mentula M, Suhonen SP, Heikinheimo O. Predicting poor compliance with follow-up and intrauterine contraception services after medical termination of pregnancy. BMJ Sex Reprod Health. 2018 Sep 15:bmjsrh-2018-200098. doi: 10.1136/bmjsrh-2018-200098. Online ahead of print.
PubMed 30219793
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial.
- ClinicalTrials.gov ID
- NCT01223521
- Acronym / sponsor ID
- TYH2010224
- Conditions
- Contraception
- Keywords
- Contraception, Abortion, First trimester, Intrauterine device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 748 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- City of Helsinki
- Study start
- Sep 2010
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 Oct 2010 (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.
A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intrauterine contraception | Experimental | Device: Immediate intrauterine contraceptionIUD (either Cu-IUD or LNG-IUS) inserted immediately after abortion. |
| Control group | No intervention | –Post-abortal contraception is prescribed by the hospital but on the responsibility of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Duration of pregnancy < 12 weeks.
- Age ≥18 years
Key exclusion criteria (1 listed)
- Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (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 |
|---|---|---|
| Immediate intrauterine contraceptionA Cu-IUD or LNG-IUS is inserted after abortion. | Device | Immediate intrauterine contraception |
Primary outcome
Number of repeat abortions
Time frame: 5 years
Number of subsequent abortions during five years follow-up time.
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 24 Aug 2018.
- Background: PubMed 26370664Pohjoranta E, Mentula M, Gissler M, Suhonen S, Heikinheimo O. Provision of intrauterine contraception in association with first trimester induced abortion reduces the need of repeat abortion: first-year results of a randomized controlled trial. Hum Reprod. 2015 Nov;30(11):2539-46. doi: 10.1093/humrep/dev233. Epub 2015 Sep 14.
- Background: PubMed 27500660Toffol E, Pohjoranta E, Suhonen S, Hurskainen R, Partonen T, Mentula M, Heikinheimo O. Anxiety and quality of life after first-trimester termination of pregnancy: a prospective study. Acta Obstet Gynecol Scand. 2016 Oct;95(10):1171-80. doi: 10.1111/aogs.12959.
- Background: PubMed 27836586Pohjoranta E, Suhonen S, Mentula M, Heikinheimo O. Intrauterine contraception after medical abortion: factors affecting success of early insertion. Contraception. 2017 Mar;95(3):257-262. doi: 10.1016/j.contraception.2016.10.012. Epub 2016 Nov 9.
- Derived from this study: PubMed 32266392Pohjoranta E, Suhonen S, Gissler M, Ikonen P, Mentula M, Heikinheimo O. Early provision of intrauterine contraception as part of abortion care-5-year results of a randomised controlled trial. Hum Reprod. 2020 Apr 28;35(4):796-804. doi: 10.1093/humrep/deaa031.
- Derived from this study: PubMed 30219793Pohjoranta E, Mentula M, Suhonen SP, Heikinheimo O. Predicting poor compliance with follow-up and intrauterine contraception services after medical termination of pregnancy. BMJ Sex Reprod Health. 2018 Sep 15:bmjsrh-2018-200098. doi: 10.1136/bmjsrh-2018-200098. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Oskari Heikinheimo, MD, PhD principal investigator
Helsinki University Central Hospital
Satu P Suhonen, MD, PhD study director
City of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate intrauterine contraception in people with 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 2 inclusion and 1 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 24 Aug 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?
Number of repeat abortions (time frame: 5 years). 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 NCT01223521, which also lists 5 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 24 Aug 2018.