Contraception After Medical AbortionNCT01755715
Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy
A study testing Immediate IUD insertion in people with Contraception After Medical Abortion, run by Riina Korjamo at 1 site in Finland.
Trial summary
The main objective of this study is to compare, in a randomised, controlled and prospective fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days) versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception one year after abortion. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception After Medical Abortion
- What is being tested?
- Immediate IUD insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2013to Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Planning medical abortion
- Planning LNG-IUD (Mirena) contraception
Who cannot join
- Pathological pregnancies or abnormality of the uterus or cervix
- Acute endometritis
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to compare, in a randomised, controlled and prospective fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days) versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception one year after abortion.
- Conditions
- Contraception After Medical Abortion
- Being tested
- Immediate IUD insertion
- Keywords
- Abortion, Contraception, Intrauterine Devices, Intrauterine Device Expulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate IUD insertionProcedure or surgery
Insertion of LNG-IUD (Mirena) (at the same day to 3 days) after expulsion of placenta.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Insertion of IUD at 2-4 weeks after abortion. |
| Immediate IUD insertion | Experimental | Insertion of IUD immediately (at the same day to 3 days) after expulsion of placenta. Receives: Procedure: Immediate IUD insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of expulsions
Number of IUD expulsions
Measured: 1 year
Use of IUD
Measured: 1 year
Secondary outcomes (2)
Bleeding profile
Measured: 3 months
Repeat abortions
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 posted24 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraception After Medical AbortionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riina Korjamo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Riina Korjamo, Helsinki University Central Hospital
- Investigators
- Oskari Heikinheimo, MD, PhD, Study director, Helsinki University Central HospitalMaarit Mentula, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755715
- Sponsor's protocol ID
- KILKE
- Status last verified
- Mar 2019
- First submitted
- 13 Dec 2012
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Later Insertion of IUD After Medical Termination of Pregnancy
- ClinicalTrials.gov ID
- NCT01755715
- Acronym / sponsor ID
- KILKE
- Conditions
- Contraception After Medical Abortion
- Keywords
- Abortion, Contraception, Intrauterine Devices, Intrauterine Device Expulsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Riina KorjamoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 Dec 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.
The main objective of this study is to compare, in a randomised, controlled and prospective fashion, initiation of intrauterine contraception (IUC) at about immediate (0 to 3 days) versus 2 to 4 weeks post medical abortion with regard to expulsions and use of contraception one year after abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Insertion of IUD at 2-4 weeks after abortion. |
| Immediate IUD insertion | Experimental | Procedure: Immediate IUD insertionInsertion of IUD immediately (at the same day to 3 days) after expulsion of placenta. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Planning medical abortion
- Planning LNG-IUD (Mirena) contraception
Key exclusion criteria (2 listed)
- Pathological pregnancies or abnormality of the uterus or cervix
- Acute endometritis
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 IUD insertionInsertion of LNG-IUD (Mirena) (at the same day to 3 days) after expulsion of placenta. | Procedure or surgery | Immediate IUD insertion |
Primary outcome
Number of expulsions
Time frame: 1 year
Number of IUD expulsions
Use of IUD
Time frame: 1 year
2 secondary outcomes
Bleeding profile
Time frame: 3 months
Repeat abortions
Time frame: 5 years
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 7 Mar 2019.
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 study director
Helsinki University Central Hospital
Maarit Mentula, MD, PhD principal investigator
Helsinki University Central Hospital
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 IUD insertion in people with Contraception After Medical Abortion, run by Riina Korjamo 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 3 inclusion and 2 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 7 Mar 2019. 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 expulsions (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.