IUC Insertion After Medical AbortionNCT01537562
Intrauterine Contraception (IUC) After Medical Abortion
A study testing Timing of IUC insertion in people with IUC Insertion After Medical Abortion, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Today a large proportion of early abortions are medical, in accordance to the woman's choice. The main objective of the present study was to compare, in a randomised fashion, initiation of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion with regard to expulsions and safety. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- IUC Insertion After Medical Abortion
- What is being tested?
- Timing of IUC insertion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2007to Oct 2010
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age above 18
- elective medical abortion up to 9 weeks (63 days) of amenorrhea
- general good health and
- good understanding of Swedish language.
Who cannot join
- pathological pregnancies or abnormality of the uterus
- complications after the medical abortion, such as on-going pregnancy retained gestational sac or endometritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion- a Randomized Controlled Trial
Today a large proportion of early abortions are medical, in accordance to the woman's choice. The main objective of the present study was to compare, in a randomised fashion, initiation of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion with regard to expulsions and safety.
- Conditions
- IUC Insertion After Medical Abortion
- Being tested
- Timing of IUC insertion
- Keywords
- Copper IUD, LNG-IUS, intrauterine contraception, medical abortion, postabortion contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of IUC insertionOther
Also called Women were free to chose the type of IUC
Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment while patients randomised to delayed insertion had the IUC insertion at about 3 to 4 weeks after mifepristone.
| Study group | Role | What they receive |
|---|---|---|
| Delayed IUC insertion | Active comparator | Patients randomised to delayed, routine, insertion had their IUC inserted at 3-4 weeks (day 21-35 after mifepristone treatment Receives: Other: Timing of IUC insertion |
| Early IUC insertion | Active comparator | Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment. Receives: Other: Timing of IUC insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion
Expulsions are recorded up to 6 months after the IUC insertion
Measured: 6 months after IUC insertion
Secondary outcomes (4)
PID
Pelvic inflammatory disease reported or diagnosed at FU
Measured: within 6 months of IUC insertion
serum hemoglobin
S-Hb was measured at IUC insertion and at 4 weeks post insertion
Measured: 4 weeks post IUC insertion
Compliance
impact on the number of women who return for IUC insertion, and compliance with IUC use during the first 6 months following insertion
Measured: 6 months
Bleeding patterns
Bleeding patterns during the first 4 weeks post IUC insertion
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startFeb 2007
- Primary completionApr 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IUC Insertion After Medical AbortionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Gemzell Danielsson, Karolinska Institutet
- Investigators
- Kristina Gemzell Danielsson, MD, PhD, Principal investigator, WHO centre, Dept of Women's and Childrens' Health, Div of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537562
- Sponsor's protocol ID
- WIUC12
- Status last verified
- Feb 2012
- First submitted
- 15 Feb 2012
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saav I, Stephansson O, Gemzell-Danielsson K. Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial. PLoS One. 2012;7(11):e48948. doi: 10.1371/journal.pone.0048948. Epub 2012 Nov 14.
PubMed 23155432
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01537562
- Acronym / sponsor ID
- WIUC12
- Conditions
- IUC Insertion After Medical Abortion
- Keywords
- Copper IUD, LNG-IUS, intrauterine contraception, medical abortion, postabortion contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Feb 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.
Today a large proportion of early abortions are medical, in accordance to the woman's choice. The main objective of the present study was to compare, in a randomised fashion, initiation of intrauterine contraception (IUC) at about 1 week versus 3 to 4 weeks post medical abortion with regard to expulsions and safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed IUC insertion | Active comparator | Other: Timing of IUC insertionPatients randomised to delayed, routine, insertion had their IUC inserted at 3-4 weeks (day 21-35 after mifepristone treatment |
| Early IUC insertion | Active comparator | Other: Timing of IUC insertionPatients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age above 18
- elective medical abortion up to 9 weeks (63 days) of amenorrhea
- general good health and
- good understanding of Swedish language.
Key exclusion criteria (2 listed)
- pathological pregnancies or abnormality of the uterus
- complications after the medical abortion, such as on-going pregnancy retained gestational sac or 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 |
|---|---|---|
| Timing of IUC insertionAlso: Women were free to chose the type of IUCPatients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment while patients randomised to delayed insertion had the IUC insertion at about 3 to 4 weeks after mifepristone. | Other | Delayed IUC insertion, Early IUC insertion |
Primary outcome
Expulsion
Time frame: 6 months after IUC insertion
Expulsions are recorded up to 6 months after the IUC insertion
4 secondary outcomes
PID
Time frame: within 6 months of IUC insertion
serum hemoglobin
Time frame: 4 weeks post IUC insertion
Compliance
Time frame: 6 months
Bleeding patterns
Time frame: 4 weeks
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 2012.
- Derived from this study: PubMed 23155432Saav I, Stephansson O, Gemzell-Danielsson K. Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial. PLoS One. 2012;7(11):e48948. doi: 10.1371/journal.pone.0048948. Epub 2012 Nov 14.
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.
Kristina Gemzell Danielsson, MD, PhD principal investigator
WHO centre, Dept of Women's and Childrens' Health, Div of Obstetrics and Gynecology, Karolinska Institutet/ Karolinska Univeristy 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 Timing of IUC insertion in people with IUC Insertion After Medical Abortion, run by Karolinska Institutet at 1 site in Sweden.
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 4 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 23 Feb 2012. 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 Sweden. 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?
Expulsion (time frame: 6 months after IUC insertion). 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 NCT01537562, which also lists 1 linked publication.
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 2012.