Contraceptive UsagePhase 3INTRAMNCT03603145
Immediate Versus Delayed Insertion of Intrauterine Contraception After Medical Abortion
A Phase 3 study testing Immediate insertion in people with Contraceptive Usage, run by Karolinska Institutet at 6 sites in Sweden.
Trial summary
PICO: Population: Women with unwanted pregnancy having a medical abortion and fulfilling inclusion and without exclusion criteria and opting for IUC as post abortion contraception. The medical abortion will be carried out according to the Swedish national evidence based guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraceptive Usage
- What is being tested?
- Immediate insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 6 sitesSweden
- Study dates
- 16 Jan 2019to 31 Dec 2024
- Phase
- Phase 3
- 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
- 18 years and older,
- eligible for medical abortion,
- opting for post abortion IUC,
- able and willing to comply with planned follow up.
Who cannot join
- Contraindication for medical abortion or
- Contraindication for IUC (contraindications may be present for LNG-IUSs but the woman may still choose a Cu-IUD and thereby enter the study),
- inability to give informed consent.
- Septic abortion
- Known hypersensiblity/allergy to levonorgestrel or any of the substances added to the LNG-IUS
- Known abnormal uterine cavity
Show all 13Show fewer
- Chorioamnionitis
- Abortion associated bleeding > 1000ml
- Uterine atony postabortion
- Placental retention
- Therapeutic antibiotic treatment during abortion, (antibiotics used only as prophylaxis is accepted)
- History of breast cancer
- If any of the following conditions are present an individual evaluation and decision must be done before inclusion: pelvic or genital infection, cervicitis, immunocompromised women, untreated cervical dysplasia, neoplasia in cervix or uterus, acute liver disease or hepatic neoplasia, migraine or other very severe headache, icterus, high uncontrolled blood pressure, serious arterial disease i.e. stroke or myocardial infarction, acute venous thrombosis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Recruiting
Falun Hospital
Falun
Sara Hogmark, MD
- Recruiting
Sahlgrenska Hospital
Gothenburg
Helena Hognert, MD, PhD
- Recruiting
Danderyd Hospital
Stockholm, 182 88
Helena Kopp Kallner, MD, PhD
- Recruiting
Karolinska University Hospital
Stockholm
Kristina Gemzell Danielsson, MD, PhD
- Recruiting
South General Hospital
Stockholm
Cecilia Berger, MD, PhD
- Recruiting
Uppsala Academiska Hospital
Uppsala
Emma Håstad, MD
About this study
Official title: Immediate Versus Delayed Insertion of Intrauterine Contraception at the Time of Medical Abortion- An Open-label, Randomized, Multicenter Study
PICO:
Population:
Read more
Women with unwanted pregnancy having a medical abortion and fulfilling inclusion and without exclusion criteria and opting for IUC as post abortion contraception. The medical abortion will be carried out according to the Swedish national evidence based guidelines.
Intervention:
Randomized to insertion of IUC within 48 hours after medical abortion.
Control:
Randomized to insertion of IUC at the time of a follow-up visit scheduled 2 to 4 weeks after the abortion according to routine care.
Objectives:
Evaluation of use of IUC, feasibility, safety, compliance, and acceptability of immediate insertion of IUC 0 to 48 hours after medical abortion compared with delayed IUC insertion at 2 to 4 weeks post abortion. The primary outcome measure will be the use of IUC at 6 months in both groups evaluated by telephone calls/emails follow up.
Time plan: Planning: -March 2018 Study start: May 2018 End of recruitment: April 2020 Last patient Last visit April 2021 Analysis: 2021 Report of primary outcome and Safety: 2021
Read the detailed description
Today 90 percent of terminations of pregnancy are medical abortions. Approximately 33 000 medical abortions are performed in Sweden each year and 20-30 percent of these women opt for IUC as post abortion contraception. Thus, the results of this study potentially affect at least 6600-9900 women every year in Sweden alone. A disadvantage with medical abortion compared with surgical abortion is the standard practice of delayed insertion of IUC. It has been shown that 42 percent of women scheduled for delayed insertion after surgical abortion did not return for the follow up and IUC insertion.(5) This problem is common also in medical abortion practice. Immediate insertion could lead to insertion rates close to 100 percent. However, this practice has not been studied for medical abortion.
The background for this trial is the belief that a higher rate of insertion of IUC, perhaps close to 100 percent, within 48 hours after medical abortion, can compensate more than well for a potentially higher rate of expulsion at immediate insertion. A clinically significant difference in IUC use at six months following the medical abortion of at least 20 percent is expected.
This large multicenter, randomized, patient centered clinical trial will investigate the effectiveness, feasibility, continued use, safety and acceptability of immediate insertion of intrauterine contraception within 0-48 hours after a completed medical abortion when compared to delayed IUC insertion at 2-4 weeks post abortion which is current practice.
Aim To study use, safety and patient acceptability of intrauterine contraception after immediate insertion compared with standard insertion 2-4 weeks post medical abortion at 3, 6 and 12 months post abortion.
Drug:
Mirena® (LNG-IUS 52mg), Kyleena® (LNG-IUS 19.5mg), Jaydess® (LNG-IUS 13.5 mg), NovaT® (Cu-IUD, medical device, but due to use outside indication it is included in this application)
Design:
Open label, randomized, controlled, multicenter study. Phase III (therapeutic confirming).
Primary objective:
To study if immediate insertion of intrauterine contraception is superior to insertion at 2-4 weeks post abortion with regard to number of women using IUC as contraception at 6 months post abortion.
Variable:
The proportion of women in each group (immediate or delayed) using IUC as contraception at 6 months post abortion (use vs non-use).
Secondary objectives:
To study if immediate insertion of intrauterine contraception is non-inferior to delayed insertion with regard to safety and acceptability.
- Conditions
- Contraceptive Usage
- Being tested
- Immediate insertion
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate insertionProcedure or surgery
Immediate insertion of intrauterine contraception within 48 hours of medical abortion
| Study group | Role | What they receive |
|---|---|---|
| Immediate insertion | Experimental | Randomized to insertion within 48 hours of medical abortion Receives: Procedure: Immediate insertion |
| Standard Insertion | No intervention | Insertion at 2-4 weeks post medical abortion |
What is being measured
The primary outcome is the main question the study is designed to answer.
use of intrauterine contraception at 6 months post abortion
use of intrauterine contraception at 6 months post abortion in both groups evaluated through follow up by telephone/email.
Measured: 6 months post abortion
Secondary outcomes (13)
Difference in the proportion of women who successfully have the IUC inserted
- Difference in the proportion of women who successfully have the IUC inserted (success versus failure),
Measured: 10 minutes after (attempted) insertion
Expulsion rate following insertion in both groups
Expulsion rate during 12 months following insertion in both groups evaluated by telephone/email follow up 12 months post abortion (complete, partial or no expulsion.
Measured: 12 months post insertion
Continued use of IUC
- Continued use of IUC at 12 months post insertion evaluated by telephone follow-up (continued use/voluntary discontinued use, involuntary discontinued use including expulsions etc) reasons for discontinuation will be recorded and subsequent use of other contraceptive methods will be noted)
Measured: 12 months post abortion
Ease of insertion
Ease of insertion according to health care provider (judged as very easy, moderately-, or very difficult)
Measured: 10 minutes after (attempted) insertion
Pain at time of insertion assessed as millimeters on a 10cm long unmarked Visual Analogue Scale.
- pain at time of insertion (women will indicate the pain before insertion, at placement of tenaculum, sound and IUC by putting a vertical mark on a 10 cm long horizontal line with a Visual Analogue Scale (VAS) from 0, indicating no pain to 10 indicating worst imaginable pain. Result will be noted in millimeters and entered into case report forms).
Measured: 10 minutes after (attempted) insertion
Post-abortion bleeding measured as number of days of fresh bleeding
Post-abortion bleeding measured as number of days of uninterrupted fresh bleeding directly following the the abortion.
Measured: max 3 months post abortion
Post-abortion bleeding measured as number of days of spotting during the first 3 months post abortion
Post-abortion bleeding measured as number of days of spotting- excluding fresh bleeding and menstruation- during the first 3 months after the abortion.
Measured: max 3 months post abortion
Reasons for non-attempted insertion of IUC
- Reasons for non-attempted insertion of IUC (change of mind, heavy bleeding, not coming for insertion, staff being unavailable etc),
Measured: within 1 month post abortion
Complications
- Complications (adverse events (AE) and serious AE) bleeding requiring any treatment, uterine perforations and cervical tears, infection requiring treatment with antibiotics, hospitalization for any reason, surgical procedures due to heavy bleeding, incomplete abortions, prolonged bleeding or patient request,
Measured: 12 months post abortion
Pregnancies occurring during the 12 month follow-up
- Pregnancies occurring during the 12 month follow-up (planned and unplanned, wanted and unwanted, pregnancy outcomes- ectopic, miscarriage, abortion, molar, kept pregnancy),
Measured: 12 months post abortion
proportion of women who would recommend immediate or delayed insertion of IUC post abortion
- proportion of women who would recommend immediate and delayed insertion of IUC by asking women if they would recommend the procedure to a friend (yes/no, asked at the time of insertion and at the 3, 6 and 12 month follow up),
Measured: 12 months post abortion
proportion of women who would recommend IUC for post abortion contraception
- Proportion of women who would recommend IUC as post abortion to a friend (yes/no) asked at the time of insertion and at the 3, 6 and 12 month follow up),
Measured: 12 months post abortion
The proportion of surgical procedures
- The proportion of surgical procedures in total and for each study site (type of procedure, reasons therefore- infection, retained products of conception, prolonged bleeding etc).
Measured: 3 months post abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start16 Jan 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Contraceptive UsageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled open label
- Masking
- None (open label)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Kopp Kallner, Karolinska Institutet
- Investigators
- Helena Kopp Kallner, MD, PhD, Principal investigator, Karolinska Institute, danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603145
- Sponsor's protocol ID
- INTRAM version III
- Acronym
- INTRAM
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2018
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hogmark S, Westermark C, Envall N, Gemzell-Danielsson K, Kopp Kallner H. Immediate placement of intrauterine device after second-trimester medical abortion-Secondary outcomes with one-year follow-up. Acta Obstet Gynecol Scand. 2026 Sep;105(9):1672-1679. doi: 10.1111/aogs.70259. Epub 2026 Jun 10.
PubMed 42266170Hogmark S, Envall N, Gemzell-Danielsson K, Kopp Kallner H. One-year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post-abortion placement of intrauterine devices. Acta Obstet Gynecol Scand. 2023 Dec;102(12):1694-1702. doi: 10.1111/aogs.14662. Epub 2023 Aug 23.
PubMed 37614066
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Delayed Insertion of Intrauterine Contraception at the Time of Medical Abortion- An Open-label, Randomized, Multicenter Study
- ClinicalTrials.gov ID
- NCT03603145
- Acronym / sponsor ID
- INTRAM / INTRAM version III
- Conditions
- Contraceptive Usage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jul 2018 (actual)
- 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.
PICO:
Population:
Women with unwanted pregnancy having a medical abortion and fulfilling inclusion and without exclusion criteria and opting for IUC as post abortion contraception. The medical abortion will be carried out according to the Swedish national evidence based guidelines.
Intervention:
Randomized to insertion of IUC within 48 hours after medical abortion.
Control:
Randomized to insertion of IUC at the time of a follow-up visit scheduled 2 to 4 weeks after the abortion according to routine care.
Objectives:
Evaluation of use of IUC, feasibility, safety, compliance, and acceptability of immediate insertion of IUC 0 to 48 hours after medical abortion compared with delayed IUC insertion at 2 to 4 weeks post abortion. The primary outcome measure will be the use of IUC at 6 months in both groups evaluated by telephone calls/emails follow up.
Time plan: Planning: -March 2018 Study start: May 2018 End of recruitment: April 2020 Last patient Last visit April 2021 Analysis: 2021 Report of primary outcome and Safety: 2021
Detailed description
Today 90 percent of terminations of pregnancy are medical abortions. Approximately 33 000 medical abortions are performed in Sweden each year and 20-30 percent of these women opt for IUC as post abortion contraception. Thus, the results of this study potentially affect at least 6600-9900 women every year in Sweden alone. A disadvantage with medical abortion compared with surgical abortion is the standard practice of delayed insertion of IUC. It has been shown that 42 percent of women scheduled for delayed insertion after surgical abortion did not return for the follow up and IUC insertion.(5) This problem is common also in medical abortion practice. Immediate insertion could lead to insertion rates close to 100 percent. However, this practice has not been studied for medical abortion.
The background for this trial is the belief that a higher rate of insertion of IUC, perhaps close to 100 percent, within 48 hours after medical abortion, can compensate more than well for a potentially higher rate of expulsion at immediate insertion. A clinically significant difference in IUC use at six months following the medical abortion of at least 20 percent is expected.
This large multicenter, randomized, patient centered clinical trial will investigate the effectiveness, feasibility, continued use, safety and acceptability of immediate insertion of intrauterine contraception within 0-48 hours after a completed medical abortion when compared to delayed IUC insertion at 2-4 weeks post abortion which is current practice.
Aim To study use, safety and patient acceptability of intrauterine contraception after immediate insertion compared with standard insertion 2-4 weeks post medical abortion at 3, 6 and 12 months post abortion.
Drug:
Mirena® (LNG-IUS 52mg), Kyleena® (LNG-IUS 19.5mg), Jaydess® (LNG-IUS 13.5 mg), NovaT® (Cu-IUD, medical device, but due to use outside indication it is included in this application)
Design:
Open label, randomized, controlled, multicenter study. Phase III (therapeutic confirming).
Primary objective:
To study if immediate insertion of intrauterine contraception is superior to insertion at 2-4 weeks post abortion with regard to number of women using IUC as contraception at 6 months post abortion.
Variable:
The proportion of women in each group (immediate or delayed) using IUC as contraception at 6 months post abortion (use vs non-use).
Secondary objectives:
To study if immediate insertion of intrauterine contraception is non-inferior to delayed insertion with regard to safety and acceptability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled open label
| Arm | Type | Receives |
|---|---|---|
| Immediate insertion | Experimental | Procedure: Immediate insertionRandomized to insertion within 48 hours of medical abortion |
| Standard Insertion | No intervention | –Insertion at 2-4 weeks post medical abortion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older,
- eligible for medical abortion,
- opting for post abortion IUC,
- able and willing to comply with planned follow up.
Key exclusion criteria (13 listed)
- Contraindication for medical abortion or
- Contraindication for IUC (contraindications may be present for LNG-IUSs but the woman may still choose a Cu-IUD and thereby enter the study),
- inability to give informed consent.
- Septic abortion
- Known hypersensiblity/allergy to levonorgestrel or any of the substances added to the LNG-IUS
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 insertionImmediate insertion of intrauterine contraception within 48 hours of medical abortion | Procedure or surgery | Immediate insertion |
Primary outcome
use of intrauterine contraception at 6 months post abortion
Time frame: 6 months post abortion
use of intrauterine contraception at 6 months post abortion in both groups evaluated through follow up by telephone/email.
13 secondary outcomes
Difference in the proportion of women who successfully have the IUC inserted
Time frame: 10 minutes after (attempted) insertion
Expulsion rate following insertion in both groups
Time frame: 12 months post insertion
Continued use of IUC
Time frame: 12 months post abortion
Ease of insertion
Time frame: 10 minutes after (attempted) insertion
Pain at time of insertion assessed as millimeters on a 10cm long unmarked Visual Analogue Scale.
Time frame: 10 minutes after (attempted) insertion
Post-abortion bleeding measured as number of days of fresh bleeding
Time frame: max 3 months post abortion
Post-abortion bleeding measured as number of days of spotting during the first 3 months post abortion
Time frame: max 3 months post abortion
Reasons for non-attempted insertion of IUC
Time frame: within 1 month post abortion
Complications
Time frame: 12 months post abortion
Pregnancies occurring during the 12 month follow-up
Time frame: 12 months post abortion
proportion of women who would recommend immediate or delayed insertion of IUC post abortion
Time frame: 12 months post abortion
proportion of women who would recommend IUC for post abortion contraception
Time frame: 12 months post abortion
The proportion of surgical procedures
Time frame: 3 months post abortion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 42266170Hogmark S, Westermark C, Envall N, Gemzell-Danielsson K, Kopp Kallner H. Immediate placement of intrauterine device after second-trimester medical abortion-Secondary outcomes with one-year follow-up. Acta Obstet Gynecol Scand. 2026 Sep;105(9):1672-1679. doi: 10.1111/aogs.70259. Epub 2026 Jun 10.
- Derived from this study: PubMed 37614066Hogmark S, Envall N, Gemzell-Danielsson K, Kopp Kallner H. One-year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post-abortion placement of intrauterine devices. Acta Obstet Gynecol Scand. 2023 Dec;102(12):1694-1702. doi: 10.1111/aogs.14662. Epub 2023 Aug 23.
- Individual participant dataSharing planned: Undecided
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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.
Helena Kopp Kallner, MD, PhD principal investigator
Karolinska Institute, danderyd Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immediate insertion in people with Contraceptive Usage, run by Karolinska Institutet at 6 sites 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 13 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: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helena Kopp Kallner, MD, PhD (+46704402070, helena.kopp-kallner@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
use of intrauterine contraception at 6 months post abortion (time frame: 6 months post abortion). 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 NCT03603145, 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 1 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.