PregnancyPhase 4NCT00877344
Better Contraceptive Choices: Immediate or Delayed Insertion of IUC After Second Trimester Abortion
A Phase 4 study testing Immediate insertion and Interval insertion in people with Pregnancy, run by University of British Columbia at 3 sites in Canada.
Trial summary
Hypothesis Intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion. Read more about this study
- Who is it for?
- Ages 10 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Immediate insertion and Interval insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2009to 30 Jun 2023
- Phase
- Phase 4
- 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 10 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have completed informed consent for an abortion at gestation between 12 weeks zero days and 23 weeks 6 days, and
- Choosing an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion, and
- Residents of British Columbia, registered with the Medical Services Plan health care system.
Who cannot join
- Intention to move from BC within the next year
- Intention to conceive within the next year.
- Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC
- Post Randomization Exclusion:
- uterine perforation at the time of abortion
- bleeding of more than 500 cc during abortion
- any of the above exclusions detected at time of abortion
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Kelowna General Hospital Women's Services Clinic
Kelowna, British Columbia
BC Women's Hospital
Vancouver, British Columbia
Elizabeth Bagshaw Women's Clinic
Vancouver, British Columbia
About this study
Official title: Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion
Hypothesis
Intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.
Study Design
Randomized Controlled Trial after their second trimester abortion comparing immediate with delayed insertion of IUC, and a non intervention control group choosing non-intrauterine contraception. Participants choosing an IUC will be randomly assigned to immediate or delayed insertion. The investigators primary outcome is pregnancy rate within one year.
Read the detailed description
This Randomized Controlled Trial will be offered to women choosing to have a LNG-IUC or CuT380 after an abortion for gestational ages from 12 to 24 weeks. [delete next insert]"and a non intervention control group offered to all others having abortions at this gestational age". Participants choosing an LNG-IUC or CUT380 will be randomly assigned to immediate or interval insertion. In conjunction with follow up visits and questionnaires, the British Columbia Linked Health Database access will determine pregnancy rate within one year for the two intervention groups [delete next insert] and in relation to the various contraceptive choices made by the women not choosing intrauterine contraception. All women will complete surveys at 3, 6, 12, 24, 36, 48 and 72 months on their satisfaction with the contraceptive method chosen and on their satisfaction with study participation.
- Conditions
- Pregnancy
- Being tested
- Immediate insertion, Interval insertion
- Keywords
- Pregnancy, IUC, abortion, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate insertionProcedure or surgery
Immediate timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.
Interval insertionProcedure or surgery
Interval Timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Immediate insertion of either a LNG-IUC or a Copper T380 IUD after 12-24 week abortion Receives: Procedure: Immediate insertion |
| 2 | Experimental | Interval insertion (two to four weeks post abortion) of either a LNG-IUC or a Copper T380 IUD after 12-24 abortion Receives: Procedure: Interval insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate at one year
The one year pregnancy rate outcome will be determined using a pragmatic approximation based on the varying exactitude of imputations based on provincial Medical Service Plan billings related to abortions, miscarriages, still births and live births. Subsequent abortions performed within our study clinics for enrolled participants will be noted along with specific clinical information on pregnancy duration. For abortions performed elsewhere such as those for BC university students studying out of province, or those performed by individual physicians at rural or remote hospitals within BC, exact gestation may not be available. In the BC health administrative databases abortions are billed as under 7 weeks for medical abortions, and as under 14 weeks, 14 weeks to under 18 weeks, and 18 weeks and over for surgical abortions. Miscarriages by definition occur anytime under 20 weeks or are classed as still birth when over 20 weeks of gestation.
Measured: 12 months
Secondary outcomes (1)
Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events.
Secondary outcomes will be assessed initially at one year, then annually through the five year device effectiveness period.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startJun 2009
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a drug (levonorgestrel-releasing intrauterine contraception ("Mirena" (R)), but as the study is conducted in Canada the FDA approval is not required. We have approval (a Letter of No Objection) from the Canadian Equivalent Institution: "Health Canada"
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia, College of Family Physicians of Canada
- Responsible party
- Principal investigator, Wendy Norman, University of British Columbia
- Investigators
- Wendy V. Norman, Ph.D, Principal investigator, University of British ColumbiaBrian Fitzsimmons, MD, Study director, University of British ColumbiaLyda Dicus, Study chair, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877344
- Sponsor's protocol ID
- H09-00363
- Status last verified
- May 2022
- First submitted
- 3 Apr 2009
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Contraceptive Choices: Immediate vs. Delayed Insertion of Intrauterine Contraception After Second Trimester Abortion
- ClinicalTrials.gov ID
- NCT00877344
- Acronym / sponsor ID
- H09-00363
- Conditions
- Pregnancy
- Keywords
- Pregnancy, IUC, abortion, contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 474 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia, College of Family Physicians of Canada
- Study start
- Jun 2009
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 7 Apr 2009 (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.
Hypothesis
Intrauterine contraception placed immediately after a second trimester abortion will result in fewer pregnancies than current standard practice of intended placement at 4 weeks post-abortion.
Study Design
Randomized Controlled Trial after their second trimester abortion comparing immediate with delayed insertion of IUC, and a non intervention control group choosing non-intrauterine contraception. Participants choosing an IUC will be randomly assigned to immediate or delayed insertion. The investigators primary outcome is pregnancy rate within one year.
Detailed description
This Randomized Controlled Trial will be offered to women choosing to have a LNG-IUC or CuT380 after an abortion for gestational ages from 12 to 24 weeks. [delete next insert]"and a non intervention control group offered to all others having abortions at this gestational age". Participants choosing an LNG-IUC or CUT380 will be randomly assigned to immediate or interval insertion. In conjunction with follow up visits and questionnaires, the British Columbia Linked Health Database access will determine pregnancy rate within one year for the two intervention groups [delete next insert] and in relation to the various contraceptive choices made by the women not choosing intrauterine contraception. All women will complete surveys at 3, 6, 12, 24, 36, 48 and 72 months on their satisfaction with the contraceptive method chosen and on their satisfaction with study participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a drug (levonorgestrel-releasing intrauterine contraception ("Mirena" (R)), but as the study is conducted in Canada the FDA approval is not required. We have approval (a Letter of No Objection) from the Canadian Equivalent Institution: "Health Canada"
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Immediate insertionImmediate insertion of either a LNG-IUC or a Copper T380 IUD after 12-24 week abortion |
| 2 | Experimental | Procedure: Interval insertionInterval insertion (two to four weeks post abortion) of either a LNG-IUC or a Copper T380 IUD after 12-24 abortion |
Who may qualify
- Ages
- 10 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Have completed informed consent for an abortion at gestation between 12 weeks zero days and 23 weeks 6 days, and
- Choosing an IUC (either LNG-IUC or CuT380-IUC) for contraception post abortion, and
- Residents of British Columbia, registered with the Medical Services Plan health care system.
Key exclusion criteria (7 listed)
- Intention to move from BC within the next year
- Intention to conceive within the next year.
- Any of the following contraindications to use of a LNG-IUC or a CuT380-IUC
- Post Randomization Exclusion:
- uterine perforation at the time of abortion
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 timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion. | Procedure or surgery | 1 |
| Interval insertionInterval Timing of insertion for a LNG-IUC OR Copper 380mg T-shaped IUD after an abortion for a gestational age between 12 weeks zero days and 23 weeks 6 days. Immediate insertions occur during the visit for the abortion immediately after the abortion is complete, interval insertions will be scheduled for not earlier than two weeks and not later than four weeks after the abortion. | Procedure or surgery | 2 |
Primary outcome
Pregnancy rate at one year
Time frame: 12 months
The one year pregnancy rate outcome will be determined using a pragmatic approximation based on the varying exactitude of imputations based on provincial Medical Service Plan billings related to abortions, miscarriages, still births and live births. Subsequent abortions performed within our study clinics for enrolled participants will be noted along with specific clinical information on pregnancy duration. For abortions performed elsewhere such as those for BC university students studying out of province, or those performed by individual physicians at rural or remote hospitals within BC, exact gestation may not be available. In the BC health administrative databases abortions are billed as under 7 weeks for medical abortions, and as under 14 weeks, 14 weeks to under 18 weeks, and 18 weeks and over for surgical abortions. Miscarriages by definition occur anytime under 20 weeks or are classed as still birth when over 20 weeks of gestation.
1 secondary outcome
Rates at one year for Expulsion, Continuation of use, Satisfaction with method, Adverse events.
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- 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.
Wendy V. Norman, Ph.D principal investigator
University of British Columbia
Brian Fitzsimmons, MD study director
University of British Columbia
Lyda Dicus study chair
University of British Columbia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate insertion and Interval insertion in people with Pregnancy, run by University of British Columbia at 3 sites in Canada.
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 7 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 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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?
Pregnancy rate at one year (time frame: 12 months). 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 20 May 2022.