ContraceptionEarly Phase 1NCT03657602
Immediate Postpartum Insertion of Contraceptive Intrauterine Devices
A Early Phase 1 study testing Kyleena Intrauterine System and Mirena Intrauterine System in people with Contraception, run by University of Oklahoma at 1 site in United States.
Trial summary
In this randomized trial, investigators intend to determine the expulsion and discontinuation rate of immediate postpartum intrauterine devices in the patient population of the University of Oklahoma Women's Healthcare Specialists Clinic (OUWHSC). Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Kyleena Intrauterine System and Mirena Intrauterine System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2019to 15 Jan 2023
- Phase
- Early Phase 1
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years or older
- desire an intrauterine device as postpartum contraception
- want to avoid pregnancy for at least 1 year
- are currently pregnant
- desire immediate postpartum IUD insertion.
Who cannot join
- known uterine or cervical anomaly
- untreated cervical infection
- untreated cervical infection
- pelvic infection within 3 months of the study
- recent (within last 3 months) or active intrauterine infection
- genital bleeding of unknown etiology
Show all 10Show fewer
- history of postpartum or postabortal sepsis
- cervical cancer or carcinoma in suit
- plan to leave Tulsa area within 10 weeks postpartum
- allergy to device ingredients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma - Tulsa
Tulsa, Oklahoma, 74135
About this study
Official title: Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices
In this randomized trial, investigators intend to determine the expulsion and discontinuation rate of immediate postpartum intrauterine devices in the patient population of the University of Oklahoma Women's Healthcare Specialists Clinic (OUWHSC).
Read the detailed description
Between 40-57% of women report having unprotected intercourse prior to the 6 week postpartum visit. Immediate postpartum long-acting reversible contraception (LARC) is extremely important in preventing short-interval and unintended pregnancies. The postpartum period is an excellent time for intrauterine device (IUD) or implant insertion as women are often highly motivated to prevent unwanted pregnancies at this time. Per the American College of Obstetrics and Gynecology (ACOG), expulsion rates for immediate postpartum IUD insertion are higher than for interval or post-abortion insertion. Despite the higher expulsion rate of immediate postpartum IUD placement over interval placement, cost-benefit analysis data strongly suggest the superiority of immediate placement in reduction of unintended pregnancy, especially for women at greatest risk of not attending the postpartum follow-up visit. This study will randomly allocate participants one to one to the Kyleena or the Mirena IUD group, and participants will be blinded to allocation of groups. Participants will follow up at routine postpartum visit within 4 weeks of delivery, and a second follow up will be performed at 10 weeks. Ultimately, this study will attempt to provide more detailed information on the difference of rates of expulsion and discontinuation of the different-sized Mirena and Kyleena intrauterine devices.
- Conditions
- Contraception
- Being tested
- Kyleena Intrauterine System, Mirena Intrauterine System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyleena Intrauterine SystemDrug
Also called levonorgestrel intrauterine system
Participant will be randomly allocated to this intervention
Mirena Intrauterine SystemDrug
Also called levonorgestrel intrauterine system
Participant will be randomly allocated to this intervention
| Study group | Role | What they receive |
|---|---|---|
| Contraceptive Kyleena | Experimental | Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Kyleena Intrauterine System Receives: Drug: Kyleena Intrauterine System |
| Contraceptive Mirena | Experimental | Determination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Mirena Intrauterine System Receives: Drug: Mirena Intrauterine System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion of intrauterine contraception
IUD string check and ultrasound check
Measured: within 10 weeks of placement
Secondary outcomes (1)
Discontinuation of intrauterine contraception
Date IUD is removed
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start15 Dec 2019
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallel
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valorie Owens, MSW, Study director, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657602
- Sponsor's protocol ID
- 9588
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Postpartum Insertion of Kyleena vs Mirena Contraceptive Intrauterine Devices
- ClinicalTrials.gov ID
- NCT03657602
- Acronym / sponsor ID
- 9588
- Conditions
- Contraception
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 5 Sep 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.
In this randomized trial, investigators intend to determine the expulsion and discontinuation rate of immediate postpartum intrauterine devices in the patient population of the University of Oklahoma Women's Healthcare Specialists Clinic (OUWHSC).
Detailed description
Between 40-57% of women report having unprotected intercourse prior to the 6 week postpartum visit. Immediate postpartum long-acting reversible contraception (LARC) is extremely important in preventing short-interval and unintended pregnancies. The postpartum period is an excellent time for intrauterine device (IUD) or implant insertion as women are often highly motivated to prevent unwanted pregnancies at this time. Per the American College of Obstetrics and Gynecology (ACOG), expulsion rates for immediate postpartum IUD insertion are higher than for interval or post-abortion insertion. Despite the higher expulsion rate of immediate postpartum IUD placement over interval placement, cost-benefit analysis data strongly suggest the superiority of immediate placement in reduction of unintended pregnancy, especially for women at greatest risk of not attending the postpartum follow-up visit. This study will randomly allocate participants one to one to the Kyleena or the Mirena IUD group, and participants will be blinded to allocation of groups. Participants will follow up at routine postpartum visit within 4 weeks of delivery, and a second follow up will be performed at 10 weeks. Ultimately, this study will attempt to provide more detailed information on the difference of rates of expulsion and discontinuation of the different-sized Mirena and Kyleena intrauterine devices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated one to one to the Kyleena or Mirena group and assessment will occur in parallel
| Arm | Type | Receives |
|---|---|---|
| Contraceptive Kyleena | Experimental | Drug: Kyleena Intrauterine SystemDetermination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Kyleena Intrauterine System |
| Contraceptive Mirena | Experimental | Drug: Mirena Intrauterine SystemDetermination of expulsion and discontinuation rates in participants randomly allocated to receive levonorgestrel intrauterine systems Mirena Intrauterine System |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 years or older
- desire an intrauterine device as postpartum contraception
- want to avoid pregnancy for at least 1 year
- are currently pregnant
- desire immediate postpartum IUD insertion.
Key exclusion criteria (10 listed)
- known uterine or cervical anomaly
- untreated cervical infection
- untreated cervical infection
- pelvic infection within 3 months of the study
- recent (within last 3 months) or active intrauterine infection
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 |
|---|---|---|
| Kyleena Intrauterine SystemAlso: levonorgestrel intrauterine systemParticipant will be randomly allocated to this intervention | Drug | Contraceptive Kyleena |
| Mirena Intrauterine SystemAlso: levonorgestrel intrauterine systemParticipant will be randomly allocated to this intervention | Drug | Contraceptive Mirena |
Primary outcome
Expulsion of intrauterine contraception
Time frame: within 10 weeks of placement
IUD string check and ultrasound check
1 secondary outcome
Discontinuation of intrauterine contraception
Time frame: Through study completion, an average of 1 year
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 25 Apr 2023.
- 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.
Valorie Owens, MSW study director
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Kyleena Intrauterine System and Mirena Intrauterine System in people with Contraception, run by University of Oklahoma at 1 site in United States.
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 5 inclusion and 10 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 25 Apr 2023. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 of intrauterine contraception (time frame: within 10 weeks of placement). 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 25 Apr 2023.