Estimating Rates of ExpulsionNCT01230242
Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.
A study testing Levonorgestrel Intrauterine Device in people with Estimating Rates of Expulsion, run by Rebecca Hunt.
Trial summary
This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The investigators will compare the postplacental insertion expulsion rate estimate with rates reported in the literature for 6 week postpartum… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Estimating Rates of Expulsion
- What is being tested?
- Levonorgestrel Intrauterine Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2010to 26 Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or greater
- obstetric patient in greater Portland, ME area
Who cannot join
- Evidence of chorioamnionitis (persistent fetal tachycardia, intra-partum fever >38.0)
- prolonged rupture of membranes (greater than 24 hours)
- intrauterine fetal demise
- use of general anesthesia at time of delivery
- postpartum hemorrhage (>500ml vaginal, >1000ml cesarean)
- magnesium administration in labor due to HELLP syndrome or preeclampsia
- preterm delivery.
About this study
Official title: Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.
This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The investigators will compare the postplacental insertion expulsion rate estimate with rates reported in the literature for 6 week postpartum insertion, which is currently the American standard for IUD insertion postpartum. Secondary outcomes will also be examined; endometritis, uterine perforation, continuation and pregnancy among others.
Read the detailed description
The average expulsion rate for 6 week postpartum IUD insertion is approximately 10-12% with a range between 3-20% at 1 year. An acceptable expulsion rate for postplacental insertion (PPI) has not been defined and varies between studies. There are limited data on the expulsion rates of levonorgestrel intrauterine systems. Expulsion rates range widely from 1-3% to as high as 30-40% depending on the IUD and the study. Studies report an average rate of expulsion in ranges approximating 10-12%, similar to 6 week insertion rates.
There are many limitations to published studies including the use of older model IUDs no longer in use, multiple insertion techniques that have been deemed ineffective in reducing expulsion rates as well as varying follow up times making comparison of expulsion rates difficult.
- Conditions
- Estimating Rates of Expulsion
- Being tested
- Levonorgestrel Intrauterine Device
- Keywords
- Mirena, postplacental intrauterine device, postpartum insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel Intrauterine DeviceDevice
Also called Mirena
levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol
| Study group | Role | What they receive |
|---|---|---|
| Mirena IUD Placement Immediately Post-delivery | Experimental | Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks. Receives: Device: Levonorgestrel Intrauterine Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Expelled IUDs by12 Weeks Postpartum
Number of participants who expelled IUDs by12 weeks postpartum across all participants
Measured: up to 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study start7 Sep 2010
- Primary completion27 Oct 2010
- Study completion26 Jul 2011
Why it stopped: Suspended to determine if Mirena device could be charged to patient insurance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Estimating Rates of ExpulsionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Mirena IUD placement
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Hunt
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth
- Responsible party
- Sponsor-investigator, Rebecca Hunt, MaineHealth
- Investigators
- Jennifer J Mueller, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230242
- Sponsor's protocol ID
- 3689
- Status last verified
- Dec 2021
- First submitted
- 28 Oct 2010
- Last updated
- 17 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.
- ClinicalTrials.gov ID
- NCT01230242
- Acronym / sponsor ID
- 3689
- Conditions
- Estimating Rates of Expulsion
- Keywords
- Mirena, postplacental intrauterine device, postpartum insertion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Suspended to determine if Mirena device could be charged to patient insurance
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Rebecca HuntUniversity, hospital or other
- Collaborators
- MaineHealth
- Study start
- 7 Sep 2010 (actual)
- Primary completion
- 27 Oct 2010 (actual)
- Study completion
- 26 Jul 2011 (actual)
- First posted
- 29 Oct 2010 (estimated)
- Results
- Posted 17 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The investigators will compare the postplacental insertion expulsion rate estimate with rates reported in the literature for 6 week postpartum insertion, which is currently the American standard for IUD insertion postpartum. Secondary outcomes will also be examined; endometritis, uterine perforation, continuation and pregnancy among others.
Detailed description
The average expulsion rate for 6 week postpartum IUD insertion is approximately 10-12% with a range between 3-20% at 1 year. An acceptable expulsion rate for postplacental insertion (PPI) has not been defined and varies between studies. There are limited data on the expulsion rates of levonorgestrel intrauterine systems. Expulsion rates range widely from 1-3% to as high as 30-40% depending on the IUD and the study. Studies report an average rate of expulsion in ranges approximating 10-12%, similar to 6 week insertion rates.
There are many limitations to published studies including the use of older model IUDs no longer in use, multiple insertion techniques that have been deemed ineffective in reducing expulsion rates as well as varying follow up times making comparison of expulsion rates difficult.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mirena IUD placement
| Arm | Type | Receives |
|---|---|---|
| Mirena IUD Placement Immediately Post-delivery | Experimental | Device: Levonorgestrel Intrauterine DeviceParticipants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 or greater
- obstetric patient in greater Portland, ME area
Key exclusion criteria (7 listed)
- Evidence of chorioamnionitis (persistent fetal tachycardia, intra-partum fever >38.0)
- prolonged rupture of membranes (greater than 24 hours)
- intrauterine fetal demise
- use of general anesthesia at time of delivery
- postpartum hemorrhage (>500ml vaginal, >1000ml cesarean)
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 |
|---|---|---|
| Levonorgestrel Intrauterine DeviceAlso: Mirenalevonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol | Device | Mirena IUD Placement Immediately Post-delivery |
Primary outcome
Number of Participants Who Expelled IUDs by12 Weeks Postpartum
Time frame: up to 12 weeks postpartum
Number of participants who expelled IUDs by12 weeks postpartum across all participants
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Jennifer J Mueller, MD principal investigator
MaineHealth
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel Intrauterine Device in people with Estimating Rates of Expulsion, run by Rebecca Hunt.
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 2 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: stopped early, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 17 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Expelled IUDs by12 Weeks Postpartum (time frame: up to 12 weeks postpartum). 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 17 Dec 2021.