ContraceptionNCT01088178
Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period
A study testing Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) in people with Contraception, run by United States Naval Medical Center, Portsmouth at 1 site in United States.
Trial summary
The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine questioning at their 36-38 week prenatal appointment or upon admission to labor and delivery are eligible for our study.
Who cannot join
- Contraindications to the LNG-IUS include: Pregnancy or suspicion of pregnancy, Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity, Postpartum endometritis within the past 3 months, Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear, untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections, acute liver disease or liver tumor, hypersensitivity to any component of the product, known or suspected carcinoma of the breast. Any of these conditions would exclude the patient from our study.
- Delivery <36 weeks
- Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
- Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery)
- Cesarean delivery if randomized to IPP or EP placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals
The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.
- Conditions
- Contraception
- Being tested
- Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
- Keywords
- Long-Acting Reversible Contraception, Contraceptive Agents, Therapeutic Uses, Contraceptive Agents, Female, Reproductive Control Agents, Pharmacologic Actions, Levonorgestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)Device
Placement of Mirena at given intervals during the postpartum period
| Study group | Role | What they receive |
|---|---|---|
| Immediate Postplacental | Experimental | Within 10 minutes from delivery of placenta Receives: Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) |
| Early Postpartum | Experimental | After 10 minutes from delivery of placenta but within 48hrs from delivery Receives: Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) |
| Interval | Experimental | After 6 weeks postpartum Receives: Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation Rates of the LNG-IUS when placed postpartum at three time periods
Determine if there is a difference in continuation rates at 6 months between participants who had the LNG-IUS placed at three different time periods: Immediate Postplacental (within 10 minutes from delivery of placenta), Early Postpartum (after 10 minutes but before 48 hours postpartum) , and Interval (after 6 weeks postpartum).
Measured: at 6 months
Secondary outcomes (2)
Expulsion rate of the LNG-IUS when placed postpartum at three time periods
Determine if there is a difference in expulsion rates at the three different time periods of placement.
Measured: at 3 weeks
Pain at placement
Determine if there is a difference pain as assessed with the Visual Analog Scale at the time of placement of the LNG-IUS at three time period: Immediate Postplacental, Early Postpartum, or Interval.
Measured: at 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionMay 2010
- Study completionJul 2010
Why it stopped: No recruitment occurred and the PI stopped the study
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 ContraceptionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088178
- Sponsor's protocol ID
- NMCP.2009.0062
- Status last verified
- Jul 2025
- First submitted
- 25 Feb 2010
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.
PubMed 21843688
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals
- ClinicalTrials.gov ID
- NCT01088178
- Acronym / sponsor ID
- NMCP.2009.0062
- Conditions
- Contraception
- Keywords
- Long-Acting Reversible Contraception, Contraceptive Agents, Therapeutic Uses, Contraceptive Agents, Female, Reproductive Control Agents, Pharmacologic Actions, Levonorgestrel
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment occurred and the PI stopped the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- Nov 2009 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Mar 2010 (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.
The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate Postplacental | Experimental | Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)Within 10 minutes from delivery of placenta |
| Early Postpartum | Experimental | Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)After 10 minutes from delivery of placenta but within 48hrs from delivery |
| Interval | Experimental | Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)After 6 weeks postpartum |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine questioning at their 36-38 week prenatal appointment or upon admission to labor and delivery are eligible for our study.
Key exclusion criteria (5 listed)
- Contraindications to the LNG-IUS include: Pregnancy or suspicion of pregnancy, Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity, Postpartum endometritis within the past 3 months, Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear, untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections, acute liver disease or liver tumor, hypersensitivity to any component of the product, known or suspected carcinoma of the breast. Any of these conditions would exclude the patient from our study.
- Delivery <36 weeks
- Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
- Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery)
- Cesarean delivery if randomized to IPP or EP placement
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 System (LNG-IUS: Mirena, Bayer)Placement of Mirena at given intervals during the postpartum period | Device | Early Postpartum, Immediate Postplacental, Interval |
Primary outcome
Continuation Rates of the LNG-IUS when placed postpartum at three time periods
Time frame: at 6 months
Determine if there is a difference in continuation rates at 6 months between participants who had the LNG-IUS placed at three different time periods: Immediate Postplacental (within 10 minutes from delivery of placenta), Early Postpartum (after 10 minutes but before 48 hours postpartum) , and Interval (after 6 weeks postpartum).
2 secondary outcomes
Expulsion rate of the LNG-IUS when placed postpartum at three time periods
Time frame: at 3 weeks
Pain at placement
Time frame: at 1 minute
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Derived from this study: PubMed 21843688Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) in people with Contraception, run by United States Naval Medical Center, Portsmouth 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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 20 Jul 2025. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Continuation Rates of the LNG-IUS when placed postpartum at three time periods (time frame: at 6 months). 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 NCT01088178, 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 20 Jul 2025.