HealthyNCT00635362
Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion
A study testing Levonorgestrel-releasing intrauterine system (LNG-IUS) in people with Healthy, run by University of Chicago at 1 site in United States.
Trial summary
The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery. 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
- Healthy
- What is being tested?
- Levonorgestrel-releasing intrauterine system (LNG-IUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Feb 2013
- 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
- Pregnant at time of enrollment
- Planning to undergo a scheduled cesarean delivery
- Desires to use the LNG-IUS for contraception
- Willing and able to sign an informed consent in English
- Willing to comply with the study protocol
- Age greater than or equal to 18 years
- English speaking
Who cannot join
- Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS
- Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result
- Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS
- Uterine anomaly which would not allow placement of the LNG-IUS
- Current cervical cancer or carcinoma in-situ
- Desire for repeat pregnancy in less than 12 months
- History of postabortal or postpartum sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial
The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.
Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.
- Conditions
- Healthy
- Being tested
- Levonorgestrel-releasing intrauterine system (LNG-IUS)
- Keywords
- Contraception, Contraceptive Devices, Intrauterine Devices, Unplanned Pregnancy, Postpartum Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel-releasing intrauterine system (LNG-IUS)Device
Also called Mirena IUD
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Levonorgestrel-releasing intrauterine system (LNG-IUS)Device
Also called Mirena IUD
Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| postplacental insertion after cesarean | Experimental | Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Receives: Device: Levonorgestrel-releasing intrauterine system (LNG-IUS) |
| delayed insertion group | Active comparator | Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) Receives: Device: Levonorgestrel-releasing intrauterine system (LNG-IUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of the LNG-IUS for Contraception
Measured: 12 months after cesarean delivery
Secondary outcomes (4)
Rates of Expulsion of the LNG-IUS
Measured: 12 months after cesarean delivery
Perforation Rates
Measured: 12 months after cesarean delivery
Satisfaction With LNG-IUS
We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
Measured: 6 months after cesarean delivery
Satisfaction With LNG-IUS
We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being "very unsatisfied," 2 "unsatisfied", 3 "neutral," 4 "satisfied," and 5 "very satisfied." For statistical purposes, subjects were determined to be "SATISFIED" with the IUS if they chose either 4 or 5 for this question.
Measured: 12 months after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMay 2007
- Primary completionJan 2011
- Study completionFeb 2013
Why it stopped: Low recruitment
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa Gilliam, MD MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635362
- Sponsor's protocol ID
- 15148A
- Status last verified
- Feb 2023
- First submitted
- 5 Mar 2008
- Last updated
- 22 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Whitaker AK, Endres LK, Mistretta SQ, Gilliam ML. Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial. Contraception. 2014 Jun;89(6):534-9. doi: 10.1016/j.contraception.2013.12.007. Epub 2013 Dec 26.
PubMed 24457061
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00635362
- Acronym / sponsor ID
- 15148A
- Conditions
- Healthy
- Keywords
- Contraception, Contraceptive Devices, Intrauterine Devices, Unplanned Pregnancy, Postpartum Period
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 13 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery.
Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postplacental insertion after cesarean | Experimental | Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) |
| delayed insertion group | Active comparator | Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant at time of enrollment
- Planning to undergo a scheduled cesarean delivery
- Desires to use the LNG-IUS for contraception
- Willing and able to sign an informed consent in English
- Willing to comply with the study protocol
Key exclusion criteria (7 listed)
- Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS
- Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result
- Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS
- Uterine anomaly which would not allow placement of the LNG-IUS
- Current cervical cancer or carcinoma in-situ
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-releasing intrauterine system (LNG-IUS)Also: Mirena IUDImmediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta | Device | postplacental insertion after cesarean |
| Levonorgestrel-releasing intrauterine system (LNG-IUS)Also: Mirena IUDInsertion of the LNG-IUS 4-8 weeks after cesarean delivery | Device | delayed insertion group |
Primary outcome
Use of the LNG-IUS for Contraception
Time frame: 12 months after cesarean delivery
4 secondary outcomes
Rates of Expulsion of the LNG-IUS
Time frame: 12 months after cesarean delivery
Perforation Rates
Time frame: 12 months after cesarean delivery
Satisfaction With LNG-IUS
Time frame: 6 months after cesarean delivery
Satisfaction With LNG-IUS
Time frame: 12 months after cesarean delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24457061Whitaker AK, Endres LK, Mistretta SQ, Gilliam ML. Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial. Contraception. 2014 Jun;89(6):534-9. doi: 10.1016/j.contraception.2013.12.007. Epub 2013 Dec 26.
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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.
Melissa Gilliam, MD MPH principal investigator
University of Chicago
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-releasing intrauterine system (LNG-IUS) in people with Healthy, run by University of Chicago 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 7 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 22 Mar 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2013). 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?
Use of the LNG-IUS for Contraception (time frame: 12 months after cesarean delivery). 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 NCT00635362, 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 22 Mar 2023.