ContraceptionIUDNCT01598662
Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement
A study testing Mirena (levonorgestrel-releasing intrauterine system) in people with Contraception, run by University of Louisville at 1 site in United States.
Trial summary
This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Mirena (levonorgestrel-releasing intrauterine system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2012
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients must be 15- 45 years of age and received their prenatal care at the University of Louisville OB/GYN clinic
- Planned vaginal delivery
- Negative third trimester cultures for Gonorrhea and Chlamydia
- Desire to use the IUD for contraception
Who cannot join
- Uterine anomalies
- Uterine or cervical neoplasia
- Past or current breast cancer
- Chorioamnionitis
- Acute liver disease
- Postpartum hemorrhage lasting greater than ten minutes or more than 500 mL blood loss
- Received prenatal other than at the University of Louisville OB/GYN Clinic
- Cesarean section
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement: A Randomized, Controlled Trial
This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.
Read the detailed description
Unintended pregnancy occurs in nearly half of all pregnancies in the United States. There are many barriers to implementation of long-term reversible contraception in the immediate postpartum period. In our indigent population, a survey of patients showed that nearly 60% of patients who chose an IUD while admitted postpartum never returned for placement, placing them at risk for early repeat pregnancy.
The intrauterine device is a safe and effective form of long-term reversible contraception when placed at 6 weeks postpartum or later with pregnancy rates of only 0.1%. The commercially available Mirena IUD contains levonorgestrel which is released slowly over five years, providing safe, reversible contraception and making menstrual flow much lighter.
This randomized controlled trial will compare traditional placement at 6 weeks or more postpartum versus immediate post-placental placement.
The investigators hypothesize that the expulsion rate of IUDs placed immediately postpartum will be acceptably low in an indigent population to still be cost effective. Studies from the world literature in Egypt and Mexico where IUDs are routinely placed immediately following placental delivery.support this hypothesis. A recent study published in 2010 by Chen et al. showed an approximately 24% expulsion rate.
Six week postpartum IUD placement for contraception will be compared to immediate post-placental IUD placement, to determine whether immediate IUD insertion after delivery has an acceptably low rate of expulsion, infection, perforation and unintended pregnancy, and a high rate of retention, patient satisfaction, and maintenance of contraception.
- Conditions
- Contraception
- Being tested
- Mirena (levonorgestrel-releasing intrauterine system)
- Keywords
- IUD placement, contraception, postpartum, intrauterine device, expulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirena (levonorgestrel-releasing intrauterine system)Device
Also called Mirena IUD
The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.
| Study group | Role | What they receive |
|---|---|---|
| 1: IUD insertion 6 Weeks after delivery | Active comparator | Device:Levonorgestrel-releasing intrauterine device marketed as Mirena.
Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. They must return for one visit within a month for a "string check". Receives: Device: Mirena (levonorgestrel-releasing intrauterine system) |
| 2: Immediate Post-placental insertion | Experimental | Device: Levonorgestrel-releasing intrauterine device marketed as Mirena
Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed manually under sterile technique and with ultrasound guidance. An ultrasound will be performed within two days postpartum to verify proper placement and again at approximately six weeks postpartum. Receives: Device: Mirena (levonorgestrel-releasing intrauterine system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUD Expulsion Rate
The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJul 2009
- Primary completion21 Mar 2011
- Study completionJul 2012
Why it stopped: Unable to secure funding
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 ContraceptionStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Elaine Stauble, University of Louisville
- Investigators
- Mary E Stauble, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598662
- Sponsor's protocol ID
- IUD Study B090743
- Acronym
- IUD
- Status last verified
- Aug 2018
- First submitted
- 13 Apr 2012
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01598662
- Acronym / sponsor ID
- IUD / IUD Study B090743
- Conditions
- Contraception
- Keywords
- IUD placement, contraception, postpartum, intrauterine device, expulsion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to secure funding
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- 21 Mar 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 26 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.
Detailed description
Unintended pregnancy occurs in nearly half of all pregnancies in the United States. There are many barriers to implementation of long-term reversible contraception in the immediate postpartum period. In our indigent population, a survey of patients showed that nearly 60% of patients who chose an IUD while admitted postpartum never returned for placement, placing them at risk for early repeat pregnancy.
The intrauterine device is a safe and effective form of long-term reversible contraception when placed at 6 weeks postpartum or later with pregnancy rates of only 0.1%. The commercially available Mirena IUD contains levonorgestrel which is released slowly over five years, providing safe, reversible contraception and making menstrual flow much lighter.
This randomized controlled trial will compare traditional placement at 6 weeks or more postpartum versus immediate post-placental placement.
The investigators hypothesize that the expulsion rate of IUDs placed immediately postpartum will be acceptably low in an indigent population to still be cost effective. Studies from the world literature in Egypt and Mexico where IUDs are routinely placed immediately following placental delivery.support this hypothesis. A recent study published in 2010 by Chen et al. showed an approximately 24% expulsion rate.
Six week postpartum IUD placement for contraception will be compared to immediate post-placental IUD placement, to determine whether immediate IUD insertion after delivery has an acceptably low rate of expulsion, infection, perforation and unintended pregnancy, and a high rate of retention, patient satisfaction, and maintenance of contraception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: IUD insertion 6 Weeks after delivery | Active comparator | Device: Mirena (levonorgestrel-releasing intrauterine system)Device:Levonorgestrel-releasing intrauterine device marketed as Mirena. Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. They must return for one visit within a month for a "string check". |
| 2: Immediate Post-placental insertion | Experimental | Device: Mirena (levonorgestrel-releasing intrauterine system)Device: Levonorgestrel-releasing intrauterine device marketed as Mirena Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed manually under sterile technique and with ultrasound guidance. An ultrasound will be performed within two days postpartum to verify proper placement and again at approximately six weeks postpartum. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients must be 15- 45 years of age and received their prenatal care at the University of Louisville OB/GYN clinic
- Planned vaginal delivery
- Negative third trimester cultures for Gonorrhea and Chlamydia
- Desire to use the IUD for contraception
Key exclusion criteria (8 listed)
- Uterine anomalies
- Uterine or cervical neoplasia
- Past or current breast cancer
- Chorioamnionitis
- Acute liver disease
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 |
|---|---|---|
| Mirena (levonorgestrel-releasing intrauterine system)Also: Mirena IUDThe Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily. | Device | 1: IUD insertion 6 Weeks after delivery, 2: Immediate Post-placental insertion |
Primary outcome
IUD Expulsion Rate
Time frame: 6 months
The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mary E Stauble, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirena (levonorgestrel-releasing intrauterine system) in people with Contraception, run by University of Louisville 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 4 inclusion and 8 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 25 Sep 2018. 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 26 Jul 2018). 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?
IUD Expulsion Rate (time frame: 6 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 25 Sep 2018.