ContraceptionPOPINCT00476021
Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery
A study testing Levonorgestrel-releasing IUD (Mirena) in people with Contraception, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks 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
- Contraception
- What is being tested?
- Levonorgestrel-releasing IUD (Mirena)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Oct 2008
- 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 greater than or equal to 18 years
- Greater than or equal to 24 0/7 weeks pregnant at time of enrollment
- Anticipates undergoing a vaginal delivery
- Desires to use the LNG-IUD (Mirena) for postpartum contraception
- Willing and able to sign an informed consent in English
- Willing to comply with the study protocol
Who cannot join
- Planning to undergo a scheduled cesarean section
- Allergy to either polyethylene or levonorgestrel or other contraindications to use of the LNG-IUD
- Exposure to or treatment for gonorrhea, chlamydia, or trichomoniasis during the pregnancy
- Presence of one or more leiomyomata greater than 3 centimeters in diameter
- Uterine anomaly (other than a repaired septate uterus)
- Current cervical cancer or carcinoma in-situ
- Desires repeat pregnancy within one year of delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.
Read the detailed description
The United States (US) has the highest unintended pregnancy rate of any developed country. Of the 6.4 million pregnancies in the US each year, almost half are unintended (49%). Roughly half of these (22% of all pregnancies) result in unintended births, while 20% of all pregnancies result in abortion. Postpartum women are particularly susceptible, with an unintended pregnancy rate of 10%-44% in the first year postpartum. These unintended pregnancies occur despite the recommendation that a contraceptive method be selected prior to hospital discharge.
Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The IUD is a highly effective but underused method of postpartum contraception. Although the expulsion rate in postplacental insertion is higher than interval insertion, the benefits of highly effective contraception available immediately after delivery may outweigh the risks of expulsion.
To date, there have been no randomized trials of postplacental insertion of the LNG-IUD in the United States. One pilot study in the United States of 20 subjects who received an ultrasound-guided postplacental insertion of the LNG-IUD showed an acceptable expulsion rate of 10% and no infections over a 10-week follow-up, thus making postplacental insertion of LNG-IUD safe for further study.
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. One hundred sixty-eight women receiving prenatal care at Magee-Womens Hospital, Pittsburgh, PA, who are interested in using the LNG-IUD for contraception will be enrolled during their pregnancy. The IUD will be inserted within 10 minutes after delivery of the placenta in women randomized to immediate insertion. Delayed IUD insertion will be performed at the first postpartum visit in 6-8 weeks. All subjects will follow up in person at 6-8 weeks and 6 months after delivery. A telephone interview will occur at 3 months after delivery for all subjects.
Subjects who are not eligible for insertion due to post-randomization ineligibility criteria will be referred to their primary gynecologist or midwife for delayed IUD placement. They will be contacted by phone at 3 and 6 months to assess quality of life, contraceptive usage, and unintended pregnancy rates.
- Conditions
- Contraception
- Being tested
- Levonorgestrel-releasing IUD (Mirena)
- Keywords
- postpartum, contraception, postplacental IUD, intrauterine devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel-releasing IUD (Mirena)Device
Also called Mirena
levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
| Study group | Role | What they receive |
|---|---|---|
| Postplacental IUD insertion | Experimental | immediate postplacental levonorgestrel-releasing IUD (Mirena) insertion Receives: Device: Levonorgestrel-releasing IUD (Mirena) |
| Delayed IUD insertion | Active comparator | delayed levonorgestrel-releasing IUD (Mirena) insertion (6-8 weeks after delivery) Receives: Device: Levonorgestrel-releasing IUD (Mirena) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUD Usage Rate at 6 Months
Usage rate of the LNG-IUD at 6 months after delivery
Measured: 6 months after delivery
Secondary outcomes (5)
Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement
Measured: 6 months
Follow-up Rates for Delayed Insertion of LNG-IUD
Measured: 6 months
Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography
Measured: 6 months
Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates
Measured: 6 months
Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion
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 posted21 May 2007 (estimated)
- Study startMay 2007
- Primary completionOct 2008
- Study completionOct 2008
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 (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatrice Chen, University of Pittsburgh
- Investigators
- Beatrice A Chen, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00476021
- Sponsor's protocol ID
- PRO06070007
- Acronym
- POPI
- Status last verified
- May 2016
- First submitted
- 17 May 2007
- Last updated
- 24 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.
PubMed 20966692Chen BA, Reeves MF, Creinin MD, Schwarz EB. Postplacental or delayed levonorgestrel intrauterine device insertion and breast-feeding duration. Contraception. 2011 Nov;84(5):499-504. doi: 10.1016/j.contraception.2011.01.022. Epub 2011 Apr 16.
PubMed 22018124
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery
- ClinicalTrials.gov ID
- NCT00476021
- Acronym / sponsor ID
- POPI / PRO06070007
- Conditions
- Contraception
- Keywords
- postpartum, contraception, postplacental IUD, intrauterine devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Posted 19 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.
Detailed description
The United States (US) has the highest unintended pregnancy rate of any developed country. Of the 6.4 million pregnancies in the US each year, almost half are unintended (49%). Roughly half of these (22% of all pregnancies) result in unintended births, while 20% of all pregnancies result in abortion. Postpartum women are particularly susceptible, with an unintended pregnancy rate of 10%-44% in the first year postpartum. These unintended pregnancies occur despite the recommendation that a contraceptive method be selected prior to hospital discharge.
Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The IUD is a highly effective but underused method of postpartum contraception. Although the expulsion rate in postplacental insertion is higher than interval insertion, the benefits of highly effective contraception available immediately after delivery may outweigh the risks of expulsion.
To date, there have been no randomized trials of postplacental insertion of the LNG-IUD in the United States. One pilot study in the United States of 20 subjects who received an ultrasound-guided postplacental insertion of the LNG-IUD showed an acceptable expulsion rate of 10% and no infections over a 10-week follow-up, thus making postplacental insertion of LNG-IUD safe for further study.
This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. One hundred sixty-eight women receiving prenatal care at Magee-Womens Hospital, Pittsburgh, PA, who are interested in using the LNG-IUD for contraception will be enrolled during their pregnancy. The IUD will be inserted within 10 minutes after delivery of the placenta in women randomized to immediate insertion. Delayed IUD insertion will be performed at the first postpartum visit in 6-8 weeks. All subjects will follow up in person at 6-8 weeks and 6 months after delivery. A telephone interview will occur at 3 months after delivery for all subjects.
Subjects who are not eligible for insertion due to post-randomization ineligibility criteria will be referred to their primary gynecologist or midwife for delayed IUD placement. They will be contacted by phone at 3 and 6 months to assess quality of life, contraceptive usage, and unintended pregnancy rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postplacental IUD insertion | Experimental | Device: Levonorgestrel-releasing IUD (Mirena)immediate postplacental levonorgestrel-releasing IUD (Mirena) insertion |
| Delayed IUD insertion | Active comparator | Device: Levonorgestrel-releasing IUD (Mirena)delayed levonorgestrel-releasing IUD (Mirena) insertion (6-8 weeks after delivery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- Greater than or equal to 24 0/7 weeks pregnant at time of enrollment
- Anticipates undergoing a vaginal delivery
- Desires to use the LNG-IUD (Mirena) for postpartum contraception
- Willing and able to sign an informed consent in English
Key exclusion criteria (7 listed)
- Planning to undergo a scheduled cesarean section
- Allergy to either polyethylene or levonorgestrel or other contraindications to use of the LNG-IUD
- Exposure to or treatment for gonorrhea, chlamydia, or trichomoniasis during the pregnancy
- Presence of one or more leiomyomata greater than 3 centimeters in diameter
- Uterine anomaly (other than a repaired septate uterus)
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 IUD (Mirena)Also: Mirenalevonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years | Device | Delayed IUD insertion, Postplacental IUD insertion |
Primary outcome
IUD Usage Rate at 6 Months
Time frame: 6 months after delivery
Usage rate of the LNG-IUD at 6 months after delivery
5 secondary outcomes
Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement
Time frame: 6 months
Follow-up Rates for Delayed Insertion of LNG-IUD
Time frame: 6 months
Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography
Time frame: 6 months
Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates
Time frame: 6 months
Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20966692Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.
- Results publication: PubMed 22018124Chen BA, Reeves MF, Creinin MD, Schwarz EB. Postplacental or delayed levonorgestrel intrauterine device insertion and breast-feeding duration. Contraception. 2011 Nov;84(5):499-504. doi: 10.1016/j.contraception.2011.01.022. Epub 2011 Apr 16.
- Click here for more information about the Center for Family Planning Research, University of PittsburghLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Beatrice A Chen, MD principal investigator
University of Pittsburgh
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 IUD (Mirena) in people with Contraception, run by University of Pittsburgh 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 6 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: finished, as of the sponsor's last update on 24 Jun 2016. 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 19 Feb 2016). 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 Usage Rate at 6 Months (time frame: 6 months after 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 NCT00476021, which also lists 2 linked publications.
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 24 Jun 2016.