Unplanned PregnancyPhase 4ImmPPIUDNCT00997932
A Pilot Study of Early Postpartum Intrauterine Contraception
A Phase 4 study testing Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration in people with Unplanned Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Unplanned Pregnancy
- What is being tested?
- Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2012
- Phase
- Phase 4
- 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 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia.
- Desires to use intrauterine contraception (IUD) after delivery
- Anticipates having a vaginal delivery
- No intention to leave the area 7 months after enrollment
- Able to consent to participate in the study in English
- Has no known uterine anomalies
- Has no allergies to any components of the intrauterine contraception
Who cannot join
- Prior cesarean delivery
- Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy
- Allergic to betadine
- Allergy to lidocaine
- Medical or personal conditions which in the judgment of study staff contradict participation in the study
- Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ
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- After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following:
- Endometritis or chorioamnionitis during the intrapartum period
- Membranes ruptured for greater than 24 hours prior to delivery
- Fever greater than or equal to 38C
- The need to use additional medications other than pitocin and/or misoprostol to control postpartum bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.
The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.
Read the detailed description
This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery.
Women were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant.
Forty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital.
Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.
- Conditions
- Unplanned Pregnancy
- Being tested
- Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration
- Keywords
- levonorgestrel releasing intrauterine device, levonorgestrel releasing intrauterine contraception, unintended pregnancy prevention, postpartum contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year DurationDrug
Also called LNG-IUS
Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Complete Cohort | Other | The complete cohort of all women enrolled and stated they wanted an LNG-IUS between 48 and 72 hours of vaginal delivery. Receives: Drug: Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUD Expulsion
Expulsion of the LNG-IUS
Measured: From time of insertion to final study date which is 6 months after IUD insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2010
- Study completionNov 2012
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 Unplanned PregnancyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gretchen Stuart, MD, University of North Carolina, Chapel Hill
- Investigators
- Gretchen Stuart, MD, MPHTM, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997932
- Sponsor's protocol ID
- SFP3-14
- Acronym
- ImmPPIUD
- Status last verified
- Mar 2017
- First submitted
- 28 Sep 2009
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Early Postpartum Intrauterine Contraception
- ClinicalTrials.gov ID
- NCT00997932
- Acronym / sponsor ID
- ImmPPIUD / SFP3-14
- Conditions
- Unplanned Pregnancy
- Keywords
- levonorgestrel releasing intrauterine device, levonorgestrel releasing intrauterine contraception, unintended pregnancy prevention, postpartum contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Posted 29 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.
The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.
Detailed description
This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery.
Women were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant.
Forty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital.
Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete Cohort | Other | Drug: Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year DurationThe complete cohort of all women enrolled and stated they wanted an LNG-IUS between 48 and 72 hours of vaginal delivery. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia.
- Desires to use intrauterine contraception (IUD) after delivery
- Anticipates having a vaginal delivery
- No intention to leave the area 7 months after enrollment
- Able to consent to participate in the study in English
Key exclusion criteria (11 listed)
- Prior cesarean delivery
- Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy
- Allergic to betadine
- Allergy to lidocaine
- Medical or personal conditions which in the judgment of study staff contradict participation in the study
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 Contraceptive System (LNG-IUS), 52 Mg, 5 Year DurationAlso: LNG-IUSLevonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours | Drug | Complete Cohort |
Primary outcome
IUD Expulsion
Time frame: From time of insertion to final study date which is 6 months after IUD insertion.
Expulsion of the LNG-IUS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gretchen Stuart, MD, MPHTM principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration in people with Unplanned Pregnancy, run by University of North Carolina, Chapel Hill 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 11 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 29 Mar 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2017). 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 (time frame: From time of insertion to final study date which is 6 months after IUD insertion.). 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 29 Mar 2017.