Postpartum ContraceptionPhase 4PPIUD1NCT01555931
Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding
A Phase 4 study testing Levonorgestrel-releasing intrauterine system in people with Postpartum Contraception, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Contraception
- What is being tested?
- Levonorgestrel-releasing intrauterine system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2013
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
- Women ages 18-45
- Pregnant and equal to or more than 24 weeks of estimated gestational age
- States an intent to breastfeed for at least 6 months
- States a plan to use the LNG-IUS postpartum
- Anticipates a vaginal delivery
- HIV negative
- Intend to stay in the Chapel Hill area for at least 6 months after birth
- No medical or personal conditions which in the judgment of study staff preclude participation in the study
- Have no allergies to any component of the LNG-IUS
- No known uterine anomalies
- Fluent in English
- No history of ectopic pregnancy
- No known or suspected carcinoma of the breast
- No known acute liver disease or liver tumor (benign or malignant)
- No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear
- No active pelvic inflammatory disease
- No known hypersensitivity to any component of the LNG-IUS
- No genital bleeding of unknown etiology
- No history of solid organ transplantation
Additional eligibility criteria for entry into the randomized trial, as assessed postpartum
- No endometritis or chorioamnionitis
- Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes)
- No fever greater than or equal to 38°C during the intrapartum or postpartum period
- Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding
- Did not have a documented estimated blood loss of greater than 750mL intrapartum
- Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage
- Did not have a third or fourth degree laceration at delivery.
- The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth
- The infant must weigh at least 2727 grams
- Must have been a singleton birth
- Infant not in the intensive care nursery
- The infant has not been diagnosed with a condition which would preclude long term feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Women's Hospital
Chapel Hill, North Carolina, 27599
About this study
Official title: Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1)
This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.
- Conditions
- Postpartum Contraception
- Being tested
- Levonorgestrel-releasing intrauterine system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel-releasing intrauterine systemDrug
Also called Mirena
Placement within 48 hours of delivery
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | Placement within 48 hours of delivery Receives: Drug: Levonorgestrel-releasing intrauterine system |
| Control | Active comparator | Placement 4-8 weeks after delivery Receives: Drug: Levonorgestrel-releasing intrauterine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding
Reported any breastfeeding at the final 6 month visit
Measured: 6 months
Secondary outcomes (1)
LNG-IUS Expulsion or Removal
Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2013
- Study completionJun 2013
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 Postpartum ContraceptionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Gretchen Stuart, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555931
- Sponsor's protocol ID
- 11-1786
- Acronym
- PPIUD1
- Status last verified
- Jun 2013
- First submitted
- 14 Mar 2012
- Last updated
- 25 Aug 2014
- 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 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1)
- ClinicalTrials.gov ID
- NCT01555931
- Acronym / sponsor ID
- PPIUD1 / 11-1786
- Conditions
- Postpartum Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Mar 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Posted 25 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Drug: Levonorgestrel-releasing intrauterine systemPlacement within 48 hours of delivery |
| Control | Active comparator | Drug: Levonorgestrel-releasing intrauterine systemPlacement 4-8 weeks after delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 systemAlso: MirenaPlacement within 48 hours of delivery | Drug | Control, Immediate |
Primary outcome
Breastfeeding
Time frame: 6 months
Reported any breastfeeding at the final 6 month visit
1 secondary outcome
LNG-IUS Expulsion or Removal
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Postpartum Contraception
Active, not recruiting
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Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare
Family Dynamics, Trust in Healthcare System
Active, not recruitingObservational study
Women's Knowledge of Contraception During the Postpartum Period
Contraception
Recruiting
Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period
Substance Use Disorders, Pregnancy Related
Recruiting
Structured Contraceptive Counseling During Pregnancy
Contraception, Intrauterine Device
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 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 system in people with Postpartum Contraception, 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?
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 25 Aug 2014. 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 25 Aug 2014). 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?
Breastfeeding (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 Aug 2014.