ContraceptionPhase 4BLISNCT01990703
BLIS - Breastfeeding Levonorgestrel IUD Study
A Phase 4 study testing Levonorgestrel IUD in people with Contraception, run by University of Utah at 2 sites in United States.
Trial summary
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel IUD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Jan 2017
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy, 18-40 year old pregnant women
- Intend to breastfeed
- Desire the LNG IUD as their method of contraception
- Agree to be randomized to early versus standard postpartum insertion
- Have delivered a healthy term infant (37 weeks gestation)
- Willing to complete all study related procedures, visits and questionnaires
Who cannot join
- Chorioamnionitis
- Obstetric complications including transfusion
- Severe pregnancy induced hypertension
- Prolonged hospitalization
- Coagulopathy
- Liver disease
- Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
Official title: Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Levonorgestrel IUD to Assess Breast Feeding Outcomes (BLIS - Breastfeeding Levonorgestrel IUD Study)
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.
Read the detailed description
Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women initiate use of this method in the post partum period. The major advantage of immediate postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with the intense demands of newborn care, but any contraceptive method initiated in the postpartum period must not interfere with breastfeeding.
Our long-term goal is to understand the impact of hormonal contraceptives, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that quality of breastfeeding is not negatively affected by progestin-only hormonal contraceptives.
We will pursue three specific aims comparing women randomized to immediate post-placental vs. delayed (4-6 week) postpartum LNG IUD insertion:
Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation, exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26 weeks postpartum in both groups
This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD.
- Conditions
- Contraception
- Being tested
- Levonorgestrel IUD
- Keywords
- Contraception, Birth Control, Levonorgestrel IUD, Mirena IUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel IUDDrug
Also called Mirena
Timing of IUD insertion
| Study group | Role | What they receive |
|---|---|---|
| Early IUD Insertion Group | Experimental | Immediate post-placental placement of the levonorgestrel IUD Receives: Drug: Levonorgestrel IUD |
| Standard Postpartum Insertion Group | Active comparator | Placement of the levonorgestrel IUD 4-6 weeks postpartum Receives: Drug: Levonorgestrel IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Continuation Rates at 8 Weeks Postpartum
To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.
Measured: 8 weeks postpartum
Secondary outcomes (1)
Time to Lactogenesis Stage 2
To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.
Measured: First 5 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionJan 2017
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 ContraceptionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning, University of New Mexico
- Responsible party
- Principal investigator, David Turok, University of Utah
- Investigators
- David K Turok, MD, Principal investigator, University of Utah Department of Obstetrics & Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990703
- Sponsor's protocol ID
- 62844
- Acronym
- BLIS
- Status last verified
- May 2017
- First submitted
- 15 Nov 2013
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hopelian NG, Simmons RG, Sanders JN, Ward K, Jenkins SM, Espey E, Turok DK. Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD. BMC Womens Health. 2021 Jan 21;21(1):33. doi: 10.1186/s12905-021-01179-7.
PubMed 33478494
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Levonorgestrel IUD to Assess Breast Feeding Outcomes (BLIS - Breastfeeding Levonorgestrel IUD Study)
- ClinicalTrials.gov ID
- NCT01990703
- Acronym / sponsor ID
- BLIS / 62844
- Conditions
- Contraception
- Keywords
- Contraception, Birth Control, Levonorgestrel IUD, Mirena IUD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Society of Family Planning, University of New Mexico
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.
Detailed description
Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women initiate use of this method in the post partum period. The major advantage of immediate postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with the intense demands of newborn care, but any contraceptive method initiated in the postpartum period must not interfere with breastfeeding.
Our long-term goal is to understand the impact of hormonal contraceptives, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that quality of breastfeeding is not negatively affected by progestin-only hormonal contraceptives.
We will pursue three specific aims comparing women randomized to immediate post-placental vs. delayed (4-6 week) postpartum LNG IUD insertion:
Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation, exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26 weeks postpartum in both groups
This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early IUD Insertion Group | Experimental | Drug: Levonorgestrel IUDImmediate post-placental placement of the levonorgestrel IUD |
| Standard Postpartum Insertion Group | Active comparator | Drug: Levonorgestrel IUDPlacement of the levonorgestrel IUD 4-6 weeks postpartum |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy, 18-40 year old pregnant women
- Intend to breastfeed
- Desire the LNG IUD as their method of contraception
- Agree to be randomized to early versus standard postpartum insertion
- Have delivered a healthy term infant (37 weeks gestation)
Key exclusion criteria (7 listed)
- Chorioamnionitis
- Obstetric complications including transfusion
- Severe pregnancy induced hypertension
- Prolonged hospitalization
- Coagulopathy
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 IUDAlso: MirenaTiming of IUD insertion | Drug | Early IUD Insertion Group, Standard Postpartum Insertion Group |
Primary outcome
Breastfeeding Continuation Rates at 8 Weeks Postpartum
Time frame: 8 weeks postpartum
To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.
1 secondary outcome
Time to Lactogenesis Stage 2
Time frame: First 5 days after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33478494Hopelian NG, Simmons RG, Sanders JN, Ward K, Jenkins SM, Espey E, Turok DK. Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD. BMC Womens Health. 2021 Jan 21;21(1):33. doi: 10.1186/s12905-021-01179-7.
- 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.
David K Turok, MD principal investigator
University of Utah Department of Obstetrics & Gynecology
2 sites 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 IUD in people with Contraception, run by University of Utah at 2 sites 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 14 Jun 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?
Breastfeeding Continuation Rates at 8 Weeks Postpartum (time frame: 8 weeks postpartum). 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 NCT01990703, 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 14 Jun 2017.