ContraceptionNCT01161095
A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
A study testing LNG-IUS in people with Contraception and Postpartum Period, run by United States Naval Medical Center, Portsmouth at 2 sites in United States.
Trial summary
The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Postpartum Period
- What is being tested?
- LNG-IUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2010to 28 May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women >37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in our study.
Who cannot join
- Contraindications to the LNG-IUS include:
- Pregnancy or suspicion of pregnancy
- Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- Postpartum endometritis within the past 3 months
- Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear
- untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections
Show all 14Show fewer
- acute liver disease or liver tumor
- hypersensitivity to any component of the product
- known or suspected carcinoma of the breast
- Any of these conditions would exclude the patient from receiving these forms of contraception in our study.
- In addition the following intrapartum findings, the following would exclude the patient:
- Delivery <37 weeks
- Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
- Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery or >1000cc for cesarean delivery)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Arkansas for the Medical Sciences
Little Rock, Arkansas, 72205
Naval Medical Center
Portsmouth, Virginia, 23507
About this study
The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).
Read the detailed description
The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement.
The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement.
Secondary outcome measures that we will obtain include:
- Pain at the time of placement
- Postpartum Depression
- Breastfeeding status
- Postpartum weight retention
- Expulsion Rates
- Bleeding Profile
- Uterine Infection(Endometritis)
- Conditions
- Contraception, Postpartum Period
- Being tested
- LNG-IUS
- Keywords
- Intrauterine Device, Postpartum contraception, Long-acting reversible contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNG-IUSDevice
Mirena (Bayer)- Levonorgestrel-Intrauterine System
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | LNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum Receives: Device: LNG-IUS |
| Interval | Active comparator | LNG-IUS insertion after 6 weeks postpartum Receives: Device: LNG-IUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation Rates
Primary objective: Determine if there is a difference in continuation rates at six months postpartum in women who have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two time periods: Immediate (after delivery of placenta to 72 hours postpartum) or Interval (after 6 weeks postpartum).
Our analysis will be conducted on all randomized women on an intention to treat basis. Once insertion has occurred, evaluation at 6 months postpartum with the presence or absence of the LNG-IUS in the uterus will be determined to calculate the continuation rate.
Measured: 6 months
Secondary outcomes (8)
Pain at insertion
Pain will be measured using the validated Visual Analog Scale (VAS) at the time of insertion.
Measured: 1 minute
Postpartum Depression
Depression history will be determined from the initial data collection sheet upon entry into the study. The Edinburgh Postnatal Depression Scale will be filled out by the participant at their six week postpartum appointment (routine), and also at six months.
Measured: 6 months
Breastfeeding Status
We will identify those who plan on breastfeeding their infants prior to discharge from the hospital. We will also determine the number of hours to Lactogenesis II (avg 40-50 hrs) via phone interview within one week from discharge. We will determine discontinuation rates and days to discontinuation of breastfeeding at six weeks and six months. We will also record infant weights at the postpartum appointment and at six months.
Measured: 6 months
Postpartum weight retention
We will determine each participant's pre pregnancy BMI, BMI at admission to labor and delivery, and BMI at the postpartum appointment and at 6 months.
Measured: 6 months
Sexual Function
We will determine the number of days from delivery to resumption of sexual intercourse. We will also have the participant complete the Female Sexual Function Index questionnaire (FSFI) at the postpartum appointment and at 6 months.
Measured: 6 months
Expulsion Rate
Expulsion rate as well as resumption of contraception (whether LNG-IUS is replaced or another form of contraception is initiated) occurs at the postpartum appointment and at six months
Measured: 6 months
Bleeding Profile
Each Participant will be asked to complete a monthly menstrual flow calendar to document light, medium, or heavy bleeding. These will be collected at the postpartum appointment and at six months.
Measured: 6 months
Infectious morbidity
Postpartum endometritis and pelvic inflammatory disease will be tracked with record review and direct participant questioning at their postpartum appointment and at six months
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 posted13 Jul 2010 (estimated)
- Study start1 Jul 2010
- Primary completion28 May 2014
- Study completion28 May 2014
Why it stopped: No recruitment occurred and the PI stopped the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, Portsmouth
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161095
- Sponsor's protocol ID
- NMCP.2010.0074
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2010
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
- ClinicalTrials.gov ID
- NCT01161095
- Acronym / sponsor ID
- NMCP.2010.0074
- Conditions
- Contraception, Postpartum Period
- Keywords
- Intrauterine Device, Postpartum contraception, Long-acting reversible contraception
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No recruitment occurred and the PI stopped the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, PortsmouthUS federal agency
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 28 May 2014 (actual)
- Study completion
- 28 May 2014 (actual)
- First posted
- 13 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).
Detailed description
The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement.
The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement.
Secondary outcome measures that we will obtain include:
- Pain at the time of placement
- Postpartum Depression
- Breastfeeding status
- Postpartum weight retention
- Expulsion Rates
- Bleeding Profile
- Uterine Infection(Endometritis)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Device: LNG-IUSLNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum |
| Interval | Active comparator | Device: LNG-IUSLNG-IUS insertion after 6 weeks postpartum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All women >37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in our study.
Key exclusion criteria (14 listed)
- Pregnancy or suspicion of pregnancy
- Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- Postpartum endometritis within the past 3 months
- Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear
- untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections
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 |
|---|---|---|
| LNG-IUSMirena (Bayer)- Levonorgestrel-Intrauterine System | Device | Immediate, Interval |
Primary outcome
Continuation Rates
Time frame: 6 months
Primary objective: Determine if there is a difference in continuation rates at six months postpartum in women who have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two time periods: Immediate (after delivery of placenta to 72 hours postpartum) or Interval (after 6 weeks postpartum). Our analysis will be conducted on all randomized women on an intention to treat basis. Once insertion has occurred, evaluation at 6 months postpartum with the presence or absence of the LNG-IUS in the uterus will be determined to calculate the continuation rate.
8 secondary outcomes
Pain at insertion
Time frame: 1 minute
Postpartum Depression
Time frame: 6 months
Breastfeeding Status
Time frame: 6 months
Postpartum weight retention
Time frame: 6 months
Sexual Function
Time frame: 6 months
Expulsion Rate
Time frame: 6 months
Bleeding Profile
Time frame: 6 months
Infectious morbidity
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LNG-IUS in people with Contraception and Postpartum Period, run by United States Naval Medical Center, Portsmouth 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 1 inclusion and 14 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: withdrawn, as of the sponsor's last update on 20 Jul 2025. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Continuation Rates (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 20 Jul 2025.