ContraceptionPhase 4NCT01594476
Early Postpartum Intrauterine Device (IUD) Placement
A Phase 4 study testing Levonorgestrel IUS in people with Contraception, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel IUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jul 2014
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- 18 years or older
- Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception
- Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment
- English or Spanish speaking
- Able to give consent and agree to terms of the study
- No contraindications to use of either intrauterine device
Who cannot join
- Preterm delivery prior to 32 weeks gestation
- Recent pregnancy with multiple gestation
- Current incarceration
- Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
- Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion)
- Suspected hypersensitivity or contraindication to the chosen IUD
- No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Early Versus Standard Interval Postpartum Intrauterine Device (IUD) Placement at 3 Weeks or 6 Weeks Following Delivery: A Prospective Randomized Trial
Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement
Read the detailed description
The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit. We will investigate whether they are more likely to return and to receive an IUD if the follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability, safety and efficacy will also be examined. This prospective, randomized, controlled trial will enroll approximately 240 women at our academic tertiary care hospital in the United States. Participants will be recruited from women who deliver a live-born singleton infant at greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine contraception. Subjects will choose to receive either a levonorgestrel-containing IUS (Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date. Women will be followed by phone contacts at 3 months and 4 months and will have a clinic visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the uterine size will be assessed at 6 months.
- Conditions
- Contraception
- Being tested
- Levonorgestrel IUS
- Keywords
- Postpartum, Contraception, Intrauterine device, Intrauterine system, Mirena, Paragard, Uterine involution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel IUSDrug
Also called Mirena IUS, Paragard IUD
20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel IUS insertion at 3 weeks | Experimental | IUD placement at 3 weeks after delivery. Receives: Drug: Levonorgestrel IUS |
| Levonorgestrel IUS insertion at 6 weeks | Experimental | IUD placement at 6 weeks after delivery. Receives: Drug: Levonorgestrel IUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects With an IUD at 3 Months Postpartum
Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .
Measured: Three months after delivery
Secondary outcomes (5)
Satisfaction With the Timing of IUD Placement.
Subjects were asked to record their overall satisfaction with the timing of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "very dissatisfied" and "very satisfied." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher satisfaction.
Measured: Immediately following IUD placement.
Uterine Thickness at the Fundus
Transvaginal ultrasound will be performed immediately following IUD placement. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in centimeters using an ultrasound caliper in the sagittal view.
Measured: At IUD placement
Subjects With an IUD at 6 Months Postpartum
Subjects will return to clinic for an ultrasound and exam at six months after delivery. We will compare the proportion of subjects with an IUD at this time of those randomized to each placement timing.
Measured: Six months after delivery
Number of Subjects With Adverse Events
Subjects will be followed for 6 months each. Over the 6 month study period, the number and proportion of subjects who experience adverse events including treatment for infection, IUD expulsion or IUD perforation will be assessed.
Measured: Six months after delivery
Pain With IUD Placement
Subjects were asked to record their current pain immediate at the time of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "no pain" and "worst pain in my life." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher pain. The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days.
Measured: At the time of IUD placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionJul 2014
Why it stopped: Incomplete study enrollment prior to depletion of funding
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Maureen Baldwin, Oregon Health and Science University
- Investigators
- Maureen Baldwin, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594476
- Sponsor's protocol ID
- 8120
- Status last verified
- Jan 2019
- First submitted
- 9 Mar 2012
- Last updated
- 11 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018 Sep;98(3):228-231. doi: 10.1016/j.contraception.2018.04.016. Epub 2018 May 8.
PubMed 29750924
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Standard Interval Postpartum Intrauterine Device (IUD) Placement at 3 Weeks or 6 Weeks Following Delivery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01594476
- Acronym / sponsor ID
- 8120
- Conditions
- Contraception
- Keywords
- Postpartum, Contraception, Intrauterine device, Intrauterine system, Mirena, Paragard, Uterine involution
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Incomplete study enrollment prior to depletion of funding
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 May 2012 (estimated)
- Results
- Posted 11 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement
Detailed description
The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit. We will investigate whether they are more likely to return and to receive an IUD if the follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability, safety and efficacy will also be examined. This prospective, randomized, controlled trial will enroll approximately 240 women at our academic tertiary care hospital in the United States. Participants will be recruited from women who deliver a live-born singleton infant at greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine contraception. Subjects will choose to receive either a levonorgestrel-containing IUS (Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date. Women will be followed by phone contacts at 3 months and 4 months and will have a clinic visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the uterine size will be assessed at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel IUS insertion at 3 weeks | Experimental | Drug: Levonorgestrel IUSIUD placement at 3 weeks after delivery. |
| Levonorgestrel IUS insertion at 6 weeks | Experimental | Drug: Levonorgestrel IUSIUD placement at 6 weeks after delivery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- 18 years or older
- Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception
- Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment
- English or Spanish speaking
Key exclusion criteria (7 listed)
- Preterm delivery prior to 32 weeks gestation
- Recent pregnancy with multiple gestation
- Current incarceration
- Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
- Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion)
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 IUSAlso: Mirena IUS, Paragard IUD20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device | Drug | Levonorgestrel IUS insertion at 3 weeks, Levonorgestrel IUS insertion at 6 weeks |
Primary outcome
Subjects With an IUD at 3 Months Postpartum
Time frame: Three months after delivery
Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .
5 secondary outcomes
Satisfaction With the Timing of IUD Placement.
Time frame: Immediately following IUD placement.
Uterine Thickness at the Fundus
Time frame: At IUD placement
Subjects With an IUD at 6 Months Postpartum
Time frame: Six months after delivery
Number of Subjects With Adverse Events
Time frame: Six months after delivery
Pain With IUD Placement
Time frame: At the time of IUD placement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29750924Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018 Sep;98(3):228-231. doi: 10.1016/j.contraception.2018.04.016. Epub 2018 May 8.
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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.
Maureen Baldwin, MD, MPH principal investigator
Oregon Health and Science University
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 IUS in people with Contraception, run by Oregon Health and Science University 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 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: stopped early, as of the sponsor's last update on 11 Jan 2019. 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 11 Jan 2019). 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?
Subjects With an IUD at 3 Months Postpartum (time frame: Three 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 NCT01594476, 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 11 Jan 2019.