Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial

Study Overview
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Brief Summary
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In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants. This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers which has already enrolled over 5,000 patients. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices. We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placenta insertion focus on expulsion rates and do not report on symptoms and satisfaction rates.

Official Title
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Randomized, Open-label, Controlled Trial of Immediate Postpartum Versus Interval Insertion of Mirena to Increase the Usage at 6 Months After Delivery

Conditions
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Postpartum Period

Intervention / Treatment
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* Device: Post-Placenta Mirena Insertion
* Device: Interval Insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 14-45 years Vaginal Delivery at Barnes-Jewish Hospital Sexually active with male partner No tubal ligation/hysterectomy Not currently using contraception Desire reversible contraception Reside in St. Louis City/County Requests Mirena(R) intrauterine device for contraception Exclusion Criteria: Allergy to Mirena(R) system Cesarean delivery Cervical cancer, breast cancer Active liver disease Untreated cervicitis Uterine anomaly/fibroids preventing Mirena(R) placement Delivery <36 weeks Chorioamnionitis Prolonged rupture of membranes (>18 hours)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interval Insertion<br>Will receive Mirena at 4-8 weeks post-partum after vaginal delivery. | Device: Interval Insertion<br>* Insertion of Mirena 4-8 weeks post partum after vaginal delivery<br>|
| Experimental: Post-Placental Mirena Insertion<br>Will receive Mirena insertion within 10 minutes of delivery of placenta | Device: Post-Placenta Mirena Insertion<br>* Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mirena in Place | Proportion of women in each arm with Mirena in place at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mirena Expulsion | The percentage of patients with post-placental placement of Mirena who experience an expulsion | 6 weeks | 
| Uterine Perforation | The proportion of patients in each arm who experience a uterine perforation | 6 months | 
| Intrauterine Infection | The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Postnatal care