Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery

Study Overview
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Brief Summary
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This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.

Detailed Description
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The United States (US) has the highest unintended pregnancy rate of any developed country. Of the 6.4 million pregnancies in the US each year, almost half are unintended (49%). Roughly half of these (22% of all pregnancies) result in unintended births, while 20% of all pregnancies result in abortion. Postpartum women are particularly susceptible, with an unintended pregnancy rate of 10%-44% in the first year postpartum. These unintended pregnancies occur despite the recommendation that a contraceptive method be selected prior to hospital discharge. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The IUD is a highly effective but underused method of postpartum contraception. Although the expulsion rate in postplacental insertion is higher than interval insertion, the benefits of highly effective contraception available immediately after delivery may outweigh the risks of expulsion. To date, there have been no randomized trials of postplacental insertion of the LNG-IUD in the United States. One pilot study in the United States of 20 subjects who received an ultrasound-guided postplacental insertion of the LNG-IUD showed an acceptable expulsion rate of 10% and no infections over a 10-week follow-up, thus making postplacental insertion of LNG-IUD safe for further study. This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. One hundred sixty-eight women receiving prenatal care at Magee-Womens Hospital, Pittsburgh, PA, who are interested in using the LNG-IUD for contraception will be enrolled during their pregnancy. The IUD will be inserted within 10 minutes after delivery of the placenta in women randomized to immediate insertion. Delayed IUD insertion will be performed at the first postpartum visit in 6-8 weeks. All subjects will follow up in person at 6-8 weeks and 6 months after delivery. A telephone interview will occur at 3 months after delivery for all subjects. Subjects who are not eligible for insertion due to post-randomization ineligibility criteria will be referred to their primary gynecologist or midwife for delayed IUD placement. They will be contacted by phone at 3 and 6 months to assess quality of life, contraceptive usage, and unintended pregnancy rates.

Official Title
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Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery

Conditions
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Contraception

Intervention / Treatment
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* Device: Levonorgestrel-releasing IUD (Mirena)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years Greater than or equal to 24 0/7 weeks pregnant at time of enrollment Anticipates undergoing a vaginal delivery Desires to use the LNG-IUD (Mirena) for postpartum contraception Willing and able to sign an informed consent in English Willing to comply with the study protocol Exclusion Criteria: Planning to undergo a scheduled cesarean section Allergy to either polyethylene or levonorgestrel or other contraindications to use of the LNG-IUD Exposure to or treatment for gonorrhea, chlamydia, or trichomoniasis during the pregnancy Presence of one or more leiomyomata greater than 3 centimeters in diameter Uterine anomaly (other than a repaired septate uterus) Current cervical cancer or carcinoma in-situ Desires repeat pregnancy within one year of delivery

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Postplacental IUD insertion<br>immediate postplacental levonorgestrel-releasing IUD (Mirena) insertion | Device: Levonorgestrel-releasing IUD (Mirena)<br>* levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years<br>* Other names: Mirena;|
| Active Comparator: Delayed IUD insertion<br>delayed levonorgestrel-releasing IUD (Mirena) insertion (6-8 weeks after delivery) | Device: Levonorgestrel-releasing IUD (Mirena)<br>* levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years<br>* Other names: Mirena;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD Usage Rate at 6 Months | Usage rate of the LNG-IUD at 6 months after delivery | 6 months after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement |  | 6 months | 
| Follow-up Rates for Delayed Insertion of LNG-IUD |  | 6 months | 
| Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography |  | 6 months | 
| Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates |  | 6 months | 
| Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum, contraception, postplacental IUD, intrauterine devices