Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

Study Overview
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Brief Summary
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The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization? The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.

Official Title
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Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

Conditions
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Contraception

Intervention / Treatment
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* Device: Paragard
* Drug: Mirena


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age ≥ 18 Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement English or Spanish speaking Willing to attend 2 follow-up visits Exclusion Criteria: Multiple gestations Delivery prior to 35 weeks gestational age Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper) Cesarean delivery Postpartum hemorrhage (estimated blood loss > 500 mL) Chorioamnionitis Abnormal uterine anatomy (including uterine anomaly or large fibroids) Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test Current cervical cancer or carcinoma in situ Current breast cancer Wilson's disease If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mirena Group<br>Women who have a postplacental Mirena IUD placed. (LNG-IUS) | Drug: Mirena<br>* The IUD will be placed as part of standard clinical care.<br>* Other names: LNG-IUS, IUD;|
| Paragard Group<br>Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) | Device: Paragard<br>* The IUD will be placed as part of standard clinical care.<br>* Other names: T380A IUD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD Expulsion Rate | The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm. | 3 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated. | 6 weeks | 
| Pregnancy | A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated. | 3 months | 
| Complications | A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported. | 3 months | 
| Satisfaction | A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants. | 3 months | 
| Intrauterine Device Expulsion (Day 1) | Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound. | Day 1 | 
| Intrauterine Device Expulsion (6 Weeks) | Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound. | 6 weeks | 
| Intrauterine Device Expulsion by 12 Weeks Postpartum | Position of the IUD within the uterus will be documented by ultrasound. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postplacental IUD placement, LNG-IUS