Early Postpartum Intrauterine Device (IUD) Placement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Versus Standard Interval Postpartum Intrauterine Device (IUD) Placement at 3 Weeks or 6 Weeks Following Delivery: A Prospective Randomized Trial

Conditions
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Contraception

Intervention / Treatment
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* Drug: Levonorgestrel IUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: Levonorgestrel IUS insertion at 3 weeks<br>IUD placement at 3 weeks after delivery. | Drug: Levonorgestrel IUS<br>* 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device<br>* Other names: Paragard IUD;|
| Experimental: Levonorgestrel IUS insertion at 6 weeks<br>IUD placement at 6 weeks after delivery. | Drug: Levonorgestrel IUS<br>* 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device<br>* Other names: Paragard IUD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) . | Three months after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | At the time of IUD placement. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum, Contraception, Intrauterine device, Intrauterine system, Mirena, Paragard, Uterine involution