Early vs. Interval Postpartum IUD Insertion

Study Overview
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Brief Summary
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Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women who desire intrauterine contraception after delivery. A two-week postpartum visit could be a convenient time for women to receive contraception, including IUDs. Offering women IUDs at two-weeks postpartum may decrease the risk of undesired pregnancy and rapid repeat pregnancy. This study will compare IUD insertion at two different times after delivery: two-weeks and six-weeks postpartum. This will allow researchers to assess whether the timing of IUD placement affects whether an IUD is expelled, or pushed out of it's ideal location.

Detailed Description
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The purpose of this study is to determine the proportion of IUDs inserted in the Early Postpartum (EPP) period that are expelled at 6 months postpartum. This prospective, multi-site randomized trial will enroll approximately 404 women at three large academic hospitals in the United States. Women will be recruited who are interested in receiving a levonorgestrel-IUD or a copper-IUD after delivery. Postpartum women who desire an IUD will be randomized to EPP IUD insertion (between 14-28 days PP) or interval postpartum IUD insertion (42-56 days PP) and the proportion of IUDs expelled will be compared between groups at 6 months postpartum. All women will be seen in clinic at 6-8 weeks and 6 months postpartum. Women randomized to EPP IUD placement will be seen at 2-3 weeks postpartum. Provider perspectives of EPP IUD placement will also be evaluated, as will whether these attitudes change after 6 to 9 months of providing early postpartum IUDs.

Official Title
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Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial

Conditions
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Contraception

Intervention / Treatment
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* Device: IUD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gave birth less than or equal to 10 days ago Desires to use an IUD for Contraception (either copper or levonorgestrel) Willing and able to sign an informed consent Willing to comply with the study protocol Age greater than or equal to 18 years English or Spanish speaking Exclusion Criteria: Uterine anomaly or leiomyomata which would not allow placement of an IUD Desire for repeat pregnancy in less than 6 months Evidence of intrauterine infection (chorioamnionitis or postpartum endometritis) treated with antibiotics Ruptured uterus at the time of delivery Received a postpartum tubal ligation or immediate postpartum IUD or implant at delivery Incarcerated women or women with significant cognitive impairment 4th degree perineal laceration sustained at delivery Any medical contraindication to IUD per the US Centers for Disease Control (CDC) Medical Eligibility Criteria Suspicion for new pregnancy

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>IUD placed 6-8 weeks postpartum (standard of care, interval placement) | Device: IUD<br>* Postpartum IUD placement<br>* Other names: Mirena, Kyleena, Skyla, Liletta, ParaGard;|
| Experimental: Intervention Group<br>IUD placed 2-4 weeks postpartum (early postpartum placement, EPP) | Device: IUD<br>* Postpartum IUD placement<br>* Other names: Mirena, Kyleena, Skyla, Liletta, ParaGard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With an IUD Expulsion (Complete) at 6 Months | Complete IUD expulsion will be defined as an IUD which no longer in the uterus on speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use | 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Using an IUD at 6 Months | IUD utilization will be defined as intrauterine use of an IUD at 6 months postpartum. A speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use | 6 months postpartum | 
| Proportion of Participants With an IUD Expulsion (Partial) at 6 Months | Partial IUD expulsions will be diagnosed in any participant found to have an IUD in which part of the body of the IUD is noted to be coming through the external cervical os on speculum exam. | 6 months | 
| Proportion of Participants With a Pelvic Infection Within 6 Months | Pelvic infection requiring antibiotics will be ascertained by patient report and/or medical record review. | 6 months | 
| Patient Satisfaction With IUD Assessed on a Five-point Likert Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement | Participants are asked how much they agree with the statement I am satisfied with using this IUD. Answers are valued 1-5, with 1 Strongly Agree, 2 Agree, 3 Neutral, 4 Disagree, and 5 Strongly Disagree. 1=Strongly Agree is considered the best outcome, 5=Strongly disagree is considered the worst outcome. Outcome reported is those who were very satisfied or satisfied. | 6 months | 
| Proportion of Participants With an IUD Perforation at 6 Months | IUD perforations through the uterus will be diagnosed when an IUD visible is not visible on transvaginal ultrasound of the uterus but is visible on x-ray of the abdomen or pelvis. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirena, ParaGard, Skyla, Liletta, Kyleena, Intrauterine Device, Intrauterine System, Postpartum, Expulsion