Early vs. Interval Postpartum IUD Insertion

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control Group

IUD placed 6-8 weeks postpartum (standard of care, interval placement)

Group Type OTHER

IUD

Intervention Type DEVICE

Postpartum IUD placement

Intervention Group

IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)

Group Type EXPERIMENTAL

IUD

Intervention Type DEVICE

Postpartum IUD placement

Interventions

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IUD

Postpartum IUD placement

Intervention Type DEVICE

Other Intervention Names

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Mirena, Kyleena, Skyla, Liletta, ParaGard

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes