Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-07

Study Completion Date

2011-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The investigators will compare the postplacental insertion expulsion rate estimate with rates reported in the literature for 6 week postpartum insertion, which is currently the American standard for IUD insertion postpartum. Secondary outcomes will also be examined; endometritis, uterine perforation, continuation and pregnancy among others.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement

NCT01598662

Contraception

TERMINATED NA

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

NCT00476021

Contraception

COMPLETED NA

Immediate Postplacental IUD Insertion

NCT02169869

Contraception

TERMINATED NA

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

NCT02067663

Contraception

COMPLETED

Bleeding Patterns and Complications After Postpartum IUD Placement: a Pilot Study

NCT01309919

Postpartum Period

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The average expulsion rate for 6 week postpartum IUD insertion is approximately 10-12% with a range between 3-20% at 1 year. An acceptable expulsion rate for postplacental insertion (PPI) has not been defined and varies between studies. There are limited data on the expulsion rates of levonorgestrel intrauterine systems. Expulsion rates range widely from 1-3% to as high as 30-40% depending on the IUD and the study. Studies report an average rate of expulsion in ranges approximating 10-12%, similar to 6 week insertion rates.

There are many limitations to published studies including the use of older model IUDs no longer in use, multiple insertion techniques that have been deemed ineffective in reducing expulsion rates as well as varying follow up times making comparison of expulsion rates difficult.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Estimating Rates of Expulsion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Mirena IUD placement

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mirena IUD Placement Immediately Post-delivery

Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks.

Group Type EXPERIMENTAL

Levonorgestrel Intrauterine Device

Intervention Type DEVICE

levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levonorgestrel Intrauterine Device

levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mirena

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age 18 or greater
* obstetric patient in greater Portland, ME area

Exclusion Criteria

* Evidence of chorioamnionitis (persistent fetal tachycardia, intra-partum fever \>38.0)
* prolonged rupture of membranes (greater than 24 hours)
* intrauterine fetal demise
* use of general anesthesia at time of delivery
* postpartum hemorrhage (\>500ml vaginal, \>1000ml cesarean)
* magnesium administration in labor due to HELLP syndrome or preeclampsia
* preterm delivery.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes