Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Postpartum Period
• Interventions: Device: Post-Placenta Mirena Insertion; Device: Interval Insertion

• Registration Number: NCT01272960
• Lead Sponsor: Washington University School of Medicine

Brief Summary

In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants. This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers which has already enrolled over 5,000 patients. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices.

We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placenta insertion focus on expulsion rates and do not report on symptoms and satisfaction rates.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2016-05-16
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Results First Posted: 2017-12-02
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

• 14-45 years
• Vaginal Delivery at Barnes-Jewish Hospital
• Sexually active with male partner
• No tubal ligation/hysterectomy
• Not currently using contraception
• Desire reversible contraception
• Reside in St. Louis City/County
• Requests Mirena(R) intrauterine device for contraception

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Exclusion Criteria

• Allergy to Mirena(R) system
• Cesarean delivery
• Cervical cancer, breast cancer
• Active liver disease
• Untreated cervicitis
• Uterine anomaly/fibroids preventing Mirena(R) placement
• Delivery <36 weeks
• Chorioamnionitis
• Prolonged rupture of membranes (>18 hours)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-Placental Mirena Insertion	Post-Placenta Mirena Insertion	Will receive Mirena insertion within 10 minutes of delivery of placenta
Interval Insertion	Interval Insertion	Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.

Primary Outcome Measures

Name	Time	Method
Mirena in Place	6 months	Proportion of women in each arm with Mirena in place at 6 months

Secondary Outcome Measures

Name	Time	Method
Uterine Perforation	6 months	The proportion of patients in each arm who experience a uterine perforation
Mirena Expulsion	6 weeks	The percentage of patients with post-placental placement of Mirena who experience an expulsion
Intrauterine Infection	6 months	The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States