Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial

NCT ID: NCT01272960

Last Updated: 2017-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-12-31

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.

Conditions

Postpartum Period

Keywords

Contraception; Postnatal care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Interval Insertion

Will receive Mirena at 4-8 weeks post-partum after vaginal delivery.

Group Type: ACTIVE_COMPARATOR

Interval Insertion

Intervention Type: DEVICE

Insertion of Mirena 4-8 weeks post partum after vaginal delivery

Post-Placental Mirena Insertion

Will receive Mirena insertion within 10 minutes of delivery of placenta

Group Type: EXPERIMENTAL

Post-Placenta Mirena Insertion

Intervention Type: DEVICE

Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Interventions

Post-Placenta Mirena Insertion

Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Intervention Type: DEVICE

Interval Insertion

Insertion of Mirena 4-8 weeks post partum after vaginal delivery

Intervention Type: DEVICE

Eligibility Criteria

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

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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorie M Harper, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Barnes Jewish Hospital

St Louis, Missouri, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 16772190 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 7409230 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

SFP4-13

Identifier Type: -

Identifier Source: org_study_id