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Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial (MISTIC)

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ClinicalTrials.gov Identifier: NCT01272960
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Postpartum Period
Interventions Device: Post-Placenta Mirena Insertion
Device: Interval Insertion
Enrollment 53
Recruitment Details  
Pre-assignment Details 53 participants were enrolled but only 29 randomized.
Arm/Group Title Interval Insertion Post-Placental Mirena Insertion
Hide Arm/Group Description

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

Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Will receive Mirena insertion within 10 minutes of delivery of placenta

Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Period Title: Overall Study
Started 14 15
Completed 14 15
Not Completed 0 0
Arm/Group Title Interval Insertion Post-Placental Mirena Insertion Total
Hide Arm/Group Description 14 subjects received Mirena at 4-8 weeks post-partum after vaginal delivery. 15 received Mirena insertion within 10 minutes of delivery of placenta Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
15
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
26.1  (4.6) 26.9  (4.2) 26.6  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
14
 100.0%
15
 100.0%
29
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14 15 29
Number of pregnancies at viable gestational age  
Measure Type: Number
Unit of measure:  Pregnancies
Number Analyzed 14 participants 15 participants 29 participants
3 6 9
1.Primary Outcome
Title Mirena in Place
Hide Description Proportion of women in each arm with Mirena in place at 6 months
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Post Placental Mirena Insertion Interval Insertion
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 15 14
Measure Type: Number
Unit of Measure: participants
10 3
2.Secondary Outcome
Title Mirena Expulsion
Hide Description The percentage of patients with post-placental placement of Mirena who experience an expulsion
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interval Insertion Post-Placental Mirena Insertion
Hide Arm/Group Description:

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

Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Will receive Mirena insertion within 10 minutes of delivery of placenta

Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
0 0
3.Secondary Outcome
Title Uterine Perforation
Hide Description The proportion of patients in each arm who experience a uterine perforation
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interval Insertion Post-Placental Mirena Insertion
Hide Arm/Group Description:

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

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

Will receive Mirena insertion within 10 minutes of delivery of placenta

Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title Intrauterine Infection
Hide Description The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interval Insertion Post-Placental Mirena Insertion
Hide Arm/Group Description:

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

Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Will receive Mirena insertion within 10 minutes of delivery of placenta

Post-Placenta Mirena Insertion: Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta

Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Interval Insertion Post Placental Mirena Insertion
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Interval Insertion Post Placental Mirena Insertion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Interval Insertion Post Placental Mirena Insertion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      1/15 (6.67%)    
Infections and infestations     
Infection  [1]  0/14 (0.00%)  0 1/15 (6.67%)  1
Indicates events were collected by systematic assessment
[1]
One LNG-IUS was removed in the immediate insertion group and not replaced due to a systemic Group B streptococcus infection diagnosed within 6-weeks post-partum.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interval Insertion Post Placental Mirena Insertion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/15 (0.00%)    
Inability to recruit and randomize our target sample size, to detect rare adverse events that may be associated with immediate insertion, women randomized to immediate insertion were more likely to return for their 6-month string check visit.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lorie Harper
Organization: University of Alabama School of Medicine
Phone: 205-975-0515
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01272960     History of Changes
Other Study ID Numbers: SFP4-13
First Submitted: January 6, 2011
First Posted: January 10, 2011
Results First Submitted: May 16, 2016
Results First Posted: December 2, 2017
Last Update Posted: December 2, 2017