Trial Outcomes & Findings for Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial (NCT NCT01272960)
NCT ID: NCT01272960
Last Updated: 2017-12-02
Results Overview
Proportion of women in each arm with Mirena in place at 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
6 months
Results posted on
2017-12-02
Participant Flow
53 participants were enrolled but only 29 randomized.
Participant milestones
| Measure |
Interval Insertion
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
|
Post-Placental Mirena Insertion
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 Study
STARTED
|
14
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mirena Intrauterine System Timing of Insertion: A Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Interval Insertion
n=14 Participants
14 subjects received Mirena at 4-8 weeks post-partum after vaginal delivery.
|
Post-Placental Mirena Insertion
n=15 Participants
15 received Mirena insertion within 10 minutes of delivery of placenta
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 4.6 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
26.6 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Number of pregnancies at viable gestational age
|
3 Pregnancies
n=5 Participants
|
6 Pregnancies
n=7 Participants
|
9 Pregnancies
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsProportion of women in each arm with Mirena in place at 6 months
Outcome measures
| Measure |
Post Placental Mirena Insertion
n=15 Participants
|
Interval Insertion
n=14 Participants
|
|---|---|---|
|
Mirena in Place
|
10 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 6 weeksThe percentage of patients with post-placental placement of Mirena who experience an expulsion
Outcome measures
| Measure |
Post Placental Mirena Insertion
n=14 Participants
|
Interval Insertion
n=15 Participants
|
|---|---|---|
|
Mirena Expulsion
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsThe proportion of patients in each arm who experience a uterine perforation
Outcome measures
| Measure |
Post Placental Mirena Insertion
n=14 Participants
|
Interval Insertion
n=15 Participants
|
|---|---|---|
|
Uterine Perforation
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsThe proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)
Outcome measures
| Measure |
Post Placental Mirena Insertion
n=14 Participants
|
Interval Insertion
n=15 Participants
|
|---|---|---|
|
Intrauterine Infection
|
0 participants
|
0 participants
|
Adverse Events
Interval Insertion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Post Placental Mirena Insertion
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interval Insertion
n=14 participants at risk
|
Post Placental Mirena Insertion
n=15 participants at risk
|
|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lorie Harper
University of Alabama School of Medicine
Phone: 205-975-0515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place