Estimating Rates of Expulsion
Conditions
Keywords
Mirena, postplacental intrauterine device, postpartum insertion
Brief summary
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.
Detailed description
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.
Interventions
levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol
Sponsors
MaineHealth
Rebecca Hunt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Mirena IUD placement
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Expelled IUDs by12 Weeks Postpartum | up to 12 weeks postpartum | Number of participants who expelled IUDs by12 weeks postpartum across all participants |
Participant flow
Pre-assignment details
Only 4 subjects were consented out of the 20. Of those 4 only 3 had the IUD inserted.
Participants by arm
| Arm | Count |
|---|---|
| Mirena IUD Placement Immediately Post-delivery Subjects to have Mirena IUD Placement Immediately Post-delivery | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Mirena IUD Placement Immediately Post-delivery |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Number of Participants Who Expelled IUDs by12 Weeks Postpartum
Number of participants who expelled IUDs by12 weeks postpartum across all participants
Time frame: up to 12 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirena IUD Placement Immediately Post-delivery | Number of Participants Who Expelled IUDs by12 Weeks Postpartum | 1 Participants |