Contraception
Conditions
Keywords
IUD placement, contraception, postpartum, intrauterine device, expulsion
Brief summary
This is randomized controlled trial designed for pregnant women who deliver vaginally at the University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted for postpartum contraception. After informed consent is obtained, eligible study participants will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10 minutes of delivery of the placenta following a normal vaginal delivery. The investigators seek to determine the expulsion rate and complication rate in subjects with IUD immediately after placental delivery compared to insertion at six weeks postpartum or later. The investigators hypothesize that immediate placement safe and has an acceptably low expulsion rate to merit earlier placement in the indigent population.
Detailed description
Unintended pregnancy occurs in nearly half of all pregnancies in the United States. There are many barriers to implementation of long-term reversible contraception in the immediate postpartum period. In our indigent population, a survey of patients showed that nearly 60% of patients who chose an IUD while admitted postpartum never returned for placement, placing them at risk for early repeat pregnancy. The intrauterine device is a safe and effective form of long-term reversible contraception when placed at 6 weeks postpartum or later with pregnancy rates of only 0.1%. The commercially available Mirena IUD contains levonorgestrel which is released slowly over five years, providing safe, reversible contraception and making menstrual flow much lighter. This randomized controlled trial will compare traditional placement at 6 weeks or more postpartum versus immediate post-placental placement. The investigators hypothesize that the expulsion rate of IUDs placed immediately postpartum will be acceptably low in an indigent population to still be cost effective. Studies from the world literature in Egypt and Mexico where IUDs are routinely placed immediately following placental delivery.support this hypothesis. A recent study published in 2010 by Chen et al. showed an approximately 24% expulsion rate. Six week postpartum IUD placement for contraception will be compared to immediate post-placental IUD placement, to determine whether immediate IUD insertion after delivery has an acceptably low rate of expulsion, infection, perforation and unintended pregnancy, and a high rate of retention, patient satisfaction, and maintenance of contraception.
Interventions
DEVICEMirena (levonorgestrel-releasing intrauterine system)
The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients must be 15- 45 years of age and received their prenatal care at the University of Louisville OB/GYN clinic 2. Planned vaginal delivery 3. Negative third trimester cultures for Gonorrhea and Chlamydia 4. Desire to use the IUD for contraception
Exclusion criteria
1. Uterine anomalies 2. Uterine or cervical neoplasia 3. Past or current breast cancer 4. Chorioamnionitis 5. Acute liver disease 6. Postpartum hemorrhage lasting greater than ten minutes or more than 500 mL blood loss 7. Received prenatal other than at the University of Louisville OB/GYN Clinic 8. Cesarean section
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IUD Expulsion Rate | 6 months | The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IUD Insertion 6 Weeks After Delivery Subjects randomized to interval placement will have their IUD placed in the office at six weeks postpartum or later. | 11 |
| Immediate Post-placental Insertion Subjects randomized to immediate post-placental placement within 10 minutes of delivery will have an IUD placed | 21 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | IUD expelled before month 6 | 0 | 2 |
| Overall Study | Lost to Follow-up | 10 | 17 |
| Overall Study | Physician Decision | 1 | 2 |
Baseline characteristics
| Characteristic | IUD Insertion 6 Weeks After Delivery | Immediate Post-placental Insertion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 21 Participants | 32 Participants |
| Region of Enrollment United States | 11 participants | 21 participants | 32 participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 32 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 21 |
| other Total, other adverse events | 0 / 11 | 0 / 21 |
| serious Total, serious adverse events | 0 / 11 | 0 / 21 |
Outcome results
Primary
IUD Expulsion Rate
The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.
Time frame: 6 months
Population: 0 participants were evaluable in the Arm IUD Insertion 6 Weeks After Delivery, as 0 participants received an IUD at 6 weeks, and 2 participants in the Arm Immediate Post-placental Insertion were evaluable, as there were only 2 participants that came back for a follow up appointment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IUD Insertion 6 Weeks After Delivery | IUD Expulsion Rate | 0 Participants |
| Immediate Post-placental Insertion | IUD Expulsion Rate | 2 Participants |