Contraception
Conditions
Keywords
Long-Acting Reversible Contraception, Contraceptive Agents, Therapeutic Uses, Contraceptive Agents, Female, Reproductive Control Agents, Pharmacologic Actions, Levonorgestrel
Brief summary
The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.
Interventions
DEVICELevonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Placement of Mirena at given intervals during the postpartum period
Sponsors
United States Naval Medical Center, Portsmouth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine questioning at their 36-38 week prenatal appointment or upon admission to labor and delivery are eligible for our study.
Exclusion criteria
* Contraindications to the LNG-IUS include: Pregnancy or suspicion of pregnancy, Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity, Postpartum endometritis within the past 3 months, Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear, untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections, acute liver disease or liver tumor, hypersensitivity to any component of the product, known or suspected carcinoma of the breast. Any of these conditions would exclude the patient from our study. * Delivery \<36 weeks * Intrapartum chorioamnionitis (defined as maternal fever \>100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid * Postpartum Hemorrhage (defined as \>500cc EBL for spontaneous vaginal delivery) * Cesarean delivery if randomized to IPP or EP placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuation Rates of the LNG-IUS when placed postpartum at three time periods | at 6 months | Determine if there is a difference in continuation rates at 6 months between participants who had the LNG-IUS placed at three different time periods: Immediate Postplacental (within 10 minutes from delivery of placenta), Early Postpartum (after 10 minutes but before 48 hours postpartum) , and Interval (after 6 weeks postpartum). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expulsion rate of the LNG-IUS when placed postpartum at three time periods | at 3 weeks | Determine if there is a difference in expulsion rates at the three different time periods of placement. |
| Pain at placement | at 1 minute | Determine if there is a difference pain as assessed with the Visual Analog Scale at the time of placement of the LNG-IUS at three time period: Immediate Postplacental, Early Postpartum, or Interval. |
Countries
United States
Outcome results
None listed