View Clinical Trial (Medical Research Study)
A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
| City: |
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Little Rock |
| State: |
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Arkansas |
| Zip Code: |
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72205 |
| Conditions: |
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Contraception - Postpartum Period |
| Purpose: |
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The primary objective of the investigators study is to determine if there is a difference in
continuation rates at six months in women who are randomized to have the Levonorgestrel
Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as
after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks
postpartum).
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| Study Summary: |
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The control arm of our study will be women who are randomized to receive LNG-IUS in the
Interval time period. The study arm will consist of women randomized to receiving Immediate
placement.
The investigators hypothesize that Immediate placement of IUD in the postpartum period will
result in a 20% decrease in continuation rates at six months compared to Interval placement.
Secondary outcome measures that we will obtain include:
- Pain at the time of placement
- Postpartum Depression
- Breastfeeding status
- Postpartum weight retention
- Expulsion Rates
- Bleeding Profile
- Uterine Infection(Endometritis)
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| Criteria: |
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Inclusion Criteria:
- All women >37 weeks gestation who desire LNG-IUS for postpartum contraception who do
not have a contraindication as described below will be offered participation in 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 receiving these forms of
contraception in our study.
In addition the following intrapartum findings, the following would exclude the patient:
- Delivery <37 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 or
>1000cc for cesarean delivery)
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| NCT ID: |
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NCT01161095 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Little Rock, Arkansas 72205
United States
Everett F Magann, MD
Phone: 501-686-8345
Email: efmagann@uams.edu
Site Status: Not yet recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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