Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding
NCT ID: NCT01555931
Last Updated: 2014-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
61 participants
INTERVENTIONAL
2012-03-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Immediate
Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system
Placement within 48 hours of delivery
Control
Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system
Placement within 48 hours of delivery
Interventions
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Levonorgestrel-releasing intrauterine system
Placement within 48 hours of delivery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Pregnant and equal to or more than 24 weeks of estimated gestational age
3. States an intent to breastfeed for at least 6 months
4. States a plan to use the LNG-IUS postpartum
5. Anticipates a vaginal delivery
6. HIV negative
7. Intend to stay in the Chapel Hill area for at least 6 months after birth
8. No medical or personal conditions which in the judgment of study staff preclude participation in the study
9. Have no allergies to any component of the LNG-IUS
10. No known uterine anomalies
11. Fluent in English
12. No history of ectopic pregnancy
13. No known or suspected carcinoma of the breast
14. No known acute liver disease or liver tumor (benign or malignant)
15. No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear
16. No active pelvic inflammatory disease
17. No known hypersensitivity to any component of the LNG-IUS
18. No genital bleeding of unknown etiology
19. No history of solid organ transplantation
Additional eligibility criteria for entry into the randomized trial, as assessed postpartum
1. No endometritis or chorioamnionitis
2. Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes)
3. No fever greater than or equal to 38°C during the intrapartum or postpartum period
4. Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding
5. Did not have a documented estimated blood loss of greater than 750mL intrapartum
6. Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage
7. Did not have a third or fourth degree laceration at delivery.
8. The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth
9. The infant must weigh at least 2727 grams
10. Must have been a singleton birth
11. Infant not in the intensive care nursery
12. The infant has not been diagnosed with a condition which would preclude long term feeding
18 Years
45 Years
FEMALE
No
Sponsors
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Society of Family Planning
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Gretchen Stuart, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of North Carolina Women's Hospital
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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11-1786
Identifier Type: -
Identifier Source: org_study_id
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