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Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding

Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postpartum Contraception

Intervention: Levonorgestrel-releasing intrauterine system (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of North Carolina, Chapel Hill

Official(s) and/or principal investigator(s):
Gretchen Stuart, MD, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill

Summary

This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.

Clinical Details

Official title: Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1)

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Breastfeeding

Secondary outcome: LNG-IUS Expulsion or Removal

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

1. Women ages 18-45 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

Locations and Contacts

University of North Carolina Women's Hospital, Chapel Hill, North Carolina 27599, United States
Additional Information

Starting date: March 2012
Last updated: August 21, 2014

Page last updated: August 23, 2015

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