Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding (PPIUD1)

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01555931
First received: March 14, 2012
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Postpartum Contraception
Drug: Levonorgestrel-releasing intrauterine system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immediate vs. 4-8 Week Postpartum Levonorgestrel-releasing Intrauterine System Placement: A Randomized Clinical Trial (Short Title: PPIUD1)

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Breastfeeding [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: March 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate
Placement within 48 hours of delivery
Drug: Levonorgestrel-releasing intrauterine system
Placement within 48 hours of delivery
Other Name: Mirena
Active Comparator: Control
Placement 4-8 weeks after delivery
Drug: Levonorgestrel-releasing intrauterine system
Placement within 48 hours of delivery
Other Name: Mirena

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555931

Locations
United States, North Carolina
University of North Carolina Women's Hospital
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Society of Family Planning
Investigators
Principal Investigator: Gretchen Stuart, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01555931     History of Changes
Other Study ID Numbers: 11-1786
Study First Received: March 14, 2012
Last Updated: June 27, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on April 22, 2014