Mode
Text Size
Log in / Sign up
Phase 4 N=35 Randomized Prevention

Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding

Postpartum Contraception

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Breastfeeding — 10; 9 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Levonorgestrel-releasing intrauterine system (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
University of North Carolina, Chapel Hill
Primary completion
Jun 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Breastfeeding
10; 9
SECONDARY
LNG-IUS Expulsion or Removal
8; 0

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.

Eligibility Criteria

  • Women ages 18-45
  • Pregnant and equal to or more than 24 weeks of estimated gestational age
  • States an intent to breastfeed for at least 6 months
  • States a plan to use the LNG-IUS postpartum
  • Anticipates a vaginal delivery
  • HIV negative
  • Intend to stay in the Chapel Hill area for at least 6 months after birth
  • No medical or personal conditions which in the judgment of study staff preclude participation in the study
  • Have no allergies to any component of the LNG-IUS
  • No known uterine anomalies
  • Fluent in English
  • No history of ectopic pregnancy
  • No known or suspected carcinoma of the breast
  • No known acute liver disease or liver tumor (benign or malignant)
  • No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear
  • No active pelvic inflammatory disease
  • No known hypersensitivity to any component of the LNG-IUS
  • No genital bleeding of unknown etiology
  • No history of solid organ transplantation

Additional eligibility criteria for entry into the randomized trial, as assessed postpartum

  • No endometritis or chorioamnionitis
  • Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes)
  • No fever greater than or equal to 38°C during the intrapartum or postpartum period
  • Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding
  • Did not have a documented estimated blood loss of greater than 750mL intrapartum
  • Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage
  • Did not have a third or fourth degree laceration at delivery.
  • The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth
  • The infant must weigh at least 2727 grams
  • Must have been a singleton birth
  • Infant not in the intensive care nursery
  • The infant has not been diagnosed with a condition which would preclude long term feeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01555931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search