Phase 4
N=35
Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding
Postpartum Contraception
Bottom Line
View on ClinicalTrials.gov: NCT01555931 ↗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
| Outcome | Result | p-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
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.