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Completed

NCT Number: NCT01555931

Postpartum Levonorgestrel-releasing Intrauterine System and Breastfeeding

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina Women's Hospital

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Levonorgestrel-releasing intrauterine system

Drug

Placement within 48 hours of delivery

Other names: Mirena

Primary outcomes

  1. Breastfeeding

    Time frame: 6 months

    Reported any breastfeeding at the final 6 month visit

Secondary outcomes

  1. LNG-IUS Expulsion or Removal

    Time frame: up to 6 months

    Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Acronym: PPIUD1

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 16, 2012
Registry last updated
Aug 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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