A randomized trial of levonorgestrel intrauterine system insertion 6 to 48 h compared to 6 weeks after vaginal delivery; lessons learned

Contraception. 2015 Apr;91(4):284-8. doi: 10.1016/j.contraception.2014.12.009. Epub 2014 Dec 29.

Abstract

The objective of this randomized trial was to compare breastfeeding among women who received a levonorgestrel-releasing intrauterine system within 6-48 h (early) or 4-6 weeks (standard) after an uncomplicated vaginal birth. Analysis groups of 86 women in each arm were needed to demonstrate a 20% difference in any breastfeeding. Thirty-five women were randomized to the early (N=17) and standard (N=18) arms. The combination of unsuccessful placement (2/17; 12%), expulsions (7/17; 41%) and removals (3/17; 18%) reached 71% (12/17) in the early arm, so the study was stopped. In our small study cohort, levonorgestrel-releasing intrauterine system insertion between 6 and 48 h after vaginal birth was associated with a high rate of expulsion or removal soon after insertion.

Keywords: Contraception; Family planning; Intrauterine device; Levonorgestrel; Postpartum.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Breast Feeding
  • Contraceptive Agents, Female / therapeutic use*
  • Delivery, Obstetric
  • Device Removal / statistics & numerical data*
  • Early Termination of Clinical Trials*
  • Female
  • Humans
  • Intrauterine Device Expulsion*
  • Intrauterine Devices, Medicated*
  • Levonorgestrel / therapeutic use*
  • Postpartum Period*
  • Time Factors

Substances

  • Contraceptive Agents, Female
  • Levonorgestrel