title: A randomized trial of levonorgestrel intrauterine system insertion 6 to 48 h compared to 6 weeks after vaginal delivery; lessons learned.
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.
authors.affiliation: Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7570. Electronic address: gstuart@med.unc.edu.
authors.forename: Gretchen S
authors.initials: GS
authors.lastname: Stuart
authors.affiliation: Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, 27599.
authors.forename: Catherine R
authors.initials: CR
authors.lastname: Lesko
authors.affiliation: Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7570; Department of Maternal and Child Health, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, 27599.
authors.forename: Alison M
authors.initials: AM
authors.lastname: Stuebe
authors.affiliation: Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7570.
authors.forename: Amy G
authors.initials: AG
authors.lastname: Bryant
authors.affiliation: Department of Obstetrics & Gynecology and Women's Health, Albert Einstein School of Medicine, Bronx, New York.
authors.forename: Erika E
authors.initials: EE
authors.lastname: Levi
authors.affiliation: Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599-7570.
authors.forename: Antoinette I
authors.initials: AI
authors.lastname: Danvers
mesh_terms: D000328:Adult; D001942:Breast Feeding; D003271:Contraceptive Agents, Female / Q000627:therapeutic use*; D036861:Delivery, Obstetric; D020878:Device Removal / Q000706:statistics & numerical data*; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007433:Intrauterine Device Expulsion; D007436:Intrauterine Devices, Medicated; D016912:Levonorgestrel / Q000627:therapeutic use*; D049590:Postpartum Period; D013997:Time Factors
chemical_list: D003271:Contraceptive Agents, Female; D016912:Levonorgestrel
keywords: Contraception; Family planning; Intrauterine device; Levonorgestrel; Postpartum