Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
Condition: Contraception
Study type: Observational

Summary: 
      The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form
      of contraception. The postpartum period is an important moment for contraceptive
      intervention; however there are many barriers to women obtaining birth control postpartum.
      The use of the IUD in the immediate postpartum setting offers many advantages and is
      considered safe, but the risk of expulsion appears to be higher than with interval insertion.
      Previous studies have shown the rate of expulsion of the copper IUD in the postplacental
      period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel
      IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While
      studies related to the copper IUD use ring forceps or the operator's hand for placement of
      the IUD, the only published study investigating immediate postplacental levonorgestrel IUD
      insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore
      ask the question, is there a difference in expulsion rates between levonorgestrel and copper
      IUDs placed post-placentally when all providers undergo a standardized training, use a
      standardized insertion technique, and when patient level characteristics are controlled by
      randomization?

      The investigators propose to perform a prospective cohort trial comparing the rates of
      expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the
      uterus within 10 minutes of the delivery of the placenta, using a standardized technique
      (placement with a ring forceps or the operator's hand) after all providers undergo a formal
      didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has
      a higher rate of expulsion as compared to the copper IUD. Additional objectives include a
      comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized
      expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the
      investigators will document the natural history of the location of the IUD within the uterus
      when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks,
      and 3 months postpartum, to better understand the relationship between position of the IUD
      and subsequent expulsion.
    


Intervention name(s): Paragard; Mirena
Intervention type(s): Device; Drug
Intervention description(s): The IUD will be placed as part of standard clinical care.; The IUD will be placed as part of standard clinical care.
Other intervention name(s): T380A IUD; LNG-IUS, IUD
Intervention MeSH terms: Levonorgestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women interested in an immediate postpartum IUD, or those who recently had one placed, who
        are willing to be followed postpartum.
      
Keywords: Postplacental IUD placement; LNG-IUS