Early Postpartum Intrauterine Device (IUD) Placement

• Proportion of subjects with an IUD at 3 months postpartum [ Time Frame: Three months after delivery ] [ Designated as safety issue: No ]
  Subjects will be contacted by phone or email at 3 months after delivery. The proportion of women who are randomized to each group (placement at either 3 weeks or 6 weeks) who report having an IUD in place at 3 months after delivery will be compared.
  
  

• Satisfaction with the timing of IUD placement. [ Time Frame: Immediately following IUD placement and at 3 months, 4 months and 6 months after delivery. ] [ Designated as safety issue: No ]
  Subjects will be asked to record their overall satisfaction with the timing of the IUD placement on a continuous 10 cm visual analog scale (VAS). The mean score in millimeters, as measured from the left end of the scale to a vertical hash mark placed on the 10 cm line by the subject, will be compared between the two randomization groups.
  
  
• Uterine thickness at the fundus [ Time Frame: At IUD placement and at 6 months after delivery ] [ Designated as safety issue: No ]
  Transvaginal ultrasound will be performed immediately following IUD placement and at 6 months after delivery. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in millimeters using an ultrasound caliper in the sagittal view. Other ultrasound measurements will be performed and compared between randomization groups including uterine width, cavity length, and the IUD-fundal distance. Details about breastfeeding and return of menses will be assessed as covariates.
  
  
• Proportion of subjects with an IUD at 6 months postpartum [ Time Frame: Six months after delivery ] [ Designated as safety issue: No ]
  Subjects will return to clinic for an ultrasound and exam at six months after delivery. The proportion of subjects with an IUD at this time will be compared between the two randomization groups.
  
  
• Number of subjects with adverse events [ Time Frame: Six months after delivery ] [ Designated as safety issue: Yes ]
  Subjects will be followed for 6 months each. Over the proposed 18 month study period, the number and proportion of subjects who experience adverse events including treatment for infection, IUD expulsion or IUD perforation will be assessed.
  
  
• Pain with IUD placement [ Time Frame: At the time of IUD placement. ] [ Designated as safety issue: No ]
  Subjects will draw a vertical hash mark on a 10 cm visual analog scale (VAS) at the time of IUD placement to indicate their current pain. The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups. Baseline pain and pain at other time points will be assessed as well to be used for comparison.
  
  

The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit. We will investigate whether they are more likely to return and to receive an IUD if the follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability, safety and efficacy will also be examined. This prospective, randomized, controlled trial will enroll approximately 240 women at our academic tertiary care hospital in the United States. Participants will be recruited from women who deliver a live-born singleton infant at greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine contraception. Subjects will choose to receive either a levonorgestrel-containing IUS (Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date. Women will be followed by phone contacts at 3 months and 4 months and will have a clinic visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the uterine size will be assessed at 6 months.