Monitoring With Ultrasound Imaging of Intrauterine Device (IUD) Position Placed Immediately After Giving Birth
Condition: Contraception; Postpartum
Study type: Observational

Summary: 
      Intrauterine devices (IUDs) are one of the most effective reversible forms of contraception,
      and are a good option in the postpartum period for women to avoid a rapid repeat pregnancy.
      IUDs can be placed immediately postpartum, after delivery of the placenta by either vaginal
      or cesarean birth. This practice has been shown to be safe, and is recommended by the
      American College of Obstetricians & Gynecologists, the World Health Organization and the U.S.
      Center for Disease Control. Immediate postpartum IUD placement has the advantage of providing
      contraception at a time that the woman is already accessing medical care, avoiding potential
      loss to follow up or risk of unintended pregnancy. Additionally, women who have anesthesia
      for delivery have reduced pain at the time of IUD placement compared to having the IUD placed
      at the postpartum follow up appointment. Immediate postpartum IUD placement is a relatively
      new practice in the US and little is known about the expected appearance of IUDs inside the
      uterus taken with an ultrasound when they have been placed at the time of delivery. It is
      less likely that IUD strings will be visible at the cervix after immediate postpartum IUD
      placement due to subsequent uterine involution, which makes it important to monitor correct
      positioning of the IUD via ultrasound. This study will document normal changes in the
      positioning of the IUD visualized via ultrasound, and determine if a correlation exists
      between IUD position and risk of expulsion. Ultrasound surveillance to document IUD position
      and distance from the fundus, will be performed at 6 weeks, 3 months and 12 months after
      placement. Symptoms of menstrual bleeding and pain will also be recorded in order to
      determine if they are correlated with IUD position.
    

Detailed description: 
      The goal of this study is to document the expected ultrasound appearance of intrauterine
      devices (IUDs) placed immediately postpartum. This practice has been shown to be safe and
      effective, but little is known about long-term follow up for IUDs placed in this setting.
      Because IUD strings will not be visualized for many patients after immediate postpartum IUD
      placement, sonographic imaging will likely be required for the majority of patients to
      determine expulsion. However, the ultrasound appearance of these IUDs, placed immediately
      after birth and before uterine involution, may be different than those IUDs placed outside of
      the postpartum period. To our knowledge no other study has documented expected ultrasound
      appearance of IUDs placed in the immediate postpartum period.

      The specific aims of this study are to: 1. document normal appearance of IUDs on ultrasound
      after immediate postpartum placement; 2. document if this appearance changes over time; and
      3. determine if location on ultrasound is associated with side effects or expulsion.

      Study design This is a prospective, observational study. All patients who have an IUD (either
      copper or levonorgestrel) placed immediately postpartum (within 10 minutes of delivery of
      placenta) after either Cesarean or vaginal delivery at Mount Sinai Medical Center and at
      Elmhurst Hospital Center will be eligible to participate in the study.

      Study visits will include a speculum exam for IUD string check at 6 weeks, and ultrasounds to
      evaluate IUD position at the following time points: 6-10 weeks following placement, 3 months
      following placement (with inclusion up to 6 months), and 12 months following placement (with
      inclusion up to 15 months).

      The ultrasound will document the following: size and position of uterus, IUD-Myometrium
      distance, IUD-endometrium distance, IUD-fundus distance and position of IUD. When
      participants present for the scheduled ultrasound visits, they will be asked to return with
      the completed symptom diary as well, to assess bleeding and pain.

      Study Endpoints IUD expulsion, removal, or completion of the 12-15 month follow up visit will
      be the study endpoints. The participant will be withdrawn from the study if IUD expulsion
      occurs, or if she requests IUD removal for any reason. Participants will also be able to
      withdraw from the study at any time if they no longer wish to participate, but they may keep
      their IUD in place if desired.

      Study procedures At the routine 6 week postpartum visit for all patients, pelvic and speculum
      exam will be performed as per normal clinical routine, and visualization of IUD strings at
      the cervical os will be documented. If IUD strings are not visualized, an ultrasound will be
      performed by the clinical provider to confirm presence or absence of IUD within the uterus.

      A formal ultrasound to evaluate IUD position will be scheduled in the FPA gynecologic
      ultrasound unit or in the Gynecology clinic at EHC at the following time points: 6-10 weeks
      following placement, 3 months following placement (with inclusion up to 6 months), and 12
      months following placement (with inclusion up to 15 months). The formal ultrasound will
      document the following: size and position of uterus, endometrial stripe (EMS) thickness,
      IUD-Myometrium distance, IUD-endometrium distance, IUD-fundus distance and position of IUD.

      Immediate postpartum placement of IUDs is a relatively new clinical practice in the United
      States; as such there is no recommended or "standard" follow up protocol in this situation.
      For IUDs placed outside of the postpartum period, the standard follow up is a string check
      (speculum exam to confirm presence of strings at cervical os) 2-6 weeks after IUD placement.
      If strings are not visible, or if the patient experiences symptoms concerning for expulsion,
      a transvaginal ultrasound will be performed. Once correct placement is confirmed by
      ultrasound, patients without visible strings generally have ultrasounds yearly to confirm
      placement. Based on this standard practice, patients with visible strings will have the
      ultrasound only for research purposes. Additionally, the three month ultrasound will be only
      for research purposes, even in those without visible strings.

      When participants present for the scheduled ultrasound visits, they will be asked to return
      with the completed symptom diary as well.
    

Intervention name(s): Immediate postpartum placement of IUD
Intervention type(s): Other
Intervention description(s): pelvic exam, transvaginal ultrasound (3 during the course of the study), bleeding and symptom diary
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from the group of women receiving prenatal care at Mount Sinai
        Hospital in New York City and Elmhurst Hospital in Queens. Patients who express an interest
        in an IUD for contraception after delivery will be given information about immediate
        postpartum IUDs and the study.
      
Keywords: Intrauterine devices; IUDs; postpartum; contraception