Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length
Condition: Dysmenorrhea; Heavy Menstrual Bleeding; Contraception
MeSH terms: Menorrhagia; Dysmenorrhea
Study type: Interventional

Summary: 
      To determine if uterine cavity length on transabdominal pelvic ultrasound corresponds to
      uterine cavity length at time of IUD insertion. If transabdominal pelvic ultrasound is
      validated as a tool for measuring uterine cavity length, it can be used to guide physicians
      and subsequently patients in IUD insertion planning.
    

Detailed description: 
      Levonogesterel (progestin only) IUDs have been used in the adult population for decades and
      due to their safety and efficacy are now successfully used in the nulliparous and adolescent
      population for menstrual regulation, dysmenorrhea, and contraception. IUDs have the highest
      continuation rate among teens of all forms of contraception at 12 months (86%). IUDs reduce
      menstrual flow by 90% 12 months post insertion, decrease menstrual cramp severity, and have
      greater than 99% effective contraception. All of this make IUDs an attractive option for our
      teens and their caregivers

      At time of IUD insertion, a uterine sound is used to measure the cavity length. A sound is a
      rigid instrument that is placed inside the uterus to directly measure the uterine cavity
      length and is the standard first step prior to IUD insertion. The cavity length will
      ultimately determine the type and size of IUD that can be placed. Two manufacturers, Mirena ®
      and Sklya ® are currently being used in clinical practice. Mirena requires uterine cavity
      length between 6-10 cm and Sklya requires 4-8 cm length. To determine this length requires a
      pelvic exam and the use of uterine sound, however, approximately 50% of our patient
      population is unable to tolerate pelvic exams due to a variety of factors, such as
      developmental disabilities or pain. Thus, this requires patients to go under general
      anesthesia to have their IUD placed. The goal of this study is to determine if the actual
      uterine cavity length corresponds to the transabdominal measurement of the uterine cavity
      length.

      Uterine size is largely under the influence of estrogen and as an adolescent progresses
      through puberty the dimensions of the uterus change. Given that a large portion of families
      seeking menstrual suppression & regulation present relatively close to menarche (mean age of
      12.3 years old) there is a precedent for an institutional standard for pre-IUD insertion
      transabdominal ultrasound to ensure the uterus is of sufficient caliber

      Prior research has focused on those undergoing intra-operative placement of a Mirena IUD. In
      one retrospective chart review of 56 adolescent patients with developmental disabilities,
      there was a 3.7% (2/56) failure rate of intra-operative IUD placement (abandoned IUD
      insertion in the operating room after anesthesia administration). One failure was due to the
      pelvimetry of the child and the other was due to a uterine cavity length of 4cm which was
      deemed insufficient for the Mirena IUD. In addition, two other patients had a uterus sound to
      less than 6 (5cm and 5.5cm) and Mirena was inserted anyways (Skyla was not available). About
      half of these patients had a pre-operative transabdominal US of the pelvis and the total
      uterine length was measured with an average length of 8.3cm. All uterine cavities were
      measured intra-op with an average length of 7.4cm.

      Ultimately, all prior research has measured the length of the full uterus (uterine fundus,
      body of the uterus, and cervix) which is not representative of the measurement in question
      for IUD placement, the uterine cavity length. We propose a prospective cohort pilot study to
      compare transabdominal ultrasound measurements with uterine sound measurements to determine
      uterine cavity length. If these measures correlate, transabdominal US could be a validated
      pre-insertion tool for the physician and patient to avoid unnecessary anesthetic events and
      have appropriate IUDs available for insertion.
    

Intervention name(s): Transabdominal Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): Transabdominal Ultrasound
Intervention model: Single Group Assignment
Intervention model description: Patients who are clinically undergoing intrauterine device (IUD) placement will be consecutively studied
Masking: None (Open Label)
Primary purpose: Diagnostic