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CompletedNCT04425577Updated Feb 28, 2023

Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length

An interventional study of Transabdominal Ultrasound in Dysmenorrhea, Heavy Menstrual Bleeding and Contraception, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to female participants aged 12 Years to 22 Years. Per ClinicalTrials.gov, last updated 2023-02-28.

Sponsored by Children's Mercy Hospital Kansas City · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2020, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
12 Years to 22 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Dysmenorrhea
  • Heavy Menstrual Bleeding
  • Contraception
03

In context

Menorrhagia

182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.

This study's enrollment of 42 is below the median of 100 across 133 interventional studies indexed under Menorrhagia.

Browse Menorrhagia studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 22 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Females age 12 - 22 years old at time of transabdominal ultrasound whom are being considered for IUD placement as part of routine clinical care will be approached for inclusion in the study.
  • IUD inserted between 12/1/19 and 12/1/20
  • Received a transabdominal US of the uterus

Exclusion criteria

Exclusion Criteria:

  • US never performed
  • Mullerian anomaly
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Other
    Transabdominal Ultrasound

    All patients enrolled will undergo a transabdominal ultrasound at a specified time point as outlined in the protocol.

    Diagnostic Test: Transabdominal Ultrasound

Interventions

  • Diagnostic testTransabdominal Ultrasound

    Transabdominal Ultrasound

06

What researchers measure

Primary outcomes

  1. Quantify Temporal Relationship between Transabdominal Ultrasound and Uterine Sound

    To determine if uterine cavity length on ultrasound corresponds to uterine cavity length at time of IUD insertion

    Time frame: Within 60 days of enrollment

07

Study locations

1 site
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
08

References and documents

Publications

  • Usinger KM, Gola SB, Weis M, Smaldone A. Intrauterine Contraception Continuation in Adolescents and Young Women: A Systematic Review. J Pediatr Adolesc Gynecol. 2016 Dec;29(6):659-667. doi: 10.1016/j.jpag.2016.06.007. Epub 2016 Jul 4. PubMed 27386754 ↗
  • Savasi I, Jayasinghe K, Moore P, Jayasinghe Y, Grover SR. Complication rates associated with levonorgestrel intrauterine system use in adolescents with developmental disabilities. J Pediatr Adolesc Gynecol. 2014 Feb;27(1):25-8. doi: 10.1016/j.jpag.2013.08.010. Epub 2013 Dec 4. PubMed 24315712 ↗
  • Dizon CD, Allen LM, Ornstein MP. Menstrual and contraceptive issues among young women with developmental delay: a retrospective review of cases at the Hospital for Sick Children, Toronto. J Pediatr Adolesc Gynecol. 2005 Jun;18(3):157-62. doi: 10.1016/j.jpag.2005.03.002. PubMed 15970247 ↗
  • Lacy J. Clinic opinions regarding IUCD use in adolescents. J Pediatr Adolesc Gynecol. 2006 Aug;19(4):301-3. doi: 10.1016/j.jpag.2006.05.013. No abstract available. PubMed 16873036 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04425577
Lead sponsor
Children's Mercy Hospital Kansas City
Responsible party
Ashli Lawson (Physician, Children's Mercy Hospital Kansas City) — Principal investigator
First posted
Jun 11, 2020
Start date
Jan 6, 2020
Primary completion
Dec 31, 2022
Completion
Feb 1, 2023
Last update
Feb 28, 2023

Study contacts

Ashli Lawson, MD
principal investigator · Children's Mercy Hospital Kansas City
Julie Strickland, MD
principal investigator · Children's Mercy Hospital Kansas City

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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