Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length

NCT04425577 | Completed DMC

• 1 other identifier: STUDY00001082
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysmenorrhea; Heavy Menstrual Bleeding; Contraception

Outcome Measures

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

  Within 60 days of enrollment

Study Arms (1)

Transabdominal Ultrasound

OTHER

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

Diagnostic Test: Transabdominal Ultrasound

Interventions

Transabdominal Ultrasound DIAGNOSTIC_TEST

Transabdominal Ultrasound

Transabdominal Ultrasound

Eligibility Criteria

• Age: 12 Years - 22 Years
• Gender Eligibility Details: This is for intrauterine device placement so all participants must have a uterus.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• IUD inserted between 12/1/19 and 12/1/20
• Received a transabdominal US of the uterus

You may not qualify if:

• US never performed
• Mullerian anomaly

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (4)

• 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.

  PMID: 27386754 BACKGROUND

• 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.

  PMID: 24315712 BACKGROUND

• 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.

  PMID: 15970247 BACKGROUND

• 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.

  PMID: 16873036 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Menorrhagia

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage

Study Officials

• Ashli Lawson, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

• Julie Strickland, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Patients who are clinically undergoing intrauterine device (IUD) placement will be consecutively studied

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: January 6, 2020
• Primary Completion: December 31, 2022
• Study Completion: February 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)