Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length
Primary Purpose
Dysmenorrhea, Heavy Menstrual Bleeding, Contraception
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transabdominal Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Dysmenorrhea
Eligibility Criteria
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:
- US never performed
- Mullerian anomaly
Sites / Locations
- Children's Mercy Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Transabdominal Ultrasound
Arm Description
All patients enrolled will undergo a transabdominal ultrasound at a specified time point as outlined in the protocol.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04425577
First Posted
June 8, 2020
Last Updated
February 24, 2023
Sponsor
Children's Mercy Hospital Kansas City
1. Study Identification
Unique Protocol Identification Number
NCT04425577
Brief Title
Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length
Official Title
Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysmenorrhea, Heavy Menstrual Bleeding, Contraception
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients who are clinically undergoing intrauterine device (IUD) placement will be consecutively studied
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transabdominal Ultrasound
Arm Type
Other
Arm Description
All patients enrolled will undergo a transabdominal ultrasound at a specified time point as outlined in the protocol.
Intervention Type
Diagnostic Test
Intervention Name(s)
Transabdominal Ultrasound
Intervention Description
Transabdominal Ultrasound
Primary Outcome Measure Information:
Title
Quantify Temporal Relationship between Transabdominal Ultrasound and Uterine Sound
Description
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
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
This is for intrauterine device placement so all participants must have a uterus.
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
US never performed
Mullerian anomaly
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashli Lawson, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie Strickland, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27386754
Citation
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.
Results Reference
background
PubMed Identifier
24315712
Citation
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.
Results Reference
background
PubMed Identifier
15970247
Citation
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.
Results Reference
background
PubMed Identifier
16873036
Citation
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.
Results Reference
background
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Ultrasound Evaluation Versus Direct Measurement of Uterine Cavity Length
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