Norwegian Adenomyosis Study I

Adenomyosis Clinical Trial

— NAPPED I  

Official title:

Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201719
• Other study ID #: 2014/637a
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: April 4, 2017
• Start date: July 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.

The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis.

Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized.

Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes.

Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology.

The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1.

NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis

Description:

Diagnosis of Adenomyosis with 3D and 2D transvaginal ultrasound. Prospective study of a consecutive series of 101 patients that are scheduled for hysterectomy and suffer from bleeding disorders, chronic pelvic pain, dysmenorrhea or dyspareunia. All patients will undergo transvaginal 2D- ultrasound, 3D-ultrasound and power doppler (PD)-ultrasound (TVU), magnetic resonance imaging of the pelvic organs (MRI) and hysterectomy.

We will investigate the specificity and sensitivity of 3D and 2D transvaginal ultrasound in the diagnosis of adenomyosis and compare data with MRI and histopathology, which is the gold standard by today. In addition, we will collect anamnestic information that might point to risk factors or connections to prior obstetrical complications and medicine use. In our study the pathologist will not be blinded to our ultrasound findings, and we want to investigate if this will raise the sensitivity of histology findings of adenomyosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• Premenopausal women aged 30 - 50 years old

• scheduled for vaginal, abdominal or laparoscopic total hysterectomy

• one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia

• junction zone definable

Exclusion Criteria:

• postmenopausal women,

• pregnancy

• gynecological cancer

• GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy

• junctional zone not identifiable

Related Conditions & MeSH terms

• Adenomyosis

Locations

Country	Name	City	State
Norway	Department of Gynecology, Oslo University Hospital Ullevål	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Helse Sor-Ost

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%)	Sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis compared to MRI.	within 4 weeks after 3D TVU
Secondary	Positive and negative predictive value of 3D TVU in percent (%)	Positive and negative predictive value of 3D TVU in diagnosis of adenomyosis. The histological examination is the end-point because it is still regarded to be the gold-standard in diagnosis of adenomyosis.	within 17 weeks after 3D TVU
Secondary	Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%)	The sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis will also be compared to 2D TVU, in addition to MRI (see primary outcome measure).	within 17 weeks after 3D TVU
Secondary	Difference in max. thickness of junction zone, in millimeters (mm)	Compares measurements of junction zone made by 3D TVU and MRI.	post ovulatory in any menstruational cycle prior to surgery, within 4 weeks after 3D TVU
Secondary	Prevalence of sub- and infertility, percent (%)	Questionnaire-based investigation. Prevalence of sub- and infertility in their medical history of the study population.	at time of enrollment
Secondary	Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%)	The sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis will also be compared to 2D TVU, in addition to MRI (see primary outcome measure) and histopathology, which is still the gold standard.	within 17 weeks after 3D TVU
Secondary	Prevalence of miscarriages, in percent (%)	Questionnaire-based investigation. Prevalence of miscarriages in the medical history of the study population.	at time of enrollment
Secondary	Prevalence of previous gynecological surgeries, in percent (%)	Questionnaire-based investigation. Prevalence of previous gynecological surgical interventions in the medical history of the study population.	at time of enrollment
Secondary	Prevalence of previous obstetrical complications, in percent (%)	Questionnaire-based investigation. Prevalence of previous obstetrical complications in the medical history of the study population.	menarche to time of enrollment