Overview

This trial is active, not recruiting.

Condition adenomyosis
Sponsor Oslo University Hospital
Collaborator Helse Sor-Ost
Start date July 2014
End date October 2016
Trial size 100 participants
Trial identifier NCT02201719, 2014/637a

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Adenomyosis present
Adenomyosis not present

Primary Outcomes

Measure
Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%)
time frame: within 4 weeks after 3D TVU

Secondary Outcomes

Measure
Positive and negative predictive value of 3D TVU in percent (%)
time frame: within 17 weeks after 3D TVU
Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%)
time frame: within 17 weeks after 3D TVU
Difference in max. thickness of junction zone, in millimeters (mm)
time frame: post ovulatory in any menstruational cycle prior to surgery, within 4 weeks after 3D TVU
Prevalence of sub- and infertility, percent (%)
time frame: at time of enrollment
Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%)
time frame: within 17 weeks after 3D TVU
Prevalence of miscarriages, in percent (%)
time frame: at time of enrollment
Prevalence of previous gynecological surgeries, in percent (%)
time frame: at time of enrollment
Prevalence of previous obstetrical complications, in percent (%)
time frame: menarche to time of enrollment

Eligibility Criteria

Female participants from 25 years up to 50 years old.

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

Additional Information

Official title Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I
Principal investigator Marit Lieng, PhD, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.