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Norwegian Adenomyosis Study I (NAPPED I)

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ClinicalTrials.gov Identifier: NCT02201719
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Helse Sor-Ost
Information provided by (Responsible Party):
Tina Tellum, Oslo University Hospital

Brief 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


Condition or disease
Adenomyosis

Detailed 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.


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I
Study Start Date : July 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Group/Cohort
Hysterectomy Adenomyosis
Adenomyosis present
Hysterectomy no adenomyosis
Adenomyosis not present



Primary Outcome Measures :
  1. Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%) [ Time Frame: within 4 weeks after 3D TVU ]
    Sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis compared to MRI.


Secondary Outcome Measures :
  1. Positive and negative predictive value of 3D TVU in percent (%) [ Time Frame: within 17 weeks after 3D TVU ]
    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.

  2. Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%) [ Time Frame: within 17 weeks after 3D TVU ]
    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).

  3. 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 ]
    Compares measurements of junction zone made by 3D TVU and MRI.

  4. Prevalence of sub- and infertility, percent (%) [ Time Frame: at time of enrollment ]
    Questionnaire-based investigation. Prevalence of sub- and infertility in their medical history of the study population.

  5. Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%) [ Time Frame: within 17 weeks after 3D TVU ]
    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.

  6. Prevalence of miscarriages, in percent (%) [ Time Frame: at time of enrollment ]
    Questionnaire-based investigation. Prevalence of miscarriages in the medical history of the study population.

  7. Prevalence of previous gynecological surgeries, in percent (%) [ Time Frame: at time of enrollment ]
    Questionnaire-based investigation. Prevalence of previous gynecological surgical interventions in the medical history of the study population.

  8. Prevalence of previous obstetrical complications, in percent (%) [ Time Frame: menarche to time of enrollment ]
    Questionnaire-based investigation. Prevalence of previous obstetrical complications in the medical history of the study population.



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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women referred to our clinic and volunteering to participate and that are registrated in Norway with a norwegian social security number.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201719


Locations
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Norway
Department of Gynecology, Oslo University Hospital Ullevål
Oslo, Norway, 0382
Sponsors and Collaborators
Oslo University Hospital
Helse Sor-Ost
Investigators
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Principal Investigator: Marit Lieng, PhD, MD Oslo University Hospital, Ullevål

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tina Tellum, Medical Doctor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02201719     History of Changes
Other Study ID Numbers: 2014/637a
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Tina Tellum, Oslo University Hospital:
Adenomyosis
Dysmenorrhea
Chronic pelvic pain
Infertility
Sensitivity histology
womens health
junction zone

Additional relevant MeSH terms:
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Adenomyosis
Uterine Diseases
Genital Diseases, Female