Objective: Evaluate uterine contraction features (frequency, amplitude, direction, and coordination) using a dedicated speckle-tracking algorithm by 2D transvaginal ultrasound measurement in postmenopausal women presenting with vaginal bleeding or…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Menopause related conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
The primary outcomes investigated were the following uterine contraction
features on TVUS:
Frequency, in contractions per minute
Amplitude (unitless)
Direction, in median velocity (from Cervix to Fundus or Fundus to Cervix)
Coordination, unitless (via mean squared error, or cross correlation)
Secondary outcome
Secondary endpoints:
- Histopathological diagnosis based on histopathological examination (benign
vs. malignant)
- TNM classification of gynaecological malignancy if applicable
- 1-year survival and treatment outcomes
- Hormonal status
Background summary
It is known that uterine contractions are heavily influenced by hormonal
activity and changes during the menstrual cycle in women of fertile age.
Uterine contraction activity thus has different characteristics and behaviour
in each phase of the menstrual cycle which correspond to varying hormone
levels. Furthermore, it is becoming generally accepted that women with benign
uterine disorders experience abnormal uterine contractions. This includes women
with intracavitary lesions such as endometrial polyps or placental remnants.
After menopause, in concordance with loss of ovarian function and the eventual
drop in gonadotrophic factors, uterine contractions are quiescent, with little
to no contraction activity.
However, no data are available on uterine contractions in (pre)malignant
conditions of the female genital tract. With this study we aim to study an
objective characterisation of uterine contraction activity in women presenting
with postmenopausal vaginal bleeding and ovarian tumours, and link this to
clinical and pathological outcomes. We hypothesise that uterine contraction
activity in women with gynaecological malignancies may play an important (but
as yet unresearched) role in the development and behaviour of gynaecological
malignancies.
Study objective
Objective: Evaluate uterine contraction features (frequency, amplitude,
direction, and coordination) using a dedicated speckle-tracking algorithm by 2D
transvaginal ultrasound measurement in postmenopausal women presenting with
vaginal bleeding or ovarian tumour
Study design
Study design and setting:
Single-centre observational prospective cohort study carried out in the
outpatient gynaecology department of the Catharina Hospital in Eindhoven, the
Netherlands.
Study burden and risks
The TVUS is part of the standard work-up at our clinic of patients presenting
with the aforementioned symptoms, and thus poses no added risk.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
Group 1:
- Age >18 years
- Postmenopausal: lack of menstrual cycle for >1 year
- Symptoms vaginal bleeding
Group 2:
- Age >18 years
- Diagnosis of ovarian tumour or mass
Exclusion criteria
- Mental disability
- Significant language barrier
- History of hysterectomy
- Uterine anomalies (congenital or not congenital)
- Uterine pathologies (leiomyomas, adenomyosis, endometriosis)
- Caesarean section in the past,
- Endometrial ablation in the past,
- Presence of IUD
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80268.100.22 |