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Trial registered on ANZCTR


Registration number
ACTRN12618000561280
Ethics application status
Approved
Date submitted
26/12/2017
Date registered
13/04/2018
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Relation between chronic endometritis and recurrent miscarriage
Scientific title
Relation between chronic endometritis and recurrent miscarriage
Secondary ID [1] 293649 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic endometritis 305936 0
Condition category
Condition code
Reproductive Health and Childbirth 305130 305130 0 0
Antenatal care
Reproductive Health and Childbirth 305131 305131 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Analysis of the hospital records over the last 5 years from January 2012 to January 2017 to identify women with unexplained recurrent miscarriage, after approval of the Obstetrics and Gynecology department of Ahmadi hospital. Inclusion criteria includes; women who will give consent, >20-40 years, with 3 or more miscarriages before 22 weeks’ gestation.
Studied women will go under diagnostic hysteroscopy in the follicular phase of the menstrual cycle, and endometrial biopsy for histological examination.
Studied women diagnosed with chronic endometritis during hysteroscopy will scheduled for endometrial biopsy in the follicular phase of the subsequent cycle, The endometrial biopsy will be cultured for the common infectious pathogens which include; Neisseria gonorrhea, Chlamydia trachomatis, Mycoplasma species, Ureaplasma urealyticum, and yeast at the endometrial levels.
Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Duration of observation for each studied woman will be 5 weeks,

Intervention code [1] 299910 0
Diagnosis / Prognosis
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304285 0
Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Studied women will go under diagnostic hysteroscopy in the follicular phase of the menstrual cycle, with thorough evaluation of the endometrial mucosa.
Chronic endometritis defined as demonstration of micro-polyps that fluctuate in the cavity, stromal edema, and focal or diffuse hyperemia.
The surgeon will take an endometrial biopsy from studied women with evidence of chronic endometritis during hysteroscopic examination for histological examination. Studied women diagnosed with chronic endometritis during hysteroscopy will scheduled for endometrial biopsy in the follicular phase of the subsequent cycle, for cultural, and histological examinations.
Endometrial samples were diluted in 2 ml of saline, and divided into 2 samples, one for cultures, and the other placed in formalin for histological examination.
Timepoint [1] 304285 0
Outcome measures; the relation between chronic endometritis and recurrent miscarriage.
Duration of observation for each studied woman will be 5 weeks,
Primary outcome [2] 304789 0
Causative organism for chronic endometritis using culture for the endometrial samples taken during hysteroscopy.
Timepoint [2] 304789 0
Results of endometrial culture takes about 3-5 days.
Secondary outcome [1] 341503 0
None
Timepoint [1] 341503 0
None

Eligibility
Key inclusion criteria
Patients and methods: Analysis of the hospital records over the last 5 years from January 2012 to January 2017 to identify women with unexplained recurrent miscarriage, after approval of the Obstetrics and Gynecology department of Ahmadi hospital.
Inclusion criteria includes; women who will give consent, >20-40 years, with 3 or more miscarriages before 22 weeks’ gestation.
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes; family history of RM, uterine abnormalities, hormonal or metabolic disorders, severe male factor infertility, previous surgery for myoma and/or endometriosis, clinical or ultrasound diagnosis of endometriosis, known clinical autoimmune disease, anti-phospholipid syndrome (APS), thrombophilic condition requiring anticoagulant therapy, and unwilling to give informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9454 0
Kuwait
State/province [1] 9454 0
Ahmadi hospital, Ahmadi, Kuwait.

Funding & Sponsors
Funding source category [1] 298266 0
Hospital
Name [1] 298266 0
Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
Address [1] 298266 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 298266 0
Kuwait
Primary sponsor type
Hospital
Name
Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
Address
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country
Kuwait
Secondary sponsor category [1] 297382 0
Individual
Name [1] 297382 0
Ibrahim A. Abdelazim
Address [1] 297382 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 297382 0
Kuwait
Secondary sponsor category [2] 297383 0
Individual
Name [2] 297383 0
Waheeb Naser
Address [2] 297383 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [2] 297383 0
Kuwait
Secondary sponsor category [3] 297384 0
Individual
Name [3] 297384 0
Mohannad AbuFaza
Address [3] 297384 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [3] 297384 0
Kuwait

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299268 0
Department of Obstetrics and Gynecology, Ahmadi hospital, Kuwait.
Ethics committee address [1] 299268 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 299268 0
Kuwait
Date submitted for ethics approval [1] 299268 0
18/12/2017
Approval date [1] 299268 0
25/12/2017
Ethics approval number [1] 299268 0

Summary
Brief summary
Background: A growing interest has been focused on the association between chronic endometritis (CE), and often asymptomatic inflammation of the endometrial lining and recurrent miscarriage (RM). Cicinelli et al, demonstrated that fluid hysteroscopy is a reliable technique for diagnosing chronic endometritis (CE) based on demonstrating specific signs such as micro polyps, stromal edema, and focal or diffuse hyperemia. Objectives: This prospective study designed to evaluate the relation between chronic endometritis, and recurrent miscarriage.
Analysis of the hospital records over the last 5 years from January 2012 to January 2017 to identify women with unexplained RM, after approval of the Obstetrics and Gynecology department of Ahmadi hospital. Inclusion criteria includes; women who will give consent, >20-40 years, with 3 or more miscarriages before 22 weeks’ gestation.
Studied women will go under diagnostic hysteroscopy in the follicular phase of the menstrual cycle. During, hysteroscopies the uterine cavity will be explored through the panoramic view, with thorough evaluation of the endometrial mucosa. Chronic endometritis defined as demonstration of micro-polyps that fluctuate in the cavity, stromal edema, and focal or diffuse hyperemia. The surgeon will take an endometrial biopsy from studied women with evidence of chronic endometritis during hysteroscopic examination for histological examination. Studied women diagnosed with chronic endometritis (CE) during hysteroscopy will scheduled for endometrial biopsy in the follicular phase of the subsequent cycle, The endometrial biopsy will be cultured for the common infectious pathogens which include; Neisseria gonorrhea, Chlamydia trachomatis, Mycoplasma species, Ureaplasma urealyticum, and yeast at the endometrial levels.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2299 2299 0 0
Attachments [2] 2305 2305 0 0

Contacts
Principal investigator
Name 79850 0
Prof Ibrahim A. Abdelazim
Address 79850 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79850 0
Kuwait
Phone 79850 0
+965-66551300
Fax 79850 0
Email 79850 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 79851 0
Prof Ibrahim A. Abdelazim
Address 79851 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79851 0
Kuwait
Phone 79851 0
+965-66551300
Fax 79851 0
Email 79851 0
dr.ibrahimanwar@gmail.com
Contact person for scientific queries
Name 79852 0
Prof Ibrahim A. Abdelazim
Address 79852 0
Address: Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 79852 0
Kuwait
Phone 79852 0
+965-66551300
Fax 79852 0
Email 79852 0
dr.ibrahimanwar@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Line-byline data collected from each participant.
When will data be available (start and end dates)?
Start date 8/5/2018
End date 1/7/2019
Available to whom?
Anyone who is wishes to access it.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
By what mechanism will data be made available?
Access subject to approvals by principal investigators.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Clinical study report
Ethical approval
Summary results
Not applicable