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Trial registered on ANZCTR


Registration number
ACTRN12619000191190
Ethics application status
Approved
Date submitted
11/01/2019
Date registered
11/02/2019
Date last updated
14/05/2019
Date data sharing statement initially provided
11/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Interleukin-6 bed side test in diagnosing sub-clinical chorioamnionitis in women with rupture of fetal membranes
Scientific title
Chorioquick® (Interleukin-6) bed side test in diagnosing sub-clinical chorioamnionitis in women with rupture of fetal membranes
Secondary ID [1] 297035 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ruptured Fetal Membranes 311018 0
Chorioamnionitis 311019 0
Condition category
Condition code
Reproductive Health and Childbirth 309666 309666 0 0
Fetal medicine and complications of pregnancy
Infection 310009 310009 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The diagnosis of ruptured fetal membranes based on patient’s history, confirmed by visualization of fluid passing from the cervical canal during sterile speculum examination, positive ferning pattern and/or positive nitrazine test and trans-abdominal ultrasound to measure the amniotic fluid index.
The gestational age will be calculated from the first day of last menstrual period and confirmed by early ultrasound scan (less than 20 weeks gestation).
Patients included in this study will be subjected to standard examination, abdominal ultrasound, sterile speculum examination to detect pooling of the amniotic fluid and for collection of the cervical-vaginal fluid using the sterile swab provided in the Chorioquick kits.
Then the non-invasive Chorioquick bed side test (Biosynex S.A., Strasbourg) used for assessment of the interleukin-6 in the cervico-vaginal secretions by the labor ward nursing staff. The Result of the Chorioquick bed side test will be detected within 10 minutes.
Pregnancy for women with ruptured fetal membranes usually terminated at 34 weeks or at development of the clinical signs of chorioamnionitis necessitate termination of pregnancy.
Clinical signs and standard tests of chorioamnionitis necessitate termination of pregnancy include; uterine tenderness, maternal leucocytosis, positive C reactive proteins, pro-calcitonin and leucocyte esterase (laboratory tests repeated twice weekly throughout the conservative treatment of the studied women).
Chorioquick will be performed on cervico-vaginal secretions on admission and repeated weekly throughout the admission and the conservative management of all women (non-randomized study) admitted with ruptured fetal membranes less than 34 weeks till the development of the clinical signs of chorioamnionitis necessitate termination of pregnancy or the spontaneous labor pains.
Within 48 hours after delivery, placenta, umbilical cord and fetal membranes samples will be obtained for histologic microscopic examination for detection of chorioamnionitis.
Presence of inflammatory cells in the samples taken for histologic examination indicate chorioamnionitis. Multiple foci of polymorph nuclear leukocytes (more than or equal 5) in the sub-chorionic fibrin indicate grade 2 inflammation, which is a sensitive indicator of culture-proven amniotic infection (gold standard and the cut-off for chorioamnionitis).
Chorioquick results will be compared by the results of the histologic examination of the samples collected within 48 hours after delivery (gold standard) to evaluate the non-invasive Chorioquick bed side test in diagnosing sub-clinical chorioamnionitis in women with ruptured fetak membranes less than 34 weeks.
Intervention code [1] 313314 0
Diagnosis / Prognosis
Comparator / control treatment
All participants will receive a Choriquick test and histologic examination, where the histologic examination is the comparator treatment"
Control group
Active

Outcomes
Primary outcome [1] 318638 0
Chorioquick results will be compared by the results of the histologic examination of the samples collected within 48 hours after delivery (gold standard) to evaluate the non-invasive Chorioquick test in diagnosing chorioamnionitis.
True positive = True positive Chorioquick test similar to positive histologic examination of the samples after delivery for chorioamnionitis.
False positive = positive Chorioquick test for chorioamnionitis and negative histologic examination of the samples after delivery for chorioamnionitis.
True negative = negative Chorioquick test and negative histologic examination of the samples after delivery for chorioamnionitis.
False negative test = negative Chorioquick test and positive histologic examination of the samples after delivery for chorioamnionitis.
Primary outcome measures the sensitivity of the Chorioquick test = True positive ÷ True positive + False negative x 100
Timepoint [1] 318638 0
Weekly until discharge from the hospital.
Primary outcome [2] 318991 0
Specificity of the Chorioquick test = True negative ÷ True negative + False positive x 100
Timepoint [2] 318991 0
Weekly until discharge from the hospital.
Primary outcome [3] 318992 0
Accuracy of the Chorioquick test = True positive + True negative ÷ True positive + True negative + False positive + False negative x 100
Timepoint [3] 318992 0
Weekly until discharge from the hospital.
Secondary outcome [1] 365557 0
Latency interval (time interval in days or weeks) between positive Chorioquick bed side test till the development of clinical chorioamnionitis tests necessitates termination of pregnancy during the conservative management of the cases with ruptured fetal membranes, which detected by using the data-linkage to medical records.


Timepoint [1] 365557 0
At discharge from the hospital

Eligibility
Key inclusion criteria
Inclusion criteria; women with ruptured fetal membranes more than 24 and less than 34 weeks without any clinical signs of chorioamnionitis (maternal fever, maternal tackycardia, uterine tenderness, maternal leucocytosis, positive C reactive proteins, pro-calcitonin and leucocyte esterase) admitted for conservative management.
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria; women with multiple pregnancies, less than 24 or more than 34 weeks` gestation, not sure of dates, on antibiotic, fetal compromise, preterm labor, bleeding, evident chorioamnionitis.

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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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] 21186 0
Kuwait
State/province [1] 21186 0
Ahmadi hospital, Ahmadi, Kuwait.

Funding & Sponsors
Funding source category [1] 301604 0
Hospital
Name [1] 301604 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address [1] 301604 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 301604 0
Kuwait
Primary sponsor type
Hospital
Name
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country
Kuwait
Secondary sponsor category [1] 301307 0
Individual
Name [1] 301307 0
Ibrahim A. Abdelazim
Address [1] 301307 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 301307 0
Kuwait

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302332 0
Ethical committee of Department of Obstetrics and Gynecology,
Ethics committee address [1] 302332 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 302332 0
Kuwait
Date submitted for ethics approval [1] 302332 0
02/12/2018
Approval date [1] 302332 0
09/12/2018
Ethics approval number [1] 302332 0

Summary
Brief summary
Women with ruptured fetal membranes more than 24 and less than 34 weeks without any clinical signs of chorioamnionitis admitted for conservative management will included in this study.
Patients included in this study will be subjected to sterile speculum examination for collection of cervico-vaginal secretions for assessment of the interleukin-6 in the cervico-vaginal secretions using the non-invasive Chorioquick bed side test. Chorioquick will be performed on admission and repeated weekly throughout the admission and the conservative management of women with ruptured fetal membranes till the development of the clinical signs of chorioamnionitis necessitate termination of pregnancy or the spontaneous labor pains.
Within 48 hours after delivery, placenta, umbilical cord and fetal membranes samples will be obtained for histologic microscopic examination for detection of chorioamnionitis.
Chorioquick results will be compared by the results of the histologic examination of the samples collected within 48 hours after delivery (gold standard) to evaluate the non-invasive Chorioquick bed side test in diagnosing sub-clinical chorioamnionitis in women with ruptured fetal membranes less than 34 weeks.

Trial website
None
Trial related presentations / publications
None
Public notes
None

Contacts
Principal investigator
Name 89850 0
Prof Ibrahim A. Abdelazim
Address 89850 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 89850 0
Kuwait
Phone 89850 0
+96566551300
Fax 89850 0
Email 89850 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 89851 0
Prof Ibrahim A. Abdelazim
Address 89851 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 89851 0
Kuwait
Phone 89851 0
+96566551300
Fax 89851 0
Email 89851 0
dr.ibrahimanwar@gmail.com
Contact person for scientific queries
Name 89852 0
Prof Ibrahim A. Abdelazim
Address 89852 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 89852 0
Kuwait
Phone 89852 0
+96566551300
Fax 89852 0
Email 89852 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?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Start date 3/3/2019
End date 5/4/2020
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Only to achive the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by principal investigator.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1023 0
Ethical approval
Citation [1] 1023 0
Link [1] 1023 0
Email [1] 1023 0
Other [1] 1023 0
Departmental Approval
Type [2] 1024 0
Study protocol
Citation [2] 1024 0
Link [2] 1024 0
Email [2] 1024 0
Other [2] 1024 0
Protocol
Type [3] 1288 0
Other
Citation [3] 1288 0
Link [3] 1288 0
Email [3] 1288 0
Other [3] 1288 0
Chorioquick test instruction for use
Summary results
No Results