Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001472268
Ethics application status
Approved
Date submitted
29/08/2018
Date registered
3/09/2018
Date last updated
8/11/2022
Date data sharing statement initially provided
15/01/2019
Date results information initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Diagnostic accuracy of PremaQuick in detection of preterm labor in symptomatic women.
Scientific title
Diagnostic accuracy of PremaQuick in detection of preterm labor in symptomatic women.
Secondary ID [1] 295937 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm labor 309442 0
Condition category
Condition code
Reproductive Health and Childbirth 308285 308285 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pregnant women with singleton pregnancy, intact membranes, between 24-36 weeks+6, presented with regular uterine contractions lasting at least 30 seconds and occurring at least four times per 30 minutes with significant cervical changes on digital examination (cervical dilatation less than 3 cm, cervical effacement less than or equal 50%) will constitute the study group. After complete history and abdominal examination, laboratory investigation will be done according to the hospital protocols.
Examination of the studied women using sterile speculum (no lubricants and/or antiseptics) for cervico-vaginal fluid sampling and PremaQuick test before the trans-vaginal assessment of the cervical length and before digital vaginal examination. The cervico-vaginal fluid sampling followed by trans-vaginal cervical length and digital vaginal examination.
Studied women will be managed according to the hospital protocol depending on the results of the PremaQuick test, trans-vaginal cervical length and the clinical findings.
Follow-up of the studied women will be done weekly in the obstetrics outpatients` clinic after discharge from the hospital until delivery.
The main outcome measures; the accuracy of the PremaQuick test in detection of preterm labor in symptomatic women presented with threatened preterm labor.

Duration of the intervention 3 minutes and the cervico-vaginal sampling will be done by the registrar on-call or by the head nurse of the obstetric ward under supervision of the registrar on-call.
Intervention code [1] 312262 0
Diagnosis / Prognosis
Comparator / control treatment
Women admitted to the hospital without symptoms of preterm labor before 37 weeks` for monitoring due to intrauterine growth retardation or control of diabetes and/or hypertension with pregnancy will constitute the controls.
Control group
Active

Outcomes
Primary outcome [1] 307256 0
Preterm labor as assessed by PremaQuick test
Timepoint [1] 307256 0
6 months post-testing
Secondary outcome [1] 351293 0
None
Timepoint [1] 351293 0
None

Eligibility
Key inclusion criteria
Inclusion criteria includes; Pregnant women with singleton pregnancy, intact membranes, between 24-36 weeks+6, presented with regular uterine contractions lasting at least 30 seconds and occurring at least four times per 30 minutes with significant cervical changes on digital examination (cervical dilatation less than 3 cm, cervical effacement less than or equal 50%).
Minimum age
20 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes; pregnant women equal or more than 37 weeks, twins or triplets, dilated cervix equal or more than 3 cm, rupture of fetal membranes, congenital fetal anomalies or intra uterine fetal demise or ante-partum hemorrhage.

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
Accuracy of the PremaQuick test in detection of preterm labor in symptomatic women presented with threatened preterm labor will detected after calculation of the sensitivity: is the proportional detection of individuals with the disease of interest in the population.
Specificity: is the proportional detection of individuals without the disease of interest in the population.
Positive predictive value (PPV): is the proportion of all individuals with positive tests, who have the disease. Negative predictive value (NPV): is the proportion of all individuals with negative tests who are non-diseased.
Sensitivity = true positive / true positive + false negative X 100
Specificity = true negative / true negative + false positive X 100
Positive predictive value = True positive / (True positive + false positive) X 100
Negative predictive value = True negative / (True negative + false negative) X 100
Accuracy = True positive + true negative / (True positive + true negative + false positive + false negative) X 100

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2019
Actual
4/06/2019
Date of last participant enrolment
Anticipated
7/10/2019
Actual
1/06/2020
Date of last data collection
Anticipated
13/04/2020
Actual
2/08/2020
Sample size
Target
250
Accrual to date
Final
244
Recruitment outside Australia
Country [1] 20813 0
Kuwait
State/province [1] 20813 0
Ahmadi hospital, Ahmadi, Kuwait.
Country [2] 21471 0
Kazakhstan
State/province [2] 21471 0
Aktobe, Kazakhastan

Funding & Sponsors
Funding source category [1] 300535 0
Hospital
Name [1] 300535 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Country [1] 300535 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] 300019 0
Individual
Name [1] 300019 0
Ibrahim A. Abdelazim
Address [1] 300019 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country [1] 300019 0
Kuwait
Secondary sponsor category [2] 302696 0
University
Name [2] 302696 0
West Kazakhastan Medical University
Address [2] 302696 0
Maresyev Street. postcode 030012, Aktobe, Kazakhastan
West Kazakhastan Medical University, Aktobe, Kazakhastan
Country [2] 302696 0
Kazakhstan
Other collaborator category [1] 280688 0
Individual
Name [1] 280688 0
Svetlana Shikanova
Address [1] 280688 0
Maresyev Street. postcode 030012, Aktobe, Kazakhastan
West Kazakhastan Medical University, Aktobe, Kazakhastan
Country [1] 280688 0
Kazakhstan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301328 0
Head of the Obstetrics, and Gynecology department, Ahmadi hospital, Kuwait.
Ethics committee address [1] 301328 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 301328 0
Kuwait
Date submitted for ethics approval [1] 301328 0
08/07/2018
Approval date [1] 301328 0
10/07/2018
Ethics approval number [1] 301328 0

Summary
Brief summary
This study will include women with threatened preterm labor between 24-36 weeks+6 in the study group and women without preterm labor as controls (women without symptoms of preterm labor before 37 weeks` admitted for monitoring).
Examination of the studied women using sterile speculum for cervico-vaginal fluid sampling and PremaQuick test before the trans-vaginal assessment of the cervical length and before digital vaginal examination.
The cervico-vaginal fluid sampling followed by trans-vaginal cervical length and digital vaginal examination for cervical assessment regarding; its consistency, position, effacement and cervical dilatation.
Studied women will be managed according to the results of the PremaQuick test, trans-vaginal cervical length and the clinical findings.
Follow-up of the studied women will be done weekly in the obstetrics outpatients` clinic after discharge from the hospital until delivery to detect the accuracy of the PremaQuick test in detection of preterm labor.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3056 3056 0 0
/AnzctrAttachments/375894(v29-08-2018-01-20-12)-PremaQuick in detection of PTL Protocol.doc (Protocol)
Attachments [2] 3059 3059 0 0
/AnzctrAttachments/375894(v29-08-2018-01-23-29)-Departmental Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 86634 0
Prof Ibrahim A. Abdelazim
Address 86634 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 86634 0
Kuwait
Phone 86634 0
+965-66551300
Fax 86634 0
Email 86634 0
[email protected]
Contact person for public queries
Name 86635 0
Prof Ibrahim A. Abdelazim
Address 86635 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 86635 0
Kuwait
Phone 86635 0
+965-66551300
Fax 86635 0
Email 86635 0
[email protected]
Contact person for scientific queries
Name 86636 0
Prof Ibrahim A. Abdelazim
Address 86636 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 86636 0
Kuwait
Phone 86636 0
+965-66551300
Fax 86636 0
Email 86636 0
[email protected]

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-by line data collected from each patient.
When will data be available (start and end dates)?
Start date 4/3/2019
End date 9/3/2020
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Only to achieve 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?




Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.