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Trial registered on ANZCTR


Registration number
ACTRN12618001891213
Ethics application status
Approved
Date submitted
14/11/2018
Date registered
21/11/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
21/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy of insulin-like growth factor binding protein-1/alpha-fetoprotein in diagnosing ruptured fetal membranes
Scientific title
Accuracy of insulin-like growth factor binding protein-1/alpha-fetoprotein (AmnioQuick Duo) in diagnosing ruptured fetal membranes
Secondary ID [1] 296592 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ruptured fetal membranes 310405 0
Condition category
Condition code
Reproductive Health and Childbirth 309120 309120 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inclusion criteria includes; pregnant women between 20-40 years old, diagnosed as preterm premature rupture of membranes (more than or equal 24 and less than 34 weeks admitted for conservative treatment) or premature rupture of membranes (more than or equal 34 and less than 39 weeks` admitted for delivery) as study group.
After thorough history, studied women will be examined by the gynaecologist on-call using trans-abdominal sonography for evaluation of the amniotic fluid index, followed by sterile vaginal speculum examination to detect leaking amniotic fluid and for collection of samples for fern, and/or nitrazine and AmnioQuick Duo test on admission.
In addition; maternal temperature and pulse rate, fetal hart rate will be checked by the maternity ward nurse, followed by specific laboratory investigations as; maternal total leucocyte count, C-reactive proteins and pro-calcitonin to exclude chorioamnionitis.
Studied women will be examined in Lithotomy position with proper illumination by the gynaecologist on-call for samples collection using sterile vaginal speculum. Sterile swabs will be used to collect the samples from the posterior vaginal fornix.
The first nitrazine yellow swab will be inserted for 15 seconds in the posterior vaginal fornix and then the colour of the swab will be checked.
The sample of the fluid collected from the posterior vaginal fornix using the second swab will be spreaded on a glass slide, creating a thin smear and will be examined by low power microscope (fern test).
Insulin growth factor binding-protein-1/ alpha fetoprotein (AmnioQuick Duo) will be done following the manufacturer's instructions. Third Nylon swab supplied in the AmnioQuick Duo (Biosynex, Strasbourg, France) kit package will be inserted in the posterior fornix of the vagina for 1 minute. Then, the swab will be removed, inserted into a unit dose vial containing solvent and rotated for 10 seconds into the solvent. Three drops of the extracted substance from the swab by the solvent will be dispensed into a round sample well of the test device. The result interpreted in 10 minutes. The test positive when both C and B lines present or when both A and C lines present. The test negative when both A and B lines absent. Test invalid when no visible purple band at line C.
The final diagnosis of whether the studied women had ruptured fetal membranes or not at the initial presentation will be made after delivery. After delivery, the recorded data of admission and delivery will be compared to evaluate the accuracy of the insulin-like growth factor binding protein-1/alpha-fetoprotein (AmnioQuick Duo) in diagnosing ruptured fetal membranes.
Intervention code [1] 312906 0
Diagnosis / Prognosis
Comparator / control treatment
Women admitted for control of blood pressure and/or diabetes with pregnancy more than or equal 24 and less than 39 weeks as control group.

Control group
Active

Outcomes
Primary outcome [1] 308098 0
Ruptured fetal membrane as assessed by AmnioQuick Duo
Timepoint [1] 308098 0
4 months
Secondary outcome [1] 353949 0
None
Timepoint [1] 353949 0
None

Eligibility
Key inclusion criteria
Inclusion criteria includes; pregnant women between 20-40 years old, diagnosed as preterm premature rupture of membranes (more than or equal 24 and less than 34 weeks admitted for conservative treatment) or premature rupture of membranes (more than or equal 34 and less than 39 weeks` admitted for delivery) as study group.
Minimum age
20 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes; rupture of membranes less than 24 weeks` or more than or equal 39 weeks` or prolonged rupture of membranes (more than 12 hours) or non-reassuring fetal cardio-tocography, multiple pregnancies, ante-partum hemorrhage, preterm labour and infection of fetal membranes (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
The required sample size will be calculated using G Power software version 3.17 for sample size calculation (Heinrich Heine Universität; Düsseldorf; Germany), setting the confidence interval at 5% and the level of confidence at 95%.

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] 21027 0
Kuwait
State/province [1] 21027 0
Department of Obstetrics and Gynecology, Ahmadi hospital, Ahmadi, Kuwait.
Country [2] 21028 0
Kazakhstan
State/province [2] 21028 0
Department of Obstetrics and Gynecology, Marat Ospanov, West Kazakhstan State Medical University, Kazakhstan

Funding & Sponsors
Funding source category [1] 301170 0
Hospital
Name [1] 301170 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait.
Address [1] 301170 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country [1] 301170 0
Kuwait
Funding source category [2] 301172 0
University
Name [2] 301172 0
Marat Ospanov, West Kazakhstan State Medical University (WKSMU), Aktobe, Kazakhstan
Address [2] 301172 0
RSE on REU West Kazakhstan Marat Ospanov State Medical University.
MH RK Republic of Kazakhstan, Aktobe, Maresyev Street 68.
Country [2] 301172 0
Kazakhstan
Primary sponsor type
Individual
Name
Ibrahim A. Abdelazim
Address
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.

Country
Kuwait
Secondary sponsor category [1] 300793 0
Individual
Name [1] 300793 0
Svetlana Shikanova
Address [1] 300793 0
RSE on REU West Kazakhstan Marat Ospanov State Medical University.
MH RK Republic of Kazakhstan, Aktobe, Maresyev Street 68.
Country [1] 300793 0
Kazakhstan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301914 0
Head of the Obstetrics, and Gynecology department of Ahmadi hospital, Kuwait
Ethics committee address [1] 301914 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Ethics committee country [1] 301914 0
Kuwait
Date submitted for ethics approval [1] 301914 0
09/10/2018
Approval date [1] 301914 0
23/10/2018
Ethics approval number [1] 301914 0
Ethics committee name [2] 301916 0
Head of the Obstetrics and Gynecology department, Marat Ospanov, West Kazakhstan State Medical University, Kazakhstan
Ethics committee address [2] 301916 0
RSE on REU West Kazakhstan Marat Ospanov State Medical University.
MH RK Republic of Kazakhstan, Aktobe, Maresyev Street 68.
Ethics committee country [2] 301916 0
Kazakhstan
Date submitted for ethics approval [2] 301916 0
09/10/2018
Approval date [2] 301916 0
23/10/2018
Ethics approval number [2] 301916 0

Summary
Brief summary
Pregnant women between 20-40 years old, diagnosed as preterm premature rupture of membranes or premature rupture of membranes will constitute the study group and women admitted for control of blood pressure and/or diabetes with pregnancy after more than or equal 24 and less than 39 weeks will constitute the control group.
After thorough history, studied women will be examined by trans-abdominal sonography (TAS) for evaluation of the amniotic fluid index, followed by sterile vaginal speculum examination to detect leaking amniotic fluid and for collection of samples for fern, and/or nitrazine and AmnioQuick® Duo test on admission.
The final diagnosis of whether the studied women had ruptured fetal membranes or not at the initial presentation will be made after delivery.

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

Contacts
Principal investigator
Name 88542 0
Prof Ibrahim A. Abdelazim
Address 88542 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 88542 0
Kuwait
Phone 88542 0
+96566551300
Fax 88542 0
Email 88542 0
dr.ibrahimanwar@gmail.com
Contact person for public queries
Name 88543 0
Prof Ibrahim A. Abdelazim
Address 88543 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 88543 0
Kuwait
Phone 88543 0
+96566551300
Fax 88543 0
Email 88543 0
dr.ibrahimanwar@gmail.com
Contact person for scientific queries
Name 88544 0
Prof Ibrahim A. Abdelazim
Address 88544 0
Ahmadi Hospital, Kuwait Oil Company (KOC), Kuwait, P.O. Box: 9758, 61008 Ahmadi, Kuwait.
Country 88544 0
Kuwait
Phone 88544 0
+96566551300
Fax 88544 0
Email 88544 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 2/12/2019
End date 2/6/2020
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?
Study protocol
Statistical analysis plan
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 232 0
Study protocol
Citation [1] 232 0
Link [1] 232 0
Email [1] 232 0
Other [1] 232 0
Type [2] 233 0
Ethical approval
Citation [2] 233 0
Link [2] 233 0
Email [2] 233 0
Other [2] 233 0
Summary results
No Results