Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000209594
Ethics application status
Approved
Date submitted
10/02/2014
Date registered
4/03/2015
Date last updated
4/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cervical Cerclage as a Rescue Procedure after Progesterone Failure in Women with Progressive Cervical Shortening.
Scientific title
Cervical Cerclage as a Rescue Procedure for prevention of pre-term labor after Progesterone Failure in Women with Progressive Cervical Shortening.
Secondary ID [1] 284060 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-term labor 291115 0
Condition category
Condition code
Reproductive Health and Childbirth 291457 291457 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transvaginal sonographic screening to measure cervical length was done.Cases with sonographically detected short cervix during mid-trimester of pregnancy were given vaginal progesterone 200 mg/day and followed up weekly for cervical length for 4 weeks. Adherence to treatment is confirmed only by patients' verbal confirmation. If progressive shortening was detected; Mcdonald cervical cerclage suture was placed. The procedure is a 10 minutes procedure done under general anaesthesia in which a synthetic band is inserted and tied around the cervix as high as possible to close internal cervical os.
Intervention code [1] 288750 0
Prevention
Intervention code [2] 288751 0
Treatment: Surgery
Intervention code [3] 290349 0
Early detection / Screening
Comparator / control treatment
women without short cervix i.e. with negative screening followed up sonographically every 4 weeks without treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291438 0
gestational age on delivery.
Timepoint [1] 291438 0
end of pregnancy
Secondary outcome [1] 306773 0
nil
Timepoint [1] 306773 0
nil

Eligibility
Key inclusion criteria
nulliparous women, singleton pregnancy, spontaneously conceived, not on medications, not diabetic or hypertensive.
Minimum age
20 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
previous history of pre-term labor, abnormal sonographic findings like polyhydramnios, placenta previa or fetal anomalies.

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
subjects were recruited as a single group that underwent screening for cervical length. at this step subjects either had normal cervix and those were followed up without treatment, or had short cervix and those had vaginal progesterone therapy to prevent further shortening. On follow up those with short cervix initially either had stable cervical length on follow up or progressive shortening of the cervix and those only were offered cerclage.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
1/06/2011
Date of last participant enrolment
Anticipated
1/08/2013
Actual
1/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 5814 0
Egypt
State/province [1] 5814 0

Funding & Sponsors
Funding source category [1] 288684 0
Self funded/Unfunded
Name [1] 288684 0
Country [1] 288684 0
Primary sponsor type
Individual
Name
Elsayed Elbadawy Awad
Address
Shatby Maternity university hospital, Pour Saeed street, Alexandria, Egypt.
03312
Country
Egypt
Secondary sponsor category [1] 287393 0
None
Name [1] 287393 0
Address [1] 287393 0
Country [1] 287393 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290531 0
Alexandria Faculty of medicine ethical committee
Ethics committee address [1] 290531 0
Ethics committee country [1] 290531 0
Egypt
Date submitted for ethics approval [1] 290531 0
Approval date [1] 290531 0
15/03/2011
Ethics approval number [1] 290531 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46122 0
Prof ElSayed Elbadawi Awad
Address 46122 0
Shatby maternity university hospital, Pour Saeed street, Alexandria, Egypt, 03312.
Country 46122 0
Egypt
Phone 46122 0
+2 01222158654
Fax 46122 0
Email 46122 0
elsayedelbadawy@yahoo.com
Contact person for public queries
Name 46123 0
Mervat Sheikhelarab Elsedeek Omran.
Address 46123 0
Shatby maternity university hospital.
649 Elhoreya road, Janaklis, Alexandria.
03312
Country 46123 0
Egypt
Phone 46123 0
+2 03 5759915
Fax 46123 0
Email 46123 0
mervatsheikhelarab@yahoo.com
Contact person for scientific queries
Name 46124 0
Mervat Sheikhelarab Elsedeek Omran.
Address 46124 0
Shatby maternity university hospital.
649 Elhoreya road, Janaklis, Alexandria.
03312
Country 46124 0
Egypt
Phone 46124 0
+2 03 5759915
Fax 46124 0
Email 46124 0
mervatsheikhelarab@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.