Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000501347
Ethics application status
Approved
Date submitted
13/08/2008
Date registered
30/09/2008
Date last updated
23/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Prophylactic Antibiotics for spontaneous prelabor rupture of membranes at term
Scientific title
Prophylactic antibiotics for spontaneous prelabor rupture of membranes at term to reduce early neonatal sepsis
Secondary ID [1] 262226 0
ASU2010
Universal Trial Number (UTN)
U1111-1122-0540
Trial acronym
PAST PROM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prelabor rupture of membranes at term 3550 0
Condition category
Condition code
Reproductive Health and Childbirth 3706 3706 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
prophylactic antibiotics
ampicillin/flucloxacillin
500 mg intravenously every 6 hours
started on admission till delivery
Intervention code [1] 3263 0
Prevention
Comparator / control treatment
The solvent of the antibiotic vial every 6 hours from admission till delivery
Control group
Placebo

Outcomes
Primary outcome [1] 4610 0
early neonatal sepsis diagnosed clinically and by laboratory markers of sepsis
Timepoint [1] 4610 0
at 1 week after randomisaton
Secondary outcome [1] 7779 0
maternal postpartum febrile morbidity diagnosed clinically
Timepoint [1] 7779 0
at 2 weeks after randomisation

Eligibility
Key inclusion criteria
spontaneous rupture of fetal membranes at 36 weeks gestation or beyond
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
chorioamnionitis
prolonged rupture of membranes >24

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment: opaque sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
15/01/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1640
Accrual to date
Final
Recruitment outside Australia
Country [1] 1152 0
Egypt
State/province [1] 1152 0

Funding & Sponsors
Funding source category [1] 3729 0
University
Name [1] 3729 0
Ain Shams University
Country [1] 3729 0
Egypt
Primary sponsor type
Individual
Name
Ashraf Nabhan
Address
50, Al-Khalifa Al-Mamoun street,
Roxi
Country
Egypt
Secondary sponsor category [1] 3346 0
Individual
Name [1] 3346 0
Amr El-Helaly
Address [1] 3346 0
Department of Obstetrics and Gynecology, Ain Shams University
Country [1] 3346 0
Egypt
Other collaborator category [1] 277663 0
Individual
Name [1] 277663 0
M Elkady Doaa Ahmed
Address [1] 277663 0
Department of Obstetrics and Gynecology, Ain Shams University, Cairo 11341, Egypt
Country [1] 277663 0
Egypt

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 28838 0
Prof Ashraf nabhan
Address 28838 0
Department of Obstetrics and Gynecology, Ain Shams University, Cairo 11341, Egypt
Country 28838 0
Egypt
Phone 28838 0
+20222595775
Fax 28838 0
Email 28838 0
[email protected]
Contact person for public queries
Name 11995 0
Ashraf Nabhan
Address 11995 0
50, Al-Khalifa Al-Mamoun street, Roxi
Country 11995 0
Egypt
Phone 11995 0
+20222595775
Fax 11995 0
Email 11995 0
[email protected]
Contact person for scientific queries
Name 2923 0
Ashraf Nabhan
Address 2923 0
50, Al-Khalifa Al-Mamoun street, Roxi
Country 2923 0
Egypt
Phone 2923 0
+20222595775
Fax 2923 0
Email 2923 0
[email protected]

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.