Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000117213
Ethics application status
Approved
Date submitted
7/02/2009
Date registered
18/02/2009
Date last updated
21/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Single deepest pocket versus amniotic fluid index to improve perinatal outcomes
Scientific title
Single deepest vertical pocket versus amniotic fluid index for pregnant women to improve perinatal outcomes
Secondary ID [1] 262227 0
ASU2009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perinatal morbidity 4283 0
Condition category
Condition code
Reproductive Health and Childbirth 3705 3705 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 4514 4514 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single deepest vertical pocket method for assessment of amniotic fluid volume using real time ultrasound. The sonographer measures the largest vertical diameter of a fluid pocket (not containing small fetal parts or loops of umbilical cord). The assessment will be performed at least one weekly from recruitment till delivery. The absence of a single 2 x 1 cm pocket will indicate decreased fluid volume
Intervention code [1] 3262 0
Diagnosis / Prognosis
Comparator / control treatment
amniotic fluid index method for assessment of amniotic fluid volume using real time ultrasound. The sonographer divides the uterine cavity into four quadrants. In each quadrant, the largest vertical diameter of a fluid pocket (not containing small fetal parts or loops of umbilical cord) is measured. The sum of these four measures provides a single value for the AFI. The assessment will be performed at least one weekly from recruitment till delivery. AFI <5 will indicate decreased fluid volume
Control group
Active

Outcomes
Primary outcome [1] 5392 0
umbilical cord pH <7.1 in an arterial blood sample after delivery of the fetus
Timepoint [1] 5392 0
immediately postpartum
Secondary outcome [1] 7778 0
length of stay in the neonatal intensive care unit as monitored by health care professionals
Timepoint [1] 7778 0
it will be monitored for up until 4 weeks postpartum.
Secondary outcome [2] 9062 0
neonatal admission to neonatal intensive care unit as indicated by health care professionals
Timepoint [2] 9062 0
it will be monitored for up until 4 weeks postpartum.

Eligibility
Key inclusion criteria
pregnant women in the third trimester
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
fetal anomalies

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central allocation (telephone)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer random number genrator using graphpad software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1850
Accrual to date
Final
Recruitment outside Australia
Country [1] 1151 0
Egypt
State/province [1] 1151 0

Funding & Sponsors
Funding source category [1] 4463 0
University
Name [1] 4463 0
Ain Shams University
Country [1] 4463 0
Egypt
Primary sponsor type
University
Name
Ain Shams University
Address
Ramses Street
Abbassia
Cairo
Country
Egypt
Secondary sponsor category [1] 4022 0
Hospital
Name [1] 4022 0
Galaa Teaching Hospital
Address [1] 4022 0
Al Galaa street
Ramses
Cairo
Country [1] 4022 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Amniotic fluid provides a supportive and protective environment for fetal development during pregnancy. A decreased amniotic fluid volume (oligohydramnios) can occur because of intrauterine growth restriction, pre-eclampsia or prolonged pregnancy. Many caregivers practice planned delivery by induction of labor or caesarean section after diagnosis of decreased amniotic fluid volume at term, to prevent an adverse pregnancy outcome. Ultrasonography is non-invasive and is used widely for the follow up of pregnancy. It can be used to determine amniotic fluid volume by measuring either the amniotic fluid index or single deepest vertical pocket. The aim of the current randomized clinical trial (RCT) is to compare the use of the amniotic fluid index with the single deepest vertical pocket measurement during pregnancy to prevent adverse pregnancy outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28837 0
Address 28837 0
Country 28837 0
Phone 28837 0
Fax 28837 0
Email 28837 0
Contact person for public queries
Name 11994 0
Ashraf Nabhan
Address 11994 0
Ali Fahmi kamel street, 16
Heliopolis,
Cairo, 11351
Country 11994 0
Egypt
Phone 11994 0
+20123317347
Fax 11994 0
Email 11994 0
[email protected]
Contact person for scientific queries
Name 2922 0
Ashraf Nabhan
Address 2922 0
Ali Fahmi kamel street, 16
Heliopolis,
Cairo, 11351
Country 2922 0
Egypt
Phone 2922 0
+20123317347
Fax 2922 0
Email 2922 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.