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Trial registered on ANZCTR


Registration number
ACTRN12612000586819
Ethics application status
Approved
Date submitted
28/05/2012
Date registered
31/05/2012
Date last updated
14/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
SAFE-Study - Single deepest vertical pocket or Amnion Fluid index as Evaluation test for preventing adverse pregnancy outcome. A randomized multicenter trial.
Scientific title
Randomized multicenter study of amniotic fluid index in comparison with the single deepest vertical pocket measurement as a screening tool for decreased amniotic fluid volume in preventing adverse pregnancy outcome in singleton pregnancies at term and with vertex presentation
Secondary ID [1] 280568 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
amniotic fluid adequacy 286572 0
adverse pregnancy outcome 286581 0
Condition category
Condition code
Reproductive Health and Childbirth 286846 286846 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound measurement of amniotic fluid volume as regular part of antepartum assessment of fetal well-being is done by the SDP method.
In order to calculate the SDP, the largest vertical diameter of a fluid pocket (not containing small fetal parts or loops of umbilical cord) is measured by two perpendicular diameters.
Oligohydramnios is diagnosed if there was no SDP of 2 x 1 cm.
Once a patient was assigned to SDP arm, all subsequent assessments of amniotic fluid were done accordingly.
The amniotic fluid estimation used for this evaluation is the last volume within 3 days of delivery.
Intervention code [1] 284954 0
Early detection / Screening
Intervention code [2] 284969 0
Diagnosis / Prognosis
Comparator / control treatment
Ultrasound measurement of amniotic fluid volume as regular part of antepartum assessment of fetal well-being is done by the AFI method.
In order to calculate the AFI, the operator 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.
Oligohydramnios is diagnosed if the AFI was under 5.1 cm.
Once a patient was assigned to AFI arm, all subsequent assessments of amniotic fluid were done accordingly.
The amniotic fluid estimation used for this evaluation is the last volume within 3 days of delivery.
Control group
Active

Outcomes
Primary outcome [1] 287213 0
Admission to neonatal intensive care unit
Timepoint [1] 287213 0
Within 24 hours after birth
Secondary outcome [1] 297614 0
Number of perinatal deaths
Timepoint [1] 297614 0
Within one week of birth
Secondary outcome [2] 297615 0
Rate of diagnosis of oligohydramnios
Timepoint [2] 297615 0
Within 24 hours after birth
Secondary outcome [3] 297616 0
Umbilical artery pH less than 7.1
Timepoint [3] 297616 0
Within 24 hours after birth
Secondary outcome [4] 297617 0
Apgar score less than 7 at five minutes
Timepoint [4] 297617 0
5 minutes after birth
Secondary outcome [5] 297618 0
Visual presence of meconium stained amniotic fluid.
Meconium changes the colour in green.
Timepoint [5] 297618 0
Within 24 hours after birth
Secondary outcome [6] 297619 0
Non-reassuring fetal heart rate tracing assessed by cardiotocograph
Timepoint [6] 297619 0
Within 24 hours after birth
Secondary outcome [7] 297620 0
Induction of labor
Timepoint [7] 297620 0
At beginning of labor induction.
Secondary outcome [8] 297621 0
Assisted vaginal delivery without specified indication and for fetal distress
Timepoint [8] 297621 0
At beginning of operative delivery
Secondary outcome [9] 297622 0
rate of caesarean section
Timepoint [9] 297622 0
At beginning of operative delivery
Secondary outcome [10] 297623 0
Caesarean delivery for fetal distress
Timepoint [10] 297623 0
At beginning of operative delivery
Secondary outcome [11] 297624 0
Length of neonatal intensive care unit stay
Timepoint [11] 297624 0
At discharge from neonatal intensive care unit

Eligibility
Key inclusion criteria
singleton pregnancy at term greater than 259 days of gestation, vertex presentation
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Premature Rupture of Membranes (PROM), cases of structural or chromosomal malformation, intrauterine fetal death, twin pregnancy, primary cesarean delivery

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)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
30/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 4338 0
Germany
State/province [1] 4338 0

Funding & Sponsors
Funding source category [1] 285334 0
University
Name [1] 285334 0
University Medical Center Mannheim, Heidelberg University
Country [1] 285334 0
Germany
Primary sponsor type
Individual
Name
Sven Kehl
Address
University Medical Center Mannheim
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country
Germany
Secondary sponsor category [1] 284187 0
None
Name [1] 284187 0
Address [1] 284187 0
Country [1] 284187 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 34236 0
Dr Sven Kehl
Address 34236 0
University Medical Center Mannheim Department of Obstetrics and Gynecology Theodor-Kutzer-Ufer 1-3 68167 Mannheim
Country 34236 0
Germany
Phone 34236 0
+49-621-3832286
Fax 34236 0
Email 34236 0
sven.kehl@gmail.com
Contact person for public queries
Name 17483 0
Sven Kehl
Address 17483 0
University Medical Center Mannheim
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 17483 0
Germany
Phone 17483 0
+49 621-3832286
Fax 17483 0
Email 17483 0
sven.kehl@gmail.com
Contact person for scientific queries
Name 8411 0
Sven Kehl
Address 8411 0
University Medical Center Mannheim
Department of Obstetrics and Gynecology
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Country 8411 0
Germany
Phone 8411 0
+49 621-3832286
Fax 8411 0
Email 8411 0
sven.kehl@gmail.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.