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SAFE-Study - Single deepest vertical pocket or Amnion Fluid index as Evaluation test for preventing adverse pregnancy outcome. A randomized multicenter trial.

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000586819
Enrollment
1000
Registered
2012-05-31
Start date
2012-07-01
Completion date
2013-09-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In the antenatal assessment of fetal well-being, amniotic fluid volume is an important parameter. Oligohydramnios is associated with poor perinatal outcomes. So, after diagnosing decreased amniotic fluid volume or oligohydramnios, many caregivers practice planned delivery by induction of labor or caesarean section. However, there is no clear consensus on the best method to assess amniotic fluid adequacy.

Interventions

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 amni

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.

Sponsors

Sven Kehl
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to 49 Years
Healthy volunteers
Yes

Inclusion criteria

singleton pregnancy at term greater than 259 days of gestation, vertex presentation

Exclusion criteria

Premature Rupture of Membranes (PROM), cases of structural or chromosomal malformation, intrauterine fetal death, twin pregnancy, primary cesarean delivery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026