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Single deepest vertical pocket or amniotic fluid index as evaluation test for predicting adverse pregnancy outcome (SAFE trial): a multicenter, open‐label, randomized controlled trial
Open accessAbstract
Objective: To determine whether the amniotic fluid index (AFI) or the single deepest vertical pocket (SDP) technique for estimating amniotic fluid volume is superior for predicting adverse pregnancy outcome. Methods: This was a multicenter randomized controlled trial including 1052 pregnant women with a term singleton pregnancy across four hospitals in Germany. Women were assigned randomly, according to a computer‐generated allocation sequence, to AFI or SDP measurement for estimation of amniotic fluid volume. Oligohydramnios was defined as AFI ≤ 5 cm or the absence of a pocket measuring at least 2 × 1 cm. The diagnosis of oligohydramnios was followed by labor induction. The primary outcome measure was postpartum admission to a neonatal intensive care unit. Further outcome parameters were the rates of diagnosis of oligohydramnios and induction of labor (for oligohydramnios or without specific indication), and mode of delivery. Results: Postpartum admission to a neonatal intensive care unit was similar between groups (4.2% (n = 21) vs 5.0% (n = 25); relative risk (RR), 0.85 (95% CI, 0.48–1.50); P = 0.57). In the AFI group, there were more cases of oligohydramnios (9.8% (n = 49) vs 2.2% (n = 11); RR, 4.51 (95% CI, 2.2–8.57); P < 0.01) and more cases of labor induction for oligohydramnios (12.7% (n = 33) vs 3.6% (n = 10); RR, 3.50 (95% CI, 1.76–6.96); P < 0.01) than in the SDP group. Moreover, an abnormal cardiotocography was seen more often in the AFI group than in the SDP group (32.3% (n = 161) vs 26.2% (n = 132); RR, 1.23 (95% CI, 1.02–1.50); P = 0.03). The other outcome measures were not significantly different between the two groups. Conclusions: Use of the AFI method increased the rate of diagnosis of oligohydramnios and labor induction for oligohydramnios without improving perinatal outcome. The SDP method is therefore the favorable method to estimate amniotic fluid volume, especially in a population with many low‐risk pregnancies. Copyright © 2015 ISUOG. Published by John Wiley & Sons Ltd.
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“However, it appears that AFI identifies more women as having oligohydramnios than does DVP, thereby increasing the rate of labor induction, but without improving the clinical outcome 37,38 .”
From ISUOG Practice Guidelines (updated): performance of the routine mid‐trimester fetal ultrasound scan (2022) · cites this paper as [38]
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Metadata
- Authors
- Kehl, S., Schelkle, A., Thomas, A., Puhl, A., Meqdad, K., Tuschy, B., Berlit, S., Weiss, C., Bayer, C., Heimrich, J., Dammer, U., Raabe, E., Winkler, M., Faschingbauer, F., Beckmann, M. W., & Sütterlin, M.
- Affiliations
- Heidelberg University (DE)
- Charité – Universitätsmedizin Berlin (DE)
- University Medical Center of the Johannes Gutenberg University Mainz (DE)
- Universitätsklinikum Erlangen (DE)
- Corresponding author
- Kehl, S.
- Venue
- Ultrasound in Obstetrics & Gynecology
- Publisher
- Wiley
- Published
- 2016-06
- Volume
- 47
- Issue
- 6
- Pages
- 674-679
- ISSN
- 0960-7692 (ISSN-L)
- 1469-0705
- OpenAlex
- W1921567863
- Cited by
- 152
- References
- 17
- Citations by year
- 2026: 15 · 2025: 16 · 2024: 11 · 2023: 27 · 2022: 15 · 2021: 14 · 2020: 17 · 2019: 12 · 2018: 11 · 2017: 11 · 2016: 3
- FWCI
- 9.46
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Ultrasound in Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Obstetrics and Gynecology › Maternal and Perinatal Health Interventions
- Health Sciences › Medicine › Obstetrics and Gynecology › Preterm Birth and Chorioamnionitis
- Health Sciences › Medicine › Obstetrics and Gynecology › Pregnancy and preeclampsia studies
- Keywords
- amniotic fluid index, oligohydramnios, adverse pregnancy outcomes, neonatal intensive care admission, labor induction, cardiotocography, term singleton pregnancy, fetal monitoring, fetal growth restriction, macrosomia, fetal hypoxia, fetal distress, fetal malpresentation, fetal malposition
- MeSH terms
- Amniotic Fluid, Female, Humans, Labor, Induced, Patient Admission, Predictive Value of Tests, Pregnancy, Pregnancy Outcome, Intensive Care, Neonatal, Oligohydramnios, Ultrasonography, Prenatal
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