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HERO ID
3147047
Reference Type
Journal Article
Title
Single deepest vertical pocket or amniotic fluid index as evaluation test for preventing adverse pregnancy outcome (SAFE trial): a multicentre, open-label randomised controlled trial
Author(s)
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, MW; Sütterlin, M
Year
2015
Language
English
PMID
26094600
DOI
10.1002/uog.14924
Abstract
OBJECTIVE:
To determine which technique of estimating amniotic fluid volume, the amniotic fluid index (AFI) or the single deepest pocket (SDP), is better to predict an adverse pregnancy outcome.
DESIGN:
A multicentre randomised controlled trial.
SETTING:
Four hospitals in Germany.
POPULATION:
A total of 1052 pregnant women with singleton pregnancy at term.
METHODS:
Women were randomly assigned according to a computer-generated allocation sequence to AFI or SDP measurement for amniotic fluid measurement. Oligohydramnios was defined as AFI <5 cm or SDP <2x1 cm, respectively. The diagnosis of oligohydramnios was followed by labour induction.
MAIN OUTCOME MEASURES:
The primary outcome measure was the postpartum admission to neonatal care unit. Further outcome parameters were the rate of diagnosis of oligohydramnios, rate of induction of labour (for oligohydramnios or without specific indication), and mode of delivery.
RESULTS:
The postpartum admission to neonatal care unit was not different (21 [4.2%] versus 25 [5.0%], RR = 0.85 (95%CI 0.48 - 1.50; p = 0.57). In the AFI group, there were more cases diagnosed as oligohydramnios (49 [9.8%] versus 11 [2.2%], p < 0.01; RR = 4.51; 95%CI 2.2 - 8.57) and more labour induction for oligohydramnios (33 [12.7%] versus 10 [3.6%], p < 0.01; RR = 3.50, 95%CI 1.76 - 6.96). Moreover, abnormal CTGs were found more often in the AFI group than in the SDP group (161 [32.3%] versus 132 [26.2%], p = 0.03; RR = 1.23; 95%CI 1.02 - 1.50). Most of the other outcome measures were not significantly different between the two techniques.
CONCLUSIONS:
Use of the AFI method increased the rate of diagnosed oligohydramnios and labour induction for oligohydramnios without improving the perinatal outcome. SDP method is therefore the favorable method to estimate amniotic fluid volume, especially in a population with many low risk pregnancies.
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