Primary outcomes

DAV^® (n = 250)

Placebo (n = 50)

P value

Sporadic episodes of preterm uterine contractions

70 (28%)

0 (0%)

0.0001

Frequent and persistent episodes of preterm uterine contractions associated with pain

50 (20%)

30 (60%)

0.0001

Maternal need for hospital admission for threatened preterm labor

50 (20%)

20 (40%)

0.001