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Related to vertex presentation: breech presentation, transverse presentation, transverse lie
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The study enrolled 728 healthy, nulliparous women with singleton pregnancies at term, with vertex presentation and cervical dilation of less than 4 cm.
It is indicated for use after membrane rupture in a singleton fetus in a vertex presentation.
The proposed indication for the device is for use in a planned vaginal delivery of a term singleton fetus in a vertex presentation when there is a need "for close fetal surveillance during labor, or there are maternal disorders and/or uteroplacental dysfunction with potential adverse influence on fetal oxygen and nutritional supply, or there is a deviation from the normal course of labor including induction/ augmentation of labor.