ICP generally has a benign prognosis in pregnant women; nevertheless, it is associated with potential adverse perinatal outcomes, including spontaneous preterm delivery, meconium-stained amniotic fluid, nonreassuring fetal status
, sudden fetal death, low APGAR scores, and neonatal respiratory distress syndrome independent of prematurity.
Patients with congenital and clinical fetal abnormalities--including nonreassuring fetal status
or episodes of resolved fetal bradycardia, patients with pregnancy-associated hypertensive disorders, diabetes mellitus, gestational diabetes, and patients with known allergy to any of the vasopressors, were excluded.
Fetal indications include nonreassuring fetal status
or a need to correct for minor degrees of malposition (asynclitism, deflexion) that historically have been addressed with the use of obstetric forceps.
Cesarean delivery was indicated if at least one of the following was present: nonreassuring fetal status
(persistent category II or III); active phase arrest of dilation; arrest of descent in the second stage of labor; or failed induction of labor.
The indications for labor induction included: Over 41 weeks of gestation, maternal complications (gestational hypertension or gestational diabetes mellitus), nonreassuring fetal status
(oligohydramnios or poor placental function), and informed choices.
When comparing the indication for cesarean section (Table 4), early artificial amniotomy was associated with fewer cesarean sections performed for active phase labor dystocia (defined as arrest of active phase or arrest of descent) and more cesarean sections for nonreassuring fetal status
or latent phase labor dystocia (defined as failed induction or failure to progress), but none of these differences were statistically significant.
Indeed, the only published study of the device so far--and the data on which the FDA approval was based--showed that while OxiFirst lowered C-section rates by 50% for nonreassuring fetal status
, it did not reduce the overall C-section rate.