Cervical ripening and labor induction with intracervical triacetin base prostaglandin E2 gel: a placebo-controlled study.
A double-blind, randomized, placebo-controlled study was undertaken to evaluate the efficacy of a single-dose, shelf-stable preparation of prostaglandin E2 gel (PGE2) when used intracervically in patients with low Bishop scores. Two different preparations (0.5 and 0.25 mg) of PGE2 were used and a total of 45 patients were studied. Both preparations of PGE2 demonstrated a statistically significant increase in the spontaneous labor rate as compared with the placebo gel. Bishop scores were altered in all patients not proceeding to labor spontaneously, but the changes were most significant in the low- and high-dose groups. No significant deleterious affects were noted. The efficacy and safety of this new, sterile, and stable preparation makes it suitable for clinical use.
D001034:Apgar Score; D001724:Birth Weight; D002584:Cervix Uteri / Q000187:drug effects*; D002986:Clinical Trials as Topic; D015232:Dinoprostone; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007231:Infant, Newborn; D007751:Labor, Induced / Q000379:methods*; D010919:Placebos; D011247:Pregnancy; D011458:Prostaglandins E / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D011459:Prostaglandins E, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D011897:Random Allocation; D013997:Time Factors; D014590:Uterine Contraction / Q000187:drug effects
D005782:Gels; D010919:Placebos; D011458:Prostaglandins E; D011459:Prostaglandins E, Synthetic; D015232:Dinoprostone