Cv. Smith et al., DOUBLE-BLIND COMPARISON OF 2.5 AND 5.0 MG OF PROSTAGLANDIN-E2 GEL FORPREINDUCTION CERVICAL RIPENING, Journal of reproductive medicine, 41(10), 1996, pp. 745-748
OBJECTIVE: To compare the effectiveness and safety of 2.5 vs. 5.0 mg o
f prostaglandin E2 (PGE2) gel for preinduction cervical ripening. STUD
Y DESIGN: Patients presenting for induction of labor with an unfavorab
le Bishop score (less than or equal to 4) were assigned randomly, in a
double-blind manner, to receive either 2.5 or 5.0 mg of PGE2 gel intr
avaginally. A repeat Bishop score was determined in four to sir hours,
and if the score was still unfavorable, the same dose of gel was admi
nistered a second time. All patients returned within 12 hours for indu
ction of labor. RESULTS: A total of 119 patients received PGE2 gel, 55
in the 2.5-mg group and 64 in the 5.0-mg group. Both groups were simi
lar with respect to age, parity, race, indication for induction and pr
einduction Bishop score. Both doses of PGE2 gel were safe and effectiv
e. The need for additional doses of gel, the need for and duration of
oxytocin use, and the duration of labor were similar in both groups. M
ore infants whose mothers received the 5.0-mg dose had one-minute Apga
r scores <7 (P=.027). No significant difference in five-minute Apgar s
cores was noted. Cesarean delivery for failed induction was uncommon,
occurring in 3.6% of patients who received 2.5 mg and in 4.7% of patie
nts who received 5.0 mg of PGE2 gel (P=NS). Finally, the incidence of
hyperstimulation was 3.6% in the 2.5-mg group and 1.6% in the 5.0-mg g
roup (P=NS). Conclusion: A 5-mg dose of PGE2 gel was neither move effe
ctive nor associated with move side effects than the more commonly use
d 2.5-mg dose.