Eficacia y seguridad del misoprostol dosificado en solución oral frente al misoprostol vaginal en la inducción del parto

Résumé

SUMMARY BACKGROUND: Childbirth induction is a very frequent medical procedure within current obstetrics. It consists on initiating labor using medical procedures, mechanical procedures or both, before labor begins spontaneously, in an attempt to have a vaginal delivery and benefits for the mother and / or fetus. OBJECTIVE: To compare the efficacy and safety of misoprostol in oral trited solution compared to the current gold standard, vaginal misoprostol, in our setting and in specific clinical situations such as, prolonged gestation (41 weeks) and premature rupture of membranes. METHODS: A double-blind controlled clinical trial of 230 pregnant women who had to be induced due to ruptured of membranes or prolonged gestation, they were given oral misoprostol from 20 mcg / hour up to 60 mcg / hour and PV placebo, or vaginal misoprostol 25 mcg and PO placebo. RESULTS: Births occurring in the first 24 hours are 69.5% of those induced with oral misoprostol, compared to 76.8% of those induced with vaginal misoprostol. The oral misoprostol group had 83.2% of vaginal deliveries, 71.6% were normal vaginal deliveries and 11.6% to instrumental ones, and there were 16.8% of cesarean sections. For the vaginal misoprostol group, there were 84.2% of vaginal deliveries, 68.4% were normal vaginal deliveries and 15.8% instrumental ones; the percentage corresponding to cesarean sections in this group was 15.8%. The differences are not statistically significant. There were no cases of fetal or neonatal death or NICU admission in any of the two groups. The percentage of perinatal asphyxia was 6.31% in the experimental group and 3.15% in the control group. Although the difference was not significant. Regarding maternal morbidity, there were no cases of uterine ruptures or dehiscence in either group. Hyperstimulation occurs for the experimental group in 4.2% and for the control group in 6.3%; Thick meconium in the experimental group occurs in 3.2% of cases and in the control group in 8.4%, but it is not statistically significant. None of the drugs used caused, neither fever nor nausea to the mothers and the percentage of women who experienced vomiting with oral misoprostol was 5.3%, whereas for the vaginal group was 3.2%, a non-significant difference. The preference between the two administration routes was clear, 95% of women prefer oral versus vaginal administration. The cesarean rate in the ruptured of membranes group was 7.7% compared to 19.6% in the other group. The differences being statistically significant. CONCLUSIONS: In our setting and with the data obtained after the clinical trial, we verified that the efficacy and safety of misoprostol in oral solution against vaginal misoprostol is similar; there have been no statistically significant differences. The percentage of vaginal deliveries achieved with the experimental medication is around 70% compared to 76% in the control group. The percentage of cesareans is around 17%, 16% respectively. But if we analyze the reason for the indication of induction, we observe that the rate of cesarean section is double, in the inductions due to prolonged pregnancy that those due to broken membranes being the differences statistically significant. The efficacy of the medication used in our trial is proven and is as efficient as the use of vaginal misoprostol. Safety for both mother and baby is similar in both groups. And women prefer the oral route. KEYWORDS: Induction, oral misoprostol, vaginal misoprostol, safety, efficacy