Second-trimester pregnancy termination with 600-microg vs. 400-microg vaginal misoprostol and systematic curettage postexpulsion: a randomized trial.

BACKGROUND: This study was conducted to compare efficacy and safety of 600 mcg of misoprostol vaginally every 6 h up to four doses vs. 400 mcg of misoprostol vaginally every 4 h up to five doses, followed by systematic curettage of the uterine cavity, for pregnancy termination between 12 and 20 weeks' gestation. STUDY DESIGN: We used a randomized clinical trial conducted at Hospital Gineco-Obstétrico "Eusebio Hernández", Havana, Cuba. Subjects were women requesting voluntary termination of pregnancies between 12 and 20 weeks' gestation. Two hundred ten women were randomly assigned to receive 600 mcg of vaginal misoprostol every 6 h up to four doses (Group I) vs. 400 mcg of vaginal misoprostol every 4 h up to five doses (Group II), followed by curettage 1 h after expulsion. The main outcomes measured were successful abortion rate and mean expulsion time. RESULTS: Successful abortion occurred in 103/105 women (98.1%) in Group I and in 99/105 (94.3%) in Group II [p=.279, relative risk (RR)=3.121 and 95% confidence interval for RR=0.615 to 15.833]. Fetus mean expulsion time was 10.7+/-1.3 (SD) h in Group I and 11.5+/-5.0 (SD) h in Group II (p=.209). CONCLUSIONS: Six hundred micrograms of misoprostol administered vaginally every 6 h was as effective as 400 mcg of misoprostol every 4 h for second-trimester pregnancy termination.

Ensayo clínico aleatorizado para evaluar la eficacia y seguridad de la administración de 25 µg de misoprostol por vía vaginal frente a 50 µg por vía sublingual para la inducción del trabajo del parto en gestantes con diabetes / Randomized clinical trial of the safety and effoprostol versus 25 µg vaginal misoprostol for labor induction at term in pregnant women with diabetes

Objetivo: Evaluar la eficacia y seguridad del uso de 50 µg de misoprostol por vía sublingual y 25 µg por vía vaginal para la inducción del trabajo de parto a término en embarazadas con diabetes.Métodos: Se asignó al azar a 300 embarazadas con diabetes a recibir 25 µg de misoprostol por vía vaginal o 50 µg por vía sublingual cada 4 h hasta 4 dosis. La variable principal fue el número de partos vaginales en 24 h.Resultados: En el grupo por vía sublingual 109 (72, 7%) de 150 pacientes tuvieron un parto vaginal en 24 h, y 104 (69,3%) de 150 pacientes en el grupo por vía vaginal; esta diferencia no fue estadísticamente significativa (p = 0,611, riesgo relativo [RR] = 1, 176; intervalo de confianza [IC] del 95% para el RR, 0, 714-1, 938). La taquisistolia fue significativamente más frecuente en el grupo de misoprostol por vía sublingual (RR = 0, 474; IC del 95% para el RR, 0, 233-0, 968). Las indicaciones de las cesáreas fueron similares en ambos grupos.Hubo una rotura uterina en una paciente del grupo sublingual a la que se le administró la tercera dosis de misoprostol estando en la fase activa del trabajo de parto.Conclusiones: No hubo diferencias significativas entre las tasas de partos vaginales con 25 µg de misoprostol por vía vaginal o 50 µg por vía sublingual en gestantes con diabetes, pero la vía sublingual con la dosis de 50 µg tuvo un perfil con mayores efectos secundarios. sublingual con la dosis de 50 µg tuvo un perfil con mayores efectos secundarios

Objective: To evaluate the safety and efficacy of misoprostol 50 µg administered sublingually versus 25 µg administered vaginally for labor induction at term in pregnant women with diabetes. Methods: Three hundred pregnant women with diabetes were randomly allocated to receive misoprostol 25 µg vaginally or 50 µg sublingually every 4 hours up to 4 doses. The main variable assessed was the rate of vaginal deliveries in 24 hours.Results: Vaginal delivery in 24 hours was achieved in 109/150 (72.7%) women in the sublingual group and in 104/150 (69.3%) in the vaginal group, with no statistically significant differences (p = 0.611; RR = 1.176; 95% CI for RR, 0.714-1.938).Tachysystole was significantly more frequent in the sublingual misoprostol group (RR = 0.474; 95% CI for RR, 0.233-0.968). The indications for caesarean section were similar in both groups. Uterine rupture occurred in one patient in the sublingual group who was administered the third misoprostol dose in the active phase of labor.Conclusions: No statistically significant differences were found in the vaginal delivery rates between sublingual and vaginal misoprostol, although adverse effects were more frequent with the sublingual route