Induction of labor with titrated oral misoprostol solution versus oxytocin in term pregnancy: randomized controlled trial / Indução do trabalho de parto por meio de solução oral titulada de misoprostol versus oxitocina em gestação a termo: estudo controlado randomizado

PURPOSE: To evaluate the effectiveness and the safety of orally administered misoprostol in comparison to intravenously infused oxytocin for labor induction in term pregnant women. METHODS: Between 2008 and 2010, a total of 285 term pregnant women whom were candidate for vaginal delivery were assessed for eligibility to enter the study. Twenty five patients were excluded for different reasons; and 260 included women were randomly assigned to one of the two groups according to the method of treatment, misoprostol or oxytocin. The misoprostol group received 25 µg every 2 hours for up to 24 hours for induction. The oxytocin group received an infusion of 10 IU which was gradually increased. The time from induction to delivery and induction to the beginning of the active phase and successful inductions within 12, 18, and 24 hours were recorded. The trial is registered at irct.ir, number IRCT2012061910068N1. RESULTS: Failure of induction, leading to caesarean section was around 38.3% in the oxytocin group and significantly higher than that of the misoprostol group (20.3%) (p<0.001). Despite the more prevalent failure in the oxytocin group, the mean time intervals from induction to active phase and labor of this group were both significantly less than the misoprostol group (10.1±6.1 and 13.2±7.7 versus 12.9±5.4 and 15.6±5.1 hours respectively, both p-values were <0.05). Maternal and fetal complications were comparable between groups except gastrointestinal symptoms which were encountered more frequently in the misoprostol (10.9 versus 3.9%, p=0.03). CONCLUSIONS: Misoprostol is a safe and effective drug with low complications for the induction of labor. Failure is seen less with misoprostol and caesarean sections are less frequently indicated as compared to oxytocin.

OBJETIVO: Avaliar a eficácia e segurança do misoprostol administrado por via oral em comparação à infusão de oxitocina para a indução do trabalho de parto em gestantes a termo. MÉTODOS: Entre 2008 e 2010, um total de 285 gestantes a termo candidatas para parto vaginal foram avaliadas quanto à eligibilidade para inclusão no estudo. Vinte e cinco pacientes foram excluídas por várias razões, e as 260 mulheres incluídas foram divididas aleatoriamente em dois grupos de acordo com o método de tratamento, misoprostol ou oxitocina. O grupo tratado com o misoprostol recebeu 25 µg cada 2 horas durante um máximo de 24 horas para indução. O grupo tratado com oxitocina recebeu infusão de 10 UI, que foi aumentada gradativamente. O tempo a partir da indução até o início da fase ativa e as induções bem-sucedidas dentro de 12, 18 e 24 horas foram registrados. O ensaio foi registrado em irct.ir, número IRCT2012061910068N1. RESULTADOS: A falha de indução levando à necessidade de cesariana foi de aproximadamente 38.3% no grupo tratado com oxitocina, sendo significativamente maior em relação ao grupo tratado com misoprostol (20,3%) (p<0,001). Apesar da falha mais prevalente no grupo tratado com oxitocina, os intervalos médios entre indução e fase ativa e trabalho de parto nesse grupo foram ambos significativamente menores em relação ao grupo tratado com misoprostol (10,1±6,1 e 13,2±7,7 versus 12,9±5,4 and 15,6±5,1 horas, respectivamente, sendo ambos os p-valores <0,05). Complicações maternas e fetais foram comparáveis entre grupos, com exceção dos sintomas gastrointestinais, que foram encontrados mais frequentemente no grupo tratado com misoprostol (10,9 versus 3,9%, p=0,03). CONCLUSÕES: O misoprostol é droga segura e eficaz para a indução do parto, com poucas complicações. Falhas são menos observadas e cesáreas são indicadas menos frequentemente com o misoprostol em relação à oxitocina.

Efeitos de misoprostol sublingual pré-operatório no tônus uterino durante anestesia com isoflurano para cesariana / Effects of preoperative sublingual misoprostol on uterine tone during isoflurane anesthesia for cesarean section / Efectos del misoprostol sublingual preoperatorio en el tono uterino durante la anestesia con isoflurano para cesárea

JUSTIFICATIVA E OBJETIVOS: Misoprostol reduz o sangramento uterino após o parto cesáreo sem efeitos prejudiciais para a mãe ou o bebê. Nosso objetivo foi avaliar os efeitos de misoprostol pré-operatório no sangramento materno e no tônus uterino e a necessidade de ocitocina após cesariana sob anestesia com isoflurano. MÉTODOS: Depois da aprovação pelo Comitê de Ética, 366 pacientes programadas para cesariana eletiva foram randomicamente designadas para receber 400 µg de misoprostol sublingual (n = 179) ou um comprimido de placebo (n = 187) após intubação. A anestesia foi mantida com CAM de isoflurano a 0,5-0,7 e óxido nitroso. Todas as pacientes receberam infusão de ocitocina (10 UI) após expulsão da placenta. A estimativa de perda sanguínea, do tônus uterino, da necessidade de ocitocina complementar, da contagem de hematócrito, dos escores de Apgar no 1º e aos 5 minutos e os efeitos adversos foram registrados. RESULTADOS: Após a indução, as pacientes que receberam misoprostol sublingual tiveram perda sanguínea perioperatória (202 ± 383,1 vs 708 ± 204,3 mL, p < 0,001), necessidade de ocitocina (p < 0,001), níveis mais elevados de hematócrito (p < 0,001) e tônus uterino (p < 0,02) menos significativos. A incidência de tremores foi maior no grupo misoprostol (p = 0,04). Não houve diferenças entre os dois grupos quanto aos índices de Apgar, náusea e vômito, distúrbios gastrointestinais e febre. CONCLUSÃO: A administração pré-operatória de misoprostol sublingual (400 µg) é segura e eficaz para atenuar o sangramento materno e o efeito no tônus uterino da anestesia com isoflurano em parto cesário.

BACKGROUND AND OBJECTIVES: Misoprostol would reduce the uterine bleeding after cesarean delivery without harmful effects on either mother or baby. We aimed to evaluate the effects of preoperative misoprostol on maternal blood loss, uterine tone, and the need for additional oxytocin after cesarean delivery under isoflurane anesthesia. METHODS: After ethical approval, 366 patients scheduled for elective cesarean delivery were randomly allocated to receive either sublingual misoprostol 400 µg (n = 179) or placebo tablet (n = 187) after intubation. Anesthesia was maintained with 0.5-0.7 MAC isoflurane with nitrous oxide. All patients received intravenous infusion of 10 IU of oxytocin after placental delivery. Perioperative estimated blood loss, uterine tone, need for supplementary oxytocin, hematocrit, Apgar scores at 1 and 5 min and adverse effects were recorded. RESULTS: After induction, patients receiving sublingual misoprostol had significant less perioperative estimated blood loss (202 ± 383.1 vs. 708 ± 204.3 mL, p < 0.001), need for oxytocin (p < 0.001), higher hematocrit levels (p < 0.001) and uterine tone (p < 0.02). The incidence of shivering was higher in the misoprostol group (p = 0.04). There were no differences between the two groups as regarding Apgar scores, nausea and vomiting, gastrointestinal disturbances and pyrexia. CONCLUSION: Preoperative administration of sublingual misoprostol 400 µg is safe and effective in attenuating the maternal bleeding and uterine atony from isoflurane anesthesia for cesarean delivery.

JUSTIFICATIVA Y OBJETIVOS: El Misoprostol reduce el sangramiento uterino después del parto por cesárea sin efectos perjudiciales para la madre o el bebé. Nuestro objetivo fue evaluar los efectos del misoprostol preoperatorio en el sangramiento materno y en el tono uterino, y la necesidad de ocitocina después de la cesárea bajo anestesia con isoflurano. MÉTODOS: Después de la aprobación por el Comité de Ética, 366 pacientes programadas para la cesárea electiva, fueron randómicamente designadas para recibir 400 µg de misoprostol sublingual (n = 179) o un comprimido de placebo (n = 187) después de la intubación. La anestesia se mantuvo con CAM de isoflurano a 0,5-0,7 y óxido nitroso. Todas las pacientes recibieron una infusión de ocitocina (10 UI) después de la expulsión de la placenta. La estimación de la pérdida sanguínea, del tono uterino, de la necesidad de ocitocina complementaria, del conteo de hematocrito, de los puntajes de Apgar en el 1º y a los 5 minutos y los efectos adversos fueron todos registrados. RESULTADOS: Después de la inducción, las pacientes que recibieron misoprostol sublingual tuvieron una pérdida sanguínea perioperatoria (202 ± 383,1 vs 708 ± 204,3 mL, p < 0,001), necesidad de ocitocina (p < 0,001), niveles más elevados de hematocrito (p < 0,001) y tonouterino (p < 0,02) menos significativos. La incidencia de temblores fue mayor en el grupo misoprostol (p = 0,04). No se registraron diferencias entre los dos grupos en cuanto a los índices de Apgar, náusea y vómito, trastornos gastrointestinales y fiebre. CONCLUSIONES: La administración preoperatoria de misoprostol sublingual (400 µg) es segura y eficaz para atenuar el sangramiento materno y el efecto en el tono uterino de la anestesia con isoflurano en el parto por cesárea.

Baixa dose de misoprostol sublingual (12,5 µg) para indução do parto / Low dose of sublingual misoprostol (12.5 µg) for labor induction

OBJETIVO: Descrever os resultados maternos e perinatais utilizando 12,5 µg de misoprostol sublingual para indução do parto em gestantes com feto vivo a termo. MÉTODOS: Realizou-se um estudo multicêntrico, tipo ensaio clínico, aberto e não randomizado, no período de julho a dezembro de 2009. Foram incluídas 30 gestantes com indicação de indução do parto, a termo, feto vivo, escore de Bishop menor ou igual a seis, apresentação cefálica, peso fetal estimado menor que 4.000 g e índice de líquido amniótico maior que cinco. Foram excluídas mulheres com cicatriz uterina, alteração da vitalidade fetal, anomalias congênitas, gestação múltipla, restrição de crescimento intrauterino, hemorragia genital e contraindicações ao parto vaginal. O comprimido de misoprostol sublingual 12,5 µg foi administrado a cada seis horas, até o início do trabalho de parto, máximo de oito doses. RESULTADOS: O trabalho de parto foi induzido satisfatoriamente em 90% das gestantes. As médias dos intervalos entre a primeira dose e o início das contrações uterinas e o parto foram de 14,3±11,7 horas e 25,4±13 horas, respectivamente. A frequência de parto vaginal foi de 60%. A taquissistolia ocorreu em duas gestantes, sendo revertida em ambos os casos sem necessitar de cesariana. A eliminação de mecônio foi observada em quatro pacientes e o escore de Apgar foi menor que sete no quinto minuto em um recém-nascido. CONCLUSÃO: Os desfechos maternos e perinatais foram favoráveis depois da indução do parto com misoprostol sublingual na dose de 12,5 µg a cada seis horas. No entanto, são necessários ensaios clínicos controlados comparando esse esquema posológico com outras doses e vias de administração.

PURPOSE: To describe the maternal and perinatal outcomes after the use of 12.5 µg of sublingual misoprostol for labor induction in women with term pregnancy and a live fetus. METHODS: We conducted a multicenter, open and non-randomized clinical trial during the period from July to December 2009. We included 30 pregnant women with an indication for labor induction at term, carrying a live fetus, with a Bishop score of six or less, cephalic presentation, estimated fetal weight of less than 4,000 g and an amniotic fluid index greater than five. We excluded women with a previous uterine scar, non-reassuring fetal status, congenital anomalies, multiple pregnancy, intrauterine growth restriction, genital bleeding, and contraindications of vaginal delivery. A tablet of 12.5 µg sublingual misoprostol was administered every six hours, until the beginning of labor, with the maximum of eight doses. RESULTS: Labor was successfully induced in 90% of pregnant women. The mean interval between the first dose and the onset of uterine contractions and delivery was 14.3±11.7 hours and 25.4±13 hours, respectively. The frequency of vaginal delivery was 60%. Uterine tachysystole occurred in two pregnant women, being reversed in both cases without the need for cesarean section. Meconium-stained amniotic fluid was observed in four patients, and an Apgar score of less than 7 at five minutes in only one newborn. CONCLUSION: Maternal and perinatal outcomes were favorable after induction of labor with sublingual misoprostol at a dose of 12.5 µg every six hours. However, controlled trials are needed to compare this regimen with other doses and routes of administration.

Sonda de Foley cervical versus misoprostol vaginal para o preparo cervical e indução do parto: um ensaio clínico randomizado / Cervical Foley catheter versus vaginal misoprostol for cervical ripening and induction of labor: a randomized clinical trial

OBJETIVO: comparar a efetividade da sonda e Foley com o uso de misoprostol vaginal para o preparo cervical e indução do parto. MÉTODOS: ensaio clínico randomizado, não cego, realizado entre Janeiro de 2006 a Janeiro de 2008. Foram incluídas 160 gestantes com indicação de indução do parto, divididas em dois grupos: 80 para uso da sonda de Foley e 80 para misoprostol vaginal. Os critérios de inclusão foram: idade gestacional a partir de 37 semanas, feto único, vivo, cefálico e índice de Bishop igual ou menor que 4. Foram excluídas pacientes com cicatriz uterina, ruptura das membranas, peso fetal estimado maior que 4000 g, placenta prévia, corioamnionite e condições que impunham o término imediato da gestação. Os testes estatísticos utilizados foram Mann-Whitney, χ2 de Pearson ou exato de Fischer, sendo considerado significativo se menor que 0,005. RESULTADOS: o misoprostol desencadeou mais vezes o parto de forma espontânea (50,0 versus 15,0 por cento para Foley p<0,001) e menor uso de ocitocina (41,2 versus 76,2 por cento), sendo que esse grupo apresentou mais taquissistolia (21,2 versus 5,0 por cento). A sonda de Foley causou mais desconforto à paciente (28,7 versus 1,2 por cento). Não houve diferenças em relação ao tempo necessário para evolução do índice de Bishop (20,69 versus 21,36 horas), para o desencadeamento do parto (36,42 versus 29,57 horas) e nas taxas de cesáreas (51,2 versus 42,5 por cento). Não houve diferenças significativas no desempenho perinatal, com frequências semelhantes de cardiotocografia anormal (20,0 versus 21,2 por cento), presença de mecônio (13,7 versus 17,5 por cento) e necessidade de UTI neonatal (3,7 versus 6,2 por cento). CONCLUSÕES: o uso da sonda de Foley apresentou efetividade semelhante ao misoprostol para o preparo cervical, porém foi menos efetivo para o desencadeamento espontâneo do parto. Nossos resultados apoiam a recomendação de seu uso para o preparo cervical, sobretudo em pacientes portadoras de uma cicatriz de cesárea.

PURPOSE: to compare the effectiveness of the Foley balloon with vaginal misoprostol for cervical ripening and labor induction. METHODS: randomized clinical trial, not blind, conducted from January 2006 to January 2008. A total of 160 pregnant women with indication for induction of labor were included and divided into two groups, 80 for Foley and 80 for vaginal misoprostol. Inclusion criteria were: gestational age of 37 weeks or more, a live single fetus with cephalic presentation and a Bishop score of four or less. We excluded patients with a uterine scar, ruptured membranes, estimated fetal weight greater than 4000 g, placenta previa, chorioamnionitis and conditions that imposed the immediate termination of pregnancy. Statistical tests employed were Mann-Whitney, χ2 test or Fisher's exact test, and p value was significant if less than 0.005. RESULTS: misoprostol triggered more frequently spontaneous delivery (50.0 versus 15.0 percent for Foley, p<0.001) and required less use of oxytocin (41.2 versus 76.2 percent), and this group presented more tachysystole (21.2 versus 5.0 percent). The Foley catheter caused more discomfort to the patient (28.7 versus 1.2 percent). There were no differences in the time required for development of the Bishop score (20.69 versus 21.36 hours), for triggering delivery (36.42 versus 29.57 hours) or in rates of cesarean delivery (51.2 versus 42.5 percent). There were no significant differences in perinatal performance, with similar rates of abnormal cardiotocography (20.0 versus 21.2 percent), presence of meconium (13.7 versus 17.5 percent) and need for neonatal intensive care unit (3.7 versus 6.2 percent). CONCLUSIONS: the use of the Foley catheter was as effective as misoprostol for cervical ripening, but less effective in triggering spontaneous labor. Our results support the recommendation of its use for cervical ripening, especially in patients with cesarean scar.

Solução oral escalonada de misoprostol para indução do parto: estudo piloto / Titrated oral solution of misoprostol for labour induction: a pilot study

OBJETIVO: avaliar a efetividade e a segurança da administração de uma nova formulação de misoprostol em solução por via oral, com doses escalonadas, para indução do parto de feto vivo a termo. MÉTODOS: realizou-se um estudo multicêntrico, do tipo ensaio clínico, aberto, não-randomizado, no período de Julho a Dezembro de 2008. Foram incluídas 30 pacientes com indicação de indução do trabalho de parto, a termo, com feto vivo, índice de Bishop <6, apresentação cefálica, peso fetal estimado pela ultrassonografia <4.000g e índice de líquido amniótico >5. Foram excluídas mulheres com cicatriz uterina, cardiotocografia alterada, gestação múltipla, restrição de crescimento fetal, hemorragia genital e presença de tumores, ulcerações ou malformações genitais. A dose inicial da solução oral foi de 20µg/h de misoprostol, nas primeiras 6 horas, aumentando em 20µg/h de misoprostol a cada 6 horas, se o trabalho de parto não fosse deflagrado, até uma dose máxima de 80µg/h, nas primeiras 24 horas, mantendo a dose máxima (80µg/h) por mais 24 horas, se necessário. RESULTADOS: o trabalho de parto foi induzido satisfatoriamente em 96,7 por cento das gestantes. O intervalo entre a primeira dose e o início das contrações uterinas foi de 3,8±1,8 horas, enquanto o intervalo entre a dose inicial e o parto variou entre 6 e 24 horas. A frequência de parto vaginal foi de 80 por cento (n=24). A maioria das gestantes iniciou o trabalho de parto com a dose de 20µg/h (60 por cento; n=18). A taquissistolia ocorreu em 13,3 por cento das gestações e líquido meconial foi detectado em 20 por cento dos casos. Houve dois casos de escore de Apgar <7 no primeiro minuto e nenhum no quinto minuto. CONCLUSÕES: a solução oral de misoprostol administrada de forma escalonada foi efetiva e segura para indução do trabalho de parto. No entanto, são necessários estudos controlados para comparação com a via vaginal.

PURPOSE: to test effectiveness and safety of the oral administration of a new misoprostol formulation in titrated doses for the induction of delivery of a live fetus at term. METHODS: an open pilot multicenter, non-randomized clinical trial was conducted from July to December 2008. A total of 30 patients with indications for induction of labor were included. The patients had a live fetus, Bishop score <6, vertex presentation, fetal weight <4,000g estimated by ultrasonography and amniotic fluid index >5. Exclusion criteria were previous uterine scar, non-reassuring fetal heart rate tracing, multiple pregnancy, fetal growth restriction, genital hemorrhage and presence of genital tumors, ulcerations or malformations. An initial dose of 20µg/hour of the oral misoprostol solution was used in the first 6 hours, and was increased progressively to 20µg/hour every 6 hours if labor did not start, up to a maximum dose of 80µg/h in the first 24 hours, maintained for additional 24 hours if necessary. RESULTS: labor was satisfactorily induced in 96.7 percent of patients. The interval between the first dose and the beginning of uterine contractions was 3.8±1.8 hours. The interval between the initial dose and delivery varied from 6 to 24 hours. The frequency of vaginal delivery was 80 percent (24 cases). Most of the patients (60 percent; n=18) initiated labor with a dose of 20mg/hour. Tachysystole occurred in 13.3 percent of women and meconium-stained fluid was detected in 20 percent of cases. There were two cases of Apgar scores <7 in the first minute and no Apgar score <7 in the fifth minute. CONCLUSIONS: the oral solution of misoprostol was effective and safe for the induction of labor. However, further randomized controlled trials are needed to compare this new formulation with misoprostol administered by the vaginal route.

A randomized comparison of rectal misoprostol with syntometrine on blood loss in the third stage of labour / Comparación randomizada del misoprostol rectal con la sintometrina en la pérdida de sangre en la tercera etapa del parto

OBJECTIVES: a) To compare the clinical effect of rectal misoprostol with intramuscular syntometrine in reducing blood loss in the third stage of labour, b) to determine the severity and incidence of side effects of both drugs and c) to measure blood loss, patient tolerance and acceptance of rectal misoprostol. METHODS: One hundred and forty parturients were randomly allocated to receive intramuscular syntometrine (syntocinon 10 IU + ergometrine 0.5 mg) or rectal misoprostol 400 ?g within five minutes of the delivery of the anterior shoulder. Blood loss was measured by the use of a plastic collection drape. Additional oxytocic therapy was instituted for uterine atony or if blood loss was in excess of one litre. RESULTS: There was no significant difference in patient demographics of each treatment group (Table 1). There was no difference in mean duration of the third stage of labour (8.4 ± 14 min vs 7.8 ± 6.6 min). The mean blood loss from those parturients receiving misoprostol (180.1 ± 120 mls) was not significantly different (p = 0.5) from those receiving syntometrine (197 ± 176.97 mls) for the active management of the third stage of labour. Treatment with syntometrine was associated with a significant elevation of post-partum systolic blood pressure compared with misoprostol treatment (mean increase 0.57 ± 18.79 mmHg vs -1.43 ± 14.17 mmHg, (mean ± SD), p < 0.04). Rectal misoprostol was well tolerated in 88.5% of participants, 11.4% reported that insertion was uncomfortable, of which 2.8% reported that they would have preferred parenteral drug administration. CONCLUSION: The clinical effect of rectal misoprostol and intramuscular syntometrine were not different at the doses used in the active management of the third stage of labour in this study. Rectal misoprostol was well tolerated by the patients and had a low side effect profile. Blood loss assessment using the blood collection drape is of invaluable benefit in resource-poor settings.

OBJETIVOS: a) Comparar el efecto clínico del misoprostol rectal con la sintometrina intramuscular en la reducción de la pérdida de sangre en la tercera etapa del parto, b) determinar la severidad y la incidencia de los efectos colaterales de ambos medicamentos, y c) medir la pérdida de sangre, la tolerancia de las pacientes y la aceptación del misoprostol rectal. MÉTODOS: Ciento cuarenta parturientas fueron elegidas de forma aleatoria para que recibieran la sintometrina intramuscular (syntocinon 10 IU + ergometrina 0.5 mg) o el misoprostol rectal 400 µg dentro de los cinco minutos de la salida del hombro anterior. Se midió la pérdida de sangre usando una bolsa plástica de recolección de sangre. Se instituyó una terapia oxitócica adicional para la atonía uterina o para el caso de que la pérdida de sangre excediera un litro. RESULTADOS: No hubo diferencia significativa en la demografía de los pacientes de cada grupo de tratamiento (tabla 1). No hubo diferencia en la duración promedio de la tercera etapa del parto (8.4 ± 14 min vs 7.8 ± 6.6 min). La pérdida promedio de sangre de las parturientas que recibieron el misoprostol (180.1 ± 120 mls) no fue significativamente diferente (p = 0.5) de las que recibieron sintometrina (197 ± 176.97 mls) para el tratamiento activo de la tercera etapa del parto. El tratamiento con sintometrina estuvo asociado con una elevación significativa de la presión sistólica postparto comparada con el tratamiento con misoprostol (aumento promedio 0.57 ± 18.79 mmHg vs -1.43 ± 14.17 mmHg, (media ± sd), p < 0.04). El misoprostol rectal fue bien tolerado por el 88.5% de las participantes, 11.4% reportaron que la inserción fue incómoda, y de ellas 2.8% reportó que hubieran preferido una administración parenteral del medicamento. CONCLUSIÓN: El efecto clínico del misoprostol rectal y el de la sintometrina intramuscular, no fueron diferentes en las dosis usadas en el tratamiento activo de la tercera etapa del parto en este estudio. El misoprostol rectal fue bien tolerado por las pacientes y tuvo un perfil de efecto colateral bajo. La evaluación de la pérdida de sangre utilizando una bolsa de recolección de sangre posee un valor inapreciable en escenarios de recursos pobres.

A study of prophylactic use of 15-methyl prostalglandin F2alpha in the active management of third stage of labour.

To compare active management of third stage of labour with 15-methyl prostaglandin F2alpha (PGF2alpha) and conventional management with methylergometrine as prophylaxis for postpartum hemorrhage, a randomised comparative study was carried out at Calcutta National Medical College and Hospital, Kolkata on 100 women. They were randomly allotted to one of the two groups. Group A included 50 women who received 15-methyl PGF2alpha (125 microg) intramusculary at the time of delivery of the anterior shoulder and group B included 50 women who underwent conventional management of the third stage of labour where methylergometrine 0.2 mg was given after delivery of placenta. Main outcome measured were duration of third stage, amount of bleeding and side-effects. The present study showed that there were significent reduction of the duration of third stage as well as reduction of amount of bleeding particularly when 125 microg of 15-methyl PGF2alpha was given intramuscularly at the time of delivery of the anterior shoulder in comparison to coventional method of management of third stage of labour with methylergometrine. Placental expulsion occurred within 4 minutes in group A and 16.5 minutes in group B. The amount of bleeding following delivery was 95.6 ml in average in group A and 249.6 ml in average in group B. 15-methyl PGF2alpha (125 microg) is certainly effective in prevention of postpartum haemorrhage particularly in developing country like India where this complication contributes a major factor for maternal mortality.

Influence of umbilical vein oxytocin on blood loss and length of third stage of labour.

In this study the effect of intraumbilical vein oxytocin on duration and amount of blood loss in third stage of labour was studied. Pregnant women were randomized into two groups of fifty each. Study group was managed with 10 units of oxytocin diluted with 10 ml of normal saline given through umbilical vein while control group was managed with 10 units of oxytocin in 500 ml of normal saline through intravenous infusion after delivery of the baby. The mean blood loss in the third stage of labour was 143.30 ml for the control group and 151.43 ml for the study group while the duration of the third stage of labour was 6.02 and 5.42 minutes for each group. There was no significant difference in the duration and amount of blood loss between the two groups.

Comparative study of misoprostol vs dinoprostone for induction of labour.

Various methods of induction of labour may be associated with risk and complications. Therefore, this study has been undertaken to compare the safety and efficacy of intra-vaginal misoprostol (PGE1 analogue) with intra-cervical dinoprostone (PGE2) in progress and induction of labour, the maternal side effects and the foetal outcome. 40 pregnant women aged between 16-35 years with indication of induction of labour participated in the study. Twenty patients (control) were administered 0.5 mg dinoprostone intra-cervically, 12 hourly while 20 patients (study group) were given misoprostol 100 microg, 4 hourly, intravaginally. The mean induction of labour initiation interval was 2.08 +/- 1.46 hours in study group and 2.21 +/- 1.20 hours in dinoprostone group. The Induction delivery interval was 6.92 +/- 4.01 hours in misoprostol group and 12.54 +/- 7.73 in dinoprostone group, whereas vaginal route of delivery was 95% in misoprostol group and 85% in dinoprostone group. Average dosages required were 1.55 +/- 1.02 in misoprostol group and 1.30 +/- 0.46 in dinoprostone group. All these result were statistically significant. Very few maternal side effects were reported in study group. There was no significant difference in foetal out come in either group. Therefore, it can be concluded that misoprostol is easy to administer and is cheap, effective, safe and convenient drug for induction of labour.

Influence of time at which oxytocin is administered during labor on uterine activity and perinatal death in pigs

Oxytocin is extensively used to induce or augment uterine contractions, especially to facilitate the third stage of labor in humans. Administration of oxytocin to parturient sows reduces duration of labor whereas mortality of the offspring may remain unchanged. This study aimed to evaluate whether time of administration of oxytocin during parturition may alter the uterine response and fetal outcomes. Two hundred parturient sows were randomly assigned to intramuscularly receive either saline solution (control group) or oxytocin 0.083 IU/kg immediately after the delivery of the 1st, 4th or 8th piglet (groups O-1, 0-4 and 0-8, respectively). Uterine effects and fetal outcomes were registered in all groups. The duration of labor was 20-40 min shorter (P < 0.0001) and time interval between babies was reduced by 3-5 min (P < 0.0001) in the three groups receiving oxytocin. The duration and intensity of contractions, meconium-stained piglets and intrapartum deaths decreased as time at which oxytocin administered during labor was increased. In group 0-8, we observed approximately 70 percent less meconium-stained piglets and intrapartum deaths than in the control group. In conclusion, oxytocin administered at early phases of parturition to sows may increase duration and intensity of uterine contractions as well as adverse fetal outcomes.

Nova formulação de misoprostol sublingual na indução do trabalho de parto / New formulation of sublingual misoprostol (25mcg) for induction of labor

OBJETIVO: Testar a efetividade e segurança do comprimido sublingual de misoprostol, na dose de 25 mcg a cada seis horas, para indução do parto em gestantes de alto risco internadas em dois hospitais-escola do Nordeste do Brasil. MÉTODOS: Realizou-se um ensaio clínico aberto, não randomizado, incluindo 40 gestantes de alto risco internadas nas Enfermarias de Patologia Obstétrica da Maternidade-Escola Assis Chateaubriand e Instituto Materno-Infantil de Pernambuco. Todas tinham idade gestacional maior que 37 semanas, feto único com boa vitalidade e escores de Bishop menores ou iguais a 7. Utilizou-se o comprimido de 25 mcg de misoprostol via sublingual, repetindo-se a cada seis horas, até no máximo de quatro doses. A análise estatística foi realizada no programa de domínio público Epi-Info 3.2.2. RESULTADOS: O trabalho de parto foi desencadeado em todas as gestantes. O intervalo entre a primeira dose e o início das contrações foi de 4,8±3,8 horas. O intervalo entre a primeira dose e o parto variou de 8 a 31 horas, com 95 por cento dos partos ocorrendo nas primeiras 24 horas, sendo 75 por cento por via vaginal. Houve necessidade de mais de uma dose de misoprostol em 60 por cento dos casos. A taquissistolia ocorreu em 12,5 por cento das gestantes. Não ocorreram complicações neonatais. CONCLUSÃO: O comprimido sublingual de 25 mcg de misoprostol foi efetivo para desencadeamento do trabalho de parto em gestantes de alto-risco. A eficácia desta nova via deve ser comparada à da via vaginal em futuros estudos clínicos randomizados.

A comparison between single dose of 50 microg oral misoprostol and 25 microg vaginal misoprostol for labor induction.

OBJECTIVE: To compare the efficacy and safety of a single dose of 50 microg oral misoprostol with 25 microg vaginal misoprostol for labor induction. MATERIAL AND METHOD: This study was a randomized, double-blind controlled trial conducting in pregnant women admitted at delivery room, Department of Obstetrics and Gynecology, Bangkok Metropolitan Administration Medical College and Vajira Hospital between March 2002 and January 2005. All 146 pregnancies at > or = 37 weeks' gestation who had indication for labor induction with unfavorable cervix were randomly divided into a group of single dose of 50 microg misoprostol orally or 25 microg misoprostol vaginally. Initial and six hours after misoprostol administration, Bishop scores were evaluated. Requirement of oxytocin augmentation, complication due to uterine hypertonus, incidence of vaginal delivery, Apgar score at 1 and 5 minutes, and number of neonate admitted at neonatal intensive care unit (NICU) were recorded. RESULTS: The baseline characteristics and median initial Bishop scores were comparable in both groups. At 6 hours after misoprostol administration the median cervical changes of women who received oral or vaginal misoprostol were statistically significant different, 3 and 4, respectively. The median time interval to vaginal delivery of women who received oral misoprostol was significantly longer than of those who had vaginal drug, 16.9 and 11.8 hours respectively. Comparable neonatal outcomes were found in both groups in terms of assigned Apgar score at 1 and 5 minutes. CONCLUSION: A single dose of 25 microg vaginal misoprostol appears to be more effective than 50 microg oral dose in improving Bishop scores and decreasing the time to vaginal delivery in women with unfavorable cervix without severe adverse effects.

comparison of oral misoprostol tablets and vaginal prostagl and in E2 pessary in induction of labour at term

To compare the cost-effectiveness, mode of delivery, fetal and maternal outcome of oral Misoprostol and vaginal prostagl and in E2 pessary in induction of labour at term. R and omized clinical trial. Hamdard University Hospital, Imam Clinic and General Hospital from February 2002 to January 2003. The trial was conducted over two groups of patient for labour induction such that Group A received 50 micro g oral Misoprostol 4 hourly to a maximum of four doses. Group B received prostagl and in Es vaginal pessary at 6 hourly intervals up to two doses. Labour induction, number of doses, need of augmentation, induction to delivery time interval, mode of delivery and neonatal outcome were the main outcomes. Test of proportions was used to compare the significance between both managements. Out of a total of 214 women, 106 received oral Misoprostol and 108 received PGE2 vaginal pessary. Ninety-three percent women in misoprostol group were successfully induced compared with 91% in PGE2 group. A significant response of labour induction with the minimal dose [58%, p = 0.001] and earlier induction to vaginal delivery [74%, p=0.01] was observed in Misoprostol group. Rate of operative delivery was also less [16%, p = 0.16] compared with PGE2 group [25%]. Oral Misoprostol administration was more efficient and cost-effective than PGE2 vaginal pessary for induction of labour due to earlier response with minimal dose and less number of operative deliveries

Incidencia de rotura uterina en el Hospital Dr. Patrocinio Peñuela Ruíz 1982-2003 / Incidence of uterine rupture at the Hospital Dr. Patrocinio Peñuela Ruíz 1982-2003

El presente es un estudio retrospectivo y longitudinal realizado en el Hospital Patrocinio Peñuela Ruíz, San Cristóbal, Estado Táchira, basado en la revisión de las historias clínicas entre los años 1982-2003 con diagnóstico de Rotura Uterina. Encontrándose una Tasa de 0.22 por 1000 partos (1 de 4512 partos). El 50 por ciento pertenecia al grupo 1 a 4 paras. La edad gestacional predominante fue 37-41 semanas 83.33 por ciento. El 66.66 por ciento de los casos tenían útero indemne, el factor determinante más frecuente fue el uso de Oxitócico (66.66 por ciento), el 50 por ciento de las rupturas fueron espontáneas, la Histeretomía fue usada en un 50 por ciento, el diagnóstico intraoperatorio fue del 83.33 por ciento, la mortalidad fetal fue del 33.33 por ciento

Vaginal misoprostol in managing premature rupture of membranes

We compared the efficacy of misoprostol with that of prostaglandin E2 in cervical ripening and labour induction. Thus 238 women with rupture of membranes beyond 36 weeks gestation without labour were randomized to receive 50 microg misoprostol vaginal gel or 5 mg of prostaglandin E2 gel. Bishop score was evaluated before drug application and 6 hours later. Clinical data and perinatal outcome were recorded. Mean time from induction to delivery and the need for oxytocin were significantly less in the misoprostol group. There were no significant differences in spontaneous labour rate, type of delivery and perinatal outcome. It is concluded that intravaginal misoprostol is safe and more effective than prostaglandin E2 for preinduction cervical ripening in premature rupture of membranes beyond 36 weeks gestation

A comparison between 50 mcg oral misoprostol every 4 hours and 6 hours for labor induction: a prospective randomized controlled trial.

OBJECTIVE: To compare the effectiveness and safety between 50 mcg oral misoprostol every 4 hours and 6 hours for labor induction. DESIGN: A prospective randomized controlled trial. SETTING: Department of Obstetrics & Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand. SUBJECTS: Eighty nine pregnant women of at least 34 weeks' gestation with indications for labor induction in the condition of unfavourable cervix (Bishop score < or = 4) and no contraindication to prostaglandin therapy. INTERVENTIONS: All pregnant women were randomized to receive either 50 mcg misoprostol orally every 4 hours or 6 hours. MAIN OUTCOME MEASURES: Treatment interval from induction to vaginal delivery, maternal and neonatal complication. RESULTS: The mean treatment intervals from induction to vaginal delivery were 22.10 +/- 18.49 hours and 20.91 +/- 11.98 hours in the misoprostol group every 4 hours and 6 hours, respectively. The treatment intervals between the two groups were not statistically significant. There was also no significant difference between both groups with regard to maternal and neonatal complications. CONCLUSION: The effectiveness in terms of treatment interval from induction to vaginal delivery were comparable between the two groups, but administration of misoprostol every 6 hours was found to have a slightly shorter interval, although it did not reach statistical significance. No serious maternal and neonatal complication was demonstrated in both groups. Either regimen in this study can be an alternative for labor induction.

A retrospective review of pregnancy outcome after misoprostol (prostaglandin E1) induction of labour

This retrospective study looked at the outcome of using 50-100 micrograms misoprostol once daily to induce labour compared to the outcome of the overall patient population delivered during the same period (1994-1996). During that period 11,255 patients were delivered and 1037 (9.2) were induced with misoprostol. Results showed a significantly lower mean Caesarean section rate: 9.3 for the misoprostol group versus 13.3 for the overall population (p = 0.002, Odds Ratio (OR) 0.67, 95 CI 0.53, 0.83). The abruption rates were not significantly different: 0.8 for misoprostol versus 0.4 (p = 0.09, OR 1.86, 95 CI 0.81, 4.09). There was more postpartum haemorrhage in the misoprostol group: 5.6 versus 3.5 (p = 0.0006, OR 1.63, 95 CI 1.22, 2.19); a higher incidence of Apgar scores less than 6 at one minute 10.2 versus 7.9 (p = 0.0093, OR 1.33, CI 1.06, 1.65) but not at five minutes 2.9 versus 2.4 (p = 0.674, OR 1.09, CI 0.73, 1.61) and a higher perinatal mortality rate 55/1000 versus 16.3/1000 (p = 0.00, OR 3.5, 95 CI 2.55, 4.80). The rate remained higher but not significantly so when a correction was made to eliminate the high number of intrauterine deaths induced with misoprostol 18/1000 versus 16.3/1000 (p = 0.69, OR 1.11, 95 CI 0.66, 1.84). There were no cases of uterine rupture in either group. In conclusion, there was a significantly lower Caesarean section rate among patients who had once daily misoprostol induction of labour. Close monitoring of the foetus, in patients with misoprostol induction, is needed to detect foetal distress and prophylaxis against postpartum haemorrhage is still mandatory.

A randomized comparison of one single dose of vaginal 50 microg misoprostol with 3 mg dinoprostone in pre-induction cervical ripening.

OBJECTIVE: To compare the efficacy and safety of one single dose of 50 pg misoprostol to one single dose of 3 mg dinoprostone administered vaginally for pre-induction cervical ripening in term-pregnant women, who had indications for induction of labor with unripe cervices. STUDY DESIGN: A randomized double-blind controlled trial. SETTING: Bangkok Metropolitan Administration Medical College and Vajira Hospital, Bangkok, Thailand. SUBJECTS: One hundred and forty-three singleton pregnant women of > or = 37 weeks of gestation, who had indications for termination of pregnancy. All patients had a Bishop score of 0-6, without contraindications for labor induction. INTERVENTION: The subjects were stratified by parity to nullipara and multipara group. The subjects in each stratum were allocated by randomization to receive a single dose of 50 microg misoprostol or 3 mg dinoprostone, administered vaginally. Twenty-four hours after medication, oxytocin augmentation was given to both groups. Main outcome measure: The Bishop score of cervix at 24 hours after insertion of the studied drugs, the occurrence of abnormal uterine contraction, and the number of vaginal deliveries within 24, 48 hours. RESULTS: The demographic data and the initial Bishop score (median score 3.5 versus 4.0) were comparable in both groups. The change of score at 24 hours was one unit higher in misoprostol-treated patients compared with dinoprostone-treated patients (mean change score 6.5 versus 5.5, with 95 per cent CI 0.04 to 2.1, p=0.042) but was not of clinical importance. There was a higher frequency of hyperstimulation syndrome in the misoprostol group (6.9% vs 0%) during 8 hours of cervical ripening. Although the difference was not statistically significant (p=0.058), it was clinically important. Comparing vaginal deliveries between the misoprostol and dinoprostone groups, the frequencies of delivery within 24 hours were 46.3 per cent versus 35.7 per cent (p=0.350), and within 48 hours were 88.9 per cent versus 89.3 per cent (p>0.05), non-significantly different. No significant differences were noted between misoprostol and dinoprostone in terms of interval from start of medication to vaginal delivery and neonatal outcomes. CONCLUSION: The efficacy of a single 50 microg dose of vaginally administered misoprostol, is not clinically different to 3 mg dinoprostone in cervical ripening. Although the study was not sufficiently large to detect the differences in abnormal uterine contractions between the two groups, there was a higher frequency of hyperstimulation syndrome in the misoprostol group compared to the dinoprostone group. Close utero-fetal monitoring in misoprostol-treated patients is needed.

Inducción del parto en embarazos de alto riesgo obstétrico: misoprostol vaginal versus ocitocina / Labor induction in high risk pregnancy: vaginal misoprostol versus oxytocin

Efectuamos ensayo clínico controlado, con 1000 ug de misoprostol intravaginal para borramiento cervical e inducción de parto, en 175 pacientes con embarazos de alto riesgo obstétrico, con score de Bishop bajo 7. Comparamos resultados con 1999 pacientes de un grupo histórico similar, sometido a inducción ocitócica. Los tiempos de lactancia y de trabajo de parto fueron significativamente menores con misoprostol (p<0,05). La polisistolia fue más frecuente con misoprostol (55 por ciento versus 1 por ciento p<0,05). El síndrome de hiperestimulación fue más frecuente con misoprostol (10,2 por ciento versus 0,05 por ciento, p<0.05) pero no representó mayor compromiso de la unidad fetoplacentaria. La cesárea fue menos frecuente con misoprostol (24,6 por ciento versus 33,6 por ciento, N.S). El éxito en 24 horas fue mayor para misoprostol (66,2 por ciento versus 43,7 por ciento p<0,05). Los resultados neonatales fueron similares. Conclusiones: misoprostol produce borramiento cervical preinducción, es más eficiente como inductor de parto y posee similar seguridad comparado con ocitocina. El análisis de riesgos relativos apoya estas conclusiones. Dosis menores de misoprostol podría ser eficientes y aún más seguras