RESUMO
BACKGROUND: The metabolic activity of endogenous nitric oxide (NO) and the medical use of nitrovasodilatory drugs like isosorbide dinitrate have been shown to be potential inducers inducers of cervical ripening prior to surgical evacuation of the uterus. OBJECTIVE: To assess the therapeutic efficacy and safety of combined isosorbide dinitrate-oxytocin in the management of intrauterine foetal death (IUFD). METHODS: Sixty women with IUFD after 20 weeks of gestation requesting uterine evacuation were randomly selected to receive isosorbide dinitrate gel solution (80 mg/1.5 mL; n = 30) or misoprostol gel solution (100 mcg/1.5 mL; n = 30) every 3 h with a maximum of four doses or until a Bishop score >7 was reached. Subsequently, patients received a high dose of intravenous oxytocin until complete uterus evacuation was achieved. Therapeutic efficacy was evaluated by mean the relative risk of the foetal expulsion based on comparison of event rates, and the proportion of women induced to labor at 7, 10 and 15 h after the administration of isosorbide dinitrate or misoprostol. Safety was assessed on the basis of woman´s vital signs and evaluation of adverse effects, including headache, abdominal pain, pelvic pain, lower back pain, nausea, dizziness and vomiting. RESULTS: The foetal expulsion rate using the isosorbide dinitrate-oxytocin combination was approximately 4.4 times, and at least 2.1 times, the foetal expulsion rate with the misoprostol-oxytocin regimen at any given point in time. The proportion of women achieved vaginal delivery at 15 hours was 100% for the isosorbide dinitrate-oxytocin group and 86.7% for the misoprostol-oxytocin group. The average delivery induction interval was significantly lower when isosorbide dinitrate-oxytocin was used (8.7 ± 3.1 h) than when misoprostol-oxytocin (11.9 ± 3.1 h) was used. A total of 20% of patients in the isosorbide dinitrate-oxytocin group recorded headache, and no cases of uterine tachysystole, haemorrhage or coagulopathy were recorded. CONCLUSION: This study indicates that intravaginal isosorbide dinitrate followed by intravenous oxytocin was more effective than the conventional method used to induce labour in the medical management of foetal death in pregnancies after 20 weeks of gestation. TRIAL REGISTRATION: Clinicaltrials.gov NCT02488642.
Assuntos
Maturidade Cervical/efeitos dos fármacos , Morte Fetal , Dinitrato de Isossorbida/administração & dosagem , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitocina/administração & dosagem , Administração Intravaginal , Adulto , Parto Obstétrico , Método Duplo-Cego , Feminino , Humanos , Infusões Intravenosas , Dinitrato de Isossorbida/efeitos adversos , Misoprostol/efeitos adversos , Ocitócicos/administração & dosagem , Ocitócicos/efeitos adversos , Ocitocina/efeitos adversos , Gravidez , Estudos Prospectivos , Fatores de Tempo , Adulto JovemRESUMO
OBJECTIVE: To compare the effectiveness and safety of sublingual versus vaginal misoprostol on improving the Bishop score after 6 h of administration. METHODS: Randomized clinical trial which includes pregnant women in gestational ages from 32/0 to 41/6, with indication of induction of labor with misoprostol. Bishop score was assessed at the time of induction and 6 h after administration of 50 µg misoprostol. Analysis was made over difference in mean Bishop score of 2 points, using a standard deviation of 2, with 90% power, reaching a 95% confidence interval. RESULTS: 102 patients were studied, 51 received sublingual misoprostol, and 51 received vaginal misoprostol. There was a statistically significant difference in cervical modifications in global terms regardless of the administration route at 6 h (P < 0.05). When analyzing each group, there was no significant difference for the mean and standard deviation for Bishop score for sublingual and vaginal route (P = 0.761). There was no significant difference in terms of mode of delivery, Apgar score, cord pH, nor in the presence of complications. CONCLUSION: There is no statistically significant difference in terms of administration route for cervical ripening using misoprostol 50 µg, whether it was sublingual or vaginal. TRIAL REGISTRATION NUMBER: NCT02732522. Registry website: https://clinicaltrials.gov/ .
Assuntos
Maturidade Cervical/efeitos dos fármacos , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Administração Intravaginal , Administração Sublingual , Adulto , Índice de Apgar , Parto Obstétrico , Feminino , Idade Gestacional , Humanos , Misoprostol/efeitos adversos , Misoprostol/uso terapêutico , Ocitócicos/efeitos adversos , Ocitócicos/uso terapêutico , Gravidez , Método Simples-CegoRESUMO
PURPOSE OF INVESTIGATION: The objective of this study was to evaluate cervix length and the presence of cervical gland area (CGA) in ultrasounds performed before and after the administration of vaginal isosorbide mononitrate (IMN) for cervical ripening. METHODS: We performed an observational, descriptive, and longitudinal study of pregnant patients indicated for labor induction and with a Modified Bishop Score (MBS) lower than six. For cervical ripening, 40 mg of vaginal IMN was administered at 0, 16, and 24 hours after the initiation of cervix preparation. RESULTS: After enrolling 11 patients, the study had to be discontinued due to adverse effects. Three patients requested that they be withdrawn. Headaches were reported by all patients. Nausea, dizziness, dyspnea, and vomiting were also reported. The average cervical lengths at 0, 16, 24 and 36 hours were 27.6, 27.7, 25.9, and 23.0 mm, respectively. CGA disappeared in one of seven patients. CONCLUSIONS: The use of IMN appears to increase the MBS, slightly reducing cervical length without altering the appearance of CGA. Considering the importance of maternal wellbeing during labor, the routine use of IMN cannot be recommended for cervical ripening in the third trimester due to the frequency and intensity of side-effects.
Assuntos
Maturidade Cervical/efeitos dos fármacos , Dinitrato de Isossorbida/análogos & derivados , Doadores de Óxido Nítrico/efeitos adversos , Administração Intravaginal , Adulto , Cardiotocografia , Colo do Útero/diagnóstico por imagem , Colo do Útero/efeitos dos fármacos , Término Precoce de Ensaios Clínicos , Feminino , Humanos , Dinitrato de Isossorbida/administração & dosagem , Dinitrato de Isossorbida/efeitos adversos , Trabalho de Parto Induzido , Doadores de Óxido Nítrico/administração & dosagem , Satisfação do Paciente , Projetos Piloto , Gravidez , Resultado da Gravidez , Terceiro Trimestre da Gravidez , Ultrassonografia Pré-Natal , Adulto JovemRESUMO
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% for Foley, p<0.001) and required less use of oxytocin (41.2 versus 76.2%), and this group presented more tachysystole (21.2 versus 5.0%). The Foley catheter caused more discomfort to the patient (28.7 versus 1.2%). 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%). There were no significant differences in perinatal performance, with similar rates of abnormal cardiotocography (20.0 versus 21.2%), presence of meconium (13.7 versus 17.5%) and need for neonatal intensive care unit (3.7 versus 6.2%). 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.
Assuntos
Maturidade Cervical/efeitos dos fármacos , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Adolescente , Adulto , Cateterismo , Colo do Útero , Feminino , Humanos , Gravidez , Vagina , Adulto JovemRESUMO
BACKGROUND: Premature rupture of membranes is a normal occurrence of labor and can occur before or after the onset of contractions. The clinical factors associated with premature rupture of membranes include: low socioeconomic status, low body mass index, prior preterm pregnancies, smoking, sexually transmitted infections and urinary tract, conization, cervical cerclage and amniocentesis. OBJECTIVE: To evaluate whether prolonged release of the vaginal insert of PGE2 is superior to dinoprostone gel to achieve cervical ripening in patients with term pregnancy that occur with premature rupture of membranes. MATERIAL AND METHOD: Randomized clinical trial in the surgical unit of play in a period of 6 months, with an estimated sample of 50 patients was randomized by block table. After assessment confirming rupture of membranes, Bishop Score and meeting inclusion criteria, group A was applied PGE2 intracervical gel 0.5 mg with a maximum of 3 doses, every 6 hours. Group B was administered at vaginal insert of PGE2 single dose for 24 hours, the patient was left to sleep 30 minutes cardio toco-monitoring chart for at least 2 hours after application. RESULTS: The average time to maturity was 310.59 minutes with a standard deviation of 198.7 and concluded that there was no significant difference between the onset of uterine activity and the onset of labor among the prolonged release dinoprostone and alternatives such as the gel cervical for cervical ripening. CONCLUSIONS: Either this is a good choice to ripen the cervix in patients with term pregnancy and premature rupture of membranes.
Assuntos
Maturidade Cervical/efeitos dos fármacos , Dinoprosta/administração & dosagem , Ruptura Prematura de Membranas Fetais/tratamento farmacológico , Adolescente , Adulto , Cesárea/estatística & dados numéricos , Dinoprosta/efeitos adversos , Dinoprosta/uso terapêutico , Suscetibilidade a Doenças , Feminino , Géis , Humanos , Recém-Nascido , Infecções , Pessoa de Meia-Idade , Gravidez , Supositórios , Nascimento a Termo , Adulto JovemRESUMO
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.
Assuntos
Adolescente , Adulto , Feminino , Humanos , Gravidez , Adulto Jovem , Maturidade Cervical/efeitos dos fármacos , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Cateterismo , Colo do Útero , VaginaRESUMO
OBJECTIVE: To investigate the action of intracervical administration of hyaluronidase (HAase) as an inductor of cervical ripening on an outpatient basis. METHODS: A randomized double-blind trial was conducted with 168 pregnant women at term, Bishop score (BS)<5, normal fetal vitality and no uterine contractions. An evaluation was performed at the first visit, when either 20,000 UI of lyophilized HAase (5 ml) or placebo was administered via cervical injection. After 48 h, if the BS remained<5, a second dose was administered. The primary outcome was the BS after 48 h or 96 h. The outcome was considered positive when BS>/=5. RESULTS: The results indicate that the proportion of positive response for the HAase group (55%) after 48 h is significantly higher (p<0.0001) than the corresponding proportion for the placebo group (7%) with an absolute risk reduction (ARR) of 48%=55-7% (95%CI=40-56%). After 96 h, these proportions are 93% in the Haase group and 22% in the placebo group (p<0.0001, ARR=71%, 95%CI=61-81%). The average duration of labour for the nulliparae in the HAase group (6.5h) is significantly smaller (p<0.0001) than for those under placebo (12.0 h) with an absolute difference of 5.5h (95%CI=4.6-6.4h). For the multiparae, the results are 4.3h for the HAase patients versus 9.5h for the placebo patients (p<0.0001) with an absolute difference of 5.2h (95%CI=4.1-6.3h). The proportion of vaginal deliveries for women who received HAase was 82% versus 51% for the placebo group (p=0.0007, ARR=31%, 95%CI=19-44%). The proportion of vaginal deliveries for patients with prior cesareans in the HAase group (69%) was also significantly higher (p<0.0001) than that corresponding to the placebo group (13%) with ARR=56% (95%CI=26-86%). No uterine hyper stimulation occurred in the study. CONCLUSION: We detected significant associations between intracervical injection of HAase and ripening of the cervix, as well as with shorter duration of labour and larger chance of vaginal delivery, suggesting that this is a simple, effective and safe method even for women with prior cesarean.
Assuntos
Maturidade Cervical/efeitos dos fármacos , Colo do Útero/efeitos dos fármacos , Hialuronoglucosaminidase/uso terapêutico , Adolescente , Adulto , Feminino , Humanos , Injeções , Trabalho de Parto Induzido/métodos , Trabalho de Parto , Gravidez , Nascimento Vaginal Após CesáreaRESUMO
OBJECTIVE: The purpose of this study was to evaluate the effectiveness and safety of misoprostol in two different formulations: vaginal tablets of 25 microg and one-eighth of a 200-microg oral tablet, also administered intravaginally, for cervical ripening and labor induction of term pregnancies with an indication for that. METHODS: A single-blind, randomized, controlled clinical trial was carried out in 120 pregnant women who randomly received one of the two formulations. The main dependent variables were mode of delivery, need for additional oxytocin, time between beginning of induction and delivery, perinatal results, complications, and maternal side effects. Student's t, Mann-Whitney, chi2, Fisher's Exact, Wilcoxon and Kolmogorov-Smirnoff tests, as well as survival analysis, were used in the data analysis. RESULTS: There were no significant differences between the groups in terms of general characteristics, uterine contractility, and fetal well-being during labor, cesarean section rates, perinatal outcomes, or maternal adverse events. The mean time between the beginning of cervical ripening and delivery was 31.3 h in the vaginal tablet group and 30.1 h in the oral tablet group, a difference that was not statistically significant. CONCLUSION: The results showed that the 25-microg vaginal tablets of misoprostol were as effective and safe for cervical ripening and labor induction as the dose-equivalent fraction of 200-microg oral tablets.
Assuntos
Maturidade Cervical/efeitos dos fármacos , Trabalho de Parto Induzido/métodos , Misoprostol/uso terapêutico , Ocitócicos/uso terapêutico , Administração Intravaginal , Adulto , Colo do Útero/efeitos dos fármacos , Feminino , Humanos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Projetos Piloto , Gravidez , Resultado da Gravidez , Método Simples-Cego , Resultado do TratamentoRESUMO
OBJECTIVE: To determine the therapeutic efficacy and safety of a nitric oxide (NO) isosorbide dinitrate donor to induce cervical ripening of women with missed abortions before surgical evacuation of the uterus. DESIGN: A prospective, randomised, double-blind controlled trial. SETTING: Tertiary referral maternity teaching hospital. Population Sixty women with missed abortions and no cervical dilation. METHODS: Women requesting surgical evacuation of the uterus were randomly selected to receive endocervical 80 mg/1.5 mL isosorbide dinitrate gel solution (n= 30) or 400 mug/1.5 mL misoprostol gel solution (n= 30) every 3 hours to a maximum of four doses or until reaching cervical ripening. Vital signs and symptoms were recorded at baseline and then every 3 hours until finishing therapy. Adverse events, such as headache, abdominal pain, pelvic pain, backache, nausea and vomiting, were evaluated. MAIN OUTCOME MEASURES: Probability of reaching cervical ripening >8 mm Hegar dilator; evaluated at 3, 6, 9 and 12 hours after application of isosorbide dinitrate or misoprostol. RESULTS: The probabilities of induction of cervical ripening by isosorbide dinitrate and misoprostol after four repeated doses at 3-hour intervals were significantly different (P<0.001). Efficacy of therapy after 12 hours was 97% for the isosorbide dinitrate group and 70% for the misoprostol group. Systolic and diastolic blood pressures were lower after administration of isosorbide dinitrate than prostaglandin analogues. The difference in the mean systolic and diastolic blood pressure between treatment groups was greatest at 3 hours, with a difference of 7.7 mmHg (P<0.001) and 5.9 mmHg (P<0.003), respectively. The most frequent side effect associated with isosorbide dinitrate administration was headache, which occurred in 18 out of 30 patients, compared with only 5 out of 30 women in the misoprostol group [relative risk (RR) 2.41, 95% confidence interval (CI) 1.45-4.03, P<0.001). Women treated with misoprostol reported mainly pelvic pain (RR 3.24, 95% CI 1.99-5.27, P<0.001). CONCLUSIONS: Intracervical administration of 80 mg isosorbide dinitrate in women with missed abortions appears to be effective for cervical ripening prior to surgical evacuation of the uterus. Differences in the incidence of non-serious adverse events are not likely to be clinically significant.
Assuntos
Maturidade Cervical/efeitos dos fármacos , Dinitrato de Isossorbida/administração & dosagem , Doadores de Óxido Nítrico/administração & dosagem , Placenta Retida/cirurgia , Aborto Induzido/métodos , Administração Tópica , Método Duplo-Cego , Feminino , Géis , Humanos , Gravidez , Primeiro Trimestre da Gravidez , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: The purpose of this study was to identify the maximum tolerable dose and to determine the efficacy of different misoprostol dose reservoirs in an intravaginal controlled-release hydrogel polymer. STUDY DESIGN: Nulliparous women at > or = 37 weeks' gestation requiring cervical ripening and induction of labor were treated with misoprostol in a controlled-release, retrievable hydrogel polymer vaginal insert. Sequential cohorts of 6 patients were to be treated with escalating dose reservoirs of 25, 50, 100, 200, and 300 mug. The insert was to be removed upon onset of active labor, at 24 hours, or earlier if treatment-related adverse events occurred. The safety end point was determination of the maximum tolerable dose (MTD) based on occurrence of hyperstimulation syndrome. Our primary efficacy end point was time to vaginal delivery. RESULTS: Increasing reservoir doses of misoprostol up to 100 microg produced more rapid increases in modified Bishop scores, less need for oxytocin, and a shorter time to vaginal delivery. Doses above 100 microg did not further enhance cervical ripening or shorten time to vaginal delivery. The median time to vaginal delivery was 14.2 hours using the 100 microg dose. Uterine hyperstimulation and adverse fetal heart rate effects occurred with the 200 and 300 microg inserts. CONCLUSION: The 100 microg vaginal insert resulted in successful cervical ripening and rapid vaginal delivery with an acceptable safety profile for future randomized clinical trials.
Assuntos
Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Administração Intravaginal , Maturidade Cervical/efeitos dos fármacos , Preparações de Ação Retardada , Feminino , Humanos , Hidrogéis , Paridade , GravidezRESUMO
The objective of this work was to compare the efficacy of 50 and 100 microg of misoprostol administered intravaginally for cervical ripening and labor induction. Ninety-five patients were randomly assigned to receive 50 microg (n=48) or 100 microg (n=47) of misoprostol. The primary measures in this study were cesarean section rate, time from induction to delivery, need for oxytocin use, rate of uterine hyperstimulation and tachysystoles, proportion of fetal distress and neonatal Apgar score. The interval from first dose of prostaglandin to delivery was significantly shorter in the 100 ,g-group (p < 0.05). The use of oxytocin augmentation was significantly higher in the 50 microg-group (64.6% vs. 31.9%). There were 9 cases (18.8%) of tachysystole in the 50-microg group and 12 cases (25.5%) in the 100 microg-group (p NS). The cesarean section rate was double in the 100 microg-group and the difference was statically significant (p < 0.05). There was no report of uterine rupture. It can be concluded that 50 microg of misoprostol applied in the posterior vaginal fornix every 4 hours is an effective dosage for labor induction and has less adverse effects and complications than the 100 microg dose.
Assuntos
Maturidade Cervical/efeitos dos fármacos , Misoprostol/uso terapêutico , Ocitócicos/uso terapêutico , Administração Intravaginal , Adolescente , Adulto , Índice de Apgar , Arritmias Cardíacas/induzido quimicamente , Cesárea/estatística & dados numéricos , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Gastroenteropatias/induzido quimicamente , Humanos , Recém-Nascido , Trabalho de Parto Induzido , Síndrome de Aspiração de Mecônio/epidemiologia , Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Misoprostol/farmacologia , Complicações do Trabalho de Parto , Ocitócicos/administração & dosagem , Ocitócicos/efeitos adversos , Ocitócicos/farmacologia , Gravidez , Complicações na Gravidez , Contração Uterina/efeitos dos fármacosRESUMO
OBJECTIVE: To evaluate the effectiveness and safety of Foley catheter and hyaluronidase for cervical ripening. METHOD: Randomized controlled trial where 140 pregnant women, with gestational age > or = 37 weeks, indication for labor induction and an unripe cervix, were enrolled, allocated in two groups according to the method of cervical ripening before labor induction. Statistical analysis used Student's t-test, Mann-Whitney, Chi-square test, survival analysis, risk ratios and number needed to treat. RESULTS: Time of induction, dose of oxytocin and mode of delivery had better results in the Foley catheter group. Comfort with the method was higher in the hyaluronidase group. CONCLUSIONS: Both methods were effective and safe for cervical ripening. The Foley catheter group experienced a shorter period of induction, required a lower dose of oxytocin and had higher vaginal delivery rates, while the women who used hyaluronidase declared greater comfort with the method.
Assuntos
Cateterismo , Maturidade Cervical , Hialuronoglucosaminidase/farmacologia , Trabalho de Parto Induzido , Gravidez Prolongada , Maturidade Cervical/efeitos dos fármacos , Cesárea , Feminino , Humanos , Satisfação do Paciente , Gravidez , Resultado da Gravidez , Estudos ProspectivosRESUMO
CONTEXT: Misoprostol, a synthetic E1 methyl analog prostaglandin, is at present receiving attention as a cervical modifier and labor induction agent. However, there is still a need for better determination of its safety and effectiveness. OBJECTIVE: To compare intravaginal misoprostol versus intravenous oxytocin for cervical ripening and labor induction in pregnant women with unripe cervices. DESIGN: Randomized controlled trial. SETTING: The study was performed at the Leonor Mendes de Barros Maternity Hospital between November 1998 and December 2000. PARTICIPANTS: 210 pregnant women with intact membranes and indication for labor induction were selected. PROCEDURES: The women randomly received 25 g of vaginal misoprostol every 4 hours, not exceeding 8 doses (105 women), or oxytocin in a continuous infusion (105 women). MAIN MEASUREMENTS: The main parameters measured were: latent period, time from induction to vaginal delivery, delivery route, occurrence of vaginal delivery with time, occurrence of uterine tonus alterations, hypoxia and neonatal morbidity. To verify the statistical significance of the differences between the groups, the chi-squared, Student t and log-rank tests were used. RESULTS: There were no significant differences between the groups concerning conditions for labor induction, age, parity, race, marital status, family income, initial Bishop Index and number of prenatal visits. The cesarean section rate, latent period and period from induction to vaginal delivery were significantly lower for the misoprostol group. With regard to uterine tonus alterations, tachysystole was significantly more common in the misoprostol group. However, there was no difference in hypoxia and neonatal morbidity between the groups. CONCLUSION: 25 g of misoprostol used vaginally every 4 hours is safer and more efficient for cervical ripening and labor induction than oxytocin.
Assuntos
Abortivos não Esteroides/administração & dosagem , Trabalho de Parto Induzido , Misoprostol/administração & dosagem , Ocitocina/administração & dosagem , Adulto , Maturidade Cervical/efeitos dos fármacos , Feminino , Humanos , Gravidez , Gravidez Prolongada/efeitos dos fármacos , Tempo de Reação , Resultado do TratamentoRESUMO
OBJECTIVES: To evaluate if labor induction with 50 microg of vaginal misoprostol twice per day is as effective as and safer than 100 microg used once per day. METHODS: Misoprostol was used to induce labor in 204 consecutive pregnant women assessed as needing labor induction, 104 at the University Hospital of the West Indies in Kingston, Jamaica, and 100 at the Victoria Jubilee Hospital, also in Kingston. At the former institution the women were administered 100 microg of misoprostol once per 24 h and at the latter 50 microg every 12 h. The doses were repeated if there was no cervical change or if the woman was not in labor. Bishop scores were determined before initiation of induction and again 12 h later. Women's records were reviewed after 24 h to determine delivery outcome. RESULTS: The indications for labor induction were similar in each group. There was no significant difference in the group demographics. In the group given 50 microg of misoprostol twice per day the mean time+/-S.D. from insertion of misoprostol to delivery was significantly shorter than in the other group (560.14+/-269.20 min vs. 729.90+/-471.65 min; P<0.01), and the percentage of women who were delivered within 12 h was higher (75% vs. 56.8%; P<0.002). There was no significant difference between the two groups in the rate of cesarean births, the need for oxytocin, or blood loss. Only two patients experienced uterine hyperstimulation, both in the group that had received 100 microg of misoprostol per day. There was no significant difference between the two groups in the birthweight of the neonates and in the number of neonates with Apgar scores less than 7 at 1 min and 5 min. There were, however, significantly fewer neonates who needed resuscitation (6% vs. 14.7%; P=0.04) and admission to the special care nursery (7% vs. 17%; P=0.03) in the group that had received 50 microg of misoprostol twice per day. CONCLUSIONS: A dose of 50 microg of misoprostol twice per day appears to be more efficient and safer than a dose of 100 microg once per day, but this may partially be due to weaknesses in the study design.
Assuntos
Trabalho de Parto Induzido/métodos , Misoprostol/uso terapêutico , Resultado da Gravidez , Administração Intravaginal , Adolescente , Adulto , Índice de Apgar , Peso ao Nascer , Maturidade Cervical/efeitos dos fármacos , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Jamaica , Gravidez , Probabilidade , Estudos Prospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: This study was designed to determine whether use of prostaglandin E(1 )(PGE(1)) is justified to improve the known clinical outcome of prostaglandin E(2) (PGE(2)) gel, because PGE(2) gel preparations are more costly than PGE(1) tablets in most countries, and data to support the use of the gel in clinical practice is not conclusive. The aim was to compare the safety and efficacy of PGE(1) gel when applied in both an in-hospital or ambulatory setting to oxytocin infusion in those women with unfavorable cervical conditions prior to surgical abortion for either medical or obstetrical indications with intrauterine fetal demise. Surgical dilatation of the unripe cervix may result in cervical injury of uterine perforation which could prolong the hospital stay. METHODS: We used PGE(1) gel prepared from tablets and administered in the ambulatory form (group 1), the same PGE(1) gel administered in the labor room (group 2) and intravenously administered oxytocin in the labor room (group 3) for the induction of abortus in women complicated with intrauterine fetus death and missed abortion. Patients requesting abortion were eligible for inclusion, with >8 and <13 weeks of gestation. Eighty-nine women with unfavorable cervices (Bishop score
Assuntos
Aborto Induzido/métodos , Alprostadil/administração & dosagem , Maturidade Cervical/efeitos dos fármacos , Morte Fetal/terapia , Tempo de Internação , Vasodilatadores/administração & dosagem , Adulto , Feminino , Géis , Humanos , Injeções Intravenosas , Ocitocina/administração & dosagem , Gravidez , Resultado do TratamentoRESUMO
An open prospective study was carried out in order to evaluate controlled-release dinoprostone pessary with retrieval system in 40 patients. The objective of the study was to obtain clinical experience in Mexico and to assess its efficacy and safety during use. The following results were obtained. The Bishop Score before treatment was 2.98 +/- 1.23, and after treatment it was 8.33 +/- 2.81. The difference was significant (P = 0.0001). Twenty-five patients (62.5%) had spontaneous vaginal delivery, and 14 patients (35%) underwent caesarean section. The indications for the withdrawal of the pessary were as follow: start of labor in 19 patients (47.5%), completation of observation period in 17 patients (42.5%), maternal complications in 2 patients (5%) and, maternal and fetal complications in 2 patients (5%). The mean time between pessary insertion and withdrawal was 8.52 hours; the mean time to start of labor was 10:17 hours; the mean time to start of the 2 degrees labor period was 16:25 hours. The mean duration of labor in all 40 patients was 8:48 hours. We conclude that this study confirms the efficacy of controlled-release dinoprostone with retrieval system in cervical ripening, being easy to insert and to withdraw, and well tolerated since adverse events only occurred in 10% of all patients (uterine hyperstimulation and fetal tachycardia which were controlled by merely withdrawing the pessary). Only one patient (2.5%) required beta-mimetic support in order to control the induced uterine hyperstimulation.