Preinduction cervical ripening. A randomized trial of intravaginal misoprostol alone vs. a combination of transcervical Foley balloon and intravaginal misoprostol.

OBJECTIVE: To determine if the addition of a mechanical ripening agent (transcervical Foley balloon) to a pharmacologic agent (intravaginal misoprostol) improves the efficiency of preinduction cervical ripening. STUDY DESIGN: Singleton patients with an indication for delivery, unfavorable cervix (Bishop score < or = 5) and no contraindication to labor were randomly assigned to two groups: misoprostol alone (25 micrograms intravaginally every 3 hours for no more than 12 hr) or combination therapy (25-French transcervical Foley balloon inflated to 50 mL of sterile water with identical intravaginal misoprostol dosing). All patients received a history and physical examination (including Bishop score), preripening ultrasound, electronic fetal heart rate and contraction monitoring (to rule out spontaneous labor and document fetal well-being). Multiple variables of perinatal outcome were analyzed, including the main outcome variables of ripening-to-delivery time and cesarean section rate. RESULTS: During August 1998 to August 1999, 81 patients were randomized, 40 to misoprostol alone and 41 to combination therapy. There were no differences between the groups with respect to maternal demographics, preripening Bishop score, maternal complications, intrapartum intervention or neonatal outcome. The misoprostol group spent longer periods of time in active labor, and there was a trend for the combination group to require oxytocin for longer intervals. These findings did not significantly affect the total ripening-to-delivery time or cesarean section rate which were similar for both groups. CONCLUSION: The addition of mechanical ripening with a transcervical Foley balloon to intravaginal misoprostol did not improve the efficiency of preinduction cervical ripening. Mechanical and pharmacologic cervical ripening agents appear to act independently rather than synergistically.     

Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor.

OBJECTIVE: To compare the efficacy and safety of 100 microg of intravaginal misoprostol with intracervical Foley catheter for cervical ripening and induction of labor. METHOD: One hundred women being induced in the Lagos University Teaching Hospital, Nigeria, were randomized to receive a single 100 microg dose of misoprostol intravaginally or intracervical insertion of Foley catheter. Data analyses were by the Student's t-test and chi-square test. RESULT: Misoprostol was more effective in terms of induction to delivery interval (11.84+/-5.43 versus 20.03+/-4.68 h, P<0.05), change in Bishop score, and number delivered within 24 h, in patients with a one-time successful induction. Uterine hyperactivity and rupture were more frequent in the misoprostol group. CONCLUSION: A single 100 microg dose of intravaginal misoprostol is more efficacious than intracervical insertion of Foley catheter for cervical ripening and induction of labor. Further studies using lower doses are needed to determine the safest dose.     

A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction

OBJECTIVE: The purpose of this study was to determine the efficacy of combination intravaginal misoprostol and intracervical Foley catheter for prelabor cervical ripening. STUDY DESIGN: A prospective, randomized controlled trial was conducted. Women who were undergoing labor induction, with a singleton gestation >or=28 weeks and an unfavorable cervix (Bishop score 相似文献   

Intracervical Foley catheter balloon vs. prostaglandin in preinduction cervical ripening.

OBJECTIVES: The aim of this study is to compare the effectiveness of the intracervical Foley balloon catheter and 3 mg prostaglandin E(2) tablet(s) in preinduction cervical ripening. METHODS: Ninety women referred to the maternity clinic for induction of labor with a Bishop score of less than or equal to 5 were randomized to receive an intracervical Foley catheter or prostaglandin E(2) tablets. The primary measured outcome was ripening of the cervix as measured with the Bishop score. RESULTS: There were no differences in mean Bishop scores between the prostaglandin and the Foley catheter groups. Bishop scores (mean+/-S.D.) after ripening were 6.6+/-0.80 and 6.7+/-0.86 for the Foley catheter and prostaglandin groups, respectively (P=0.54). The Foley catheter group showed a statistically shorter time to ripening compared with the prostaglandin group (3.4+/-2.1 and 6.5+/-3.2 h, respectively (P=0.001). There was no statistically significant difference in induction time (4.8+/-1.8 h and 5.3+/-2.4 h, respectively (P=0.36). CONCLUSIONS: There are no differences in preinduction cervical ripening efficacy between prostaglandin E(2) and the Foley catheter, but the Foley catheter has the advantage of ripening an unfavorable cervix in a shorter time.     

Extra-amniotic Foley catheter and prostaglandin E(2) gel for cervical ripening at term gestation.

OBJECTIVE: This study evaluated the efficacy of intravaginal prostaglandin E(2) gel in comparison with that of a Foley catheter for cervical ripening and induction of labor. STUDY DESIGN: Consecutive patients with unfavorable cervix requiring preinduction cervical ripening and induction of labor at term gestation were asked to participate in the study. One hundred and two patients were assigned to treatment with intravaginal prostaglandin E(2) gel (group 1) and 122 patients underwent the placement of an intracervical Foley catheter (group 2). After a maximum of three applications of intravaginal prostaglandin E(2) gel (18h) or after 18h from Foley catheter insertion oxytocin was administered to patients not in active labor. Labor profiles and pregnancy and neonatal outcome were compared between groups. RESULTS: The groups were comparable in term of demographic characteristics, indications for induction of labor, Bishop score at admission. The induction to labor time and the induction to delivery time were similar between groups. The cesarean sections rate was higher in group 1 than in group 2 (26.5 versus 14.7%, P<0.05). This remained significant when the analysis was restricted to nulliparous patients (32.3 versus 14.2%). The incidence of urinary tract infections, chorioamnionitis, and febrile morbidity was similar between groups. CONCLUSION: For preinduction cervical ripening, the Foley catheter is a valid alternative to the application of intravaginal prostaglandin E(2) gel and it is associated with a lower cesarean rate in nulliparous women.     

Unsucessful labour induction in women with unfavourable cervical scores: predictors and management

BACKGROUND: Misoprostol fails to induce labour in 5-20% of women at term. AIM: To analyse possible predictors of unsuccessful induction with 50 microg vaginal misoprostol and effectiveness and the safety of intracervical Foley catheter application in induction failures. METHODS: An observational study was conducted on 1030 women with singleton, live fetuses, vertex presentation, > 34 weeks of gestation and Bishop score < 5. Induction of labour with 50 microg vaginal misoprostol repeated every 6 h was attempted. Women without regular uterine contractions and cervical changes at the end of 24 h were considered to be unsuccessful, and a transcervical Foley balloon catheter was placed and inflated with 50 mL saline. Possible predictors of induction failures were analysed via logistic regression analysis. Neonatal outcomes and vaginal delivery achieved after Foley catheter were also determined. RESULTS: Induction was successful in 918 cases (89.1%) and Foley catheter was placed in 112 (10.8%) women. Increasing gestational age in weeks (odds ratio [OR] 0.77, 95% confidence interval [CI] 0.68-0.88) and increasing Bishop score (OR 0.73, 95% CI 0.60-0.90) decreased the risk of failed induction. Failure rates were 16% (27/169) in post-term nulliparous women with Bishop score 相似文献   

Preinduction cervical ripening techniques compared

OBJECTIVE: To assess the clinical efficacy of pharmacologic, mechanical and combination techniques of cervical ripening. STUDY DESIGN: From March 1997 to August 1998, all cervical-ripening patients at Lehigh Valley Hospital were randomly assigned to three groups: intravaginal misoprostol, intracervical Foley catheter, or combination prostaglandin E2 (PGE2) gel and Foley catheter. Inclusion criteria included Bishop score < or = 5 and no contraindication to labor. The remaining delivery process was actively managed according to established guidelines. Multiple variables in perinatal outcome were analyzed, with the cesarean section rate and time from ripening to delivery as the main outcome variables. RESULTS: Of the 205 patients, 65 were randomized to the misoprostol group, 71 to the Foley group and 69 to the catheter-and-gel group. There were no differences between groups in delivery indications, maternal demographics, ultrasound findings, labor interventions, intrapartum times, mode of delivery, postpartum complications or neonatal outcomes. The misoprostol group demonstrated a higher rate of uterine tachysystole and required oxytocin less when compared to the two catheter groups. CONCLUSION: The higher rate of uterine tachysystole with misoprostol did not increase the cesarean section rate. The higher rate of oxytocin required by the two catheter groups did not increase the delivery time intervals. There appears to be no benefit to adding intracervical or intravaginal PGE2 gel to the intracervical Foley balloon. The misoprostol and catheter ripening techniques have similar safety and efficacy.     

Cervical ripening and induction of labor with misoprostol,dinoprostone gel,and a Foley catheter: a randomized trial of 3 techniques

OBJECTIVE: The purpose of this study was to compare the efficacy of 3 different techniques of cervical ripening and induction. STUDY DESIGN: Patients who required cervical ripening and induction were randomized to one of 3 groups: (1) supracervical Foley catheter and intravaginal dinoprostone gel, (2) supracervical Foley catheter and 100 microg oral doses of misoprostol, or (3) serial 100-microg oral doses of misoprostol. Intravenous oxytocin was administered when a protraction disorder of labor was identified. RESULTS: There were 339 women randomized. There was no significant difference in the time from first intervention to delivery in the 3 groups (P =.546). In each group, a similar percentage of women required oxytocin (P =.103). The rates of cesarean delivery were equivalent among the groups (P =.722). Rates of tachysystole were high but statistically equivalent among the 3 groups. There were no significant differences in Apgar scores or umbilical artery pH. CONCLUSION: Oral 100 microg serial doses of misoprostol, with or without the use of a supracervical Foley catheter, were equivalent to the use of a supracervical Foley catheter and serial 4-mg doses of dinoprostone gel for cervical ripening and the induction of labor.     

Pre-induction cervical ripening: transcervical foley catheter versus intravaginal misoprostol.

The object of this study was to compare the effectiveness of the intravaginal Misoprostol and transcervical Foley catheters as pre-induction cervical ripening agents, to estimate the proportion of patients achieving vaginal delivery and to compare the complications of labour and foetal outcome between the two groups. The study was a prospective, randomised study of pregnant women, with singleton pregnancies who presented for antenatal care and delivery at the University College Hospital (UCH), Ibadan, Nigeria. Ninety-nine patients were invited to participate and ninety-six (96) agreed. No patient withdrew from the study. The patients were assigned by means of computer-generated random numbers to receive transcervical Foley catheters (Size 16F, with 30 ml balloon capacity) or 50 microg intravaginal Misoprostol (Cytotec tablet, Searle & Co., Chicago). Fifty (50) patients received intravaginal Misoprostol and Forty-six (46) received Transcervical Foley catheters. The proportions of nulliparous, primiparous and multiparous patients were 52, 20 and 28% in the misoprostol group and 43.5, 26.1 and 30.4%, respectively, in the Foley catheter group. The time to achieve a favourable cervical status was significantly shorter in the Misoprostol group, with 98.0% of the subjects attaining Bishop score > or = 6 within 6-12 hours of insertion of the study agent, in contrast to 69.0% of the subjects in the Foley catheters group (P<0.001). Thirteen (26.6%) and three (6.5%) patients in the Misoprostol and Foley catheters groups, respectively, went into labour while undergoing cervical ripening and all had uneventful vaginal deliveries (P<0.05). The induction-delivery interval did not differ significantly between the groups. The incidence of caesarean delivery was 6.0% in the Misoprostol group compared with 2.2% in the Foley catheter group (P=0.62). Instrumental vaginal delivery rates were similar in both groups. Overall, the mode of delivery did not differ significantly between the groups. The number of neonates with 1-minute Apgar score <7 did not differ significantly in both groups and no neonate had 5-minute Apgar score <7. Meconium stained liquor was noticed in 5 (Misoprostol) vs 2 (Foley catheters) patients in labour. None of the neonates had any features suggestive of meconium aspiration. Labour complications were mainly precipitate labour {2 (Misoprostol) vs 1 (Foley catheters) } and 1 patient with transient tachysystole (> or =6 contractions in 10 minutes for two consecutive 10-minute periods) in the Misoprostol group. Hyperstimulation was not noticed in any of the patients in either arm of the study groups. Intravaginal Misoprostol is as effective a pre-induction cervical ripening agent as transcervical Foley catheters, with added advantages of shorter duration of cervical ripening, reduced oxytocin requirement for induction of labour and greater acceptability to patients. The incidence of caesarean sections, other labour complications and the foetal outcome were similar with both methods.     

Preinduction cervical ripening with the Foley catheter and the risk of subsequent preterm birth

OBJECTIVE: The Foley catheter is a safe and effective form of preinduction cervical ripening and is quickly growing in popularity. Its major effect appears to be through mechanical dilation, which has raised the concern that the use of the Foley catheter for cervical ripening may damage the cervix and result in a higher rate of subsequent preterm birth. STUDY DESIGN: We conducted a review of all induction of labor at our institution from July 1998 to July 2001 that required preinduction cervical ripening and had a subsequent birth. The primary outcome variable was preterm birth at <35 weeks of gestation. Demographic and potential confounding variables were analyzed. A probability value of <.05 was considered significant. RESULTS: The cases of 126 women (63 women in the Foley group and 63 women in the prostaglandin group) were studied. Women in the prostaglandin group had a prostaglandin agent used. There was no difference in maternal age, gravidity, parity, Bishop score, total time of induction, gestational age, oxytocin use, maximum oxytocin level, tobacco or drug use, or type of delivery in the index pregnancy between the groups. In the subsequent pregnancies, there were no differences in maternal age, gravidity, parity, spontaneous abortions, terminations, cone or Loop Electrosurgical Excision Procedure (LEEP) procedures, history of cervical manipulation, tobacco or drug use, stillbirth, need for induction, mode of delivery, episiotomy, gestational age at delivery, Apgar scores, labor duration, use of oxytocin, or birth weight. There were no differences in preterm birth at 37, 35, or 32 weeks of gestation between the groups. CONCLUSION: The use of the Foley catheter for preinduction cervical ripening does not appear to increase the risk of preterm birth in a subsequent pregnancy.     

Oral misoprostol vs. intravaginal prostaglandin E2 for preinduction cervical ripening. A randomized trial

OBJECTIVE: To compare orally administered misoprostol with intravaginal prostaglandin E2 for cervical ripening and labor induction. STUDY DESIGN: Patients presenting with medical or obstetric indications for labor induction whose Bishop's score was < or = 6 were randomly allocated to receive either 50 micrograms of oral misoprostol or 4 mg of intravaginal prostaglandin E2. If adequate cervical ripening (Bishop score of 9 or cervical dilatation of 3) or active labor did not ensue, repeat doses of each medication were administered every four hours. A maximum of six doses of either oral misoprostol or intravaginal prostaglandin E2 was permitted. Intravenous oxytocin was subsequently administered according to a standardized infusion protocol. RESULTS: Sixty patients were enrolled, with 29 randomized to the oral misoprostol arm and 31 to the prostaglandin E2 group. The data on 58 patients were eligible for analysis. Delivery occurred within 48 hours in 96.4% (27/28) of those administered oral misoprostol as compared to 76.7% (23/30) of those who received intravaginal prostaglandin E2 (P = .03). The mean time intervals from the start of induction to delivery were similar between the two groups (1,496 +/- 120 vs. 1,723 +/- 230 minutes, P = .40). No statistically significant differences existed between the two groups with respect to intrapartum complications, tachysystole, uterine hyperstimulation or adverse neonatal outcomes. CONCLUSION: Oral administration of misoprostol is an effective alternative to intravaginal prostaglandin E2 for preinduction cervical ripening.     

Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening

BACKGROUND: The success of induced labor depends on the degree of ripening of cervix. Pharmacological preparations are in widespread use for cervical ripening but are not free from side-effects and complications. Mechanical methods, i.e. the use of Foley catheter balloon, though effective have not gained much popularity because of the fear of infection. Therefore, this study has been conducted to prove the efficacy and safety of extraamniotic Foley catheter balloon and to compare it with intracervical prostaglandin E2 (PGE2) gel. METHODS: The randomized prospective study was conducted in the Department of Obstetrics and Gynecology and Medical Microbiology of Nehru Hospital. Hundred women attending the labor ward for induction of labor were divided into two groups: Group A--Foley catheter, Group B--PGE2 gel. Cervical swabs before and after the insertion of ripening agents were taken for culture studies. Placental membranes were also sent for culture. Labor outcome, side-effects, and complications were compared in both the groups. The statistical methods used were Student's compared t-test, Chi-square test, and Wilcoxon-Mann-Whitney test. RESULTS: Foley catheter proved to be a very effective preinduction ripening agent for unfavorable cervix compared with PGE2 gel, as is evident by the mean Bishop score at 12 h (P<0.001). Preparation delivery interval was significantly shorter (P<0.05) in women who underwent cervical ripening with Foley catheter balloon than with the PGE2 gel. No clinical evidence of chorioamnionitis was present in both the groups. CONCLUSION: This study concludes that extraamniotic Foley catheter balloon is an effective, safe, simple, low-cost, reversible, non-pharmacological mechanical method of preinduction cervical ripening.     

Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial

OBJECTIVE: To compare the efficacy of transcervical Foley catheter alone (Foley) to transcervical Foley catheter with extraamniotic saline infusion for labor induction and cervical ripening in women with an unfavorable cervix. METHODS: This was a multicenter, randomized, controlled trial of women presenting for labor induction with a singleton, cephalic fetus, intact membranes, and unfavorable cervix (Bishop score 6 or less). Eligible women were randomly assigned to receive either Foley catheter alone or Foley catheter with extraamniotic saline infusion. All women received concurrent oxytocin administration. The primary study outcome was the induction-to-delivery interval. Secondary outcomes included cesarean delivery, maternal infectious outcomes, and immediate neonatal outcomes. Analysis was by intent to treat. RESULTS: One hundred eighty-eight women met eligibility criteria and were randomly assigned (Foley plus extraamniotic saline infusion, n=97; Foley, n=91). Baseline demographic characteristics, including parity, gestational age, and Bishop score were similar between the study groups. The median induction-to-delivery interval in the extraamniotic saline infusion arm (12.6 hours, interquartile range 9.3-18.8 hours) was similar to that in the Foley arm (13.4 hours, interquartile range 9.6-17.5 hours) (P=. 70). The proportion of women delivered by 24 hours was comparable between groups (delivery 24 hours, extraamniotic saline infusion 89.7%, Foley 87.9%, P=.70), as was the rate of cesarean delivery (Foley 18.7%, extraamniotic saline infusion 27.8%, P=.14). No significant differences were noted between the study groups with respect to rate of chorioamnionitis, endometritis, or immediate birth outcomes. CONCLUSION: In women with an unfavorable cervix, the addition of extraamniotic saline infusion to a transcervical Foley catheter does not improve efficacy for labor induction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00442663 LEVEL OF EVIDENCE: I.     

Using of Misoprostol for preinduction and induction of labor in term pregnancy

Labour induction is frequently indicated in women with an unfavourable cervix. Oxytocin and prostaglandins are the most common drugs used for labour induction. Induction of labour with prostaglandins offers the advantage of promoting both cervical ripening and myometrial contractility. The purpose of the study was to evaluate the safety and efficacy intravaginal administration prostaglandin E1 methyl analogue, misoprostol in cervical ripening and induction of labour in term pregnancy and in women with unfavourable cervix (Bishop score < = 4). The approval for this study was given by the Board of Medical Ethics, University Medical School of Lublin in Poland. MATERIALS AND METHODS: 64 women with indication for termination of pregnancy received either misoprostol (Cytotec-Searle) vaginally (group M, n = 30) or intravenous drip infusion of oxytocin(group Ox, n = 34). We evaluated profile of the studied women (gravidity, weight, height, maternal age, gestational age), effectiveness and safety of the misoprostol and need for oxytocin administration in group M, start of induction-to-active labour interval (contractions), start of induction-to-vaginal delivery interval, hyperstimulation syndrome, delivery within 24 hours of drug application and caesarean section rate. Before starting labour induction a Bishop score was obtained. Statistical analysis was performed. Baseline and outcome variables were tested with student's t-test and c2 analysis. We needed p < 0.05 for statistical significance. RESULTS: There were no differences in the patient profiles (gravidity, weight, height, maternal age, gestational age) between groups except the score of cervical ripening. The Bishop score before induction was lower in group M. The interval between the initiation of induction to active labour was shorter in the misoprostol group (334.23 +/- 126.35 versus 610.00 +/- 352.14 minutes). The mean time between the initiation of induction to delivery was shorter in group M (707.69 +/- 341.15 +/- versus 1025.77 +/- 369.16 minutes). These differences were statistically significant. 28 (93.33%) patients in the misoprostol group delivered within 24 hours compared with 24 (70.59%) women in the oxytocin group. 8 patients in the misoprostol group and 8 patient in the oxytocin group had caesarean section. Labor induction was successful in 30 (100%) women in the misoprostol group compared with 24 (70.59%) patients in the group Ox. CONCLUSIONS: Intravaginal misoprostol is an effective, easy to use and cheap drug for the induction of labour, especially for cervical ripening in women with unfavourable cervix (Bishop score < = 4).     

Digital and transvaginal ultrasound cervical assessment for prediction of successful labor induction.

OBJECTIVE: To compare the values of preinduction transvaginal cervical length measurements and Bishop score to predict successful labor induction. METHODS: A prospective, observational trial of nulliparous women undergoing labor induction. Inclusion criteria were gestational age between 36 and 42 weeks, singleton cephalic presentation of the fetus, and intact membranes. Preinduction cervical ripening was performed using 25 microg intravaginal misoprostol (PGE1), repeated every 4 h, up to a maximum of 3 doses. Induction was subsequently continued by oxytocin and amniotomy. RESULTS: A total of 43 women met the inclusion criteria. Mean preinduction cervical length for women with successful or failed labor induction was 26 mm (95% Confidence interval [CI], 27-32) and 34 mm (95% CI, 33-38), respectively (P=0.002). Mean Bishop scores for successful and failed induction groups were 5.4 (95% CI, 5.2-6.2) and 3.1 (95% CI, 2.8-3.5), respectively (P=0.003). CONCLUSION: Digital examination and transvaginal ultrasound of the cervix predict successful labor induction with reasonable accuracy.     

Cervical ripening: A randomized comparison between intravaginal misoprostol and an intracervical balloon catheter combined with intravaginal dinoprostone

OBJECTIVES: Our purpose was to compare the efficacy of intravaginal misoprostol and intracervical Foley catheter/intravaginal dinoprostone for cervical ripening. STUDY DESIGN: Patients admitted for induction of labor were randomized to receive intravaginal misoprostol 25 μg every 4 hours or intracervical Foley catheter/intravaginal dinoprostone 4 mg every 4 hours. Patients not entering active labor and having ruptured membranes or arrest of dilatation received intravenous oxytocin. RESULTS: Sixty-five patients received Foley catheter/dinoprostone gel and 62 patients received misoprostol. The mean time until cervical ripening was less in the catheter/gel group (7.5 ± 3.4 vs 12.0 ± 5.9 hours, p < 0.01). The mean time until vaginal delivery was less in the catheter/gel group (17.4 ± 6.9 vs 21.2 ± 7.5 hours, p = 0.004). Among vaginal deliveries, more patients in the catheter/gel group delivered within 24 hours (90% vs 69%, p = 0.013). CONCLUSIONS: Intracervical Foley catheter/intravaginal dinoprostone was associated with more rapid cervical ripening, shorter induction to vaginal delivery interval, and greater number of vaginal deliveries within 24 hours. (Am J Obstet Gynecol 1998;178:1333-40.)     

Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial

OBJECTIVE: To estimate whether adding oxytocin to transcervical Foley catheter preinduction cervical ripening improves induction success. METHODS: This trial enrolled 200 women with singleton pregnancies presenting for preinduction ripening. Patients were randomly assigned to receive either Foley catheter alone (control) or Foley catheter plus low-dose oxytocin (treatment). Providers were not blinded to use of oxytocin, and labor was managed according to routine obstetric protocols. This study was powered to detect a 20% difference in the proportion of patients delivered within 24 hours. Secondary outcomes were related to vaginal delivery rate, duration of induction, complications, and pain management. RESULTS: Results were available for 183 (92 treatment, 91 control) of 200 patients randomly assigned. There were no differences in proportions of deliveries-overall (65% compared with 60%; relative risk [RR] 1.08, 95% confidence interval [CI] 0.86-1.35, number needed to treat 21) or vaginal (48% compared with 46%; RR 1.04, 95% CI 0.76-1.41, number needed to treat 60)-in 24 hours, or cesarean deliveries or times to deliveries between treatment or control groups. Rates of complications were comparable; however, the treatment group had a higher proportion of regional analgesia requirement during induction than controls (23% compared with 9%, P=.01; RR 2.60, 95% CI 1.21-5.56). CONCLUSION: Addition of oxytocin to transcervical Foley catheter does not shorten the time to delivery and has no effect on the likelihood of delivery within 24 hours or vaginal delivery rate, although there is an increased use of analgesia by these patients during ripening. The use of oxytocin in addition to Foley catheter ripening is not justified. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00468520. LEVEL OF EVIDENCE: I.     

Randomised trial of intravaginal misoprostol and intracervical Foley catheter for cervical ripening and induction of labour.

Induction of labour may be indicated despite an unripe cervix. The purpose of this study was to compare the safety and efficacy of intravaginal misoprostol and an intracervical Foley's balloon catheter for preinduction cervical ripening and labour induction. A total of 120 patients requiring indicated induction of labour with an unfavourable cervix (Bishop's score < or =4) were randomised prospectively to receive either 50 mug intravaginal misoprostol every 6 h for a maximum of two doses, or an intracervical Foley balloon catheter for 12 h followed by an intravenous oxytocin infusion. The two arms of the study were comparable with respect to maternal age, parity, gestational age, indication for induction, and initial Bishop's scores. There were significant change in the Bishop's score in the two groups (5.9 +/- 0.2 and 4.0 +/- 0.2, respectively, p < 0.001) but no inter group differences. Oxytocin induction or augmentation of labour occurred more in the catheter group (95%) than in the misoprostol group (43.3%) (p < 0.0001). Induction to delivery interval was significantly shorter in the misoprostol group than in the catheter group (8.7 +/- 2.4 vs 11.9 +/- 2.7 h p < 0.0001). There was no significant difference noted in the caesarean or other operative delivery rates among patients in the two treatment groups. There was a higher incidence of tachysystole and hyperstimulation in the misoprostol group than in the catheter group (p < 0.03). No differences were observed between groups for meconium passage, 1- or 5-min Apgar scores < 7 and admission into the neonatal intensive care unit. In conclusion, the maternal and perinatal outcomes in this study have shown no difference confirming the efficacy and safety of both methods, however we observe a decrease in the induction-to-delivery interval when misoprostol is used for this purpose.     

A randomized trial comparing vaginal misoprostol versus Foley catheter with concurrent oxytocin for labor induction in nulliparous women

The objective of this study was to compare the efficacy and safety of intracervical Foley catheter with concurrent use of oxytocin versus vaginal misoprostol for labor induction in nulliparous women. Nulliparous women with Bishop score <6 who presented for labor induction were randomized to either 25 microg vaginal misoprostol every 4 hours followed by oxytocin, if indicated, or intracervical Foley catheter with simultaneous use of oxytocin. Among the 162 patients enrolled, 79 (49%) received misoprostol and 83 (51%) received Foley/oxytocin. We were unable to demonstrate a statistically significant difference between the misoprostol group and Foley/oxytocin group in the incidence of cesarean delivery (35% versus 29%; p = 0.37). The induction-to-delivery time was significantly shorter in the Foley/oxytocin group (18 versus 24 hours; p < 0.01). No differences in intrapartum complications, neonatal outcomes, or maternal morbidity were found. When compared with vaginal misoprostol, intracervical Foley catheter combined with oxytocin has a similar efficacy and safety profile for labor induction in nulliparous women. Foley/oxytocin results in a shorter induction-to-vaginal delivery time compared with misoprostol.     

30 mL和60 mL容量宫颈扩张球囊对足月妊娠促宫颈成熟效果比较

目的：探讨两种不同容量的宫颈扩张球囊用于足月妊娠促宫颈成熟的临床疗效观察,为提高引产成功率,降低产后不良影响提供临床依据。方法：随机抽取2017年6月-2017年12月同济大学附属第一妇婴保健院收治的具有引产指征且宫颈评分＜6分的足月单胎孕妇400例作为观察对象,根据不同的球囊注水容量随机分为2组,Foley单球囊注水30 mL促宫颈成熟组（F30组）200例,Foley单球囊注水60 mL促宫颈成熟组（F60组）200例,比较2组患者的促宫颈成熟效果、引产效果以及孕产妇和新生儿转归情况。结果：2组患者治疗前Bishop评分比较,差异无统计学意义（χ2=1.280,P=0.201）,治疗后2组患者Bishop评分均上升,治疗后Bishop评分比较,差异有统计学意义（χ2=-4.137,P=0.000）。2组初产妇的引产-分娩时间比较差异有统计学意义（t=4.204,P=0.000）。多因素分析显示球囊容量是初产妇24 h内成功阴道分娩的影响因素（OR=1.990,95%CI：1.444～2.742,P=0.000）。研究中20例瘢痕子宫孕妇用宫颈扩张球囊促宫颈成熟,其中18例顺利阴道分娩,无相关并发症。2组孕产妇和新生儿结局比较,差异均无统计学意义（均P＞0.05）。结论：对足月宫颈条件不成熟的孕妇（包括剖宫产术后再次妊娠者）采用宫颈扩张球囊引产,安全有效,Foley 60 mL球囊在促宫颈成熟方面效果更好,且适当缩短引产-分娩时间。