A comparison of prostaglandin E2 pessaries and laminaria tents for ripening the cervix before termination of pregnancy

Forty primigravid women aged 15-45 years were randomly allocated to receive either an intravaginal pessary of 3 mg prostaglandin E2 (PGE2) or an intracervical 5-mm laminaria tent (LT) 12-16 h before termination of pregnancy at 6-14 weeks gestation. The degree of dilatation of the cervix at operation and its resistance to further dilatation during the procedure were assessed by a 'blind' operator. Laminaria tents were more effective in achieving dilatation and softening of the cervix than were PGE2 pessaries and in 40% of women no further dilatation was necessary. There were no associated side-effects or complications. A cervical tear occurred in two of 20 patients treated with PGE2 pessaries and all 20 required further dilatation of the cervix. Laminaria tents provide a simple, safe, acceptable and effective means of 'ripening' the cervix prior to termination of early pregnancy.     

A comparison of single prostaglandin E2 vaginal tablet with prostaglandin E2 vaginal pessaries for induction of labor at term.

This study represents the first of its kind in Kuwait. Two preparations of prostaglandin E2 (PGE2) have been compared as agents for induction of labor. In a randomized controlled study of 200 women of low parity and unfavorable cervical induction features induction of labor by means of a single vaginal tablets of PGE2 was compared with locally prepared PGE2 vaginal pessaries. The gradual increase of uterine contractions and the establishment of labor in a similar way to that observed during spontaneous labor was more apparent after PGE2 tablets. Labor induction was successful in 80% of patients in PGE2 tablet group compared with 59% in PGE2 pessaries group. The incidence of cesarean section was equal in both groups (4%), but none was performed due to uterine hyperactivity. The data presented indicate that the PGE2 vaginal tablet is safe and effective in induction of labor in healthy women at term.     

Intravenous oxytocin and oral prostaglandin E2 for ripening of the unfavourable cervix.

A clinical trial involving 60 patients was conducted to assess the relative efficacy of intravenous oxytocin and oral prostaglandin E2 in ripening the unfavourable cervix, when given as a priming dose on the day before induction of labour. There was significant improvement in the Bishop score, and the subsequent induction-delivery interval following priming with prostaglandin. This improvement appeared to be dose-related.     

The effect of vaginal prostaglandin E2 pessaries on induction of labor

In a prospective randomized study, patients with a valid obstetric indication for induction of labor received either 3 mg prostaglandin E₂ vaginal pessaries immediately prior to oxytocin (prostaglandin group, n = 99), or oxytocin alone (oxytocin group, n = 103). At the conclusion of the second day of induction, a significant reduction was noted in the incidence of failed induction in the prostaglandin group (4%) as compared to the oxytocin group (13%) (p < 0.05). Twenty percent of patients in the prostaglandin group experienced successful induction with prostaglandin pessaries only. When oxytocin was required in the prostaglandin group, the maximal concentration of oxytocin infused and the duration at this concentration were significantly less than in the oxytocin group. No perinatal complications were attributed to the use of prostaglandin. Three minor maternal complications that were attributed to vaginal prostaglandin E₂ did not require treatment. Our conclusion is that patients who require an induction of labor, when artificial rupture of the membranes is not feasible, benefit from the use of prostaglandin pessaries before the administration of oxytocin.     

A comparison of Lamicel and prostaglandin E2 vaginal gel for cervical ripening before induction of labor

The efficiency and safety of Lamicel, a new synthetic cervical ripening agent, were compared with those of intravaginal prostaglandin E2 gel in a group of 80 primigravid women about to undergo induction of labor. Lamicel caused less uterine activity and fetal distress than prostaglandin gel, although the induction-delivery intervals were similar in both groups. More normal deliveries occurred in the Lamicel group than in the prostaglandin group. It is suggested that Lamicel is a useful, efficient preinduction ripening agent that is safer than intravaginal prostaglandin gel.     

Induction of labor with vaginal prostaglandin E2 pessaries

Prostaglandin E2 vaginal pessaries (3 mg) were compared with conventional amniotomy and oxytocin infusion as a method of induction of labor in 160 patients in the study group compared with 160 in the control group. Each group consisted of 100 primigravidae and 60 multigravidae. When the features of labor, delivery and fetal status were analyzed for the study and the control groups, the patients who received PGE2 pessaries had a better outcome. The difference was more significant for those patients with a low Bishop score. Compared with controls, the PGE2-treated patients had fewer cesarean sections either for failed induction or fetal distress (P less than 0.01); the incidence of infants with low Apgar score was significantly less (P less than 0.05) and there were fewer postpartum haemorrhages (P less than 0.01).     

A comparison of four methods of ripening the unfavourable cervix.

A comparison was made between four methods of ripening the unfavourable cervix (extra-amniotic prostaglandin E2 gel, oral prostaglandin E2, intravaginal prostaglandin E2 and intravenous oxytocin) in a clinical trial involving 60 primigravidae. In all groups there was an improvement in cervical status. This was significantly greater in those patients who received extra-amniotic prostaglandin gel and they also showed significant decreases in the mean induction-delivery interval and in the incidence of Caesarean section.     

A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor

OBJECTIVE: The purpose of this study was to compare the efficacy of different routes of misoprostol administration for cervical ripening and the induction of labor. STUDY DESIGN: Three hundred thirty women at > or = 32 weeks gestation with a Bishop score < or = 6 and an indication for induction were randomized to 1 of 3 double-blinded groups: (1) 25 microg orally administered misoprostol plus 25 microg vaginally administered misoprostol, (2) orally administered placebo plus 25 microg vaginally administered misoprostol, or (3) 25 microg orally administered misoprostol plus vaginally administered placebo. Doses were repeated every 4 hours until onset of labor or a maximum of 12 doses were given. The primary outcome of the trial was vaginal delivery within 24 hours of the initiation of induction. Secondary outcomes were the time from induction to delivery, need for oxytocin augmentation, mode of delivery, frequency of side effects, and neonatal and maternal outcome. Analysis of variance, chi-square test, and logistic regression were used for analysis. RESULTS: There were no significant differences in maternal characteristics or indications for induction. The percentage of women who achieved vaginal delivery within 24 hours was highest in the vaginally administered misoprostol group: 67% compared with 53% in the oral-plus-vaginal group (P < .05) and 36% in the oral group (P < .05). The median time to vaginal delivery was shorter in the vaginal and oral-plus-vaginal misoprostol groups, 13.5 hours and 14.3 hours, respectively, when compared with 23.9 hours in the oral group (P < .05). The rate of cesarean delivery was lowest in the vaginal misoprostol group (17% compared with 30% in the oral-plus-vaginal group and 32% in the oral group; P < .05). Uterine tachysystole occurred least frequently in the oral misoprostol group (10% compared with 32% in the vaginal group and 34% in the oral-plus-vaginal group; P < .05). Uterine hyperstimulation also occurred least frequently in the oral misopro-stol group (4% compared with 15% in the vaginal group and 22% in the oral-plus-vaginal group; P < .05). CONCLUSION: At the doses studied, induction of labor with vaginally administered misoprostol is more efficacious than either oral-plus-vaginal or oral-only route of administration.     

A comparison of prostaglandin E2 pessaries and laminaria tents for ripening the cervix before termination of pregnancy

Summary. Forty primigravid womcn aged 15–45 years were randomly allocated to receive either an intravaginal pessary of 3 mg prostaglandin E, (PGE₂) or an intracervical 5-mm laminaria tent (LT) 12–16 h before termination of pregnancy at 6–14 weeks gestation. The degree of dilatation of the cervix a t operation and its resistance t o further dilatation during the procedure were assessed by a 'blind' operator. Laminaria tents were more effective in achieving dilatation and softening of the cervix than were PGE₂ pessaries and in 40% of women no further dilatation was necessary. There were no associated side-effects or complications. A cervical tear occurred in two of 20 patients treated with PGE₂ pessaries and all 20 required further dilatation of the cervix. Laminaria tents provide a simple. safe, acceptable and effective means of 'ripening' the cervix prior to termination of early pregnancy.     

Oral prostaglandin E2 for induction of labor

PGE2 (prostaglandin E2) had been successfully used in initiating labor in term pregnancies (Karim and Sharma, 1971). This study evaluates the safety and efficacy of prostaglandin for induction of labor in 23 patients (gestational length, 38-41 weeks; mean age, 27; age range, 17 to 40; parity 0 to 6). 20 received an oral PGE2 0.5 mg tablet hourly while 3 received an initial dose of 0.5 mg with 0.5 mg incremental increase hourly. 20 patients delivered vaginally liveborn infants without neonatal depression according to Apgar score and subsequent behavior in the nursery. 2 patients delivered by C-section and 1 was excluded from the study because of inadequate duration of treatment. Mean time to delivery was 5 hours, 47 minutes; mean drug dose, 2.53 mg. Mild transient emesis and diarrhea occurred in 2 patients, and emesis only in 1. Bishop induction score did not correlate with total dose of PGE2 used. Parity correlated negatively with dose necessary to achieve delivery (p0.05). The findings confirm the efficacy and safety of oral PGE, which provides an alternate drug and route for induction of labor. Oxytocin induction is briefly compared with prostaglandin induction.     

Intracervical prostaglandin E2 gel. Safety for outpatient cervical ripening before induction of labor.

Cervical ripening prior to induction of labor is often necessary for medical complications of pregnancy. We proposed to prospectively determine the safety of administering prostaglandin E2 (PGE2) gel intracervically in an outpatient setting. Four hundred forty-six patients underwent 515 gel procedures as outpatients. Trained perinatal nurses placed 0.5 mg of PGE2, prepared in a standard methylcellulose base, in the intracervical canal. The PGE2 dose was administered every two hours for a total of three doses if labor did not start. The patient was sent home two hours after the last dose if she was not in active labor. Labor started in 90 patients (20%) during the gel procedure; they were admitted to the labor-and-delivery unit. The remaining patients were discharged. Eighty-eight patients (20%) were later admitted in active labor prior to scheduled induction. One patient (0.02%) was found to have occasional prolonged decelerations on admission and underwent a cesarean section two hours after admission; the Apgar scores were 8 and 9 and the arterial pH, 7.21. Hyperstimulation with excessive intrauterine activity caused significant deceleration of the fetal heart rate in four patients (0.8%), two of whom required transfer to the labor-and-delivery unit but none of whom needed a cesarean section for fetal distress. PGE2 gel can be administered safely intracervically as an outpatient procedure by trained perinatal nurses.     

Cervical ripening and labor induction with prostaglandin E2 gel: a placebo-controlled study

A randomized double-blind, placebo-controlled study was undertaken to evaluate the effect of a single intracervical application of prostaglandin E2 gel on the ripening of the cervix and on the subsequent induction of labor with oxytocin in patients with low Bishop scores (less than or equal to 4). Compared to controls receiving gel only, the group receiving prostaglandin E2 gel had significant increases in their cervical Bishop scores, shorter induction-to-delivery intervals, shorter time requiring use of oxytocin, and more successful labor induction without oxytocin. Systemic side effects were minimal and fetal outcomes were comparable, as were the routes of delivery.     

Term labor induction by prostaglandin (PG) E2 oral administration prior to amniotomy

Term labor induction was attempted by testing, prior to amniotomy, the uterine reactivity to the oral administration of twice one tablet of 0.5 mg PGE₂ at 1 h interval. In presence of a positive test (i.e., in case of any progress in the Bishop score and/or of occurrence of at least 10 contractions in 1 h), labor induction was thereafter continued by low amniotomy, further oxytocic treatment was given only if required by dyskinetic labor progress.Out of 70 cases (44% of nulliparous and 56% of multiparous) with a Bishop score at least equal to 3, 59 patients exhibited a positive test and were thus eventually delivered. After amniotomy, 47% of these cases did not require any further drug administration; since the protocol did not allow the administration of total doses of PGE₂ greater than 3.0 or 3.5 mg, 4 patients (7%) required oxytocin. Delivery was achieved in all cases within 12 h of drug administration. Maternal side-effects were very infrequent (6%); no uterine hypertony was recorded in any case and the Apgar scores were equal to or greater than 7 in 92% of the cases.     

Myometrial activity after local application of prostaglandin E2 for cervical ripening and term labor induction

Twelve pregnant women at term with unfavorable cervices (less than or equal to 5 points according to Bishop score) were given prostaglandin E2 for cervical priming and labor induction. Prostaglandin E2 was given in the following manner: 0.5 mg in gel strictly intracervically (n = 4), extraamniotically (n = 4), or prostaglandin E2 (4 mg) in gel vaginally (n = 4). The myometrial activity was registered over a period of 30 minutes before and at least 3 hours after gel application by means of an extraamniotic microtransducer catheter. After both extraamniotic and vaginal gel application, myometrial activity was significantly increased compared with intracervical application. All the women had favorable cervical states 6 hours after treatment and were delivered vaginally within 24 hours. All infants were delivered in good condition with 1-minute Apgar scores greater than 7. From these results we conclude that proper intracervical prostaglandin E2 gel application, in contrast to extraamniotic or vaginal application, induces cervical ripening without significant myometrial activity. Because careful intracervical application appears to avoid or minimize the risks of myometrial hyperstimulation, this technique should be considered particularly in women with unfavorable cervices and delicate fetuses.     

Cervical prostaglandin injection: a novel method of administration for ripening the cervix and induction of labor

Twenty pregnant women with greater than or equal to 36 weeks gestation and Bishop score of less than or equal to 4 were subjected to either intracervical injection of PGE2 (0.25 mg) every 4 h to ripen the cervix and induce labor (study group n = 10) or injection of only the diluent (control group n = 10). PGE2 cases showed significant increase in Bishop score and were successfully induced. The mean induction-establishment and induction-delivery intervals were 4.3 +/- 0.1 min and 6.07 +/- 1.7 h, respectively. The control group showed no response. PGE2 cervical injection is a safe and effective method for cervical ripening and labor induction.     

A comparison of misoprostol and prostaglandin E2 gel for preinduction cervical ripening and labor induction

Objective: Our purpose was to compare the safety ad efficacy of intravaginal misoprostal versus intracervical prostaglandin E₂ (dinoprostone) gel for preinduction cervical ripening and induction of labor.Study design: One hundred thirty-five patients with indications for induction of labor and unfavorable cercices were randomly assigned to receive either intravaginal misoprostol or intracervical dinoprostate. Fifty microgram tablets of misoprostol were placed in the posterior vaginal fornix every 3 hours for a maximum of six doses. Prostaglandin E₂ in gel form, 0.5 mg, was placed into the endocervix every 6 hours for a maximum of three doses. Medication was not given after either spontaneous rupture of membranes or beginning of active labor.Results: Among 135 patients enrolled, 68 received misprostol and 67 dinoprostone. The average interval from start of induction to vaginal delivery was shorter in the misoprostol group (903.3 ± 482.1 minutes) than in the dinoprostone group (1410.9 ± 869.1 minutes) (p < 0.001). Oxytocin augmentation of labor occurred more often in the dinoprostone group (65.7%) than in the misoprostal group (33.8%) p < 0.001). There were no significant differences between routes of delivery. Ten of the misoprostol-treated patients (14.7%) and 13 of the dinoprostone-treated patients (19.4%) had cesarean deliveries. There was a higher prevalence of tachysystole (six or more uterine contractions in a 10-minute window for two consecutive 10-minute periods) in the misoprostol group (36.7%) than in the dinoprostone group (11.9%) (p < 0.001). However, there were no significant differences in frequency of uterine hyperstimulation or hypertonus. There was a higher prevalence of meconium passage in the misoprostol group (27.9%) than in the dinoprostone group (10.5%) (p < 0.05). Thee was no significant difference in frequency of abnormal fetal heart rate tracings, 1- or 5-minute Apgar scores <7, neonatal resuscitations, or admissions to the neonatal intensive care unit between the two groups.Conclusions: Vaginally administered misoprostol is an effective agent for cervical ripening and induction of labor; however when given at this dosage, it is associated with a higher prevalence of tachysystole and meconium passage than is dinoprostone. Further studies to compare the safety of misoprostol to that of dinoprostone and to delineate an optimal dosing regimen for misoprostol are needed.     

Open randomized comparison of prostaglandin E2 given by intracervical gel or vagitory for preinduction cervical ripening and induction of labor.

Intracervical application of prostaglandin E2 (PGE2) in a viscous gel was compared with conventional wax-based PGE2 vagitories (pessaries) for ripening of the cervix prior to induction of labor. A total of 226 healthy pregnant women at term were randomly allocated to receive intracervical gel with an effective dose of 0.5 mg (n = 116) or vagitories containing 2.5 mg PGE2 (n = 110). All women had a modified cervical score of less than or equal to 4. The numbers of cases contributed by each of the three centers were similar. There was no significant difference in parity, gestational length, maternal characteristics, indications for induction or preinduction cervical scores between the treatment groups. The rate of spontaneous birth was 71% in the gel group, compared with 69% in the vagitory group. Successful treatment was defined as active labor within 24 h or a change in cervical dilatation allowing artificial rupture of the membranes with subsequent progressive labor. The success rate was not significantly different in the gel group (82%) compared with the vagitory group (80%). There were no differences in the frequency of fetal distress, outcome of labor, assisted delivery rates or maternal side effects. The cervical scores were not different at 12 and 24 h after application. Intracervical gel and intravaginal application of PGE2 were similar in their efficacy and safety for ripening of the cervix and inducing labor at term.     

Cervical ripening before medical induction of labor: a comparison of prostaglandin E, estradiol, and oxytocin

Objective: Our purpose was to evaluate the effectiveness of oxytocin, prostaglandin, E² intracervical gel, and estradiol cream for ripening the very unfavorable cervix in patients requiring induction of labor at term.Study design: This prospective, randomized study was conducted in a population of women with a very unfavorable cervix (Bishop score <4) requiring induction of labor. The patients received prostaglandin E² gel (0.5 mg) intravervically (three doses 6 hours apart), 4 mg estradiol cream in the anterior fornix of the vagina (three doses 6 hours apart), or oxytocin at induction per protocol with an infusion pump.Results: Ninety-nine women were recruited into this trial and evenly distributed among the three groups. The demongraphics of maternal age, race, parity, gestational age, initial Bishop score, and indication for induction were similar among the groups. The incidence of cesarean deliveries was similar in the three groups with approximately 59% of pregnancies delivered abdominally. For patients undergoing abdominal delivery the maximum cervical dilatation among the oxytocin, estradiol, and prostaglandin E² groups was similar (3.90 = 3.02 cm, 3.63 ± 2.79 cm, and 4.65 ± 2.78 cm, respectively; p > 0.05). For all patients birth weight and Apgar scores at 1 and 5 minutes were comparable across all regimens (p > 0.05). In the subset of patients delivered vaginally patients receiving oxytocin for cervical ripening had the greatest improvement on Bishop score over baseline (p = 0.023) with an improvement of 7.08 ± 2.42.Conclusion: No differences were detected among prostaglandin E₂ gel, estrogen, and oxytocin in relation to cervical ripening in patients with an unfavorable cervix at term who require an induction of labor. Patients with a very unfavorable cervix at term who require delivery may benefit from serial ripening and inductions.