Evaluation of glyceryl trinitrate, misoprostol, and prostaglandin E2 gel for preinduction cervical ripening in term pregnancy

AIM: To compare the efficacy of glyceryl trinitrate (GTN), dinoprostone and misoprostol for preinduction cervical ripening in primigravida at term. METHODS: Sixty-five term primigravida, each with an unfavorable cervix (Bishop score 6) in a greater proportion of subjects in the misoprostol (n = 18, 81.8%) and dinoprostone (n = 14, 66.7%) groups compared with the GTN group (n = 11, 55%). In subjects with a severely unfavorable cervix (Bishop score 相似文献   

An intravaginal controlled-release prostaglandin E2 pessary for cervical ripening and initiation of labor at term.

The purpose of this randomized, double-blind study was to evaluate the efficacy and safety of a new controlled-release hydrogel pessary for ripening the cervix and initiating labor. Subjects had an entry Bishop score of 4 or less and gestational age of 37 or more weeks. One hundred fourteen women received a placebo pessary and 101 received the hydrogel pessary, containing 10 mg of prostaglandin (PG) E2. Compared with the placebo group, those given the PGE2 pessary were more likely to have an increase in Bishop score of 3 or more (60 or 59% versus 21 or 18%; P less than .0001), change to a Bishop score of 6 or higher (59 or 58% versus 18 or 16%; P less than .0001), and active labor (68 or 67% versus 15 or 13%; P less than .0001). Including the crossover study, uterine hyperstimulation (28 of 182, 15%) and fetal heart rate abnormalities (18 of 182, 10%) in PGE2-treated subjects were reversed on removal of the pessary with no apparent harm to the mother or fetus. These temporary adverse effects appeared while the pessary was in place and after the onset of active labor. Oxytocin was unnecessary in 89 of 182 (49%) of the PGE2-treated cases and was used more often to augment than to induce labor. We conclude that the described controlled-release PGE2 vaginal pessary induces appreciable cervical ripening and frequently initiates active labor with little or no need for oxytocin. The pessary may cause uterine hyperstimulation or fetal heart rate abnormalities, but these would be expected to reverse on removal of the pessary.     

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.     

A comparison of prostaglandin E2 gel and prostaglandin F2 alpha gel for preinduction cervical ripening

The unfavorable cervix remains a major obstacle to the successful induction of labor. Reported are results from an ongoing study of topical prostaglandin preparations used to effect preinduction cervical ripening. The current study compares the efficacy of 40 mg of prostaglandin (PG) F2 alpha versus 5 mg of PGE2, applied to the cervix in a methyltylose gel the night before attempted induction of labor. A prospective double-blind protocol was used similar to that which previously established the efficacy of the 5 mg of PGE2 preparation versus placebo at this institution. Results indicate the superiority of the PGE2 preparation as measured by change in Bishop score, Pitocin requirement, rate of cervical dilatation, and percentage of failed inductions. Cesarean section rates were similar in the two study groups, and no fetal or maternal morbidity was attributable to the preinduction ripening technique.     

A randomized trial of prostaglandin E2 in a controlled-release vaginal pessary for cervical ripening at term.

OBJECTIVE: The purpose of this study was to determine if prostaglandin E2 in a controlled-release vaginal pessary can produce cervical ripening at term. STUDY DESIGN: This was a double-blind, randomized, placebo-controlled study conducted at a university center and involving 81 patients with 42 receiving active agent. Categoric data were analyzed by Pearson's chi 2 or logistic regression. Continuous variables were analyzed by analysis of variance and the F test. RESULTS: Prostaglandin E2 was significantly better than placebo at cervical ripening and at decreasing the time to rupture of membranes, the time to onset of labor, the need to give oxytocin, and the time to vaginal delivery. Multiparous women benefitted more than primiparous ones. The cesarean section rate decreased only for multiparous women. Uterine hyperstimulation occurred only with prostaglandin E2 and after the onset of labor. CONCLUSIONS: Prostaglandin E2, when administered in a controlled-release vaginal pessary, is affective in producing cervical ripening at term. This agent should be used on inpatients who are under continuous monitoring and it should be removed at the onset of labor.     

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.     

Sweeping of membranes vs. intracervical prostaglandin E2 gel for cervical ripening. Randomized trial

OBJECTIVE: To compare intracervical prostaglandin E2 gel and membrane sweeping for cervical ripening. STUDY DESIGN: Fifty patients were randomized to either intracervical prostaglandin E2 or membrane sweeping. A Bishop score was assigned by a blinded examiner prior to and 24 hours following the procedure. RESULTS: The Bishop scores assigned 24 hours after prostaglandin instillation and membrane sweeping were not significantly different (3.4, SE 0.42, vs. 3.3, SE 0.37, respectively; P > .05). The proportions of women entering active labor or delivering within 24 hours were similar in the prostaglandin and membrane groups (21% and 19%, respectively; P > .05). CONCLUSION: When both intracervical prostaglandin insertion and membrane sweeping are feasible, their salutary effects are comparable.     

Double-blind comparison of intravaginal prostaglandin E2 gel and "chip" for preinduction cervical ripening

The intravaginal application of prostaglandin E2 for preinduction cervical ripening has proved to be advantageous in the management of patients with an unfavorable cervix. The purpose of this double-blind randomized investigation was to compare the efficacy and safety of two methods of prostaglandin E2 delivery. Patients who were to have preinduction cervical ripening because of an unfavorable cervix (Bishop score less than or equal to 4) were randomly assigned to be given a single dose of prostaglandin E2 as either 2.5 mg of gel or a 3.0 mg "chip" intravaginally in a placebo-controlled manner. Sixty-nine patients received the active prostaglandin E2, 34 in the gel group and 35 in the "chip" group. The groups were similar in maternal age, race, parity, gestational age, and initial Bishop score. Both forms of prostaglandin E2 were easy to administer and helpful in priming an unfavorable cervix. The need for, duration of, and maximum dose of oxytocin were similar in both groups. Cesarean delivery because of failed induction occurred in 5 of 35 (14.3%) patients receiving a "chip" and 4 of 34 (11.8%) receiving the gel. However, patients receiving a "chip" experienced a 20% (7/35) incidence of hyperstimulation, compared with 2.9% (1/36) in those receiving the gel (p less than 0.05). The only case requiring immediate cesarean delivery because of intractable uterine hyperstimulation received a "chip." We conclude that both methods were effective for cervical ripening, but the lower incidence of uterine hyperstimulation seen with the gel would suggest that it is preferable to the "chip."     

Preinduction cervical ripening with prostaglandin E2 intracervical gel

A double-blind, placebo-controlled, dose-ranging study was undertaken to evaluate the efficacy of two doses of intracervical prostaglandin E2 gel in patients with unfavorable Bishop scores. Mean change in Bishop score, success of softening, time to labor, and time to delivery were all significantly different in the two treatment groups as compared with the placebo group. Twenty-three of 30 treated patients had uterine contractions lasting greater than four hours and eight patients delivered during the observation period. Moreover, one case of uterine hyperactivity and five cases of severe fetal heart rate decelerations were noted in the treatment groups. Although efficacious for cervical ripening, caution is warranted when using this technique in patients at risk for placental insufficiency.     

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.     

Plasma prostaglandin metabolite levels after use of prostaglandin E2 gel for cervical ripening

An ideal agent for cervical ripening should produce an increase in cervical scores without stimulating myometrial contractions. Currently used methods of preinduction ripening with prostaglandin E2 are frequently associated with contractions, limiting their use in high-risk patients. To discriminate between a direct effect of absorbed prostaglandin E2 and a triggering of the intrinsic mechanisms of labor, we measured circulating levels of stable metabolites of prostaglandin E2 and prostaglandin F2 alpha. Prostaglandin E2 gel insertion followed by a rise in prostaglandin E2 metabolite but not prostaglandin F2 alpha metabolite implies that contractions are secondary to absorbed prostaglandin E2.     

Hygroscopic cervical dilators and prostaglandin E2 gel for preinduction cervical ripening. A randomized, prospective comparison.

A randomized, prospective study compared the safety and efficacy of hygroscopic cervical dilators (36 patients) with intracervical prostaglandin E2 (PGE2) gel (38 patients) in preinduction cervical ripening. Maternal age, gestational age and parity were similar in both groups. Both groups had similar cervical Bishop scores upon admission. The change in the cervical score was 3.0 +/- 0.3 (mean +/- SEM) in the dilator group and 2.8 +/- 0.4 in the PGE2 group (P = .7). The mean length of time from amniotomy to delivery was similar in both groups (10.1 +/- 1.0 and 10.3 +/- 1.3 hours, respectively) (P = .9). The proportions of patients in each arm of the study undergoing cesarean section were similar. Eight cesarean sections (21.0%) were performed in the PGE2 group; seven (19.4%) were performed in the dilator group (P = .9). Maternal morbidity, five-minute Apgar scores and admissions to the neonatal intensive care unit were similar in the two groups. Because patients were required to stay in the labor-and-delivery unit for four to six hours of fetal monitoring after PGE2 application, the costs were higher in that group. The dilators and PGE2 gel appear comparable in efficacy as preinduction cervical ripening agents. The need to monitor patients receiving PGE2 gel, however, appears to favor the choice of the dilators from a cost and convenience perspective.     

Induction of labor and cervical ripening by intracervical prostaglandin E2

A randomized double-blind trial was conducted over 48 hours comparing the effectiveness of prostaglandin E2 gel administered intracervically with that of demoxytocin buccal tablets for induction of labor in 103 patients with unripe cervical status (Bishop score 5 or less). A statistically significant difference was found in success frequency between the two groups, both on the first day (54.7 and 34.0%, respectively) and on the second day (82.0 and 61.9%, respectively; P less than .05). Without being matched, variables influencing the course of labor in the two groups were comparable. There was no statistically significant difference in the induction-delivery interval between the two groups during the first and second days of the trial. In both the prostaglandin E2 and the demoxytocin groups, patients who had not gone into labor during the first day showed a statistically significant increment in the Bishop score on the morning of the second day (2.4 and 1.3, respectively; P less than .01). The frequency of instrumental deliveries and cesarean section was the same in both groups; neither hypertonic uterine contractions nor side effects were observed in any patient. It is concluded that prostaglandin E2 gel administered intracervically is particularly well suited for the induction of labor in patients with unripe cervical status because of its combined contraction-inducing and cervical-ripening properties.     

Use of prostaglandin E2 for cervical ripening in pregnancies with oligohydramnios

The effectiveness of intracervical prostaglandin E2 (PGE2) was studied in 96 primigravidas with unfavorable cervix and need for induction of labor. Group A consisted of 49 oligohydramnios and group B of 47 cases with normal amniotic fluid volume (controls). A single dose of 0.5 mg PGE2 gel was applied intracervically and several parameters were recorded during the next hours. The mean number of uterine contractions increased during the first 2 h in both groups, decreased during the next one and did not change significantly afterwards. The mean fetal heart rate (FHR) in group A decreased during the first 2 h and then increased, staying always within normal limits. The mean FHR in group B increased for 2 h, decreased during the next hour and did not change significantly afterwards. No significant differences were found between the two groups regarding mode of delivery, Apgar score and neonatal acidosis. Intracervical PGE2 appeared to effectively stimulate cervical ripening and labor induction in oligohydramnios, without causing side effects to the uterus and fetus.     

Preinduction cervical ripening with sequential use of prostaglandin E2 gel

Two hundred patients received a prostaglandin E2-containing gel for preinduction cervical ripening. The gel was administered every 6 hours until a Bishop score greater than or equal to 7 was obtained or the attending physician deemed induction necessary. Forty-eight percent of the patients labored "spontaneously" after one or more gel applications. The average cumulative change in Bishop score with sequential application of the gel was 2.7. Sequential application of the prostaglandin gel proved no more effective in the process of preinduction cervical ripening than single application of the gel with a similar period of observation.     

Preinduction cervical ripening with prostaglandin E2 (Prepidil) gel

The effect of preinduction cervical ripening with Prepidil, a commercially prepared prostaglandin E2 gel (0.5 mg), on the outcome of induction of labor with intravenous oxytocin was investigated. Fifty-nine pregnant women were randomized either to receive intracervical application of the gel or to undergo sham application. Compared to control subjects, patients in the group given Prepidil had significant increases in cervical Bishop scores, shorter induction-to-delivery intervals, lower maximum doses of oxytocin, and fewer days of induction. Systemic side effects were minimal, but 37% (11 of 30) of the gel-treated patients experienced labor prior to receiving oxytocin and 20% (six of 30) were actually delivered during the 12-hour ripening period. No differences in route of delivery or fetal outcome were found between the two groups.     

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.