Dinoprostone Gel Research Articles

Effect of Vaginal pH on Efficacy of the Dinoprostone Gel on Labor Induction and Outcomes

Effect of Vaginal pH on Efficacy of the Dinoprostone Gel on Labor Induction and Outcomes

Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: A randomized comparative trial

To compare immediate induction with vaginal misoprostol tablets and immediate induction with vaginal dinoprostone (naturally occurring prostaglandin E2 [PGE2]) gel in women with premature rupture of membranes (PROM) at term. Two hundred and twelve women with PROM at term were assigned randomly to receive either an intravaginal 25 µg misoprostol tablet, 4-hourly, with a maximum of five doses, or 0.5 mg intravaginal PGE2 gel, 6-hourly, with a maximum of two doses. The primary outcome measures were the admission-to-delivery interval and the induction-to-delivery interval. Secondary outcomes included cesarean section rate, mode of delivery, and maternal and neonatal safety outcome. Results were calculated applying Fisher's exact test, χ2-test, t-test and calculating the P-value using an alpha level of 0.05 for Type I errors. The mean time from admission to delivery was 13.53 h in the misoprostol group and 12.30 h in the PGE2 group (P = 0.090). The induction-to-delivery interval was also comparable between the groups (10.75 h vs. 9.37 h), while the cesarean section rate did not differ significantly between them (7.61% vs. 15.30%). More women in the misoprostol group had an instrumental delivery (12.38% vs. 2.94%). The only significant difference in neonatal outcome was a greater number of babies born with Apgar score < 7 at 1 min in the misoprostol group. Maternal outcomes were not significantly different, except for a higher number of digital vaginal examinations in the misoprostol group. Vaginal misoprostol is equally efficacious in labor induction and demonstrates a similar fetal and maternal safety profile to PGE2 gel.

Obesity and cervical ripening failure risk

Objective. To estimate the impact of obesity on cervical ripening with prostaglandin E2 (PGE2).Materials and method. A retrospective study compared the cervical ripening efficiency of PGE2 on patients with BMI above 30 kg/m2 and normal weight patients with BMI between 20 kg/m2 and 25 kg/m2. In case of a Bishop score (≤3), a dinoprostone tampon was used over 12 h. In case of a Bishop score (4;6), a dinoprostone gel was used over 6 h. Failure of first cervical ripening attempt was defined, as the persistence of a Bishop score <6, 12 h after dinoprostone tampon or 6 h after dinoprostone gel.Results. Ninety-five obese patients were matched according to parity to 190 non-obese patients. The failure rate of the first attempt at cervical ripening was significantly higher (P = 0.0016) among obese patients (53.7%) as compared to patients with a BMI in between 20 and 25 (34.2%). After multivariate analysis BMI ≥ 30 (OR = 2.32 (1.47–4.00), P = 0.0019), parity ≤2 (OR = 2.50 (1.20–5.26) P = 0.0137), and the Bishop score ≤3 (OR = 2.62 (1.45–4.72), P = 0.0014) were significantly and independently associated to prostaglandin ripening failure.Conclusion. Obesity seems to be associated to lower E2 prostaglandin sensitivity.

Análisis de sensibilidad estructural

The aim of this study was to perform a structural sensitivity analysis of a decision model and to identify its advantages and limitations. A previously published model of dinoprostone was modified, taking two scenarios into account: eliminating postpartum hemorrhages and including both hemorrhages and uterine hyperstimulation among the adverse effects. The result of the structural sensitivity analysis shows the robustness of the underlying model and confirmed the initial results: the intrauterine device is more cost-effective than intracervical dinoprostone gel. Structural sensitivity analyses should be congruent with the situation studied and clinically validated. Although uncertainty may be only slightly reduced, these analyses provide information and add greater validity and reliability to the model.

A randomized controlled trial comparing low dose vaginal misoprostol and dinoprostone gel for labor induction

Objectives To compare the safety and efficacy of low dose misoprostol and dinoprostone for cervical ripening and labor induction

Dinoprostone gel of benefit for labour induction

Dinoprostone gel of benefit for labour induction

Induction of labor and pain: a randomized trial between two vaginal preparations of dinoprostone in nulliparous women with an unfavorable cervix

Objective. To compare pain associated with vaginal dinoprostone pessary vs. gel for induction of labor in women with an unfavorable cervix.Study design. A randomized controlled trial in a large academic public general hospital. A total of 52 nulliparous women of gestational age ≥38 weeks, with Bishop score ≤4 and intact membranes were allocated either to a controlled-release vaginal dinoprostone pessary or repeat doses of vaginal dinoprostone gel. Pain was recorded hourly from early induction until the onset of labor.Results. Mean pain experienced by women belonging to the two groups differed significantly (p < 0.01). Women in the controlled-release device group were also significantly more often severe pain-free than women receiving gel (p < 0.05). Both methods had similar rates of oxytocin infusion and vaginal deliveries.Conclusions. The two induction procedures should be considered equivalent as far as ripening the cervix and initiating labor. In view of this finding, the low Bishop score should be considered an indication to prefer the controlled-release device, since it reduces pain thereby improving the physical and emotional wellbeing of the parturient.

Factors influencing the duration of late first and second-trimester termination of pregnancy with prostaglandin derivates

Objective To examine the time interval between first induction and fetal expulsion in fetal defect-related termination of pregnancy and to determine the relevant factors that influence this time interval. Study design Retrospective study involving singleton pregnancies that were terminated due to fetal abnormalities between 2005 and 2009. Induction was done by either 200 μg misoprostol, 1 mg gemeprost or in case of a previous caesarean section by 0.5 mg dinoprostone gel or 1 mg gemeprost. The length of the induction interval between first induction and fetal expulsion was examined according to different maternal and fetal characteristics. Univariate and multivariate logistic regression analyses were used to determine the significant contributors for a delivery within 24 h. Results One hundred and eighty-four singleton pregnancies fulfilled the inclusion criteria. The median gestational age at first induction was 19.2 weeks of gestation. The median time interval between first induction and expulsion was 18 h (25–75th centile, 11–30 h) and in 59 (32.1%) cases, the induction interval was longer than 24 h. Multivariate logistic regression analysis in the prediction of fetal expulsion within 24 h after first induction indicated significant contribution from gestational age and history of spontaneous delivery without previous caesarean section. Conclusions The only relevant contributors to an estimation of the time interval were gestational age and previous history of spontaneous delivery. By combining this information it was possible to correctly anticipate fetal expulsion within 24 h after first induction in 90% of the cases.

Outcomes of different methods of induction of labour

ObjectiveTo compare outcomes of induction of labour with dinoprostone gel (Prostin), dinoprostone slow release pessary (Propess) and cervical ripening balloon.DesignProspective observational study of 78 primiparous and multiparous women induced for...

Comparing efficiency and outcomes of propess (dinoprostone slow release pessary) and prostin gel as a method of inducing labour

ObjectivesTo compare dinoprostone slow release pessary (propess) and gel (prostin) for induction of labour at term in nulliparous women.Method100 case notes were reviewed with 50 women in both the propess...

A randomized controlled trial of 24‐hour vaginal dinoprostone pessary compared to gel for induction of labor in term pregnancies with a Bishop score ≤ 4

To compare 24-hour controlled-release vaginal dinoprostone pessary vs. gel for induction of labor at term in women with an unfavorable cervix. Randomized controlled trial. University hospital. A total of 133 women with singleton pregnancies, fetal cephalic presentation, Bishop score < or = 4, gestational age of 37-42 weeks, no previous cesarean section and intact membranes admitted for induction of labor. Random allocation to either 24-hour 10-mg controlled-release vaginal dinoprostone pessary or repeat doses of 2 mg vaginal dinoprostone gel. Rate of spontaneous vaginal, operative vaginal and cesarean delivery. The rate of spontaneous vaginal delivery was significantly higher in the pessary group (72%) than in the gel group (54%), paralleled by a lower rate of operative vaginal deliveries (3 vs. 15%). The difference in cesarean section rate (25 vs. 31%) did not reach statistical significance. Both methods of induction of labor appeared to be safe, with no cases of 5-minute Apgar scores < 7 or episodes of uterine hyperstimulation in either group. The medication cost was lower in the pessary group, with a median saving of 50.20 euro compared to the gel group. Both the 24-hour dinoprostone vaginal pessary and the vaginal gel appear to be safe for labor induction. In women induced at term with a Bishop score < or = 4 the pessary achieved a significantly higher rate of spontaneous vaginal delivery.

Safety and Efficacy of Misoprostol and Dinoprostone as Cervical Ripening Agents

The study compares safety and efficacy of misoprostol and dinoprostone as cervical ripening agents. Patients with term, vertex, singleton pregnancy and Bishop score of 4 or less were randomly assigned to receive misoprostol pessary (n=35, 50 microg intravaginally) or dinoprostone gel (n=31, 0.5 mg intracervically) at 6 hourly intervals. If there were no progress in cervical dilatation or effective uterine contraction even after maximum dose, patients were taken for cesarean section. Patients who achieved Bishop's score more than 7 but the delivery was not progressing, were augmented with oxytocin drip. No uterine hyperstimulation was observed in both groups. However, abnormal fetal heart rate was observed in 3(8.6%) cases in misoprostol group and 2 (6.5%) in dinoprostone group. There was no statistically significant difference in meconium passage in two groups. Apgar score less than 7 at 1 minute was seen in 6 (19.4%) and 11 (31.4%) neonates in dinoprostone and misoprostol group respectively. However Apgar score less than 7 at 5 minutes was found in only one neonate of dinoprostone treated patient. Both drugs were found to be equally effective in improving Bishops score with no significant difference in mean induction to delivery time. Cesarean section was done among 32.3% and 28.6% respectively in dinoprostone and misoprostol groups. There was significant reduction in the need for oxytocin augmentation in misoprostol (37.1%) group than in dinoprostone (67.7%) group. Vaginal misoprostol is an effective, safer and cheaper alternative to dinoprostone as a cervical ripening agent in underdeveloped countries.

Comparaison de deux régimes d’administration intracervicale de Prépidil® dans le déclenchement artificiel du travail à terme : essai prospectif randomisé

To compare efficacy and safety of two regimens of intracervical dinoprostone (Prepidil) in cervical ripening before labor induction at term. This was a prospective randomized clinical study including 148 patients with single pregnancy, viable fetus at gestational age greater than 36 weeks gestation and a Bishop score less than five, who required induction of labor. Patients were randomised to receive either repeated doses of dinoprostone gel 0.5mg (Prepidil) every 6 hours (group I) or every 12 hours (group II) for maximum three times before inducing labor with Oxytocin. The main outcome was the rate of caesarean sections. The two groups were similar in patient characteristics, indication for labor induction and preinduction Bishop scores. The caesarean rate was lower in group I (20.3%) than in group II (23%); though the difference did not reach statistical difference: p=0.69. Delivery rate in the first 24 hours was significantly higher in group I (62.2%) than in group II (40.5%); p=0.009. Prepidil secondary effects were experienced in 8.1% of patients in group I versus 1.4% in group II; p=0.11. Median umbilical artery pH at birth was 7.232+/-0.47 in group I and 7.294+/-0.58 in group II; p=0.30. Maternofetal infections rate was lower in group I (1.4%) than in group II (2.7%) without significant difference (p=0.56). Repeated intracervical doses of Prepidil every 6 hours, in cervical ripening before labor induction at term, enables higher delivery rate in the first 24 hours without inducing excess of caesarean sections or maternofetal morbidity when compared to its administration every 12 hours.

Induction of labour: A comparison between controlled‐release dinoprostone vaginal pessary (Cervidil®) and dinoprostone intravaginal gel (Prostin E2®)

There are various prostaglandin preparations available for inducing labour. Controlled-release dinoprostone vaginal pessary is used in a number of centres in Australia and New Zealand. To compare the efficacy and safety of controlled-release dinoprostone vaginal pessary (Cervidil) with dinoprostone intravaginal gel (Prostin E2) for induction of labour. Retrospective cohort study of 969 women who were induced using either 10-mg controlled-released dinoprostone vaginal pessary (n=507) or intravaginal dinoprostone gel (n=462) at National Women's Health, Auckland City Hospital. Study outcomes included induction to delivery interval, mode of delivery, rate of oxytocin augmentation and incidence of uterine hyperstimulation. Induction to vaginal birth interval was longer among nullipara receiving the pessary compared to those receiving intravaginal gel (21.5 vs 17.8 h, P=0.004). There was no difference in rates of oxytocin augmentation or in mode of birth between pessary and gel groups. There was a trend to more uterine hyperstimulation among women induced with the pessary compared with those induced with intravaginal gel (22 (4.5%) vs 11 (2.4%) relative risk (RR) 1.9 (0.9-3.9)). Hyperstimulation associated with an abnormal fetal heart pattern (14 (2.9%) vs 2 (0.4%), RR 6.5 (1.5-28.9)) or treated with tocolytics (9 (1.8%) vs 1 (0.2%), RR 8.4 (1.1-66)) was more common in women who received the pessary. Use of dinoprostone vaginal pessaries did not shorten time to delivery or improve any other birth outcome measured compared to dinoprostone intravaginal gel. Clinically significant hyperstimulation appeared more common following use of the pessary. Large randomised controlled trials are needed to confirm or refute these findings.

Selection of Appropriate Prostaglandin for the Induction of Labor at Term is More Predictive for the Achievement of Delivery within 24 Hours than Pre-assessed Cervical Parameters - A Prospective, Randomized Trial

Objective: To compare the efficacy of vaginal misoprostol and dinoprostone gel for induction of labor at term and to evaluate the predictive value of pre-assessed Bishop score and sonographic estimated cervical length. Methods: One hundred and seven patients were prospectively randomized to receive either 50 µg misoprostol vaginally every 12 hours, or 2 mg of dinoprostone gel for nulliparae with an unfavorable cervix. 1 mg was given in case of multiparity or nulliparity with a Bishop score of > 5, according to the RCOG guidelines. Primary outcome was the achievement of vaginal delivery within 24 hours. Secondary outcome parameters included the induction to delivery interval, mode of delivery, drug related side effects, and the predictive value of the Bishop score and sonographic estimated cervical length. Results: The probability of delivering within 24 hours was more than threefold higher with misoprostol than with dinoprostone: odds ratio [OR]: 3.23; 95 percent confidence interval [CI]: 1.14 - 9.16, p: 0.03. In contrast, predictive values of both cervical parameters for delivery within 24 hours were not significant (Bishop score: [OR]: 1.28; [CI: 0.92 - 1.77], p: 0.14, cervical length: [OR]: 0.98; [CI: 0.92 - 1.03], p: 0.40). No difference was observed in the induction to delivery interval between both groups, and no correlation between cervical parameters and induction to delivery interval. Conclusion: Vaginal misoprostol is an effective, safe and cost-effective alternative to dinoprostone for cervical ripening and labor induction. The preinduced assessed cervical parameters showed poor predictive values for estimation of delivery within 24 hours and no correlation with the induction to delivery interval.

Prospective randomised controlled trial to compare safety and efficacy of intravaginal Misoprostol with intracervical Cerviprime for induction of labour with unfavourable cervix

SummaryA randomised prospective trial was carried out to compare the efficacy and safety of intravaginal Misoprostol with intracervical dinoprostone gel for induction of labour in cases of unfavourable cervix. One hundred women with an unfavourable cervix requiring induction of labour were randomised to receive either 25 µm vaginal Misoprostol 4-hourly or 0.5 mg of intracervical dinoprostone 12 hourly. The outcome measured was change in Bishop's score, percentage of women going into labour, induction to delivery interval, need for oxytocin, mode of delivery and complications. The parity, mean period of gestation and Bishop's score were similar in both the groups. The improvement in Bishop's score at 12 h was significantly better in the Misoprostol group. Induction to delivery interval was shorter in the Misoprostol group, 16.59 ± 5.13 h vs 27.77 ± 12.71 h. The rate of complications was comparable. Vaginal Misoprostol 25 µg 4-hourly is safe and effective for induction of labour with shorter induction to delivery interval.

Comparing two dinoprostone agents for cervical ripening and induction of labor: A randomized trial

Objective To compare dinoprostone gel and insert in achieving successful vaginal delivery in nulliparous and multiparous women. Study design 220 nulliparous and 100 multiparous with a Bishop score ≤7 were randomized to receive dinoprostone either gel or insert for cervical ripening. The main outcome measures were the rate and latency of vaginal delivery. Results In nulliparous women no significant differences were found between the gel and insert groups in the rate of vaginal delivery (85.6% vs. 80.7%) delivery ≤12 (36.8% vs. 32.9%) and ≤24 h (85.3% vs. 93.4%) regardless of the preinduction Bishop score. Nulliparous with Bishop score ≤4 treated with the insert had a decreased risk ( p < 0.05) of post partum hemorrhage (4.8%) when compared with nulliparous treated with gel (16.7%). On the contrary, in multiparous the time to delivery interval was significantly shorter in the gel treated group (9.9 ± 4.9 h vs. 13.1 ± 5 h; p < 0.001) with more patients delivering vaginally ≤12 h (75% vs. 37.5%, p < 0.001), regardless of the preinduction Bishop score. Conclusion Both dinoprostone gel and insert are efficient in achieving cervical ripening and successful labor in nulliparous and multiparous. In multiparous, however, the gel significantly reduces the time to vaginal delivery with more patients delivering vaginally ≤12 h, regardless of the Bishop score.

Efficacy and safety of six hourly vaginal misoprostol versus intracervical dinoprostone: a randomized controlled trial

To compare the efficacy and safety of intravaginal misoprostol versus dinoprostone cervical gel for cervical ripening and labour induction. We carried out an experimental clinical trial in which we enrolled 130 cervical consecutive patients with cervical ripening, randomly assigned to one of the following two treatment groups: (1) intravaginal misoprostol and (2) intracervical dinoprostone gel. A total of 50 microm of misoprostol was placed in the posterior vaginal fornix every 6 h for a maximum period of 24 h and 0.5 mg of dinoprostone was administrated in the uterine cervix every 6 h, for a maximum period of 24 h. The primary outcome measure was the number (rate) of women who went to vaginally deliver within 24 h of the protocol initiation. Among 130 patients evaluated, 65 were allocated to the misoprostol group and 65 to the dinoprostone group. The proportion of vaginal delivery within 24 h was significantly higher in the misoprostol group (75%) than in the dinoprostone group (53.8%) (RR = 1.40, 95% CI [1.07-1.45], P = 0.02). There was no significant difference between the mean time interval of delivery in the misoprostol group and the dinoprostone group (14.9 vs.15.8 h) (P = 0.51). The Bishop score was significantly higher in the misoprostol group, 6 h after the onset of the study (1.38; relative risk, 95% CI [1.02-1.85], P = 0.03). The Caesarean delivery rate for fetal distress was higher in the dinoprostone group (21 vs. 10.8%, P = 0.15). The tachysystole (Misoprostol 6.1% vs. dinoprostone 4.6%, relative risk 1.15, 95% CI [0.6-2.24]) and hyperstimulation syndrome rates (Misoprostol 7.6% vs. dinoprostone 4.6%, relative risk 1.26, 95% CI [0.72-2.24]) were slightly increased in the misoprostol group than in the dinoprostone group without reaching the level of statistical signification. Misoprostol as used in this protocol is more effective than cervical dinoprostone gel application in the cervical ripening and labour induction. There is a tendency for an increase in the rate of tachysystole and hyperstimulation syndrome.

PLAC1 mRNA levels in maternal blood at induction of labor correlate negatively with induction–delivery interval

Objective This study was conducted to determine whether, in low risk women having labor induced using prostaglandin gel (dinoprostone gel), there is a relationship between the concentration of mRNA for the PLAC1 gene (a trophoblast-specific gene) in maternal blood and the time elapsed between the first gel administration and spontaneous delivery. Study design Blood was collected from 49 selected women at 40.2–41.4 weeks’ gestation. Total RNA was extracted by means of an ABI Prism 6100 nucleic acid Prep Station and quantitative real-time PCR analysis was performed by use of a PE Applied Biosystems 5700 Sequence Detection System. Sequence data were obtained from the Genebank Sequence Database. To determine the amount of cDNA, the PLAC1 locus was used. Results Thirty women (61.2%) had a spontaneous delivery. A caesarean section, either for fetal dystocia or fetal distress, was performed in 19 (38.8%). The crude delivery rates of the women who ended up with a spontaneous delivery were 30% at 24 h and 43% at 48 h. Women ( n = 19) with a blood concentration of log PLAC1 mRNA ≥2.00 displayed a median time to delivery of 23.50 h, (95% CI: 13.13–33.87) while those with a log PLAC1 mRNA <2.00 ( n = 30) had a median time of 54 h. (95% CI: 37.86–70.14; p = 0.0043, log-rank test). By means of multivariate analysis, quantitative Bishop score (from 2 to 7) at the time of the first gel administration and log PLAC1 mRNA ≥2.00 were associated with a higher rate of delivery per unit of time with an odds ratio of 1.35 (95% CI: 1.07–1.71) and 3.48 (95% CI: 1.55–7.80), respectively. Conclusions In induced term pregnancies, PLAC1 mRNA in maternal blood at the beginning of the treatment correlates with the time elapsed before delivery. This evidence demonstrates that the fetomaternal trafficking of nucleic acids is more consistent when the labor is about to begin.

A study of midtrimester abortion using cerviprime gel and extra-amniotic prostodin

Background: A study was carried out to evaluate the efficacy of intra cervical dinoprostone gel and extra-amniotic prostodin in midtrimester abortions. Material and Method: A total of 25 cases were included in this study. Dinoprotone gel was inserted intracervically in the evening and next morning Inj Prostodin diluted in saline was injected extra amniotically. The efficacy and side effects of the method were studied. Results: The mean induction abortion interval was found to be 17.32 hrs and there were no failures. 04 cases required assistance for removal of placenta. There were no other complications. Conclusion: Intra-cervical dinoprostone gel combined with extraamniotic prostodin is an effective and safe method of mid trimester abortion.