Prostaglandin E2 Vaginal Insert Research Articles

Maternal and perinatal outcomes of failed prostaglandin induction of labour: A retrospective cohort study

BackgroundInduction of labor is performed in up to 25% of pregnant women. When the cervix is unfavorable, cervical ripening may be safely and effectively performed using slow-release vaginal inserts of prostaglandin E2. However, the risk factors, management, and outcome of patients who fail to respond remain unclear. ObjectiveTo evaluate the outcomes of women who fail to respond to cervical ripening with prostaglandins. MethodsA retrospective cohort analysis (2013–2019) was conducted. Women with a singleton gestation who underwent induction of labor due to post-date pregnancy using a slow-release prostaglandin E2 vaginal insert for cervical ripening were included. Data on clinical and outcome factors were derived from the medical files, and findings were compared between patients who achieved ripening within 24 h of treatment onset and those who did not. The primary outcome measure was the vaginal delivery rate following the ripening process. Secondary outcome measures were adverse composite maternal and neonatal outcomes. A model combining maternal characteristics and response rates to ripening was constructed. ResultsThe final cohort included 1285 women: 1202 responded to cervical ripening (93.54%) and 83 (6.46%) did not. Compared to non-responders, responders had higher rates of vaginal delivery (96.51% vs. 66.27%, P < 0.001); lower rates of adverse maternal composite outcome (12.81% vs. 24.10%, P = 0.031) and adverse neonatal composite respiratory outcome (1.33% vs. 6.02%, P = 0.009). Responders were younger than non-responders (mean 30.03 years vs 31.73 years, P = 0.005) and had a lower nulliparity rate (50.99% vs 76.92%, P < 0.001). On multivariate analysis, failure to achieve cervical ripening was an independent risk factor for intrapartum cesarean delivery due to prolonged labor (aOR 11.90, 95% CI 6.13–23.25). ConclusionWomen who achieve cervical ripening with prostaglandin E2 vaginal inserts are younger and more often multiparous than women who fail to respond. Good response to the cervical ripening process is associated with lower rates of intrapartum cesarean delivery and of adverse outcomes.

Optimizing cervical ripening in women presenting with decreased fetal movements

Objective To determine the optimal method for cervical ripening in women presenting with decreased fetal movements at term. We hypothesized that women who undergo induction of labor for decreased fetal movements represent a higher risk group, and will benefit from mechanical intervention with cervical ripening balloon rather than with pharmacological prostaglandin E2 vaginal insert. Study design Retrospective cohort study from January 2014 and January 2019. We recommended induction of labor to every woman ≥39 weeks’ gestation with complaints of persistent decreased fetal movements. We excluded women with major fetal anomalies, Bishop score of ≥6 on admission, and cases with contraindications to prostaglandins. Women were allocated into one of two groups based on the cervical ripening agent used. In group 1 we introduced the prostaglandin E2 vaginal insert (10 mg dinoprostone in a timed-release formulation). In group 2 we placed the mechanical cervical ripening balloon. The primary outcome of the study, analyzed separately to nulliparous and multiparous women, was the rate of cesarean delivery in each of the groups. Results During the 5-years study, 294 women were included in the final analysis, of which 201 were in the prostaglandin E2 vaginal insert group and 93 were in the cervical ripening balloon group. The rate of cesarean delivery was comparable between the groups (nulliparous: 20.8%, 16/77 versus 21.3%, 10/47. multiparous: 16.9%, 21/124 versus 7%, 3/46, respectively). Other maternal and neonatal secondary outcomes, including the induction-to-delivery time (nulliparous: 32.5 ± 25.3 h versus 26.5 ± 12.2 h. multiparous: 24.6 ± 17.2 h versus 21.25 ± 12.3 h, respectively), were also not different between the two induction methods used. A longer induction-to-delivery time was observed in nulliparous women who had repeat prostaglandin E2 vaginal insert compared with the cervical ripening balloon group (74.6 ± 27.3 h versus 26.5 ± 12.2 h, p < .01). Conclusion Both pharmacological and mechanical methods can safely and efficiently be used for cervical ripening in women presenting with decreased fetal movements at term. With repeat prostaglandin E2 use, nulliparous women may experience a prolong labor compared with the cervical ripening balloon group, but maternal or fetal safety are not compromised.

416: Does tachysystole influence maternal and neonatal outcomes during induction of labor?

To evaluate the rate of tachysystole during induction of labor and to estimate its impact on obstetrical and neonatal outcomes A retrospective cohort study of all women, at 37+0 to 41+6 gestational weeks, who underwent induction of labor, from 2015 to 2016 in a university-affiliated tertiary medical center. Induction of labor was done with prostaglandin E2 vaginal insert. Women were routinely followed at 12 and 24 hours post initiation of cervical ripening and at any time point if contractions or ruptured membranes were reported by the women. Electronic fetal heart rate tracings and medical records were carefully inspected and documented, to evaluate contraction frequency and fetal heart rate patterns. Obstetrical and neonatal outcomes were analyzed and compared between two groups - women with tachysystole (defined as > 5 contractions in 10 minutes) and those without. 414 met eligibility criteria, of whom 118 (28.5%) had tachysystole and 296 (71.5%) did not. Women in the tachysystole group had a shorter time to vaginal delivery: 18.5 vs. 25 hours (P<0.05). Other obstetrical and neonatal outcomes did not differ between two groups, including rates of operative vaginal delivery or cesarean delivery, as well as Apgar score and umbilical cord pH. In women undergoing induction of labor, tachysystole rate was higher than previously reported. However, our data suggests that tahcysytole does not influence maternal and neonatal outcomes, and is associated with a shorter time to delivery.

Can we predict successful cervical ripening with prostaglandin E2 vaginal inserts?

Previous studies have suggested that a variety of maternal and obstetrical characteristics may predict successful prostaglandin E2 (PGE2) cervical ripening. However, in most studies women were administered vaginal tablets or gel so scarce is known regarding potential predictors in women administrated slow-release vaginal inserts. We aimed to characterize the response of cervical ripening for labor induction using slow-release PGE2 vaginal insert and to identify predictors for success. A retrospective cohort study in a single center (2013-2015). The association between maternal characteristics at admission and cervical ripening success/failure were explored. Cervical ripening failure was defined as a Bishop's score <7 following 24h from cervical ripening or the need for cesarean delivery (CS) due to arrest of dilatation at cervical dilatation ≤5cm. Cases with major fetal anomalies, multiple gestations, non-vertex presentation or any contraindication for vaginal delivery were excluded. Of 15,564 deliveries during the study period, 986 (6.3%) women met inclusion criteria, of them, 774 (78.56%) succeeded and 212 (21.5%) failed cervical ripening. Cervical ripening success was associated with (OR, 95% CI): nulliparity (0.42, 0.22-0.81, p=0.009, i.e., nulliparity was negatively associated with successful ripening), gestational age (GA) at delivery (1.29, 1.02-1.61, p<0.03), and cervical dilation at admission (4.58, 2.57-8.17, p<0.001). The indications for labor induction were not associated with cervical ripening success. A prediction model which included the abovementioned characteristics had an AUC of 0.792 (95% CI 0.743-0.840). Overall, basic parameters, such as parity, cervical dilatation at admission and gestational age can predict successful cervical ripening PGE2 vaginal inserts.

Second dose of PGE2 vaginal insert versus Foley transcervical balloon for induction of labor after failure of cervical ripening with PGE2 vaginal insert

Purpose: To determine the success rate of induction of labor (IOL) using Foley transcervical balloon (FTB) versus prostaglandin E2 (PGE2) vaginal insert, following failure of cervical ripening with PGE2 vaginal insert. Materials and methods: A retrospective cohort study of all pregnant women admitted for IOL with either FTB or PGE2 vaginal insert. Either second dose of PGE2 vaginal insert or FTB was used as a second line treatment after failure (not giving birth in 24 h from insertion) of first PGE2 vaginal insert. Results: During the study period, 1162 women were admitted for IOL. Failure was reported in 322/852 (37.8%) in the FTB versus 162/310 (52.2%) in the PGE2 group (p < 0.001). Among 162 patients treated with PGE2 as first line who did not deliver after 24 h, 14 had spontaneous rupture of membranes, 15 underwent stripping and 42 were in still in active labor. The remainder were allocated to either second trial of PGE2 treatment (n = 58) or FTB (n = 33) with failure rate higher in the PGE2 group, not statistically significant (p = 0.23). Conclusion: IOL with FTB was not superior to PGE2 vaginal insert for IOL following failure of cervical ripening with PGE2 vaginal insert.

566: Effect of obesity on duration and outcome of labor inductions with either the Foley catheter or the prostaglandin E2 vaginal insert

566: Effect of obesity on duration and outcome of labor inductions with either the Foley catheter or the prostaglandin E2 vaginal insert

593: Effect of parity on duration and outcome of labor inductions with either Foley catheter or the prostaglandin E2 vaginal insert

593: Effect of parity on duration and outcome of labor inductions with either Foley catheter or the prostaglandin E2 vaginal insert

60: Randomized trial comparing Foley catheter to the prostaglandin E2 vaginal insert for induction of labor

To assess the efficacy of the Foley catheter compared to the 10 mg controlled release prostaglandin E2 vaginal insert (PGE2) for cervical ripening in term and near term women presenting for labor induction.

Strip of the Month: April 2011

Strip of the Month: April 2011

In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour.

To measure the release rate of prostaglandin E2 (PGE2) in vivo from a controlled-release vaginal insert used for cervical ripening and induction of labour at term in women with intact membranes or pre-labour rupture of membranes (PROM). Open-label, single centre study. Women at term (> or = 37 gestational weeks) with unripe cervices (Bishop score < or = 6) scheduled for labour induction for mainly medical reasons. sixty-eight women (47 with intact membranes and 21 with PROM) had the PGE2 vaginal insert placed in the posterior fornix of the vagina. Each insert was removed from the women at a predetermined time interval between 0.5 h and 24 h, or earlier if labour was induced, fetal distress was detected or maternal complications occurred. After removal, the vaginal insert was frozen and stored for subsequent assay of residual PGE2. Blood samples were collected immediately before insertion and at 4-hour intervals until removal of the vaginal insert to determine plasma concentrations of PGE2 and the major PGE metabolite, 15-Keto-13, 14-dihydro-PGF2alpha (PGEm). Vaginal pH was measured immediately before insertion and directly after removal of the vaginal insert. Bishop score was assessed before induction, after 8 h, 12 h and immediately after removal of the vaginal insert. There was a positive linear relationship between the amount of PGE2 released from the insert and the duration of treatment in women with intact membranes (rp = 0.95, P = 0.0001), with a calculated PGE2 release rate of 0.52 +/- 0.33 mg/h over 24 h. The PGE2 release rate in women with PROM was not linear. The PGE2 release rate was dependent on vaginal pH, with a faster release rate at higher vaginal pH. Forty-seven women (69.1%) had the insert removed due to the successful induction of labour and consequently discontinued study treatment before their allocated time period. At vaginal delivery, the released amount of PGE2 at onset of labour was 4.0 +/- 3.0 mg and 2.4 +/- 2.1 mg for nulliparous women with PROM and intact membranes, respectively (P = 0.1). In multiparous women, the equivalent mean released amount was 3.2 +/- 2.6 mg and 1.9 +/- 1.4 mg, respectively (P = 0.14). In women with intact membranes, the mean plasma concentrations of PGE2 and PGEm after treatment were not statistically different to those women with PROM (P = 0.27 and 0.64, respectively). In women who were delivered vaginally, the median induction to delivery time interval was 17.0 h (range 4-42) in nulliparous women and 8.7 h (range 5-19) in multiparous women (P = 0.003). Ten (14.7%) women, who were all nulliparous, were delivered by caesarean section. In women with intact membranes, the PGE2 release rate was linear over 24 hours. There was a positive linear relationship between vaginal pH and PGE2 release rate. The metabolite analysis revealed no evidence of dose dumping neither in women with intact membranes or in women with PROM.

Plasma prostaglandin E2 metabolite levels during labor induction with a sustained-release prostaglandin E2 vaginal insert

Plasma prostaglandin E2 metabolite levels during labor induction with a sustained-release prostaglandin E2 vaginal insert

Is cervidil appropriate for outpatient cervical ripening?

Objective: To determine whether this sustained-release prostaglandin E2 vaginal insert would be appropriate for preinduction cervical ripening on an outpatient basis.Methods: Persons with a valid indication for induction of labor and an unfavorable cervix (Bishop score less than 4) were monitored outside of labor and delivery during a 10-month period. Nursing supervision was not undertaken, and continuous uterine activity and fetal heart rate (FHR) tracings were evaluated during the first 12 hours postdosing. The onset of regular uterine contractions (3 in 10 minutes, lasting 60 seconds or more, with moderate patient discomfort) and the reason for any premature removal of the insert were sought.Results: Regular contractions ensued in 26 (24.3%) of the 111 study cases. Primary reasons for removal of the prostaglandin E2 insert in 31 (27.0%) cases included active labor (19), ruptured membranes (5), uterine hyperstimulation (5), and a nonreassuring FHR tracing (2). The average time from insertion until premature removal was 5.7 hours (95% CI 4.5–6.9 hours). The insert fell out in 6 (5.4%) cases.Conclusion: The high rate of initiating regular contractions and the frequent need for removal of this cervical ripening agent should limit its use to inpatient therapy only.