PGE2 Tablets Research Articles

The association between repeated doses of vaginal PGE2 (Dinoprostone, Prostin®) and both maternal and neonatal outcomes among women in the north of Jordan

Objective: To evaluate the association between repeated doses of vaginal PGE2 and the maternal and neonatal outcomes for primigravid and multiparous women. Study design: A retrospective descriptive study was conducted at a teaching university hospital in Jordan. The study involved 885 women with singleton live fetuses; these women had been admitted to the labor ward for an induction of labor by vaginal PGE2 (Dinoprostone, Prostin®) for different indications from January 2015 to December 2016. The women were classified according to parity into two main groups, namely, primigravid and multiparous. In the primigravid group, the women who had received two or fewer doses of a vaginal PGE2 tablet (3 mg Dinoprostone) were compared with those who had received a PGE2 tablet three times. In the multiparous group, the women who had received one or two doses of half the usual vaginal PGE2 tablet (1.5 mg Dinoprostone) were compared with those who had received the same dose three times. The main outcomes studied were the cesarean section rate and the APGAR score. Results: There was a statistically significant association, namely, X2 (1) = 13.96, P = 0.001, between the repeated doses of PGE2 and the mode of delivery. This indicates that primigravid women who received more than two doses of PGE2 were more likely to have a cesarean section (65.5%, n = 57 out of 87) compared with primigravid women who received two or fewer doses of PGE2 (42.9%, n = 132 out of 308). There was no significant association between repeated doses of PGE2 insertion and admission either to the nursery or the neonatal intensive care unit (NICU) X2 (1) = 2.11, P = 0.14. Moreover, the results also showed that there was no significant association between repeated doses of PGE2 insertion and the APGAR score X2 (1) = 0.06, P = 0.88. For multiparous women, there was no statistically significant association X2 (1) = 2.15, P = 0.14 between repeated doses of PGE2 insertion and the mode of delivery. Conclusion: In both groups of primigravid and multiparous women, the third dose of vaginal PGE2 was not associated with a significant increase in maternal or neonatal morbidity. In the primigravid group, despite the third dose of PGE2 being associated with a higher rate of cesarean section in comparison with two or fewer doses of it, nearly a third of the women nevertheless achieved vaginal delivery. In the multiparous group, the third dose of PGE2 was not associated with a higher rate of cesarean sections.

Methods of term labour induction for women with a previous caesarean section.

Worldwide, caesarean birth is common, with percentages ranging from 25% to 50% of reported births. Current clinical practice guidelines support vaginal birth and trial of labour among women who have had a previous caesarean birth. Women with a prior caesarean birth have an increased risk of uterine scar rupture, particularly when labour is induced. This is a serious complication, often leading to negative outcomes for mother and child, such as hysterectomy, genitourinary tract injury, and postpartum blood transfusions for the mother, and neurological impairment or even death for the child. Labour induction is a common obstetric procedure that is carried out when the risk of continuing pregnancy outweighs the benefits. Methods include: prostaglandin medication (including oral or vaginal prostaglandins E2 (PGE2) or misoprostol); mifepristone; mechanical methods (including Foley catheters and double balloon catheters); and oxytocin. The goal of this review was to assess the harms and benefits of different methods of induction of labour in women with a prior caesarean birth, should induction of labour be required in their present pregnancy. Two randomised controlled studies (involving 80 women in their third trimester) met our inclusion criteria. The studies used different methods of inducing labour, vaginal PGE2 inserts versus oxytocin, and misoprostol versus oxytocin.. Comparing PGE2 to oxytocins, no differences were found in the risk of caesarean section, nor other primary or secondary outcomes, of which only instrumental vaginal deliveries, epidural analgesia, Apgar score, perinatal death were reported. One uterine rupture was reported in the PGE2 group. The second study compared misoprostol to oxytocin. This study was stopped prematurely after the inclusion of 38 women because of the occurrence of two uterine ruptures in the misoprostol group. This study did not report on other outcomes than uterine rupture. Risk of bias in the included studies was judged as low or unclear. They were underpowered to detect clinically relevant differences in the outcomes measured.

Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

Prostaglandins have been used for induction of labour since the 1960s. This is one of a series of reviews evaluating methods of induction of labour. This review focuses on prostaglandins given per vaginam, evaluating these in comparison with placebo (or expectant management) and with each other; prostaglandins (PGE2 and PGF2a); different formulations (gels, tablets, pessaries) and doses. To determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except misoprostol). We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 March 2014) and bibliographies of relevant papers. Clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment, with each other, or other methods listed above it on a predefined list of labour induction methods. We assessed studies and extracted data independently. Seventy randomised controlled trials (RCTs) (11,487 women) are included. In this update seven new RCTs (778 women) have been added. Two of these new trials compare PGE2 with no treatment, four compare different PGE2 formulations (gels versus tablets, or sustained release pessaries) and one trial compares PGF2a with placebo. The majority of trials were at unclear risk of bias for most domains.Overall, vaginal prostaglandin E2 compared with placebo or no treatment probably reduces the likelihood of vaginal delivery not being achieved within 24 hours. The risk of uterine hyperstimulation with fetal heart rate changes is increased (4.8% versus 1.0%, risk ratio (RR) 3.16, 95% confidence interval (CI) 1.67 to 5.98, 15 trials, 1359 women). The caesarean section rate is probably reduced by about 10% (13.5% versus 14.8%, RR 0.91, 95% CI 0.81 to 1.02, 36 trials, 6599 women). The overall effect on improving maternal and fetal outcomes (across a variety of measures) is uncertain.PGE2 tablets, gels and pessaries (including sustained release preparations) appear to be as effective as each other, small differences are detected between some outcomes, but these maybe due to chance. Prostaglandins PGE2 probably increase the chance of vaginal delivery in 24 hours, they increase uterine hyperstimulation with fetal heart changes but do not effect or may reduce caesarean section rates. They increase the likelihood of cervical change, with no increase in operative delivery rates. PGE2 tablets, gels and pessaries appear to be as effective as each other, any differences between formulations are marginal but may be important.

PLD.07 A Review of Outcomes following 3 vaginal prostaglandin (PGE2) pessaries for Induction of Labour

Induction of labour (IOL) is the use of drugs or interventions to start labour. Women with uncomplicated pregnancies should usually be offered IOL between 41+0 and 42+0 weeks. One of...

PLD.21 Impact of Induction of labour on labour ward and finding alternative ways to improve women satisfaction

IntroductionNational UK average of Induction of labour (IOL) is 22.1%. It has huge impacts on labour ward and staffing. Most common pharmacological method used is vaginal PGE2 tablet (Prostin), which...

Pre-induction cervical ripening: comparing between two vaginal preparations of dinoprostone in women with an unfavorable cervix

Objective: Prostaglandin E2 (PGE2-Dinoprostone) is accepted for both ripening of the cervix and induction of labor. As conflicting data exist concerning the efficiency and safety of different treatment modalities, we aimed to compare slow-release vaginal insert PGE2 with serial vaginal tablets of PGE2 for cervical ripening and induction of labor.Methods: A retrospective cohort study comparing all pregnancies who underwent induction of labor by either a single slow-release vaginal insert of 10 mg PGE2 (study group) to a historical control group of women who were treated with serial administration of 3 mg vaginal PGE2 tablets in a 2:1 ratio, matched by parity.Results: Overall, 639 women were enrolled (213 treated with PGE2 tablets and 426 with slow-release vaginal inserts). Vaginal insert was associated with shorter initiation-to-ripening interval (12.4 ± 7.7 versus 18.6 ± 15.2 h, p < 0.001) and a higher rate of delivery within 24 h (61.5 versus 51.6%, p = 0.018). Vaginal insert was associated with an increased rate of tachysystole (8.0 versus 3.1%, p < 0.01); however, the rates of cesarean section or operative delivery due to non-reassuring fetal heart rate (NRFHR) were similar. On multivariable analysis, slow-release vaginal insert was independently associated with a higher rate of delivery within 24 h (OR 1.50, 95% CI 1.04–2.18).Conclusion: Slow-release PGE2 vaginal insert achieves cervical ripening and subsequently delivery over a shorter time period than PGE2 tablets, without increasing uterine hyperstimulation rate.

Induction of labour in postdates pregnant women.

To differentiate the effect of gestation on the mode of delivery by analysing the difference in the mode of induction, length of labour and the difference in parity or Bishop score and their effect on the mode of delivery of postdates women. A cross-sectional observational study. PAEC General Hospital, Islamabad, from July 2006 to July 2008. Patients were induced at 41 weeks (Group B) and > 40 weeks (Group A) of gestation. Tab misoprostol and PGE2 tablets were administered according to amniotic fluid index (AFI) and parity. Study variables included duration of gestation, mode of induction, length of labour, difference in parity and Bishop score assessed before induction in each group. The outcome was assessed by applying Chi-square test by comparing mode of delivery with the study variables in both groups. A total of 78 patients were inducted in the study. They were divided in group B (n = 39) induced 41 weeks and group A (n = 39) induced at 40 weeks. Eighty four percent (n = 35) patients in group B delivered vaginally as compared to 71% (n = 28) in the 40 weeks group (p < 0.0001). The higher number of vaginal deliveries in 41 weeks group was independent of association between the induction agent, parity and mode of delivery. The mean length of gestation was the single most important factor among the studied variables in predicting a vaginal delivery.

Induction of labour with vaginal prostaglandin tablet vs gel

The objective of this study was to compare outcomes in women whose labour was induced with vaginal prostaglandin E2 tablets with those induced with prostaglandin gel. We compared outcomes of induction during two audits conducted in 2005 (PGE2 gel) and 2009 (PGE2 tablets). We found that there was no difference in induction rates; 21% in 2005 and 24% in 2009. The recommended dose of prostaglandin E2 was exceeded in 6% and 17% of women induced with gel and tablets, respectively (p = 0.007). There was a difference in use of syntocinon to augment uterine contractions, 39% vs 58% for women induced with gel and tablets, respectively (p = 0.001). There was no difference in overall operative delivery, 37% in gel and 38% in tablets. There was no difference in the proportion of women who had vaginal birth within 24 h; 50% vs 42% for gel and tablet, respectively (p = 0.187). We conclude that compared to prostaglandin gel, women who received prostaglandin tablets were more likely to require syntocinon to augment contractions.

Indicated labor induction with vaginal prostaglandin E2 increases the risk of cesarean section even in multiparous women with no previous cesarean section.

To evaluate the impact of induction of labor with vaginal tablets of prostaglandin E2 on the rate of cesarean section (CS), and to identify possible predictors of successful vaginal delivery. 1541 consecutive women admitted for induction of labor with vaginal tablets of PGE2 were retrospectively compared with 574 consecutive women with spontaneous onset of labor. Maternal age, nulliparity, previous CS, gestational age, and birth weight were similar in the study and control groups. The CS rate was twofold higher in the study group (20.7% vs 10.6%). CS rates in the study and control groups were 26.9% and 12.8% for the nulliparous women, and 11.2% and 5.1% for the multiparous women with no previous CS. Neither group had major maternal or fetal complications. A logistic regression model and stepwise analysis showed that nulliparity, previous CS, maternal age, number of PGE2 applications, birth weight, and the induction of labor by itself were independent significant risk factors for increased CS rate. Induction of labor with vaginal PGE2 tablets results in a vaginal delivery rate of 79.3%, with apparently no serious maternal or fetal complications. Nulliparity, and previous CS are the most significant risk factors for increased CS rate. However, even after these risk factors are excluded and controlling for possible predictors for CS, PGE2 induction is independently associated with a twofold increase in CS rate, most often because of labor dystocia.

Randomized Comparison of Glyceryl Trinitrate and Prostaglandin E2 for Cervical Ripening at Term

In Brief Objective To estimate the adverse effects of glyceryl trinitrate compared with prostaglandin (PG) E2 vaginal tablet for cervical ripening in term pregnancy. Methods One hundred ten women with term pregnancies referred for induction of labor with Bishop scores of 6 or less were randomly assigned to receive a 500-μg glyceryl trinitrate tablet vaginally (n = 54) or a 3-mg PGE2 tablet vaginally (n = 56), every 6 hours for maximum of two doses. Subjects were sent to the labor ward for amniotomy or oxytocin if their Bishop scores were more than 6 or their cervices were not ripe 24 hours after treatment. Adverse effects, changes in the Bishop scores, progress, and outcomes of labor were assessed. Results Glyceryl trinitrate was associated with fewer episodes of uterine tachysystole (0% versus 9%; P = .02). The median Bishop score after 12 hours was lower in women given glyceryl trinitrate compared with those given PGE2. Adverse effects, including headache and palpitations, were more frequent with glyceryl trinitrate than with PGE2. The cesarean rate was not significantly different between groups. Conclusion Cervical ripening with glyceryl trinitrate resulted in fewer episodes of tachysystole, but there were significantly more minor side effects. It can be used for cervical ripening at term, but it was not as effective as PGE2. Glyceryl trinitrate for cervical ripening caused fewer tachysystoles but was less effective than prostaglandin E2.

Randomized comparison of glyceryl trinitrate and prostaglandin E2 for cervical ripening at term

Objective: To estimate the adverse effects of glyceryl trinitrate compared with prostaglandin (PG) E2 vaginal tablet for cervical ripening in term pregnancy. Methods: One hundred ten women with term pregnancies referred for induction of labor with Bishop scores of 6 or less were randomly assigned to receive a 500-μg glyceryl trinitrate tablet vaginally ( n = 54) or a 3-mg PGE2 tablet vaginally ( n = 56), every 6 hours for maximum of two doses. Subjects were sent to the labor ward for amniotomy or oxytocin if their Bishop scores were more than 6 or their cervices were not ripe 24 hours after treatment. Adverse effects, changes in the Bishop scores, progress, and outcomes of labor were assessed. Results: Glyceryl trinitrate was associated with fewer episodes of uterine tachysystole (0% versus 9%; P = .02). The median Bishop score after 12 hours was lower in women given glyceryl trinitrate compared with those given PGE2. Adverse effects, including headache and palpitations, were more frequent with glyceryl trinitrate than with PGE2. The cesarean rate was not significantly different between groups. Conclusion: Cervical ripening with glyceryl trinitrate resulted in fewer episodes of tachysystole, but there were significantly more minor side effects. It can be used for cervical ripening at term, but it was not as effective as PGE2.

A randomized trial of two preparations of vaginal prostaglandin for pre-induction cervical ripening

To compare two prostaglandin (PG) E2 preparations for pre-induction cervical ripening in a randomized clinical trial. Two milligrams of vaginal PGE2 gel was compared with a vaginal PGE2 3-mg tablet in 200 nulliparous women. Outcomes assessed were induction failure, need for labor augmentation, pain relief requirements, fetal heart rate (FHR) abnormalities, operative delivery rate, induction-to-delivery interval, neonatal condition, and occurrence of uterine hyperstimulation. There was no statistical difference in pre- and post-dose cervical scores. Compared with the tablet group, women in the gel group were more likely to have significant FHR abnormalities in early labor (odds ratio [OR] 4.77, 95% confidence interval [CI] 1.15-19.5) requiring cesarean delivery. Fetal heart rate tracings in the active phase of labor were also more likely to be abnormal in the gel group (chi 2 = 4.31, P < .05). Compared with the gel group, women in the tablet group were significantly more likely to require operative delivery for poor progress in labor (OR 2.83, 95% CI 1.20-7.24). Other clinical outcomes were identical, with no significant differences in the overall rate of failed induction, cesarean delivery, rate of assisted delivery, requirement for oxytocin infusion, induction-to-delivery interval, pain relief requirements, or neonatal condition. When compared with the PGE2 tablet, the use of PGE2 gel for cervical ripening and labor induction in nulliparous women did not result in significant improvements in labor outcome. Whereas the gel was associated with an increase in significant FHR abnormalities, the tablet was associated with an increase in the rate of operative delivery for poor progress in labor.

Effects of induction of labor with prostaglandin E2 on fetal breathing and body movements: Controlled, randomized, double‐blind study

To evaluate the effects of prostaglandin (PG) E2, given for induction of labor at term, on fetal breathing and body movements.Eighteen women with term pregnancies, mild gestational hypertension, intact membranes, and unripe cervices who were not in labor participated in this study. After a 60-minute baseline ultrasound examination of fetal chest and body movements, recorded on videotape, the patients were randomly assigned to either 3 mg intravaginal PGE2 tablets or controls (placebo intravaginal tablets). Following tablet insertion and a 3-hour observation time, a second 60-minute ultrasound recording of fetal movements was taped. The videotape recordings were interpreted according to the total amount of time occupied by fetal body movements and fetal breathing movements.There was a total of 2180 minutes of ultrasound tape recordings, with 136.2 minutes of fetal body movements (6.2%) and 207.8 minutes of fetal breathing movements (9.5%). Mean (+/- standard deviation) observation times per patient before and after tablet insertion were 60.3 +/- 1.2 and 56.4 +/- 1.2 minutes for the PGE2 group and 60.1 +/- 1.3 and 60.4 +/- 1.1 minutes for the control group. Three hours after PGE2 insertion, there were significant decreases in the percentage of time occupied by body movements (7.8 +/- 3.1 versus 3.4 +/- 2.0%; P < .003) and breathing movements (10.6 +/- 8.6 versus 3.9 +/- 2.3%; P < .007). Three hours after tablet insertion, there were statistically significant decreases in the percentage of time occupied by body movements (P < .025) and breathing movements (P < .01) between the control and study groups.Induction of labor with intravaginal PGE2 tablets inhibits fetal body and breathing movements. The effects could be due to direct action on the fetus or indirect effects of PGE2 (through uterine contraction and/or endogenous PG).

Experiences in 2,149 labor inductions using 3 mg prostaglandin E2 vaginal tablets. A retrospective analysis

This study is a retrospective analysis of induction of labour by means of PGE2 tablets, one group being electively, the other group medically indicated; in all, 2149 primi- and multiparae during a period of 5 years. Application of the vaginal tablets containing 3 mg PGE2 was effected every 6 hours. Low-risk women stayed mobile up to the amniocentesis performed at about 4-5 cm. Patients with specific risks or spontaneous ruptures of the membranes were supervised correspondingly. About 80% of the primiparae, respectively 90% of the multiparae of the elective induction group delivered within 24 hours after the first application of a vaginal tablet. The rate of Caesarian sections was extremely low. As expected in patients in whom induction of labour was necessary usually before term, the percentage of successful inductions was lower and the rate of Caesarian sections higher. The foetal outcome in both groups in respect of Apgar scores, and the blood gases of the umbilical cord as well as length and weight ranged within the normal limits. The cleared perinatal mortality was 0% (1 congenital defect with death). This study shows that the good results of prospective studies with a smaller number of cases can be confirmed by a retrospective analysis of an extensive group of patients, demonstrating the increasing acceptance of induction of labour by means of PGE2 tablets in elective as well as in medical indications.

Induction of Labor by Oral PGE2 Administration—Evaluation of Different Dose Schedules

The efficacy and safety of different oral doses of PGE2 in tablet form were evaluated in 30 women admitted to the hospital for labor induction at or near term. The aim was to select a recommendable dose schedule based on recording of uterine contractility, clinical outcome and measurement of the resulting plasma levels of the two prostaglandin metabolites 15-keto-13, 14-dihydro-PGE2 and 15-keto-13, 14-dihydro-PGE2 alpha by gas-chromatography-mass spectrometry and by radio-immunoassay. Measurements of uterine contractility and of plasma levels of the PGE2 metabolite both showed that the preferable interval between oral doses of PGE2 tablets is one hour. Following 1.0 mg PGE2, the plasma concentration peaked after 45 to 60 minutes and had returned to approximately pretreatment levels after 120 minutes. With a two-hour interval between doses there was above all a decreased frequency of contractions in the last part of the interval. No such variation in the contractility pattern was seen when 1.0 mg PGE2 was administered every hour. When the individual dose was increased to 2.0 mg, signs of overstimulation of uterine contractility were observed. The plasma concentration of the E2 metabolite increased in accordance with the oral dose. A slow rise in the plasma concentrations of the E2 and F2 alpha metabolites was found some hours following initiation of treatment, possibly indicating an increased endogenous prostaglandin biosynthesis, probably secondary to the stimulated uterine contractility.

Preinduction cervical priming with oral prostaglandin E2

Seventy-three women, primigravidas and multigravidas, received 1.0 mg PGE2 tablets hourly for 5 doses the evening prior to scheduled induction of term labor to improve cervical ripeness. The over-all response to treatment depended upon the initial cervical score. Gastrointestinal side effects occurred infrequently and no complications to mother or fetus were observed. While the protocol used provoked an improvement in cervical favorability it is anticipated that a more prolonged PGE2 administration might achieve better results.

Preoperative cervical dilatation by oral PGE 2

In fifty healthy nulliparous women who underwent therapeutic abortion in the second trimester of pregnancy according to the method of Finks, cervical dilatation has been satisfactorily carried out with PGE 2-tablets. The average dosage was 3mg. In 70% of the cases a “positive PG-effect” was observed which facilitated and therefore rendered safer, the subsequent mechanical procedure.

The effects on platelet aggregation of oral prostaglandin E2 used for the induction of labour.

Secondary ADP induced platelet aggregation was inhibited in 17 patients after the administration of oral prostaglandin E2 tablets for the induction of labour. Primary ADP induced aggregation was shown to be inhibited by oral prostglandin E2 when the platelets responded to the lower concentration of 0-5 mug/ml of ADP. This inhibition was not detectable when the higher concentration of 1-0 mug/ml ADP was necessary. There would appear to be a decreased risk of thrombosis initiated by platelet aggregation as a result of using oral PGE2 tablets for inducing labour.