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

doi:10.1016/0002-9378(95)91415-3

American Journal of Obstetrics and Gynecology

Volume 172, Issue 6, June 1995, Pages 1804-1810

https://doi.org/10.1016/0002-9378(95)91415-3 Get rights and content

Abstract

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.

References (7)

FW Kubli et al.
Observations on heart rate and pH in human fetus during labor
Am J Obstet Gynecol
(1969)
RP Prins et al.
Preinduction cervical ripening with sequential use of prostaglandin E₂ gel
Am J Obstet Gynecol
(1986)
MJNG Keirse
Prostaglandins in preinduction cervical ripening: meta-analysis of worlwide clinical experience
J Reprod Med
(1993)

There are more references available in the full text version of this article.

Cited by (227)

Methods for the induction of labor: efficacy and safety
2024, American Journal of Obstetrics and Gynecology
This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 μg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.
Prostaglandin E2 prevents radiotherapy-induced alopecia by attenuating transit amplifying cell apoptosis through promoting G1 arrest
2023, Journal of Dermatological Science
Growing hair follicles (HFs) harbor actively dividing transit amplifying cells (TACs), rendering them highly sensitive to radiotherapy (RT). Clinically, there is still a lack of treatment options for radiotherapy-induced alopecia (RIA).
Our present study aimed to investigated the effect and mechanism of local prostaglandin E2 (PGE2) treatment in RIA prevention.
We compared the response of growing HFs to radiation with and without local PGE2 pretreatment in a mouse model in vivo. The effect of PGE2 on the cell cycle was determined in cultured HF cells from fluorescent ubiquitination-based cell cycle indicator mice. We also compared the protective effects of PGE2 and a cyclin-dependent kinases 4/6 (CDK4/6) inhibitor against RIA.
The local cutaneous PGE2 injection reduced RIA by enhancing HF self-repair. Mechanistically, PGE2 did not activate HF stem cells, but it preserved more TACs for regenerative attempts. Pretreatment of PGE2 lessened radiosensitivity of TACs by transiently arresting them in the G1 phase, thereby reducing TAC apoptosis and mitigating HF dystrophy. The preservation of more TACs accelerated HF self-repair and bypassed RT-induced premature termination of anagen. Promoting G1 arrest by systemic administration of palbociclib isethionate (PD0332991), a CDK4/6 inhibitor, offered a similar protective effect against RT.
Locally administered PGE2 protects HF TACs from RT by transiently inducing G1 arrest, and the regeneration of HF structures lost from RT is accelerated to resume anagen growth, thus bypassing the long downtime of hair loss. PGE2 has the potential to be repurposed as a local preventive treatment for RIA.
Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial
2022, American Journal of Obstetrics and Gynecology
Early amniotomy shortens the duration of spontaneous labor, yet there is no clear evidence on the optimal timing of amniotomy following cervical ripening. There are limited high-quality studies on the use of early amniotomy intervention following labor induction.
This study aimed to evaluate whether amniotomy within 1 hour of Foley catheter expulsion reduces the duration of labor among individuals undergoing combined misoprostol and Foley catheter labor induction at term.
This was a randomized clinical trial conducted from November 2020 to May 2021 comparing amniotomy within 1 hour of Foley catheter expulsion (early artificial rupture of membranes) with expectant management. Randomization was stratified by parity. Labor management was standardized among participants. Individuals undergoing induction at ≥37 weeks with a singleton gestation and needing cervical ripening were eligible. Our primary outcome was time to delivery. Wilcoxon rank sum, Pearson chi-square, and Cox survival analyses with intent-to-treat principles were performed adjusting for age, body mass index, parity, mode of delivery, Bishop score, and the interaction between randomization group and parity. A sample size of 160 was planned to detect a 4-hour reduction in delivery time.
A total of 160 patients (79 early artificial rupture of membranes, 81 expectant management) were randomized. Early artificial rupture of membranes achieved a faster median time to delivery than expectant management (early artificial rupture of membranes: 11.1 hours; interquartile range, 6.25–17.1 vs expectant management: 19.8 hours; interquartile range, 13.2–26.2; P<.001). A greater percentage of individuals in the early artificial rupture of membranes group delivered within 24 hours (86% vs 70%; P=.03). There was no difference in the cesarean delivery rate between the 2 groups (22% vs 31%; P=.25). Individuals delivered 2.3 times faster following early artificial rupture of membranes (hazard ratio, 2.3; 95% confidence interval, 1.5–3.4; P<.001). There were no significant differences in maternal and neonatal outcomes.
Amniotomy within 1 hour of Foley catheter expulsion resulted in 2.3 times faster delivery than expectant management. Therefore, early artificial rupture of membranes should be considered in individuals undergoing mechanical cervical ripening at term.
Comparison of intracervical and intravaginal prostaglandin E2 for induction of labor in term pregnancies with unfavorable cervix: Randomized controlled trial
2022, European Journal of Obstetrics and Gynecology and Reproductive Biology
Citation Excerpt :
Maternal outcomes included postpartum hemorrhage (PPH), 3rd and 4th degree perineal tear, uterus rupture, NICU admission and septicemia. Before study commencement sample size analysis was performed based on data from previously published studies [13,14]. For an alpha error of 5%, test power of 80% and possible drop-out of 15%, it was calculated that a total of 212 pregnant women should be randomly included in the study, 106 in each group.
The aim of this study was to compare intracervical (IC) and intravaginal (IV) application of prostaglandin E2 (PGE2) for labor induction in term pregnancies with unfavorable cervix.
This prospective randomized trial included 212 pregnant women with term pregnancy and unfavorable cervix randomly assigned for labor induction with either IC (0.5 mg) or IV (2 mg) PGE2 formulation. Main outcome measured was time interval from labor induction to delivery. Difference in mode of delivery and adverse perinatal outcomes between two studied groups was also investigated. Significance was set at p < 0.05.
Studied groups did not significantly differ regarding main characteristics such as age, parity, body mass index or Bishop score. Women in IV group compared to those in IC group had shorter induction to delivery time interval (p < 0.001) and induction to active phase time interval (p = 0.001), higher prevalence of vaginal delivery within 24 h of labor induction (63,3% vs 40,6%, p = 0.002) and higher prevalence of successful induction of labor (95,9% vs. 86,5%, p = 0.020). The analysis did not reveal significant difference in mode of delivery between groups (p = 0.453) or other adverse perinatal outcomes.
IV application of PGE2 compared to IC application is more efficacious and comparably safe for labor induction in term pregnancies with unfavorable cervix and should be the method of choice for labor induction.
Effect of intramuscular and intravaginal PGE-2 treatment compared to intramuscular oxytocin treatment in eutocic sows on the farrowing performance in a free farrowing system
2021, Theriogenology
A duration of parturition beyond 300 min negatively impacts the health of the sow and the survival of piglets during parturition. Hence, oxytocin is widely used to speed up the parturition. However, oxytocin’s negative side effects raise the need of finding alternative treatments such as those already implemented in human medicine. The aim of this study was to evaluate the efficacy of Prostaglandin E2 (PGE2) applied intravaginally (PGE2-V) (1.0 mg) or intramuscularly (PGE2-M) (2.5 mg) to improve the parturition process after expulsion of the fourth piglet compared to a placebo (P–V), which was sterile intravaginal gel or intramuscular oxytocin application (OXY-M) (20 iu) in free farrowing systems.In total, 201 eutocic sows were examined after stratification by parity and random allocation into groups: 54 (P–V), 48 (OXY-M), 50 (PGE2-V), 49 (PGE2-M). Farrowing duration (time between first piglet and last piglet), piglet interval and placenta expulsion duration (time between first and last placenta) were recorded, and each piglet was scored for meconium staining and vitality. Furthermore, stillborn piglets were categorized into ante-partum and intra-partum deaths.Under the present conditions, neither administration of PGE2 nor oxytocin revealed a significant effect on the farrowing process or the vitality of the piglets when compared to untreated sows. Nonetheless, significant differences could be detected between PGE-2 and oxytocin treatments. The duration of farrowing was significantly shorter in oxytocin-treated sows (156 min) compared to sows treated intramuscularly with PGE2 (238 min). Furthermore, the placenta expulsion duration in the OXY-M group (130 min) significantly differed from PGE2-V (198 min) and PGE2-M group (218 min). Although these accelerations of parturition might be considered as a beneficial effect, routine treatment with uterotonic agents after birth of the fourth piglet in free farrowing eutocic sows cannot be recommended, because an overall benefit when compared to untreated sows was not approved.
Abnormal Labor and Induction of Labor
2016, Obstetrics: Normal and Problem Pregnancies

View all citing articles on Scopus

^☆: Frank W. Lynch Memorial Essay, presented at the Sixty-first Annual Meeting of the Pacific Coast Obstetrical and Gynecological Society, Scottsdale, Arizona, October 24–29, 1994.

View full text

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

Abstract

Am J Obstet Gynecol

Am J Obstet Gynecol

Prostaglandins in preinduction cervical ripening: meta-analysis of worlwide clinical experience

J Reprod Med

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