Dinoprostone Insert Research Articles

Cardiotocographic abnormalities associated with misoprostol and dinoprostone cervical ripening and labor induction

Objective To characterize the incidence and timing of cardiotocographic (CTG) abnormalities associated with misoprostol and dinoprostone vaginal inserts during labor induction. Study design This was a secondary analysis of data collected during the misoprostol vaginal insert (MVI) trial, a multi-site, double-masked, randomized trial of women requiring cervical ripening before induction of labor. The timing, incidence and clinical outcomes associated with CTG abnormalities were analyzed among three study groups. Results 1308 subjects were randomized to receive dinoprostone pessary, misoprostol 50 mcg (MVI 50) or 100 mcg (MVI 100) vaginal insert. 6.8% of MVI 50-treated women had a uterine contractile abnormality (hyperstimulation, hypertonus and/or tachysystole) while the study drug was in situ, compared to 17.4% with dinoprostone insert ( p < 0.001) and 17.3% with MVI 100 ( p < 0.001). There was no significant difference in incidence of fetal heart rate (FHR) abnormalities that occurred with the study drug—11.2% with dinoprostone, compared to 9.9% with MVI 50 and 10.7% with MVI 100. Cardiotocographic (CTG) abnormalities while the study drug was in situ occurred later in women treated with MVI 50 (7.5 h [6.2–9.8]) compared to dinoprostone (5.5 h [4.2–6.6], p = 0.003) and MVI 100 (7.0 h [5.7–7.9], p = 0.13). Eight participants in MVI 50 group underwent cesarean section secondary to a CTG event that was initially noted with the study drug in situ, compared to eight dinoprostone-treated participants and 16 in the MVI 100 group, but these differences were not statistically significant. Conclusion Cardiotocographic abnormalities were less frequent and occurred after longer exposure with MVI 50 than MVI 100 or dinoprostone. Clinical outcomes were similar among the groups.

Retention of Dinoprostone Vaginal Insert Beyond 12 Hours for Induction of Labor

We evaluate the likelihood of cesarean delivery and identify risks of retaining a sustained-release dinoprostone vaginal insert beyond 12 hours. In a secondary analysis of outcomes, data were collected during a large, randomized trial comparing different sustained-release prostaglandin vaginal inserts for labor induction. Outcomes were compared between cases in whom the dinoprostone insert was removed early (within 12 hours) or late (12 to 24 hours). A total of 431 subjects had the dinoprostone vaginal insert in place for 12 to 24 hours ( N = 226, 52.4%) or within 12 hours ( N = 205, 47.6%). Insert removal for labor complications was less frequent in the late group than in the early group (5.8% versus 21.5%; P ≤ 0.001). Abnormal uterine contractility patterns were less common in the late than early group (25.2% versus 37.6%; P = 0.03). Rates of cesarean delivery during the first hospitalization were similar for late and early groups (25.0% versus 29.2%; P = 0.33). Percentages of infants requiring immediate attention or intensive care were low and similar between groups. Sustained-release intravaginal dinoprostone left in place beyond 12 hours did not increase the risks of intrapartum complications, cesarean delivery, or immediate adverse neonatal events.

383: Efficacy and safety of slow release dinoprostone insert for induction of labor: Correlation with parity

383: Efficacy and safety of slow release dinoprostone insert for induction of labor: Correlation with parity

Comparative efficacy and cost of the prostaglandin analogs dinoprostone and misoprostol as labor preinduction agents

Objective: The purpose of this study was to compare the relative efficacy and cost of three commercially available prostaglandin analogs, misoprostol (Cytotec), dinoprostone gel (Prepidil), and dinoprostone insert (Cervidil), as labor preinduction agents. Study design: One-hundred eleven women with an unfavorable cervix who underwent labor induction were assigned randomly to receive either misoprostol 50 μg every 6 hours for two doses, dinoprostone gel 0.5 mg every 6 hours for two doses, or dinoprostone insert 10 mg for one dose intravaginally. Twelve hours later, oxytocin induction was initiated per standardized protocol. Efficacy and cost of the labor preinduction/induction with the study treatments were compared. Results: Mean Bishop score change (±SD) over the initial 12-hour interval was significantly greater in the misoprostol group (5.2 ± 3.1) compared with the dinoprostone insert (3.2 ± 2.3) or the dinoprostone gel groups (2.2 ± 1.3, P < .0001). The proportion of women who reached complete dilation (68.4%, 50.0%, 51.4%, respectively; P = .14) and who were delivered (60.5%, 47.4%, 40.0%, respectively; P = .10) within 24 hours of the initiation of induction were not significantly different between the misoprostol, dinoprostone insert, and dinoprostone gel groups. Induction-to-delivery intervals, however, were significantly shorter among women who treated with misoprostol (24.0 ± 10.8 hours) compared with either the dinoprostone gel (31.6 ± 13.4 hours) or the dinoprostone insert (32.2 ± 14.7 hours, P < .05). Overall mean cost per patient that was incurred by labor induction was significantly less for the misoprostol group ($1036.13) compared with the dinoprostone insert group ($1565.72) or the dinoprostone gel group ($1572.92, P < .0001). No significant differences were noted with respect to the mode of delivery or to the adverse maternal/neonatal outcome. Conclusion: Misoprostol is more cost-effective than the comparable commercial dinoprostone prostaglandin preparations as an adjuvant to labor induction in women with an unfavorable cervix. (Am J Obstet Gynecol 2003;188:560-5.)

Randomized trial of concurrent oxytocin with a sustained-release dinoprostone vaginal insert for labor induction at term

Objective: The purpose of this study was to determine whether the concurrent administration of oxytocin with sustained-release dinoprostone results in shorter induction times when compared with oxytocin after the removal of the dinoprostone insert. Study Design: Women with singleton pregnancies at ≥36 weeks, vertex presentations, reactive nonstress tests, no prior uterine scar, intact membranes, and Bishop scores of ≤6 were randomly assigned to receive oxytocin either immediately after placement of a sustained-release dinoprostone insert (immediate) or 30 minutes after its removal (delayed). The primary outcome was the time interval from induction to delivery. Results: Seventy-one patients were enrolled (immediate, 34 patients; delayed, 37 patients). There were no differences between treatment groups in nonreassuring fetal heart tracings, excess uterine activity, and epidural use. The mean time from dinoprostone placement until delivery was 544 minutes, shorter in the immediate group (972 vs 1516 minutes; P =.001). The proportion of deliveries within 24 hours was higher (90% vs 53%; P =.002) in the immediate group. Cesarean delivery rates were similar between the immediate and delayed groups (16% vs 13%; P =.73). No adverse maternal or neonatal outcomes were observed with concurrent therapy. Conclusion: Oxytocin that is administered concurrently with sustained-release dinoprostone significantly shortens induction-to-delivery times and results in a higher proportion of vaginal deliveries of ≤24 hours with no apparent adverse effects. (Am J Obstet Gynecol 2002;186:61-5.)