Sustained-Release Dinoprostone Vaginal Pessary with Concurrent High-Dose Oxytocin Infusion Compared to Sustained-Release Dinoprostone Vaginal Pessary Followed 6 h Later by High-Dose Oxytocin Infusion for Labor Induction in Women at Term with Unfavorable Cervix: A Randomized Controlled Trial

Abstract

Objective: To compare the efficacy and safety of sustained-release dinoprostone vaginal pessary and concurrent high-dose oxytocin infusion with sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for cervical ripening and labor induction. Methods: A total of 500 nulliparous or multiparous women with a singleton pregnancy, Bishop score ≤4 and admitted for labor induction. Women were randomly assigned to induction of labor using intravaginal dinoprostone with concurrent high-dose oxytocin (n = 250) or intravaginal dinoprostone pessary followed 6 h later by high-dose oxytocin (n = 250). The primary outcome was the number of vaginal deliveries achieved within 24 h of labor induction. Results: Baseline characteristics of both groups were comparable. Vaginal delivery within 24 h of labor induction was significantly increased with sustained-release dinoprostone followed 6 h later by high-dose oxytocin infusion (92.8 vs. 82.0%, RR 2.82, 95% CI 1.58–5.04). There were more cesarean section deliveries in the dinoprostone with concurrent high-dose oxytocin group (16.8 vs. 6.8%, RR 0.36, 95% CI 0.20–0.65). Maternal outcomes did not differ significantly. An Apgar score of <7 at 5 min was found more often in the dinoprostone with concurrent high-dose oxytocin group (3.6%) in comparison to dinoprostone pessary followed 6 h later by high-dose oxytocin (0.8%), although this was not statistically different (RR 0.21, 95% CI 0.04–1.01). Conclusion: Sustained-release dinoprostone followed 6 h later by high-dose oxytocin infusion appears to be safer and more effective than sustained-release dinoprostone with concurrent high-dose oxytocin infusion in achieving cervical ripening and successful vaginal delivery.

Oxytocin versus sustained‐release dinoprostone vaginal pessary for labor induction of unfavorable cervix with Bishop score ≥4 and ≤6: A randomized controlled trial

“…concluded that oxytocin is less effective than vaginal and cervical prostaglandin E2 (PGE2) in bringing about vaginal delivery within 24 h; however, a recent Cochrane review of vaginal prostaglandin for induction of labor at term reported that prostaglandin was effective for inducing labor and to increase vaginal delivery rates . In addition, there are many protocols in the literature . suggesting the use of cervical priming agents and oxytocin together for IOL with poor Bishop scores.…”

“…However, we know that dinoprostone can prime the cervix and cause contractions but its effect on augmentation is still a query. The longer median delivery time for the dinoprostonw group pointed out the need for concurrent or post‐retrieval use of effective induction agents . Data on the need for pre‐induction cervical priming for half‐ripened cervix Bishop scores (≥4 or ≤6) are scarce, and pre‐induction cervical ripening may not lower the cesarean delivery rate in nulliparas with an unfavorable cervix for this subgroup …”

“…Most of the historical and recent research has supported the increased use of prostaglandins for term gestations with an unfavorable cervix using the criterion of a Bishop score of ≤4 or ≤5 . In most of these studies, patients were stratified into two groups according to their Bishop scores, which were defined as favorable (Bishop score >6) or unfavorable (Bishop score <6) . However, the data coming from articles that stratify the patients' Bishop scores between 4 and 6 are limited, and little information exists in the literature dealing with detailed Bishop scores for this subgroup.…”

Challenges and Limitations of Clinical Trials on Labor Induction: A Review of the Literature

“…Of the 103 trials identified, just 63 were RCTs. 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 The majority of RCTs were single-center trials conducted in academic hospitals, which can limit the generalizability of the results to other community-based populations. Among the 12 multicenter trials, the number of centers ranged from 2 to 49 and tended to include both university-affiliated and community hospitals.…”

Does Preincubation with Prostaglandin E1 or Prostaglandin E2 Enhance Oxytocin-Induced Myometrial Contractility In Vitro?

“…4,5 As normal labor depends on efficient myometrial contractions to efface and dilate a compliant cervix, when the cervix is unfavorable, administration of ripening agents is followed by intravenous infusion of oxytocin. 10 Recent randomized controlled trials have indicated that in the event of an unripe cervix, local application of PGs followed by oxytocin infusion is safer and more effective than oxytocin administration alone or concurrent with PGs 16,17 ; therefore, we sought to investigate in vitro the myometrial response to oxytocin after incubation with PGE1 and PGE2. Surprisingly, we found that PGs did not affect or even decreased myometrial response to oxytocin.…”