dinoprostone
Regulatory sources consulted
Approved indications
- Initiation of cervical ripening in term patients from 37 completed weeks of gestation.
Contraindications
Absolute
- Established labor or concomitant oxytocic administration.
- Prior major uterine surgery or cesarean section, cephalopelvic disproportion, malpresentation, fetal distress, placenta previa, or unexplained vaginal bleeding.
- Untreated pelvic inflammatory disease or hypersensitivity to dinoprostone.
Clinical warnings
- Major warning · Hospital use only. Continuously monitor uterine activity and fetal status; remove immediately for excessive contractions, hypertonus, or maternal or fetal complications. Uterine rupture and postpartum DIC may occur. — CIMA/AEMPS, ficha técnica 62088
- Major warning · Use cautiously with a history of asthma, glaucoma, or uterine hypertonus, in multiple pregnancy, after more than three term deliveries, or with ruptured membranes. With ruptured membranes, closely monitor uterine activity and fetal status because amniotic fluid may alter dinoprostone release. — CIMA/AEMPS, ficha técnica 62088
- Major warning · The risk of postpartum DIC increases from age 35, with pregnancy complications such as gestational diabetes, hypertension, or hypothyroidism, and beyond 40 weeks of gestation; use cautiously and look for early signs of fibrinolysis in the immediate postpartum period. Anaphylaxis and, rarely, anaphylactoid syndrome of pregnancy or amniotic fluid embolism have been reported. — CIMA/AEMPS, ficha técnica 62088
- Major warning · Discontinue nonsteroidal anti-inflammatory drugs, including acetylsalicylic acid, before administering dinoprostone. — CIMA/AEMPS, ficha técnica 62088
Drug interactions
- HighOxytocin or other uterotonics
Mechanism: Prostaglandins potentiate uterotonic effects.
Recommendation: Do not administer concomitantly; wait at least 30 minutes after removal before oxytocin.
CIMA/AEMPS, ficha técnica 62088https://cima.aemps.es/cima/dochtml/ft/62088/FT_62088.html
- HighNonsteroidal anti-inflammatory drugs, including acetylsalicylic acid
Mechanism: The product information establishes this precaution without detailing a specific mechanism.
Recommendation: Discontinue these medicines before administering dinoprostone.
CIMA/AEMPS, ficha técnica 62088https://cima.aemps.es/cima/dochtml/ft/62088/FT_62088.html
Adverse events
Common (≥1%)
Fetal heart-rate disorder · Abnormal uterine contractions or hyperstimulation · Abnormal labor affecting the fetus
Rare but serious
Anaphylaxis or severe hypersensitivity · Anaphylactoid syndrome of pregnancy or amniotic fluid embolism
Pregnancy and lactation
Indicated only at term for cervical ripening. Excretion into colostrum or milk is expected to be minimal, and no effects in breastfed newborns were observed in clinical studies.
Recent literature (PubMed)
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 hygrosco
Intrauterine devices (IUDs) are a safe and highly effective contraceptive method, but pain poses a significant barrier to IUD uptake and satisfaction. Data on existing modalities for insertional pain management are limited, and there remains no consensus on standard of care. To summarize the existing literature on pharmacologic and nonpharmacologic pain management options available for IUD insertion pain. Articles published since 1995 were identified via literature search in PubMed and Ovid; relevant articles were reviewed. IUD insertion pain management interventions with the strongest evidence to date include cervical block, 10% lidocaine spray, and 5% lidocaine-prilocaine cream. Some low-risk interventions such as ultrasound guidance, music, and the "cough" method have less robust evidence but may be warranted for patients at risk for severe pain, including nulliparous patients, patients who have experienced dysmenorrhea or violence, and patients with high reported anticipated pain. More research is necessary to discern the effectiveness of certain nonsteroidal anti-inflammatory drugs, dinoprostone, transcutaneous electrical nerve stimulation, and acupuncture. Despite common practice to offer ibuprofen prior to IUD insertion, topical and injectable lidocaine formulations are more effective at reducing pain. Further research is necessary to strengthen recommendations, elucidate the efficacy of other adjunctive options, and optimize clinic workflow, but these findings suggest that lidocaine-based analgesics may represent the future of IUD insertion pain management. Providers can utilize this summary to offer individualized, evidence-based pain management options for patients seeking an IUD.
Oral and vaginal misoprostol are effective induction methods, but there is a delicate balance between a quicker labour and avoiding side effects. In randomised comparisons with balloon catheters, oral misoprostol resulted in more vaginal births in the first 24 h as well as fewer caesarean sections without an increase in hyperstimulation events. Vaginal misoprostol was most effective when used concurrently with a balloon catheter. In comparison with dinoprostone, oral misoprostol had lower rates of caesarean section and uterine hyperstimulation with foetal heart rate changes, but fewer babies were born vaginally within 24 h. In contrast, vaginal misoprostol resulted in more vaginal births within 24 h, with no significant differences in caesarean section rates. There were no differences in perinatal adverse events with either route. When oral and vaginal misoprostol were compared, vaginal misoprostol resulted in more vaginal births in the first 24 h, but with more maternal and neonatal complications.
The comparison between prostaglandin E2 (PGE2) and oxytocin and for induction of labor (IOL) remains controversial. The present study aimed to determine the safety and efficacy of these two agents in IOL. PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov. from the establishment of the database to April 23, 2023. A search was conducted with keywords "labor, induction, prostaglandin E2/PGE2/dinoprostone, and oxytocin". Only randomized clinical trials comparing oxytocin and vaginal dinoprostone in women who were at least late preterm (gestational age [GA] ≥34 weeks), singleton pregnant, and had intact membranes were enrolled for further meta-analysis. We conducted both a descriptive analysis and a meta-analysis. In the meta-analysis, we utilized the Mantel-Haenszel random effects model to analyze dichotomous data, employing the relative risk (RR) as the effect measure along with 95% confidence intervals (CIs). The study quality was evaluated using Cochrane Collaboration's risk of bias assessment tool (RoB 2). A random-effects model was applied for the meta-analysis. After screening 3303 articles from five databases, a total of nine randomized controlled studies composed of 1071 patients were included. Our analysis included 534 patients in the PGE2 group and 537 patients in the oxytocin group. The pooled estimate of vaginal deliveries following PGE2 induction stood at 84.2%, while after oxytocin induction, it was 79.8%. The meta-analysis showed no statistical difference between the two groups in terms of the rate of vaginal delivery (pooled RR, 1.05; 95% CI: 0.95-1.16; P value for Q, 0.001; I2, 71.14%), cesarean section (pooled RR, 0.84; 95% CI: 0.52-1.35; P value for Q, 0.007; I2, 61.69%) and induction-delivery interval (pooled standard mean difference, 0.09; 95% CI: -0.67 to 0.85; P value for Q, 0.000; I2, 96.45%). Since the results for fetal distress and uterine hyperstimulation were consistent across all enrolled studies, no further meta-analy