Evidence map›Paper›PMID 39400318›Full record

Observational studyInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2025

Safety of the use of dinoprostone gel and vaginal insert for induction of labor: A multicenter retrospective cohort study.

Mariarosaria Di Tommaso, Rosamaria Pellegrini, Oumaima Ammar, Serena Lecis, Mor Huri, Fabio Facchinetti

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Safety of the use of dinoprostone gel and vaginal insert for induction of labor: A multicenter retrospective cohort study.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Mariarosaria Di TommasoDivision of Obstetrics and Gynecology, Department of Health Sciences, University of Florence, Florence, Italy.ORCID https://orcid.org/0000-0001-8248-929X
Rosamaria PellegriniDepartment of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Modena, Italy.
Oumaima AmmarDivision of Obstetrics and Gynecology, Department of Health Sciences, University of Florence, Florence, Italy.
Serena LecisDepartment of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Modena, Italy.
Mor HuriDivision of Obstetrics and Gynecology, Department of Health Sciences, University of Florence, Florence, Italy.
Fabio FacchinettiDepartment of Medical and Surgical Sciences for Mother, Child and Adult, University of Modena and Reggio Emilia, Azienda Ospedaliero Universitaria Policlinico, Modena, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess adverse obstetric and neonatal outcomes associated with the use of dinoprostone for induction of labor, with particular attention on categories for which caution is recommended by the Italian Medicines Agency and the European Medicine Agency.

methodsA retrospective multicenter observational study was conducted on a population of 1687 patients undergoing induction of labor with vaginal dinoprostone (gel or insert) between August 2019 and June 2022. Patients were subdivided based on maternal age, gestational age, and obstetric disorders. Data regarding the mode of delivery, the incidence of tachysystole, and the obstetric and perinatal outcomes were collected.

resultsThe main adverse event associated with the use of dinoprostone was tachysystole. However, tachysystole was not associated with an increased risk of cesarean section (CS), neonatal intensive care (NICU) admission, low 1-min Apgar, or umbilical cord acidosis. Maternal age greater than 35 years, gestational age greater than 40 weeks, and obstetric disorders were not associated with an increased rate of tachysystole, NICU admission, low 1- and 5-min Apgar scores, and cord acidosis. The only associated adverse outcomes in those categories were postpartum hemorrhage with age greater than 35 years and tachysystole with gestational diabetes mellitus and hypertensive disorders. Not a single case of severe outcome (disseminated intravascular coagulation, uterine rupture, maternal and fetal death) was reported in the cohort.

conclusionProviding there is adequate maternal and fetal surveillance, in an inpatient setting, dinoprostone could be safely administered for the induction of labor and considered appropriate in high-risk pregnancies. Tachysystole can be self-identified by the patient and effectively managed.

Indexed as

DinoprostoneLabor, InducedOxytocicsAdministration, IntravaginalAdultCesarean SectionFemaleHumansInfant, NewbornItalyPregnancyPregnancy OutcomeRetrospective StudiesVaginal Creams, Foams, and JelliesDinoprostoneOxytocicsVaginal Creams, Foams, and Jelliesadverse maternal and neonatal eventsdinoprostoneinduction of labortachysystole

Identifiers

PMID39400318
PMCPMC11823324

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.