Evidence map›Paper›PMID 31915047›Full record

ArticleTrials2020

Is there an interest in repeating the vaginal administration of dinoprostone (Propess®), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial.

P Coste Mazeau, M Hessas, R Martin, J-L Eyraud, F Margueritte, Y Aubard, C Sallee, F Sire, T Gauthier

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02888041 (Is There an Interest in Repeating the Vaginal Administration of Dinoprostone), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.6field-weighted citation impact, top 27% of its field
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.

NCT02888041 phase3terminatednot on this map

Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?

TypeinterventionalSponsorUniversity Hospital, LimogesRan2016 to 2022Enrolled160ConditionsCervical Ripening, PregnancyArmsDinoprostone, Oxytocine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Term induction of labour in nulliparous women: When to draw the line?European journal of obstetrics & gynecology and reproductive biology: X · 2022
    Article
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

9 authors at 1 institution in 1 country.

P Coste MazeauDepartment of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France. perrine.costemazeau@chu-limoges.fr.
M HessasDepartment of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.
R MartinClinical Investigation Center, CHRU Limoges, 2 Avenue Dominique Larrey, 87000, Limoges, France.
J-L EyraudDepartment of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.
F MargueritteDepartment of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.
Y AubardDepartment of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.
C SalleeDepartment of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.
F SireDepartment of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.
T GauthierDepartment of Gynaecology and Obstetrics, Mother and Children's Hospital, Limoges Regional University Hospitals, 8 Avenue Dominique Larrey, 87000, Limoges, France.
Université de Limoges · FR

Funding

PHRC-I 2015 15-075
6 · The paper itself

Abstract

backgroundLabor is induced in over 20% of women in France. Prostaglandins, especially intravaginal dinoprostone (Propess®), are widely used to initiate cervical ripening. If labor does not start within 24 h, there is uncertainty about whether to administer a second dinoprostone pessary or to use oxytocin to induce labor in order to achieve a vaginal delivery.

methodsRE-DINO is a prospective, open-label, multicenter, randomized superiority trial with two parallel arms running in six French hospitals. A total of 360 patients ≥ 18 years of age at > 37 weeks of gestation who exhibit unfavorable cervical conditions (Bishop score < 6) 24 h after placement of the first Propess®, with fetuses in cephalic presentation, will be included. Patients with premature membrane rupture, uterine scars, or multiple pregnancies will be excluded. Our principal objective is to determine whether placement of a second Propess® (followed by oxytocin [Syntocinon®], if necessary) in women for whom the first Propess® failed to induce cervical ripening increases the vaginal delivery rate compared to direct oxytocin injection. The vaginal delivery rate is therefore the primary outcome. The secondary outcomes are the induction failure rates and maternofetal morbidity and mortality. DISCUSSION: This study may help in determining the optimal way to induce labor after failure of a first Propess®, an unresolved problem to date. This trial explores the effectiveness and safety of placing a second Propess® and may contribute to development of an obstetric consensus.

trial registrationRegistered on 2 September 2016 at clinicaltrials.gov (identification number NCT02888041).

Indexed as

Labor, InducedAdministration, IntravaginalAdultCervical RipeningClinical Trials, Phase III as TopicDinoprostoneEquivalence Trials as TopicFemaleFranceHumansInfusions, IntravenousMulticenter Studies as TopicOxytocicsOxytocinPregnancyRandomized Controlled Trials as TopicDinoprostoneOxytocicsOxytocinDinoprostoneInduction of laborOxytocinPregnancy

Identifiers

PMID31915047
PMCPMC6950885
OpenAlexW2998833263

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.