Evidence map›Paper›PMID 35329852›Full record

ArticleJournal of clinical medicine2022

Double Balloon Catheter (Plus Oxytocin) versus Dinoprostone Vaginal Insert for Term Rupture of Membranes: A Randomized Controlled Trial (RUBAPRO).

Eric Devillard, Fanny Petillon, Marion Rouzaire, Bruno Pereira, Marie Accoceberry, Céline Houlle, Lydie Dejou-Bouillet, Pamela Bouchet, Amélie Delabaere, Denis Gallot

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2022. 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
1.1field-weighted citation impact, top 24% 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.

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, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

10 authors at 2 institutions in 1 country.

Eric DevillardDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Fanny PetillonDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Marion RouzaireDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.ORCID 0000-0001-8618-299X
Bruno PereiraBiostatistics Unit (DRCI), CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.ORCID 0000-0003-3778-7161
Marie AccoceberryDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Céline HoulleDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Lydie Dejou-BouilletDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Pamela BouchetDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Amélie DelabaereDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Denis GallotDepartment of Obstetrics and Gynecology, CHU Clermont-Ferrand, 63000 Clermont-Ferrand, France.
Centre Hospitalier Universitaire de Clermont-Ferrand · FRCentre National de la Recherche Scientifique · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The aim of this study is to demonstrate that a double balloon catheter combined with oxytocin decreases time between induction of labor and delivery (TID) as compared to a vaginal dinoprostone insert in cases of premature rupture of membranes at term. Methods: This is a prospective, randomized, controlled trial including patient undergoing labor induction for PROM at term with an unfavorable cervix in Clermont-Ferrand university hospital. We compared the double balloon catheter over a period of 12 h with adjunction of oxytocin 6 h after catheter insertion versus dinoprostone vaginal insert. After device ablation, cervical ripening continued only with oxytocin. The main outcome was TID. Secondary outcomes concerned delivery mode, as well as maternal and fetal outcome, and were adjusted for parity. Results: 40 patients per group were randomized. Each group had similar baseline characteristics. The study failed to demonstrate reduced TID (16.2 versus 20.2 h, ES = 0.16 (−0.27 to 0.60), p = 0.12) in the catheter group versus dinoprostone except in nulliparous women (17.0 versus 26.5 h, ES = 0.62 (0.10 to 1.14), p = 0.006). The rate of vaginal delivery <24 h significantly increased with combined induction (88.5% versus 66.6%, p = 0.03). No statistical difference was observed concerning caesarean rate (12.5% versus 17.5%, p > 0.05), chorioamnionitis (0% versus 2.5%, p = 1), postpartum endometritis, or maternal or neonatal outcomes. Procedure-related pain and tolerance to devices were found to be similar for the two methods. Interpretation: The double balloon catheter combined with oxytocin is an alternative for cervical ripening in case of PROM at term, and may reduce TID in nulliparous women.

Indexed as

cervical ripening balloonlabor inductionnulliparouspremature rupture of membranesunfavorable cervix

Identifiers

PMID35329852
PMCPMC8952372
OpenAlexW4220833200

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.