Evidence map›Paper›PMID 29411072›Full record

ArticleInternational urogynecology journal2018

Prospective evaluation of the safety and feasibility of a pelvic floor dilator during active labor.

Francisco J Orejuela, Rajshi Gandhi, Lauren Mack, Wesley Lee, Haleh Sangi-Haghpeykar, Hans P Dietz, Susan M Ramin

Abstract read
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In one paragraph

Article in International urogynecology journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 36% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. The effect of antenatal vaginal dilators on perineal trauma: A systematic review and meta-analysis.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Pooled it
  2. Trial
  3. Article
  4. Review
  5. 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

7 authors at 2 institutions in 2 countries.

Francisco J OrejuelaDepartment of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA. orejuela@bcm.edu.ORCID http://orcid.org/0000-0002-7396-9803
Rajshi GandhiDepartment of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA.
Lauren MackDepartment of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA.
Wesley LeeDepartment of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA.
Haleh Sangi-HaghpeykarDepartment of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA.
Hans P DietzDepartment of Obstetrics and Gynecology, Sydney Medical School Nepean, The University of Sydney, Sydney, NSW, Australia.
Susan M RaminDepartment of Obstetrics and Gynecology, Baylor College of Medicine and Texas Children's Hospital Pavilion for Women, 6651 Main Street, Houston, TX, 77030, USA.
Baylor College of Medicine · USThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introduction and hypothesisThe objective was to assess the safety and feasibility of using a pelvic floor dilator during active labor to prevent injuries to the levator ani muscle (LAM) and perineum.

methodsIn a prospective pilot study, a pelvic floor dilator using soft pads was introduced into the vaginal canal to gradually expand the vagina, in 30 nulliparous women and in 10 controls. The primary outcomes were adverse events related to the device. Secondary outcomes were perineal lacerations after delivery, sonographically defined levator ani injury, hiatal area dimensions, and anal sphincter disruption, all at 12-20 weeks postpartum, and maximum pelvic floor dilation, time to achieve maximum dilation, and device retention rate.

resultsFrom October 2014 through November 2016, a total of 494 women were screened, and 61 consented to the study. Thirty women used the device and 27 returned for follow-up. No maternal or neonatal injuries were related to use of the dilator. The average maximum dilation of the vaginal canal was 7.4 cm (SD 0.7, range 5.5-8.0). Dilation time averaged 27 min (SD 13, range 5-60). Device insertion adjustment was needed in 13 out of 30 cases (43%). Similar rates of 3th-4th degree perineal lacerations were seen in both groups. Levator ani avulsion was diagnosed in 2 out of 27 (7%) in the device group and in 1 out of 9 (11%) in the control group (p = 0.2). The rate of partial injury in the device group was 2 out of 27 (7%) vs 2 out of 9 (22%) in the comparison group (p = 0.2).

conclusionThe use of the pelvic floor dilator during active labor is feasible. No safety issues were identified.

Indexed as

AdultAnal CanalDilatationFeasibility StudiesFemaleHumansLacerationsObstetric Labor ComplicationsPelvic FloorPelvic Floor DisordersPerineumPilot ProjectsPregnancyProspective StudiesTreatment OutcomeVaginaLevator avulsionPelvic floor trauma prevention

Identifiers

PMID29411072
OpenAlexW2793815184

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.