Evidence map›Paper›PMID 21373274›Full record

ArticleDeutsches Arzteblatt international2011

Self-testing of vaginal pH to prevent preterm delivery: a controlled trial.

Eva-Maria Bitzer, Andrea Schneider, Paul Wenzlaff, Udo B Hoyme, Elisabeth Siegmund-Schultze

Abstract readControlled Clinical TrialMulticenter Study
In one paragraph

Article in Deutsches Arzteblatt international, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
–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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. The prevention, diagnosis and treatment of premature labor.Deutsches Arzteblatt international · 2013
    Pooled it
  3. Article
  4. [Patients in radiotherapy].Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2012
    Article
  5. Review
  6. Correspondence (letter to the editor): methodological problems.Deutsches Arzteblatt international · 2011
    Article
  7. Correspondence (letter to the editor): serious shortcomings.Deutsches Arzteblatt international · 2011
    Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Eva-Maria BitzerInstitut für Sozialmedizin, Epidemiologie und Gesundheitssystemforschung e. V.Bereich Outcome- und Evaluationsforschung, Lavesstrasse 80, Hannover, Germany.
Andrea Schneider
Paul Wenzlaff
Udo B Hoyme
Elisabeth Siegmund-Schultze

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFrom 2004 to 2006, in a model project carried out by four German health insurers, expectant mothers were offered self-testing of vaginal pH in order to prevent preterm delivery. They were given pH test gloves on request so that they could measure their vaginal pH twice a week from the 12(th) to the 32(nd) week of gestation. They were instructed to consult with a gynecologist after any positive result. All further diagnostic or therapeutic decisions were at the discretion of the treating gynecologist. We assessed the effectiveness of the screening intervention, using delivery before the 37th week of gestation as the primary endpoint.

methodsIn this prospective, controlled trial, we collected data on deliveries from 2004 to 2006 that were covered by the four participating insurers in five German federal states. We compared the outcomes of pregnancy in women who did and did not request test gloves (intervention group, [IG], and control group, [CG]). The data were derived from claims data of the participating insurers, as well as from a nationwide quality assurance auditing program for obstetrics and perinatal care. Propensity score matching and multivariate adjustment were used to control for the expected self-selection bias.

resultsThe study sample comprised 149 082 deliveries. 13% of the expectant mothers requested test gloves, about half of them up to the 16(th) week of gestation. As expected, women with an elevated risk of preterm birth requested test gloves more often. Delivery before the 37(th) week of gestation was slightly more common in the intervention group than in the control group (IG 7.97%, CG 7.52%, relative risk 1.06, 95% confidence interval 1.00-1.12). This result was of borderline statistical significance in the propensity score matched analysis, but it was not statistically significant in the multivariate model.

conclusionThis trial did not demonstrate the efficacy of self-testing of vaginal pH for the prevention of preterm delivery (< 37 weeks of gestation).

Indexed as

Diagnostic Self EvaluationAdolescentAdultComorbidityFemaleGermanyHumansHydrogen-Ion ConcentrationMiddle AgedPregnancyPregnancy OutcomePremature BirthPrevalenceReproducibility of ResultsRisk AssessmentRisk Factors

Identifiers

PMID21373274
PMCPMC3047717

What OpenQuestion holds

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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.