Why Were the Results of Randomized Trials on the Clinical Utility of Fetal Fibronectin Negative? A Systematic Review of Their Study Designs.
Summary of "Why Were the Results of Randomized Trials on the Clinical Utility of Fetal Fibronectin Negative? A Systematic Review of Their Study Designs."
Randomized trials on the clinical utility of fetal fibronectin in women with symptoms of preterm labor have thus far failed to demonstrate benefits. We systematically reviewed the methodology of these trials to assess if these negative results may be related to their study designs. We searched the literature for randomized trials that evaluated fibronectin testing in women with symptoms of preterm labor. Study results were evaluated and five methodological criteria were assessed: (1) randomization of discordant test results, (2) use of a fixed management protocol, (3) description of interventions in relation to the test result, (4) evaluation of a learning curve, and (5) sample size calculation in agreement with the prevalence of the test results. We detected four randomized trials that met inclusion criteria. All trials allocated women to a strategy with or without availability of fibronectin results without using a discordancy design or a fixed management protocol. One study reported the given treatment in relation to the test results. Learning curves were evaluated in one study. Two studies used transport sample size calculations. The negative results of randomized trials on fetal fibronectin may be due to particular choices in their study design.
Affiliation
Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam.
Journal Details
This article was published in the following journal.
Name: American journal of perinatology
ISSN: 1098-8785
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/20706976
- DOI: http://dx.doi.org/10.1055/s-0030-1263297
Medical and Biotech [MESH] Definitions
Controlled Clinical Trials As Topic
Clinical trials involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicines, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trials are characterized as RANDOMIZED CONTROLLED TRIALS AS TOPIC.
Randomized Controlled Trials As Topic
Clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table.
Clinical Trial
Work that is the report of a pre-planned clinical study of the safety, efficacy, or optimum dosage schedule of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques in humans selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. While most clinical trials concern humans, this publication type may be used for clinical veterinary articles meeting the requisites for humans. Specific headings for specific types and phases of clinical trials are also available.
Early Termination Of Clinical Trials
Earlier than planned termination of clinical trials.
Clinical Trials As Topic
Pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries.
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