European journal of obstetrics, gynecology, and reproductive biology
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Jun 2020
EditorialData integrity of 35 randomised controlled trials in women' health.
While updating a systematic review on the topic of ovulation of induction, we observed unusual similarities in a number of randomised controlled trials (RCTs) published by two authors from the same institute in the same disease spectrum in a short period of time. We therefore undertook a focused analysis of the data integrity of all RCTs published by the two authors. We made pairwise comparisons to find identical or similar values in baseline characteristics and outcome tables between trials. ⋯ For 35 trials published between September 2006 and January 2016, we found a large number of similarities in both the baseline characteristics and outcomes of 26. Analysis of the baseline characteristics of the trials indicated that their distribution was unlikely to be the result of proper randomisation. The procedures demonstrated in this paper may help to assess data integrity in future attempts to verify the authenticity of published RCTs.
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Eur. J. Obstet. Gynecol. Reprod. Biol. · Aug 2004
Editorial Clinical TrialEfficient prematurity prevention is possible by pH-self measurement and immediate therapy of threatening ascending infection.
In two prospective investigations, the effectiveness of the self care programme for prematurity prevention, developed by Saling, was investigated. Pregnant women in Erfurt have been offered to perform self measurements of their vaginal pH by means of test gloves twice a week in order to screen for any disturbances in the vaginal milieu. The women were instructed to see their physician immediately, if abnormal pH > or = 4.7 or other risk factors were present, in order to get them confirmed and to start lactobacillus acidophilus therapy or in case of bacterial vaginosis to treat with clindamycin cream i. vag. ⋯ On this basis, a significant reduction of early prematurity from 1.58 to 0.99% was seen, respectively (P < 0.001). Comparing low birthweights a significant reduction of cases was achieved as well in all groups. On the basis of the data obtained we recommend the extension of the campaign in whole of Germany.