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Prospective randomised controlled trial of an infection screening programme to reduce the rate of preterm delivery

BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38169.519653.EB (Published 12 August 2004) Cite this as: BMJ 2004;329:371
  1. Herbert Kiss (herbert.kiss{at}akh-wien.ac.at), associate professor of obstetrics and gynaecology1,
  2. Ljubomir Petricevic, research fellow1,
  3. Peter Husslein, professor of obstetrics and gynaecology1
  1. 1 Department of Obstetrics and Gynaecology, University of Vienna Medical School, Währinger Gürtel 18-20, A-1090 Vienna, Austria
  1. Correspondence to: H Kiss
  • Accepted 23 June 2004

Abstract

Objective To evaluate whether a screening strategy in pregnancy lowers the rate of preterm delivery in a general population of pregnant women.

Design Multicentre, prospective, randomised controlled trial.

Setting Non-hospital based antenatal clinics.

Participants 4429 pregnant women presenting for their routine prenatal visits early in the second trimester were screened by Gram stain for asymptomatic vaginal infection. In the intervention group, the women's obstetricians received the test results and women received standard treatment and follow up for any detected infection. In the control group, the results of the vaginal smears were not revealed to the caregivers.

Main outcome measures The primary outcome variable was preterm delivery at less than 37 weeks. Secondary outcome variables were preterm delivery at less than 37 weeks combined with different birth weight categories equal to or below 2500 g and the rate of late miscarriage.

Results Outcome data were available for 2058 women in the intervention group and 2097 women in the control group. In the intervention group, the number of preterm births was significantly lower than in the control group (3.0% v 5.3%, 95% confidence interval 1.2 to 3.6; P = 0.0001). Preterm births were also significantly reduced in lower weight categories at less than 37 weeks and ≤ 2500 g. Eight late miscarriages occurred in the intervention group and 15 in the control group.

Conclusion Integrating a simple infection screening programme into routine antenatal care leads to a significant reduction in preterm births and reduces the rate of late miscarriage in a general population of pregnant women.

Footnotes

  • Acknowledgments: We thank the medical-technical assistants of the Microbiology Laboratory of the Department of Obstetrics and Gynaecology for their commitment throughout the study, and H Leitich, A Ugwumadu for constructive criticism. We also thank A Millendorfer and G Niernberger for their statistical analysis and constructive comments.

  • Contributors HK contributed to design, analysis, and interpretation of results, and writing of the report and is the study guarantor. LP managed the collection and documentation of data and contributed to the statistical analyses, and PH contributed to the original design of the study. The following, non-hospital based obstetricians from the Vienna area enrolled pregnant women presenting for the routine antenatal visits into the study: P Bruck, A Colloredo-Mannsfeld, M Elnekheli, W Eppel, A Fink, R Fitz, W Forster, H Fröhlich-Dolinar, N Ghazanfari-Sawadkuhi, B Haghi, D Jelincic, E-M Joura, E Küffer, W Markel, W Miechowiecki, P Mohammadi, I Müller-Klingspor, K M Radner, R Reichel, M Stany, G Stegner, M Stiglbauer jun, S Stino, N Vavra, B Wiesenthal.

  • Funding Fund “Healthy Austria” (“Fonds Gesundes Österreich”) grant PNr. 205/V/12 and Federal Ministry of Education, Science, and Culture grant GZ 70.069/1-Pr4/2000.

  • Competing interests None declared.

  • Ethical approval Ethics committee of the University of Vienna Medical School, Austria.

  • Accepted 23 June 2004
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