Examination of maternal gingival crevicular fluid for the presence of selected periodontopathogens implicated in the pre-term delivery of low birthweight infants

Background: Reports show that more than 20 million infants world-wide are born prematurely with 95% of all pre-term births occurring in developing countries. Oral colonization of Gram-negative anaerobes has been implicated as a risk factor for preterm delivery of low birth weight infants. Results: Association of bacterial species with the risk of periodontal disease and thus the risk of preterm delivery was only observed when they occurred in pairs or groups of three or more. Aa appeared to be a necessary co-factor for significant associations of bacterial groups with the variables recorded. Materials and Methods: This study comprised 200 women admitted to the department of obstetrics and gynecology of the teaching hospital of Butare in Rwanda. Gingival crevicular fluid was collected from each quadrant of the mother’s mouth (using paper points) within 24 hours of delivery. A dichotomous score of presence or absence of gingival inflammation was recorded for each patient along with demographic data such as age, marital status etc. Samples were examined by PC R for the presence of Aggregatibacter actinomycetemcomitans and selected members of the red and orange complexes described by Socransky et al. (1998), and their presence associated with age, gingival inflammation and pregnancy outcomes.National Research Foundation of South AfricaWeb of Scienc

CLSI-Derived Hematology and Biochemistry Reference Intervals for Healthy Adults in Eastern and Southern Africa

BACKGROUND: Clinical laboratory reference intervals have not been established in many African countries, and non-local intervals are commonly used in clinical trials to screen and monitor adverse events (AEs) among African participants. Using laboratory reference intervals derived from other populations excludes potential trial volunteers in Africa and makes AE assessment challenging. The objective of this study was to establish clinical laboratory reference intervals for 25 hematology, immunology and biochemistry values among healthy African adults typical of those who might join a clinical trial. METHODS AND FINDINGS: Equal proportions of men and women were invited to participate in a cross sectional study at seven clinical centers (Kigali, Rwanda; Masaka and Entebbe, Uganda; two in Nairobi and one in Kilifi, Kenya; and Lusaka, Zambia). All laboratories used hematology, immunology and biochemistry analyzers validated by an independent clinical laboratory. Clinical and Laboratory Standards Institute guidelines were followed to create study consensus intervals. For comparison, AE grading criteria published by the U.S. National Institute of Allergy and Infectious Diseases Division of AIDS (DAIDS) and other U.S. reference intervals were used. 2,990 potential volunteers were screened, and 2,105 (1,083 men and 1,022 women) were included in the analysis. While some significant gender and regional differences were observed, creating consensus African study intervals from the complete data was possible for 18 of the 25 analytes. Compared to reference intervals from the U.S., we found lower hematocrit and hemoglobin levels, particularly among women, lower white blood cell and neutrophil counts, and lower amylase. Both genders had elevated eosinophil counts, immunoglobulin G, total and direct bilirubin, lactate dehydrogenase and creatine phosphokinase, the latter being more pronounced among women. When graded against U.S. -derived DAIDS AE grading criteria, we observed 774 (35.3%) volunteers with grade one or higher results; 314 (14.9%) had elevated total bilirubin, and 201 (9.6%) had low neutrophil counts. These otherwise healthy volunteers would be excluded or would require special exemption to participate in many clinical trials. CONCLUSIONS: To accelerate clinical trials in Africa, and to improve their scientific validity, locally appropriate reference ranges should be used. This study provides ranges that will inform inclusion criteria and evaluation of adverse events for studies in these regions of Africa

IgG intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval.

<p>IgG intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval.</p

Hemoglobin intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval and cutoff for DAIDS grade one severity (vertical dashed line).

<p>Hemoglobin intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval and cutoff for DAIDS grade one severity (vertical dashed line).</p

Neutrophil intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval and cutoff for DAIDS grade one severity (vertical dashed line).

<p>Neutrophil intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval and cutoff for DAIDS grade one severity (vertical dashed line).</p

Hematology results, U.S.-based comparison intervals and out of range (OOR) values

*<p><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0004401#pone.0004401-Kratz1" target="_blank">[22]</a>, except differential counts <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0004401#pone.0004401-Bakerman1" target="_blank">[23]</a> and CD4/CD8 counts [Beckton Dickson package insert]</p>‡<p>The number and percent of African values outside the U.S.-based comparison interval</p>1<p>Excludes men from Kangemi and KNH, and women from Kangemi</p>2<p>Excludes women from Kangemi</p>3<p>Excludes men from Masaka</p>4<p>Excludes all Lusaka volunteers</p>5<p>Excludes all Lusaka and Entebbe volunteers, and women from Kilifi</p

Total bilirubin intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval and cutoff for DAIDS grade one severity (vertical dashed line).

<p>Total bilirubin intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval and cutoff for DAIDS grade one severity (vertical dashed line).</p

Analyte results and frequency of “adverse events” graded against western-derived DAIDS AE cutoffs^*

*<p>Chemistry cutoffs <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0004401#pone.0004401-DAIDS1" target="_blank">[16]</a> derived from <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0004401#pone.0004401-Kratz1" target="_blank">[22]</a>. Hemoglobin, platelets, WBC, neutrophil, lymphocyte and CD4 counts provided in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0004401#pone.0004401-DAIDS1" target="_blank">[16]</a></p

CD4 count intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval and cutoff for DAIDS grade one severity (vertical dashed line).

<p>CD4 count intervals and medians by site and gender (men: blue, women: white) including U.S.-based comparison interval and cutoff for DAIDS grade one severity (vertical dashed line).</p

Chemistry results, U.S.-based comparison intervals, and out of range (OOR) values

*<p><a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0004401#pone.0004401-Kratz1" target="_blank">[22]</a></p>‡<p>The number and percent of African values outside the U.S.-based comparison interval</p>1<p>Excludes women from Kilifi</p>2<p>Excludes men from Masaka</p>3<p>Excludes all Masaka volunteers and males from KNH</p>4<p>No data available from KNH, Kangemi, Entebbe or Masaka</p