Research - the science behind practices

Research is among the most important goals for this website. Clinical research is critically important for understanding what we should and should not be doing. Medical research tends to focus on those things that are done in current practice in comparison with the new and improved procedure, test, or medicine. While the quality of the designs may vary, the bigger problem is often the nature of the questions that are being asked.

For example, Intrapartum Antibiotic Prohylaxis for maternal Group B Strep colonization came about as the result of research that showed the administration of antibiotics during labor to women who had a positive screen for vaginal Group B Strep decreased the likelihood that the newborn would manifest GBS disease after birth. The protocol was put into place and it became the standard of care, because it was assumed that if the incidence of GBS infection decreased, than fewer newborns would die of GBS. But studies to determine whether fewer newborns would die were not done until some years later.

It turns out that giving antibiotic prophylaxis to laboring moms does decrease the number of newborns who get sick, but it doesn't decrease the number who die from the disease. No one had bothered to ask that question.

This part of the website is my tool for asking some of the many question that still haven't been asked about treatments, protocols, recommendations that have never been adequately addressed in the literature.

The Study

The first question I am addressing is also about the impact of the intrapartum antibiotic prophylaxis protocol. There is research emerging that shows that being delivered via planned cesarean delivery is associated with an increased incidence of many different disorders later in life. The assumed reason for this is that babies who are removed from the womb without having come in ontact with the vaginal environment do not become "seeded" with the appropriate microorganisms which are encountered during a vaginal delivery.

If this is the case then one might wonder whether receiving antibiotics while still in utero, might also result in a poorly seeded microbiome. That is the question this study seeks to gather information on.

There are actually two studies, a retrospective cohort study and a prospective cohort study.

The retrospective study is for those who have had children at least two years prior to entering the study. It is retrospective meaning that it looks backward from the point at which you enter into the study to examine the events that occured in your prior pregnancy. It has a prosepctive component in that, for children under ten years of age it will continue to collect data until they reach the age of ten. If you have had more than one pregnancy you can submit a separate form for each previous pregnancy that meets the criteria.

The prospective study is for people who are currently pregnant and will look forward from the date of entry into the study and continue to collect data until your child reaches the age of ten. You can also submit additional forms for future pregnancies.

Finally, if you have had previous children and are currently pregnant you can participate in both the retrospective and prospective studies.

The criteria for entry into the retrospective study are as follows:

1. Must have had a vaginal delivery, between 36 and 42 weeks gestation. (Complete a separate form for each delivery) 2. Mother must have had no complications requiring hospital admission prior to the onset of labor. 3. Mother must have had no no fever immediately prior to or during labor. 4. Labor must have begun spontaneously, with or without spontaneous rupture of membranes (breaking waters). 5. Chorioamniotic sac (bag of water) must not have broken more than twelve hours prior to the onset of labor. 6. Infant must not have required NICU admission following delivery. 7. Mother and baby must have been discharged home within 48 hours of delivery. 8. Infant must have been breast fed exclusively for the first two months of life.

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Works Cited:

1. "Human Microbiome Project / Reference Genomes Data". Data Analysis and Coordination Center (DACC) for the National Institutes of Health (NIH). Retrieved 8 March 2012.

2. Gronland, M.M., M. Gueimonde, K. Laitinen, G. Kociubinski et al. (2007). Maternal breast milk and intestinal bifidobacteria guide the compositional development of the Bifidobacterium microbiota in infants at risk of allergic diseases. Clin. Experim. Allergy 37:1764-1772.

3. Palmer, C., E. M. Bik, D.B. DiGiulio, D. A. Relman and P.O. Brown (2007). Development of the human infant intestinal microbiota. PLoS Biol. 5:e177

4. Hooper, L.V. and J.I. Gordon (2001). Commensal host-bacterial relationships in the gut. Science 292:1115-1118.

5. Round, J.L., and S. Mazmanian (2009). The gut microbiota shapes immune responses during health and disease. Nature Reviews Immunology. 9:313-323.

#research #researchdesign #clinicalresearch #prospectivestudy #restrospectivestudy

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