Case of the month: July 1998 - 21 year old man with new-onset seizures and a temporal lobe mass.
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Adult↗
Biomedical subjects
G Wells
Publications and source records attributed to G Wells.
Molecular and antigenic structure of nicotinic acetylcholine receptors.
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Animals↗
Biosynthetic and synthetic AChR sequences to study T cells in myasthenia gravis.
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Autoantigens↗
Test-treatment strategies for patients suspected of having Lyme disease: a cost-effectiveness analysis.
PURPOSE: To examine the cost-effectiveness of test-treatment strategies for patients suspected of having Lyme disease. DATA SOURCES: The medical literature was searched for information on outcomes and costs. Expert opinion was sought for information on utilities. STUDY SELECTION: Articles that described patient population, diagnostic criteria, dose and duration of therapy, and criteria for assessment of outcomes. DATA EXTRACTION: The decision analysis evaluated the following strategies: 1) no testing-no treatment; 2) testing with enzyme-linked immunosorbent assay (ELISA) followed by antibiotic treatment of patients with positive results; 3) two-step testing with ELISA followed by Western blot and antibiotic treatment for patients with positive results on either test; and 4) empirical antibiotic therapy. Three patient scenarios were considered: myalgic symptoms, rash resembling erythema migrans, and recurrent oligoarticular inflammatory arthritis. Results were calculated as costs per quality-adjusted life-year and were subjected to sensitivity analysis. Adjustment was made for the diagnostic value of common clinical features of Lyme disease. DATA SYNTHESIS: For myalgic symptoms without other features suggestive of Lyme disease, the no testing-no treatment strategy was most economically attractive (that is, had the most favorable cost-effectiveness ratio). For rash, empirical antibiotic therapy was less costly and more effective than other strategies. For oligoarticular arthritis with a history of rash and tick bite, two-step testing was associated with the lowest cost-effectiveness ratio. Testing with ELISA and empirical antibiotic therapy cost an additional $880,000 and $34,000 per quality-adjusted life-year, respectively. For oligoarticular arthritis with one or no other features suggestive of Lyme disease, two-step testing was most economically attractive. CONCLUSIONS: Neither testing nor antibiotic treatment is cost-effective if the pretest probability of Lyme disease is low. Empirical antibiotic therapy is recommended if the pretest probability is high, and two-step testing is recommended if the pretest probability is intermediate.
Anti-Bacterial Agents↗
Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent?
OBJECTIVE: To determine whether improvement of more than 20% in core set parameters should be required before patients are characterized as improved in rheumatoid arthritis (RA) clinical trials. METHODS: Data from 6 RA trials were reanalyzed to evaluate the discriminant validity (ability to differentiate active treatment from control) of 4 proposed definitions of improvement: the current American College of Rheumatology (ACR) definition (a 20% threshold for core set parameters [ACR 201), a 50% threshold (ACR 50), a 70% threshold (ACR 70), and an ordinal definition in which a patient could be classified in any of 3 categories (unimproved, ACR 20, or ACR 50). To evaluate the discriminant validity of these 4 definitions of improvement, we characterized each patient in each trial as improved or not, based on each definition, and computed a chi-square value differentiating the active treatment group from the control group, with the corresponding P value. RESULTS: With an increase in the threshold for improvement, the percentage of placebo-treated patients who were classified as experiencing response dropped dramatically in all trials, as did the percentage of patients receiving active therapy (second-line drug, combination therapy, tumor necrosis factor p75-Fc fusion protein) who were classified as experiencing response. Generally, the drop in active treatment response rates was greater than the drop in placebo response rates, leaving the difference between the 2 groups less at the higher thresholds. Therefore, chi-square values fell as the threshold for response was raised. The ordinal definition of improvement yielded chi-square values similar to those obtained using ACR 20 alone. CONCLUSION: Adopting a definition of efficacy in RA trials that requires 50% or 70% improvement in core set parameters would likely compromise statistical power and make it more difficult to distinguish between 2 treatments with different efficacy. ACR 20 should continue to be the primary measure of efficacy in RA trials, with higher thresholds for improvement being determined and reported as secondary efficacy measures.
Antirheumatic Agents↗
Establishing reference intervals for DPC's free testosterone radioimmunoassay.
OBJECTIVE: To establish reference intervals for serum free testosterone for DPC's Free Testosterone assay. METHODS: We used data from healthy subjects and patients to determine reference intervals by parametric and non-parametric methods after partitioning by sex and age. RESULTS: In males, there was a significant decrease in free testosterone concentrations with age. Reference intervals derived from a combination of 2075 "healthy" and patients' results gave similar values by parametric and nonparametric methods. However, the subgroups failed the test for Gaussian distribution. For each decade from 20 years on and > or = 60 years, the intervals based on 2.5th and 97.5th percentiles were: 24.1-94.8, 25.0-89.3, 23.4-81.7, 22.5-80.4, and 21.5-74.3 pmol/L respectively, in females, there was little change with age. The frequency distribution of 1915 patients was positively skewed, and showed a wider range than "healthy." Using square roots of values gave a Gaussian distribution. The central 95% intervals based on 187 "healthy" subjects were: 0.5-8.1 and 0.0-6.4 pmol/L for 20-59 and > or = 60 years, respectively. CONCLUSION: Developing reference intervals for free testosterone was complicated by the need to partition data by gender and age, difficulty in establishing disease in subjects and presence of physiological and other factors which can affect concentration in health and disease.
Adolescent↗
Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome.
STUDY OBJECTIVE: To compare the 1-year cosmetic outcome of wounds treated with octylcyanoacrylate tissue adhesive and monofilament sutures and to correlate the early, 3-month, and 1-year cosmetic outcomes. METHODS: We prospectively randomized 136 cases of traumatic laceration to repair with octylcyanoacrylate tissue adhesive or 5-0 or smaller monofilament suture. A wound score was assigned by a research nurse, and validated by a second nurse blinded to the treatment, at 5 to 10 days after injury (early), 3 months, and 1 year. Standardized photographs were taken at 3 months and 1 year and shown to a cosmetic surgeon blinded to the method of closure, who rated the wounds on a validated cosmesis scale. RESULTS: We were able to examine 77 lacerations at 1 year for follow-up. No differences were found in the demographic or clinical characteristics between groups. Likewise, at 1 year no difference was found in the optimal wound scores (73% versus 68%, P =.60) or in visual analog scale cosmesis scores (69 versus 69 mm, P =.95) for octylcyanoacrylate and sutures, respectively. Agreement was poor between early and 3-month wound scores (kappa=.34; 95% confidence interval [CI],.10 to.58) but a strong association existed between 3-month and 1-year wound scores (kappa=.71; 95% CI,.52 to.90). We noted a moderate correlation between 3-month and 1-year results on the visual analog cosmesis scale (intraclass correlation,.48; 95% CI, .30 to.63). CONCLUSION: One year after wound repair, no difference is noted in the cosmetic outcomes of traumatic lacerations treated with octylcyanoacrylate tissue adhesive and sutures. The assessment of wounds 3 months after injury and wound repair provides a good measure of long-term cosmetic outcome.
Adult↗
Quinine for nocturnal leg cramps: a meta-analysis including unpublished data.
OBJECTIVE: With respect to the use of quinine for the treatment of nocturnal leg cramps, to determine whether the findings of a previously performed meta-analysis of published data are altered with the addition of unpublished data, and whether publication bias is present in this area. DESIGN: A meta-analysis of eight (four published and four unpublished) randomized, double-blind, placebo-controlled trials, seven of which had a crossover design. SETTING: Randomized trials that were available as of July 1997. SUBJECTS: Ambulatory patients (659) who suffered from regular nocturnal leg cramps. MAIN RESULTS: When individual patient data from all crossover studies were pooled, persons had 3.60 (95% confidence interval [CI] 2.15, 5.05) fewer cramps in a 4-week period when taking quinine compared with placebo. This compared with an estimate of 8.83 fewer cramps (95% CI 4.16, 13.49) from pooling published studies alone. The corresponding relative risk reductions were 21% (95% CI 12%, 30%) and 43% (95% CI 21%, 65%), respectively. Compared with placebo, the use of quinine was associated with an increased incidence of side effects, particularly tinnitus. Publication bias is present in the reporting of the efficacy of quinine for this indication, as almost all published studies reported larger estimates of its efficacy than did unpublished studies. CONCLUSIONS: This study confirms that quinine is efficacious in the prevention of nocturnal leg cramps. However, its benefit may not be as large as reported from the pooling of published studies alone. Given the side effect profile of quinine, nonpharmacologic therapy (e.g., regular passive stretching of the affected muscle) is the best first-line treatment. For persons who find this ineffective and whose quality of life is significantly affected, a trial of quinine is warranted. Prescribing physicians must closely monitor the risks and benefits in individual patients. Publication bias is present in this area even though there is controversy about the role of quinine in the treatment of leg cramps. To minimize the possibility of this bias, persons performing medication-related meta-analyses should seek high-quality unpublished data from drug regulatory agencies and pharmaceutical companies.
Humans↗
A Canadian survey of transfusion practices in critically ill patients. Transfusion Requirements in Critical Care Investigators and the Canadian Critical Care Trials Group.
OBJECTIVES: To characterize the contemporary red cell transfusion practice in the critically ill and to define clinical factors that influence these practices. DESIGN: Scenario-based national survey. STUDY POPULATION: Canadian critical care practitioners. MEASUREMENTS AND MAIN RESULTS: We evaluated transfusion thresholds before transfusion and the number of red cell units ordered, under the given conditions. Of 254 Canadian critical care physicians, 193 (76%) responded to the survey. The primary specialty of most respondents was internal medicine (56%). Internal medicine respondents were in practice for an average of 8.4 +/- 5.7 (SD) yrs, and worked most often in combined medical/surgical intensive care units. Baseline hemoglobin transfusion thresholds averaged from 8.3 +/- 1.0 g/dL in a scenario involving a young stable trauma victim to 9.5 +/- 1.0 g/dL for an older patient after gastrointestinal bleeding. Transfusion thresholds differed significantly (p< .0001) between all four separate scenarios. With the exception of congestive heart failure (p> .05), all clinical factors (including age, Acute Physiology and Chronic Health Evaluation II score, preoperative status, hypoxemia, shock, lactic acidosis, coronary ischemia, and chronic anemia) significantly (p< .0001) modified the transfusion thresholds. A statistically significant (p< .01) difference in baseline transfusion thresholds was noted across four major regions (with a maximum of five academic centers per region) of the country. Low physician numbers in two of the regions did not allow for further investigation of regional variations. CONCLUSIONS: There is significant variation in critical care transfusion practice, with many intensivists adhering to a 10.0-g/dL threshold, while other physicians described a much more restrictive approach to red cell transfusion. Also, many physicians opted to administer multiple units, despite published guidelines to the contrary. Additionally, the administration of red cells was strongly influenced by a number of clinical factors, many unique to intensive care unit patients. There is a need for prospective studies to define optimal practice in the critically ill.
Adult↗
A prospective randomized trial comparing 2 diuresis renography techniques for evaluation of suspected upper urinary tract obstruction in children.
PURPOSE: We compare the diagnostic impact of 2 diuresis renography techniques for evaluation of suspected upper urinary tract obstruction in children. MATERIALS AND METHODS: A total of 72 children were randomly assigned to 1 of 2 standardized diuresis renography protocols. The protocols were identical, except for the time of furosemide (F) injection. In the F+20 scans furosemide was given 20 minutes after the 99mtechnetium pentetic acid radiopharmaceutical. With the modified F-15 scans furosemide was injected 15 minutes before renography. Hydration, bladder catheterization, urine output determination, radiopharmaceutical injection and scan acquisition were identical. Renography outcomes (obstructed, nonobstructed or equivocal) were analyzed for the investigated side(s) and for the contralateral side, which was used as a control in children with suspected unilateral obstruction. Chi-square test was used to compare the percentage of obstructed and nonobstructed scans of both protocols. Fisher's exact test was used to compare the nonobstructed scans and equivocal results of both protocols. RESULTS: Of the 96 scans performed 8 were excluded because of technical problems. The remaining scans included 44 F+20 and 44 F-15. Of the 88 scans 10 were used to evaluate possible bilateral obstruction. A total of 48 boys and 24 girls were evaluated. Because 2 children had a solitary kidney each, the total number of renal units studied for outcome was 174. The F-15 scan showed 7 times more obstruction than the F+20 scan on the investigated side, and this difference was statistically significant. No obstruction was diagnosed on the contralateral side with either technique when used to investigate cases of suspected unilateral obstruction. CONCLUSIONS: The timing of the furosemide injection (F-15 scan versus F+20) has a significant impact on the obstructive versus nonobstructive renography results when evaluating children with suspected upper urinary tract obstruction.
Child, Preschool↗
How Canadian and US rheumatologists treat moderate or aggressive rheumatoid arthritis: a survey.
OBJECTIVE: To determine which second line agents Canadian and US rheumatologists use to treat patients with active rheumatoid arthritis (RA). METHODS: A one page survey was sent by fax or mail to all 263 members of the Canadian Rheumatology Association and 320 members of the American College of Rheumatology (10% random sample weighted by region) known to practice adult rheumatology. The survey asked for first and second treatment preferences in patients with (1) aggressive RA; (2) moderate RA; and (3) aggressive RA failing a trial of methotrexate (MTX) 25 mg. RESULTS: Altogether 231 (87.8%) Canadian and 230 (71.7%) US rheumatologists responded, and 214 responses in each survey were analyzable. In aggressive RA. MTX was the drug of first choice of most Canadian (68.7%) and US (78.5%) rheumatologists. Intramuscular gold was a drug of first choice for 14.5 and 1.9% of Canadians and Americans, respectively. 93.9% of Canadian and 90.2% of US respondents preferred single agents for the treatment of moderate RA. Among US rheumatologists. no clear leader emerged as a single agent alternative for the management of aggressive RA unresponsive to MTX. Most said they would use combination (38.3%) or triple (23.8%) therapy involving MTX plus sulfasalazine and/or hydroxychloroquine. 52.3% of Canadians preferred single agent therapy, with 34.6% choosing gold as an alternative to MTX. CONCLUSION: Canadian and US rheumatologists preferred MTX for the treatment of aggressive RA. Canadian rheumatologists saw a small but significant role for intramuscular gold. No single agent emerged as a clear alternative to MTX among US rheumatologists.
Antirheumatic Agents↗
Laboratory evaluation in the diagnosis of Lyme disease.
PURPOSE: To provide a qualitative evaluation of the predictive value of the laboratory diagnosis of Lyme disease and to use the resultant data to formulate guidelines for clinical diagnosis. DATA SOURCES: A MEDLINE search of English-language articles or articles with English-language abstracts published from 1982 to 1996. DATA EXTRACTION: Sensitivity, specificity, and likelihood ratios were calculated, and a random-effects model was used to combine the proportions from the eligible studies. Prespecified criteria were used to determine which studies were eligible for analysis. DATA SYNTHESIS: Laboratory testing in general is not clinically useful if the pretest probability of Lyme disease is less than 0.20 or greater than 0.80. When the pretest probability is 0.20 to 0.80, sequential testing with enzyme-linked immunosorbent assay and Western blot is the most accurate method for ruling in or ruling out the possibility of Lyme disease. CONCLUSIONS: Laboratory testing is recommended only in patients whose pretest probability of Lyme disease is 0.20 to 0.80. If the pretest probability is less than 0.20, testing will result in more false-positive results than true-positive results; a negative test result in this situation effectively rules out the disease.
Bacteriological Techniques↗
Synthesis and biological activity of a series of potent fluoromethyl ketone inhibitors of recombinant human calpain I.
Calpain I, an intracellular cysteine protease, has been implicated in the neurodegeneration following an episode of stroke. In this paper, we report on a series of potent dipeptide fluoromethyl ketone inhibitors of recombinant human calpain I (rh calpain I). SAR studies revealed that while calpain I tolerates a variety of hydrophobic groups at the P1 site, Leu at P2 is preferred. However, the nature of the N-terminal capping group has a significant effect on the inhibitory activity of this series of compounds. Compound 4e [(1,2,3,4-tetrahydroisoquinolin-2-yl)carbonyl-Leu-D,L-Phe-CH2F+ ++], having a tetrahydroisoquinoline containing urea as the N-terminal capping group, is the most potent dipeptide fluoromethyl ketone inhibitor of calpain I (with a second-order rate constant for inactivation of 276,000 M-1 s-1) yet reported; tripeptide 4k (Cbz-Leu-Leu-D,L-Phe-CH2F) is equipotent. A number of compounds presented in this study displayed excellent selectivity for calpain I over cathepsins B and L, two related cysteine proteases. Compounds which exhibited good inhibitory activity in the assay against isolated rh calpain I also inhibited intracellular calpain I in a human cell line. Thus, in an intact cell assay, compounds 4e and 4k inhibited calpain I with IC50 values of 0.2 and 0.1 microM, respectively. Finally, we also disclose the first example of fluorination of a dipeptide enol silyl ether to generate the corresponding dipeptide fluoromethyl ketone.
Calpain↗
Contemporary practice patterns in the management of newly diagnosed hypertension.
OBJECTIVE: To determine what proportion of patients with hypertension are managed in accordance with guidelines established by the Canadian Hypertension Society. DESIGN: Retrospective medical record review. SETTING: Outpatients seen in primary care offices and internal medicine referral clinics in Edmonton. PATIENTS: All 969 adults who presented with a new diagnosis of essential hypertension from Sept. 1, 1993, to Dec. 31, 1995. OUTCOME MEASURES: Initial laboratory tests performed, advice concerning nonpharmacologic treatment given, antihypertensive drugs prescribed and any contraindications to thiazide diuretics or beta-adrenergic blocking agents documented. RESULTS: The mean age of the 969 patients in the sample was 52.5 years; 129 (13%) of the patients were older than 70 years of age; and 500 (52%) were women. Most of the patients (704, 73%) had mild or moderate diastolic hypertension. In the 617 patients who underwent laboratory tests related to hypertension, the creatinine level was determined in 466 (76%), the cholesterol level in 372 (60%), a urinalysis was conducted in 378 (61%), the serum potassium level was checked in 343 (56%), the sodium level in 323 (52%) and an electrocardiogram was performed in 303 (49%). Liver function tests, which are not recommended in the guidelines, were performed in 338 patients (55%). Although there were differences in prescribing among physicians in the 711 patients given first-line therapy, most (238, 34%) were prescribed angiotensin-converting-enzyme (ACE) inhibitors. Lifestyle modification, without drug therapy, was suggested for 180 (25%) of the patients. Although the guidelines recommend their use for first-line drug therapy, only 82 patients (12%) were given beta-adrenergic blocking agents and only 75 (11%) were given thiazide diuretics. Of the patients who were prescribed an antihypertensive other than a thiazide or beta-adrenergic blocking agent as first-line drug therapy, only 161 (43%) had a documented contraindication to thiazides or beta-adrenergic blocking agents. CONCLUSIONS: There is variation in the contemporary care of patients with hypertension. Further studies are required to determine the reasons underlying physicians' noncompliance with the evidence-based guidelines established by the Canadian Hypertension Society.
Adult↗
A randomized trial comparing octylcyanoacrylate tissue adhesive and sutures in the management of lacerations.
OBJECTIVE: To assess the effectiveness of a new tissue adhesive for laceration closure. DESIGN: A prospective, randomized controlled trial. SETTING: An adult teaching hospital. PARTICIPANTS: One hundred thirty patients with 136 lacerations who consented to enrollment during a 5-month period. The lacerations included all eligible nonmucosal facial lacerations, as well as selected extremity and torso lacerations (not on hands, feet, or joints). One hundred six lacerations were available for early follow-up, and 98 were available for 3-month evaluation. INTERVENTIONS: Lacerations were randomly allocated to have skin closure with octylcyanoacrylate adhesive or monofilament suture. MAIN OUTCOME MEASURE: A 3-month photograph of the wound was assigned a cosmesis score on a previously validated 100-mm visual analog cosmesis scale by a plastic surgeon who was unaware of the method of wound closure. RESULTS: There were no differences in the mean visual analog cosmesis scores (67 mm for octylcyanoacrylate vs 68 mm for sutures; P=.65). Similarly, there was no difference in the percentage of early (80% vs 82%; P=.80) or late (72% vs 75%; P=.74) optimal wound evaluation scores. The tissue adhesive was a faster method of wound repair (3.6 vs 12.4 minutes; P<.001) as well as being less painful (visual analog pain scores, 7.2 vs 18.0 mm; P<.001). CONCLUSIONS: Octylcyanoacrylate tissue adhesive effectively closes selected lacerations. This relatively painless and fast method of wound repair can replace the need for suturing several million lacerations each year.
Adult↗
Deciding about mechanical ventilation in end-stage chronic obstructive pulmonary disease: how respirologists perceive their role.
OBJECTIVE: To determine when respirologists approach patients with end-stage chronic obstructive pulmonary disease (COPD) to decide about the use of mechanical ventilation, what information they provide to patients and how they provide it. DESIGN: Self-administered national survey. PARTICIPANTS: All Canadian specialists in respiratory medicine; of 401 eligible respirologists, 279 (69.6%) returned a completed questionnaire. OUTCOME MEASURES: Timing and content of doctor-patient discussions regarding mechanical ventilation; physicians' perception of their level of involvement in the decision-making process; and patient and physician characteristics that may influence decisions. RESULTS: Discussions were reported to occur most often at advanced stages of COPD: when the patient's dyspnea was severe (reported by 235 [84.2%] of the respondents) or when the patient's forced expiratory volume in the first second was 30% or less than predicted value (reported by 210 [75.3%]). A total of 120 respondents (43.0%) stated that they discuss mechanical ventilation with 40% or less of their COPD patients before an exacerbation necessitates ventilatory support. Most (154 [55.2%]) described the decision-making process as a collaboration between patient and physician; 83 (29.7%) reported that the patient decides after he or she has considered the physician's opinion. Over half (148 [53.0%]) of the respondents indicated that they occasionally, often or always modify the information provided to patients in order to influence their decision about mechanical ventilation. CONCLUSIONS: Discussions with COPD patients concerning end-of-life decisions about mechanical ventilation are reported to occur in advanced stages of the disease or not at all, with patients' input where possible. Information presented to patients is often modified in order to influence the decision. Future studies should explore ways to involve patients further in the decision-making process and to improve the process for both patients and physicians.
Adult↗
Combination treatment of severe rheumatoid arthritis with cyclosporine and methotrexate for forty-eight weeks: an open-label extension study. The Methotrexate-Cyclosporine Combination Study Group.
OBJECTIVE: To determine whether the clinical benefit and favorable safety profile previously noted with the combination of cyclosporine (CSA) and methotrexate (MTX) given for 24 weeks in patients with rheumatoid arthritis (RA) would be maintained for a further 24 weeks, and whether the addition of CSA in patients who had previously been randomized to receive placebo + MTX would result in clinical benefit. METHODS: Eligible subjects from the initial study (weeks 0-24), in which the addition of placebo or CSA to MTX therapy was compared in patients with RA that was partially responsive to MTX, were enrolled. Patients who had received CSA + MTX continued this regimen for a further 24 weeks (weeks 24-48) (group 1; n = 48), and patients who had initially received placebo + MTX now received CSA + MTX for 24 weeks (weeks 24-48) (group 2; n = 44), in an open-label extension study. The primary outcome measures were the number of tender joints, number of swollen joints, physician and patient global assessments, pain, functional disability as measured by the modified Health Assessment Questionnaire, and erythrocyte sedimentation rate. RESULTS: Of the 92 patients enrolled, 80 (87%) completed the extension study. In patients in group 1, the clinically and statistically significant improvement in response outcomes previously noted at week 24, ranging from 25% to 50%, was maintained through week 48. In patients in group 2, the addition of CSA resulted in significant clinical improvement. By week 48, most outcome measures in group 2 patients were similar to those in group 1 patients. CSA treatment resulted in a small increase in serum creatinine levels, but only 1 patient was withdrawn from the study for this reason. CONCLUSION: The clinical improvement previously observed in patients treated with the CSA + MTX combination for 24 weeks was maintained for 24 subsequent weeks, without serious adverse effects, and was also observed in the patients whose treatment was switched from placebo + MTX to CSA + MTX.
Adult↗
A randomized controlled trial of strict glycemic control and tertiary level obstetric care versus routine obstetric care in the management of gestational diabetes: a pilot study.
OBJECTIVES: The purpose of this study was to determine whether strict maternal glycemic control for the treatment of gestational diabetes lessened the risk of fetal macrosomia, birth trauma, neonatal hypoglycemia, and operative delivery. The aim of the pilot study was to prepare for a multicenter trial by assessing patient acceptance of the study, by determining realistic accrual rates, and by detecting any major adverse outcomes in the control group that received routine obstetric care. STUDY DESIGN: The study was a prospective randomized controlled trial comparing fetal-neonatal and maternal outcomes in 300 women with gestational diabetes. Women randomized to the treatment arm were managed by strict glycemic control and tertiary level obstetric care, and women in the control arm received routine obstetric care. RESULTS: Three hundred women with gestational diabetes mellitus were studied. There was no difference in maternal age, weight, or length of gestation between groups. The treatment mean birth weight was 3437 +/- 575 gm compared with 3544 +/- 601 gm in the control group, a difference of 107 gm (not significant). Macrosomia rates were similar. There was no birth trauma in either group. The frequency of neonatal hypoglycemia and other metabolic complications was the same. The mode of delivery also showed similar patterns. The treatment group had significantly lower preprandial and postprandial glucose levels by 32 weeks' gestation, which continued to term. CONCLUSION: This pilot study suggests that intensive treatment of gestational diabetes mellitus may have little effect on birth weight, birth trauma, operative delivery, or neonatal metabolic disorders. It has demonstrated the safety of proceeding to a multicenter trial of sufficient sample size to confirm these findings.
Adult↗