A retrospective cohort study of a community-based primary care program's effects on pharmacotherapy quality in low-income Peruvians with type 2 diabetes and hypertension.

Little is known about the effects of the Chronic Care Model (CCM) and community health workers (CHWs) on pharmacotherapy of type 2 diabetes and hypertension in resource-poor settings. This retrospective cohort implementation study evaluated the effects of a community-based program consisting of CCM, CHWs, guidelines-based treatment protocols, and inexpensive freely accessible medications on type 2 diabetes and hypertension pharmacotherapy quality. A door-to-door household survey identified 856 adults 35 years of age and older living in a low-income Peruvian community, of whom 83% participated in screening for diabetes and hypertension. Patients with confirmed type 2 diabetes and/or hypertension participated in the program's weekly to monthly visits for < = 27 months. The program was implemented as two care periods employed sequentially. During home care, CHWs made weekly home visits and a physician made treatment decisions remotely. During subsequent clinic care, a physician attended patients in a centralized clinic. The study compared the effects of program (pre- versus post-) (N = 262 observations), and home versus clinic care periods (N = 211 observations) on standards of treatment with hypoglycemic and antihypertensive agents, angiotensin converting enzyme inhibitors, and low-dose aspirin. During the program, 80% and 50% achieved hypoglycemic and antihypertensive standards, respectively, compared to 35% and 8% prior to the program, RRs 2.29 (1.72-3.04, p <0.001) and 6.64 (3.17-13.9, p<0.001). Achievement of treatment standards was not improved by clinic compared to home care (RRs 1.0 +/- 0.08). In both care periods, longer retention in care (>50% of allowable time) was associated with achievement of all treatment standards. 85% compared to 56% achieved the hypoglycemic treatment standard with longer and shorter retention, respectively, RR 1.52 (1.13-2.06, p<0.001); 56% compared to 27% achieved the antihypertensive standard, RR 2.11 (1.29-3.45, p<0.001). In a dose-dependent manner, the community-based program was associated with improved guidelines-based pharmacotherapy of type 2 diabetes and hypertension.

The second stage of labor.

The second stage of labor extends from complete cervical dilatation to delivery. During this stage, descent and rotation of the presenting part occur as the fetus passively negotiates its passage through the birth canal. Generally, descent begins during the deceleration phase of dilatation as the cervix is drawn upward around the fetal presenting part. The most common means of assessing the normality of the second stage of labor is to measure its duration, but progress can be more meaningfully gauged by measuring the change in fetal station as a function of time. Accurate clinical identification and evaluation of differences in patterns of fetal descent are necessary to assess second stage of labor progress and to make reasoned judgments about the need for intervention. Three distinct graphic abnormalities of the second stage of labor can be identified: protracted descent, arrest of descent, and failure of descent. All abnormalities have a strong association with cephalopelvic disproportion but may also occur in the presence of maternal obesity, uterine infection, excessive sedation, and fetal malpositions. Interpretation of the progress of fetal descent must be made in the context of other clinically discernable events and observations. These include fetal size, position, attitude, and degree of cranial molding and related evaluations of pelvic architecture and capacity to accommodate the fetus, uterine contractility, and fetal well-being. Oxytocin infusion can often resolve an arrest or failure of descent or a protracted descent caused by an inhibitory factor, such as a dense neuraxial block. It should be used only if thorough assessment of fetopelvic relationships reveals a low probability of cephalopelvic disproportion. The value of forced Valsalva pushing, fundal pressure, and routine episiotomy has been questioned. They should be used selectively and where indicated.

The latent phase of labor.

The latent phase of labor extends from the initiation of labor to the onset of the active phase. Because neither margin is always precisely identifiable, the duration of the latent phase often can only be estimated. During this phase, the cervix undergoes a process of rapid remodeling, which may have begun gradually weeks before. As a consequence of extensive changes in its collagen and ground substance, the cervix softens, becomes thinner and dramatically more compliant, and may dilate modestly. All of these changes prepare the cervix for the more rapid dilatation that will occur during the active phase to follow. For the clinician, it is important to recognize that the latent phase may normally extend for many hours. The normal limit for the duration of the latent phase should be considered to be approximately 20 hours in a nullipara and 14 hours in a multipara. Factors that have been associated with a prolonged latent phase include deficient prelabor or intrapartum cervical remodeling, excessive maternal analgesia or anesthesia, maternal obesity, and chorioamnionitis. Approximately 10% of women with a prolonged latent phase are actually in false labor, and their contractions eventually abate spontaneously. The management of a prolonged latent phase involves either augmenting uterine activity with oxytocin or providing a sedative-induced period of maternal rest. Both are equally effective in advancing the labor to active phase dilatation. A very long latent phase may be a harbinger of other labor dysfunctions.

The active phase of labor.

The active phase of labor begins at various degrees of dilatation when the rate of dilatation transitions from the relatively flat slope of the latent phase to a more rapid slope. No diagnostic manifestations demarcate its onset, other than accelerating dilatation. It ends with apparent slowing of dilatation, a deceleration phase, which is usually short in duration and frequently undetected. Several aberrant labor patterns can be detected during the active phase, including protracted dilatation, arrest of dilatation, prolonged deceleration phase and failure of descent. Underlying factors may include cephalopelvic disproportion, excessive neuraxial block, poor uterine contractility, fetal malpositions, malpresentations, uterine infection, maternal obesity, advanced maternal age and previous cesarean delivery. When an active-phase disorder is identified, cesarean delivery is justifiable if there is compelling clinical evidence of disproportion. A prolonged deceleration disorder is strongly associated with disproportion and second stage abnormalities. Shoulder dystocia may occur if vaginal delivery eventuates. This review discusses several issues raised by the introduction of new clinical practice guidelines for labor management.

Dysfunctional labor and delivery: adverse effects on offspring.

There is no doubt that parturition can produce fetal and neonatal adversity, but the frequency with which this occurs is uncertain, particularly in modern healthcare settings. Moreover, there is a paucity of recent studies in this area. Substantial challenges impede epidemiologic study of the effect of parturition on offspring. Randomized trials would be ethically fraught. Therefore, large observational samples with detailed data concerning labor and delivery events are needed. Importantly, long-term follow-up of infants is necessary to reach reliable conclusions. Few such data sets exist, and it is difficult, expensive, and time-consuming to create and to study them. Reports of immediate newborn condition in relation to the antecedent labor are helpful, but this evidence is an imperfect predictor of long-term neurologic status. In this review, we endeavor to summarize existing information about the relationship between objectively defined abnormalities of labor progress and long-term disability in offspring. The only data available are from collected experiential information on outcomes stratified according to labor and delivery events. Most studies do not ensure against confounding by the many concurrent conditions that may affect outcome, or use inconsistent criteria to define abnormal labor. According to the best available evidence, dysfunctional labor patterns are potentially associated with poor outcomes for surviving infants. The question of whether these adverse effects can be mitigated by early diagnosis and expeditious management deserves to be answered, but cannot be at this time. In the absence of more conclusive results from well-designed studies, we can conclude that the best interests of offspring are served by adhering to evidence-based paradigms for the prompt identification and treatment of dysfunctional labor patterns.

Disquiet concerning cesarean birth.

Cesarean birth has increased substantially in many parts of the world over recent decades and concerns have been raised about the propriety of this change in obstetric practice. Sometimes, a cesarean is necessary to preserve fetal and maternal health. But in balancing the risks of surgical intervention the implicit assumption has been that cesarean birth is an equivalent alternative to vaginal birth from the standpoint of the immediate and long-term health of the fetus and neonate. Increasingly, we realize this is not necessarily so. Delivery mode per se may influence short-term and abiding problems with homeostasis in offspring, quite independent of the indications for the delivery and other potentially confounding factors. The probability of developing various disorders, including respiratory compromise, obesity, immune dysfunction, and neurobehavioral disorders has been shown in some studies to be higher among individuals born by cesarean. Moreover, many of these adverse effects are not confined to the neonatal period and may develop over many years. Although the associations between delivery mode and long-term health are persuasive, their pathogenesis and causality remain uncertain. Full exploration and a clear understanding of these relationships is of great importance to the health of offspring.

Approaches to Preventing Intrapartum Fetal Injury.

Electronic fetal monitoring (EFM) was introduced into obstetric practice in 1970 as a test to identify early deterioration of fetal acid-base balance in the expectation that prompt intervention ("rescue") would reduce neonatal morbidity and mortality. Clinical trials using a variety of visual or computer-based classifications and algorithms for intervention have failed repeatedly to demonstrate improved immediate or long-term outcomes with this technique, which has, however, contributed to an increased rate of operative deliveries (deemed "unnecessary"). In this review, we discuss the limitations of current classifications of FHR patterns and management guidelines based on them. We argue that these clinical and computer-based formulations pay too much attention to the detection of systemic fetal acidosis/hypoxia and too little attention not only to the pathophysiology of FHR patterns but to the provenance of fetal neurological injury and to the relationship of intrapartum injury to the condition of the newborn. Although they do not reliably predict fetal acidosis, FHR patterns, properly interpreted in the context of the clinical circumstances, do reliably identify fetal neurological integrity (behavior) and are a biomarker of fetal neurological injury (separate from asphyxia). They provide insight into the mechanisms and trajectory (evolution) of any hypoxic or ischemic threat to the fetus and have particular promise in signaling preventive measures (1) to enhance the outcome, (2) to reduce the frequency of "abnormal" FHR patterns that require urgent intervention, and (3) to inform the decision to provide neuroprotection to the newborn.

Performance of a Maternal Abdominal Surface Electrode System for Fetal Heart Rate and Uterine Contraction Monitoring from 34 to 37 Weeks.

OBJECTIVE: The objective of this study was to compare performance of a maternal surface electrode patch with ultrasound- and tocodynamometer-based monitoring to detect fetal heart rate and uterine contractility in late preterm labors. STUDY DESIGN: Thirty women between 340/7 and 366/7 weeks' gestation were monitored simultaneously with a Doppler/tocodynamometer system and a wireless fetal-maternal abdominal surface electrode system. Fetal and maternal heart rate and uterine contraction data from both systems were compared. Reliability was measured by the success rate and percent agreement. Deming regression and Bland-Altman analysis estimated the concordance between the systems. Uterine contractions were assessed by visual interpretation of monitor tracings. RESULTS: The success rate for the surface electrode system was 89.5% (95% confidence interval [CI], 85.7-93.3), and for ultrasound it was 88.4% (95% CI, 84.9-91.9; p = 0.73), with a percent agreement of 88.1% (95% CI, 84.2-92.8). Results were uninfluenced by the patients' body mass. The mean Deming slope was 1 and the y-intercept was -3.0 beats per minute (bpm). Bland-Altman plots also showed a close relationship between the methods, with limits of agreement less than 10 bpm. The percent agreement for maternal heart rate was 98.2% (95% CI, 97.4-98.8), and for uterine contraction detection it was 89.5% (95% CI, 85.5-93.4). CONCLUSION: Fetal heart rate and uterine contraction monitoring at 340/7 to 366/7 weeks using abdominal surface electrodes was not inferior to Doppler ultrasound/tocodynamometry for fetal-maternal assessment. REGISTRATION: clinicaltrials.gov/February 20, 2017/identifier NCT03057275. KEY POINTS: · Monitoring the preterm fetal heart rate with surface electrodes is feasible.. · Preterm contractions can be monitored with surface electrodes.. · The technique was noninferior to standard external monitors..

Attenuation of sympathoadrenal function during delivery in the fetus of a diabetic mother.

OBJECTIVE: We compared the association between cord arterial catecholamine levels and fetal oxygenation in newborns of mothers with diabetes mellitus to those of nondiabetic pregnancies. METHODS: Cord blood obtained at delivery in 25 term appropriate-for-gestational age newborns of women with diabetes and 27 nondiabetic controls were assayed for norepinephrine, epinephrine, insulin, glucose, and blood gases. RESULTS: There was no statistical difference in parity, birth weight, gestational age, delivery mode, use of epidural analgesia, or frequency of low 1-min Apgar scores between the groups. The pO2 and frequency of cord arterial pH < 7.20 were also similar. Diabetic pregnancies had somewhat higher fetal glucose and substantially higher insulin levels than controls. Regression analysis using cord arterial pH to reflect oxygenation revealed significant inverse relationships between cord artery pH and ln norepinephrine (Prob > F = .001) and ln epinephrine (Prob > F = .019) in controls. In newborns of women with diabetes, however, neither relationship was significant. CONCLUSION: The expected surge in catecholamines associated with diminished oxygenation was attenuated in fetuses of diabetic mothers. This suggests the possibility that fetal exposure to hyperglycemia or other metabolic derangements in pregnant diabetics might compromise the fetal ability to adapt to changes in oxygenation, and might thereby contribute to the risk of fetal death.

Clinical evaluation of labor: an evidence- and experience-based approach.

During labor mother and fetus are evaluated at intervals to assess their well-being and determine how the labor is progressing. These assessments require skillful physical diagnosis and the ability to translate the acquired information into meaningful prognostic decision-making. We describe a coordinated approach to the assessment of labor. Graphing of serial measurements of cervical dilatation and fetal station creates "labor curves," which provide diagnostic and prognostic information. Based on these curves we recognize nine discrete labor abnormalities. Many may be related to insufficient or disordered contractile mechanisms. Several factors are strongly associated with development of labor disorders, including cephalopelvic disproportion, excess analgesia, fetal malpositions, intrauterine infection, and maternal obesity. Clinical cephalopelvimetry involves assessing pelvic traits and predicting their effects on labor. These observations must be integrated with information derived from the labor curves. Exogenous oxytocin is widely used. It has a high therapeutic index, but is easily misused. Oxytocin treatment should be restricted to situations in which its potential benefits clearly outweigh its risks. This requires there be a documented labor dysfunction or a legitimate medical reason to shorten the labor. Normal labor and delivery pose little risk to a healthy fetus; but dysfunctional labors, especially if stimulated excessively by oxytocin or terminated by complex operative vaginal delivery, have the potential for considerable harm. Conscientiously implemented, the approach to the evaluation of labor outlined in this review will result in a reasonable cesarean rate and minimize risks that may accrue from the labor and delivery process.

Guidelines for labor assessment: failure to progress?

The ongoing debate about what models of cervical dilatation and fetal descent should guide clinical decision-making has sown uncertainty among obstetric practitioners. We previously argued that the adoption of recently published labor assessment guidelines promoted by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine may have been premature. Before accepting any new clinical approaches as the standard of care, their underlying hypotheses should be thoroughly tested to ensure they are at least equivalent (or, preferably, superior) to existing management paradigms. Some of the apparent urgency to subscribe to new clinical tactics has been fueled by legitimate concerns about the rise in the cesarean delivery rate over the past several decades. A major contributor to this change in practice patterns is that more cesarean deliveries are being done for diagnoses that fall under the rubric of dystocia than ever before. As a consequence, traditional labor curves-fundamental for assessing labor progress-and the practice paradigms associated with them have received intense scrutiny as a possible contributor to this delivery trend. Moreover, the recent proposal of new labor curves and accompanying management guidelines has, understandably, fed the appetite to correct a perceived problem. However, the cesarean delivery rate rose most rapidly during decades when there was no major change in traditional labor curves or in the guidelines for their interpretation. Also, during the years since the new guidelines were first published, there has been no major fall in cesarean delivery frequency. This raises the question of whether there was truly a fundamental flaw in the traditional labor management paradigms or whether their proper interpretation and use had been somehow forgotten, ignored, or corrupted. More important, existing studies have shown that application of the new guidelines often (but not always) results in a modest fall in the cesarean delivery rate, but that this change may be accompanied by significant increases in maternal and neonatal morbidity. These results strongly suggest more caution in the adoption of the American College of Obstetricians and Gynecologists / Society for Maternal-Fetal Medicine labor assessment recommendations. They are based on a hypothesis that has yet to undergo thorough evaluation of its risks and benefits.

Relative accuracy of computerized intrapartum fetal heart rate pattern recognition by ultrasound and abdominal electrocardiogram detection.

INTRODUCTION: Noninvasive fetal heart rate monitoring using transabdominal fetal electrocardiographic detection is now commercially available and has been demonstrated to be an effective alternative to traditional Doppler ultrasonographic techniques. Our objective in this study was to compare the results of computerized identification of fetal heart rate patterns generated by ultrasound-based and transabdominal fetal electrocardiogram-based techniques with simultaneously obtained fetal scalp electrode-derived heart rate information. MATERIAL AND METHODS: We applied an objective computer-based analysis for recognition of fetal heart rate patterns (Monica Decision Support) to data obtained simultaneously from a direct fetal scalp electrode, Doppler ultrasound, and the abdominal-fetal electrocardiogram techniques. This allowed us to compare over 145 hours of fetal heart rate patterns generated by the external devices with those derived from the scalp electrode in 30 term singleton uncomplicated pregnancies during labor. The direct fetal scalp electrode is considered to be the most accurate and reliable technique used in current clinical practice, and was, therefore, used as the standard for comparison. The program quantified the baseline heart rate, long- and short-term variability. It indicated when an acceleration or deceleration was present and whether it was large or small. RESULTS: Ultrasound was associated with significantly greater deviations from the fetal scalp electrode results than the abdominal fetal electrocardiogram technique in recognizing the correct baseline heart rate, its variability, and the presence of small and large accelerations and small decelerations. For large decelerations the two external methods were each not significantly different from the scalp electrode results. CONCLUSIONS: Noninvasive fetal heart rate monitoring using maternal abdominal wall electrodes to detect fetal cardiac activity more reliably reproduced the computerized analysis of heart rate patterns derived from a direct fetal scalp electrode than did traditional ultrasound-based monitoring. Abdominal-fetal electrocardiogram should, therefore, be considered a primary option for externally monitored patients.

Obstetric practice guidelines: labor's love lost?

Implementation of clinical practice guidelines may moderate health care costs, improve care, reduce medicolegal liability, and provide a uniformity in care allowing meaningful investigation of treatments and outcomes. However, new guidelines are often uncritically embraced by clinicians, risk management organizations, insurance companies, and the courts as the standard of care. Adoption of incompletely vetted recommendations can lead to patient harm. Recent recommendations made by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine for assessment and management of labor provide an example of well-intended guidelines adopted uncritically. Ideally, but unattainably, each step in a practice guideline would be supported by results of prospective randomized trials. Usually, data from lower on the hierarchy of proof are included, and the personal or institutional preferences of the guideline developers influence the final product. These multiple resources help illuminate critical issues and balance competing perspectives, but can introduce biases that become embedded in our practice. The new labor management guidelines, which were never shown to be superior (or even equivalent) to current standards, have achieved widespread acceptance. Although they provide a formula for reducing the cesarean rate, they do so without concern for their potentially adverse effects on maternal or neonatal outcome. New guidelines should be outcome-based and address how to practice obstetrics to yield the best possible results for mother and baby.

The assessment of labor: a brief history.

In the 1930s, investigators in the US, Germany and Switzerland made the first attempts to quantify the course of labor in a clinically meaningful way. They emphasized the rupture of membranes as a pivotal event governing labor progress. Attention was also placed on the total number of contractions as a guide to normality. Beginning in the 1950s, Friedman determined that changes in cervical dilatation and fetal station over time were the most useful parameters for the assessment of labor progress. He showed all normal labors had similar patterns of dilatation and descent, differing only in the durations and slopes of their component parts. These observations led to the formulation of criteria that elevated the assessment of labor from a rather arbitrary exercise to one guided by scientific objectivity. Researchers worldwide confirmed the basic nature of labor curves and validated their functionality. This system allows us to quantify the effects of parity, analgesia, maternal obesity, prior cesarean, maternal age, and fetal presentation and position on labor. It permits analysis of outcomes associated with labor aberrations, quantifies the effectiveness of treatments and assesses the need for cesarean delivery. Also, dysfunctional labor patterns serve as indicators of short- and long-term risks to offspring. We still lack the necessary translational research to link the physiologic manifestations of uterine contractility with changes in dilatation and descent. Recent efforts to interpret electrohysterographic patterns hold promise in this regard, as does preliminary exploration into the molecular basis of dysfunctional labor. For now, the clinician is best served by a system of labor assessment proposed more than 60 years ago and embellished upon in considerable detail since.

Clinical assessment of uterine contractions.

The assessment of uterine contractions is important in clinical decision-making, but the precise role for appraising contractions remains controversial. Four clinical approaches to assessing contractions are available: manual palpation; intrauterine pressure determination; external tocodynamometry; and electrohysterography. Palpation is inexpensive and harmless but requires the constant bedside presence of a trained observer. Intrauterine pressure measurement is considered the most sensitive and specific technique, and has become the standard by which other methods are judged; however, its quantitative measurements are not always precise or reproducible. Moreover, the availability of intrauterine pressure measurements does not seem to improve maternal or neonatal outcomes in most situations. External tocodynamometry is the most widely used technique. It is easy to apply and provides reasonably accurate information about the frequency and duration of contractions, but not their amplitude. It can require frequent adjustment during labor and might not work well in patients who are obese. Electrohysterography is a recently available noninvasive technology that detects uterine electrical activity using electrodes placed on the mother's abdominal wall. This approach is at least as reliable and accurate as tocodynamometry.