Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section.

OBJECTIVE: The goal of this study was to compare carbetocin, a long-acting oxytocin analog, with oxytocin in the prevention of uterine atony after cesarean section. STUDY DESIGN: We enrolled 694 patients undergoing elective cesarean section in a Canadian multicenter, double-blind, randomized clinical trial. We compared the effect of a single 100 microg dose of carbetocin with that of a standard 8-hour infusion of oxytocin. The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony. A variable sample size, sequential design was used. RESULTS: The overall oxytocic intervention rate was 7.4%. The odds of treatment failure requiring oxytocic intervention was 2.03 (95% confidence interval 1.1 to 2.8) times higher in the oxytocin group compared with the carbetocin group, respectively, 32 of 318 (10.1%) versus 15 of 317 (4.7%), P <.05. CONCLUSIONS: Carbetocin, a new drug for the prevention of uterine atony, appears to be more effective than a continuous infusion of oxytocin and has a similar safety profile.

Prenatal and postnatal counselling in hypoplastic left heart syndrome.

Full text is available as a scanned copy of the original print version.

Report of the Canadian Hypertension Society Consensus Conference: 3. Pharmacologic treatment of hypertensive disorders in pregnancy.

OBJECTIVE: To provide Canadian physicians with evidence-based guidelines for the pharmacologic treatment of hypertensive disorders in pregnancy. OPTIONS: No medication, or treatment with antihypertensive or anticonvulsant drugs. OUTCOMES: Prevention of maternal complications, and prevention of perinatal complications and death. EVIDENCE: Pertinent articles published from 1962 to September 1996 retrieved from the Pregnancy and Childbirth Module of the Cochrane Database of Systematic Reviews and from MEDLINE; additional articles retrieved through a manual search of bibliographies; and expert opinion. Recommendations were graded according to levels of evidence. VALUES: Maternal and fetal well-being were equally valued, with the belief that treatment side effects should be minimized. BENEFITS, HARMS AND COSTS: Reduction in the rate of adverse perinatal outcomes, including death. Potential side effects of antihypertensive drugs include placental hypoperfusion, intrauterine growth retardation and long-term effects on the infant. RECOMMENDATIONS: A systolic blood pressure greater than 169 mm Hg or a diastolic pressure greater than 109 mm Hg in a pregnant woman should be considered an emergency and pharmacologic treatment with hydralazine, labetalol or nifedipine started. Otherwise, the thresholds at which to start antihypertensive treatment are a systolic pressure of 140 mm Hg or a diastolic pressure of 90 mm Hg in women with gestational hypertension without proteinuria or pre-existing hypertension before 28 weeks' gestation, those with gestational hypertension and proteinuria or symptoms at any time during the pregnancy, those with pre-existing hypertension and underlying conditions or target-organ damage, and those with pre-existing hypertension and superimposed gestational hypertension. The thresholds in other circumstances are a systolic pressure of 150 mm Hg or a diastolic pressure of 95 mm Hg. For nonsevere hypertension, methyldopa is the first-line drug; labetalol, pindolol, oxprenolol and nifedipine are second-line drugs. Fetal distress attributed to placental hypoperfusion is rare, and long-term effects on the infant are unknown. Magnesium sulfate is recommended for the prevention and treatment of seizures. VALIDATION: The guidelines are more precise but compatible with those from the US and Australia.

Report of the Canadian Hypertension Society Consensus Conference: 2. Nonpharmacologic management and prevention of hypertensive disorders in pregnancy.

OBJECTIVE: To provide Canadian physicians with comprehensive, evidence-based guidelines for the nonpharmacologic management and prevention of gestational hypertension and pre-existing hypertension during pregnancy. OPTIONS: Lifestyle modifications, dietary or nutrient interventions, plasma volume expansion and use of prostaglandin precursors or inhibitors. OUTCOMES: In gestational hypertension, prevention of complications and death related to either its occurrence (primary or secondary prevention) or its severity (tertiary prevention). In pre-existing hypertension, prevention of superimposed gestational hypertension and intrauterine growth retardation. EVIDENCE: Articles retrieved from the pregnancy and childbirth module of the Cochrane Database of Systematic Reviews; pertinent articles published from 1966 to 1996, retrieved through a MEDLINE search; and review of original randomized trials from 1942 to 1996. If evidence was unavailable, consensus was reached by the members of the consensus panel set up by the Canadian Hypertension Society. VALUES: High priority was given to prevention of adverse maternal and neonatal outcomes in pregnancies with established hypertension and in those at high risk of gestational hypertension through the provision of effective nonpharmacologic management. BENEFITS, HARMS AND COSTS: Reduction in rate of long-term hospital admissions among women with gestational hypertension, with establishment of safe home-care blood pressure monitoring and appropriate rest. Targeting prophylactic interventions in selected high-risk groups may avoid ineffective use in the general population. Cost was not considered. RECOMMENDATION: Nonpharmacologic management should be considered for pregnant women with a systolic blood pressure of 140-150 mm Hg or a diastolic pressure of 90-99 mm Hg, or both, measured in a clinical setting. A short-term hospital stay may be required for diagnosis and for ruling out severe gestational hypertension (preeclampsia). In the latter case, the only effective treatment is delivery. Palliative management, dependent on blood pressure, gestational age and presence of associated maternal and fetal risk factors, includes close supervision, limitation of activities and some bed rest. A normal diet without salt restriction is advised. Promising preventive interventions that may reduce the incidence of gestational hypertension, especially with proteinuria, include calcium supplementation (2 g/d), fish oil supplementation and low-dose acetylsalicylic acid therapy, particularly in women at high risk for early-onset gestational hypertension. Pre-existing hypertension should be managed the same way as before pregnancy. However, additional concerns are the effects on fetal well-being and the worsening of hypertension during the second half of pregnancy. There is, as yet, no treatment that will prevent exacerbation of the condition. VALIDATION: The guidelines share the principles in consensus reports from the US and Australia on the nonpharmacologic management of hypertension in pregnancy.

A case of varix dilatation of the umbilical vein and review of the literature.

Umbilical cord cysts diagnosed antenatally present a challenge to the clinician as they may be associated with adverse perinatal outcomes including abnormal karyotypes and stillbirths. We present a case of an umbilical cord cyst diagnosed by routine ultrasound at 30 weeks of gestation. Findings on sonography included unidirectional movement of echogenic particles suggesting a large varix of the umbilical vein. The patient delivered vaginally at 39 weeks and histopathology confirmed the diagnosis.

Intrauterine thoracentesis of fetal cystic lung malformations.

Fetal pulmonary malformations comprise a rare but often lethal group of congenital anomalies. Until recently, diagnosis and therapy were directed postnatally and therefore some cases of fetal compromise were inevitably missed. We present 2 cases in which intermittent thoracentesis of fetal cystic lung malformations resulted in a successful outcome. Intrauterine thoracentesis should be considered in the second and third trimester of pregnancy in cases which demonstrate early fetal compromise.

Maximum possible impact of tocolytics in preventing preterm birth: a retrospective assessment.

Although tocolytic drugs are widely used to try to stop preterm labor, their actual contribution to preventing preterm deliveries is unknown. Since tocolytic drugs are not used at the University of Manitoba, it was possible to estimate the proportion of preterm deliveries that might have been eligible for tocolytic drug therapy. Of 364 consecutive preterm deliveries between 24 and 35 weeks, only 9% would have been eligible for, let alone prevented by, tocolytic drug therapy, and even a smaller percentage of babies would actually have benefitted from their use. The use of tocolytic drugs can, at best, benefit only a very small percentage of babies born preterm. Whether the risks of treatment justify this small benefit is arguable.

Fetal assessment based on fetal biophysical profile scoring. IV. An analysis of perinatal morbidity and mortality.

The relationship between the last biophysical profile score result and perinatal outcome was determined among a large referred population of high-risk pregnancies. A highly significant inverse linear correlation was observed for fetal distress, admission to neonatal intensive care unit, intrauterine growth retardation, 5-minute Apgar score less than 7, and umbilical cord pH less than 7.20 but not for the incidence of meconium or major anomaly. A highly significant inverse exponential (log 10) relationship was observed for perinatal mortality in total and by component parts and cause. These data strongly suggest the biophysical profile scoring method of fetal risk assessment is accurate and also provides insight into the extent of fetal compromise.

Clinical experience with phenytoin prophylaxis in severe preeclampsia.

In North America, magnesium sulfate is the traditional treatment for severe preeclampsia and eclampsia. Its use has been strongly criticized, in that it acts peripherally with no central effect and maternal and neonatal complications are well known. Phenytoin, the mechanism of action of which is clear, seems a logical alternative. Our aim was to develop a safe, practical, effective regimen with the use of phenytoin. In this prospective, descriptive study four dosage regimens were investigated in 104 patients. The initial regimens produced unexpected and unacceptable side effects in comparison with the nonpregnant population. The final regimen (15 mg/kg intravenously, given as 10 mg/kg initially then 5 mg/kg 2 hours later) provided therapeutic levels and had minimal maternal and perinatal side effects. No seizures occurred after its correct usage. This regimen is simple, safe, effective, and provides ongoing anticonvulsant coverage in the postpartum period. We suggest that phenytoin may represent a suitable alternative anticonvulsant in this condition.

Twin with hydramnios: treating premature labor at source.

Six twin pregnancies complicated by hydramnios and premature labor were prospectively studied to determine whether indomethacin reduces amniotic fluid. Requirements for study entry included a gestational age less than 32 completed weeks and an amniotic fluid greater than 10 cm in one or both sacs. The amniotic fluid was measured using real-time ultrasonography before, during, and after treatment. Indomethacin treatment was initiated as a 100 mg rectal suppository and maintained thereafter by 50 mg orally every 6 hours. Treatment was discontinued after 32 completed weeks' gestation, if the patient was asymptomatic and the amniotic fluid was "normal" (less than 8 cm) or after the onset of oligohydramnios in one or both sacs (less than 2 cm). The interval from initiation of treatment to delivery ranged from 12 to 101 days. A coincidental reduction in amniotic fluid was observed in all seven treatment cycles. The time interval to obtain "normal" fluid ranged from 4 to 20 days (mean, 12.5 days). There were no perinatal complications attributable to indomethacin treatment. These data suggest that in selected pregnancies complicated by hydramnios, indomethacin may be of value not only in prolonging gestation but also in amniotic fluid reduction.

Biophysical profile scoring in the management of the diabetic pregnancy.

Biophysical profile scoring was the principal technique of antepartum fetal surveillance in 238 well-controlled diabetic pregnancies. Fifty insulin-dependent diabetics had twice-weekly testing, and 188 gestational diabetics had weekly testing. Intervention was not pursued unless there were maternal or fetal complications. There were no stillbirths and three neonatal deaths, all resulting from congenital anomalies, giving a corrected perinatal mortality rate of 0. The incidence of abnormal biophysical profile scores, eight of 238 (3.3%) overall, was low, with no significant difference between types of diabetics. In those with an abnormal score, intervention was mandated; the cesarean section rate was 50% and the rate of intensive care nursery admissions was high. Of the 230 fetuses with a normal biophysical profile score, 200 (87%) were delivered at term with minimal maternal or neonatal morbidity. Amniocentesis for phospholipid profile was performed in only 33 cases (13.9%). Hyaline membrane disease was confined to five premature neonates (incidence 2.1%). We conclude that antepartum fetal surveillance using the biophysical profile score permits safe expectant management in the diabetic pregnancy, yielding significant clinical advantages to both mother and fetus.

Fetal assessment based on fetal biophysical profile scoring: experience in 19,221 referred high-risk pregnancies. II. An analysis of false-negative fetal deaths.

The incidence of false-negative fetal death, which is defined as stillbirth unrelated to major anomaly or alloimmunization occurring after a last normal fetal biophysical score, was determined in 19,221 referred high-risk pregnancies. The calculated rate of fetal death after a last normal test was 0.726/1000 (14 deaths), which remained relatively constant despite a progressive increase in tests and patients studied. We conclude that a normal fetal biophysical profile score confers a high probability of perinatal survival.

Antepartum fetal risk assessment: the role of the fetal biophysical profile score.

In the art of medicine we have always known that establishing an accurate diagnosis of health or disease is essential. An active search for the physical signs, both the time honoured and newly discovered, are a crucial step in achieving diagnostic accuracy, in monitoring disease progression, and in assigning prognosis. In extrauterine medicine it is common practice to gather together sets of biophysical data in order to determine immediate health, to monitor condition, and to estimate prognosis: witness the use of vital signs, and, in the newborn, the Apgar score. The providers of perinatal care have known since biblical days that fetal biophysical activities were a reflection of fetal condition (Luke: Chapter 1, Verses 44-45), yet lacked the ability to categorize these activities in an objective and complete manner. The introduction of dynamic ultrasound imaging methods to perinatal medicine at last create the window through which the principles of extrauterine medicine may now be applied to the intrauterine patient--the fetus. Fetal biophysical profile scoring is a method that utilizes this new wealth of information to differentiate the normal fetus from the fetus at risk for death or damage in utero. The method is based on the concept that the discrimination of fetal health and disease improves as more variables are considered. The now extensive clinical experience with the method, in which both overall (gross) and selected (corrected) perinatal death are reduced, while maintaining a remarkably low false negative predictive error, indicate the validity of the concept. Comparative studies lead us to believe that reliance upon single biophysical variables, such as fetal movement counts, or antepartum fetal heart rate monitoring, is no longer of sufficient accuracy to support its use as a sole measure of fetal condition. Looking forward, we anticipate that while the concept on which fetal biophysical profile scoring is based will remain unchanged, inclusion of additional variables is likely to occur. It seems likely that addition of new variables, as may be now measured using high-resolution dynamic ultrasound methods, both B-mode and Doppler, will improve diagnostic accuracy even more. We believe that the application of the current and future modified methods of composite fetal risk assessment will render the occurrence of the tragedy of perinatal loss even more infrequent. While the goal of complete elimination of perinatal deaths remain elusive, this method may be one step towards this goal.

Fetal biophysical profile scoring: selective use of the nonstress test.

The fetal biophysical profile score was modified by selective use of the nonstress test. In 2712 study patients (7851 tests) the incidence of nonstress test was reduced to 2.7% with no measurable effect or test accuracy. The nonstress test was most useful in evaluation of abnormal ultrasound monitored variables.

Fetal assessment by biophysical profile scoring: 1985 update.

In extrauterine medicine, physicians have come to rely upon sampling of multiple biophysical variables as a means of differentiating states of well-being and compromise. This basic tenet of medicine is expressed by obtaining an Apgar score or some variant in the newborn and as a measure of vital signs in later life. Few, if any, decisions regarding well-being are ever based on a single-variable assessment and, conversely, definition of compromise is rarely based upon a single variable. Through the use of dynamic ultrasound imaging it now becomes possible to visualize the fetus and its biophysical responses in health and disease. Through such visualization it becomes possible to bring to bear some of the basic principles that sustain extrauterine medicine on the intrauterine patient, the fetus. Fetal biophysical profile scoring describes a method that encompasses this concept. The results obtained by application of this method are promising. We would argue that consideration of multiple fetal biophysical variables will, in most instances, yield superior results to single-variable monitoring alone. Hence we have abandoned antepartum fetal heart rate testing as the sole method of fetal risk assessment and used the tool only in conjunction with others of the many variables that may be monitored by dynamic ultrasound methods. This concept of multiple-variable analysis as the superior method for fetal assessment seems clear and well-justified. It is our opinion, however, that the concept of fetal bioprofile scoring may be more important than the method itself in its original description.(ABSTRACT TRUNCATED AT 250 WORDS)

Biophysical profile scoring in the management of the postterm pregnancy: an analysis of 307 patients.

Management and outcome were reviewed in 307 consecutive postterm pregnancies assessed by biophysical profile scoring. Twice-weekly scores accurately differentiated normal fetuses from those at risk for intrauterine hypoxia. When the profile score is normal, waiting for spontaneous labor results in healthy neonates and a much lower cesarean section rate (15% versus 42% for "prophylactic" induction). Confident conservative management of postterm pregnancy is possible.

Cord prolapse: is antenatal diagnosis possible?

Cord presentation was diagnosed antenatally in nine patients at term referred for fetal ultrasound assessment (incidence of 0.61%). Seven patients were delivered by cesarean section; cord position was confirmed in four and suspected in three patients. There were two vaginal deliveries, one following spontaneous version and the other a stillbirth associated with cord prolapse.

Intrauterine transfusion in an Rh-immunized twin pregnancy: a case report of successful outcome and a review of the literature.

Fifteen sets of twins have been reported among 2331 pregnancies complicated by Rh alloimmunization of sufficient severity to warrant intrauterine transfusions. Four of the 15 sets were managed in Winnipeg, Canada. One of the four is described in detail in the present report. Serial amniocenteses (N = 15) and intrauterine transfusions (N = 8) were used in the management of the dizygous affected twin fetuses with a favorable outcome. Factors contributing to the survival of the twins are described.