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Biomedical subjects

T M Goodwin

Publications and source records attributed to T M Goodwin.

At least 19 recordsLinked to original sources
PubMed2006

The prevalence of intrahepatic cholestasis of pregnancy in a primarily Latina Los Angeles population.

OBJECTIVE: To establish the prevalence of intrahepatic cholestasis of pregnancy (ICP) in a primarily Latina population in the United States. STUDY DESIGN: Over a period of 16 months, a convenience sample of subjects admitted to labor and delivery in the third trimester was enrolled. Each subject completed a questionnaire rating their severity of pruritus on a numeric scale of 1 to 10. Serum was analyzed via radioimmunoassay for total bile acid concentration. ICP was defined as pruritus score >4 and a total serum bile acid concentration of >or=20 micromol/l. Ethnicity was determined from hospital record demographic data. RESULTS: All invited participants enrolled in the study. Three hundred and forty subjects were enrolled. Three hundred and sixteen subjects (93%) were identified as Latina. The serum bile acid concentration range for the entire study population was 1 to 580 micromol/l with a mean of 10.4+/-34.9 micromol/l. Twenty-four (7.1%) subjects had a serum bile acid concentration >or=20 micromol/l. A pruritus score >4 was found in 19.7% (67/340). Of the 24 subjects with a bile acid concentration >or=20 micromol/l, 19 also had a pruritus score >4. Thus, the prevalence of ICP in this population was 5.6% (19/340). In subjects with ICP, the mean serum bile acid concentration was 89.5+/-124.0 micromol/l. When controlling for confounders, women with ICP were associated with higher rates of chorioamnionitis (P=0.043) and their fetuses had higher rates of thick meconium (P=0.053). CONCLUSIONS: The overall prevalence of ICP in this population was 5.6%, 10 to 100 times higher than previously reported data from the United States. Larger studies of perinatal morbidity examining the diagnostic criteria of cholestasis need to be conducted.

Adult↗
PubMed2006

Regulatory and methodologic challenges to tocolytic development.

The development of tocolytic medications faces challenges common to all drug development programmes, principally related to evolving understanding of the pathophysiology. There are unique impediments to drug development for pregnancy-related conditions in general and for tocolysis in particular. The purpose of this brief overview is to familiarize the obstetrician with the current challenges to drug development, focusing in particular on the problems of tocolytic development. A strategy for encouraging drug development for preterm labour and for pregnancy-related problems in general is presented.

Clinical Trials as Topic↗
PubMed2005

Pregnancy outcomes during treatment with interferon beta-1a in patients with multiple sclerosis.

BACKGROUND: Although patients with multiple sclerosis (MS) are advised to stop interferon (IFN) beta-1a therapy before becoming pregnant, some patients become pregnant while on treatment. METHODS: We examined individual patient data from eight clinical trials with IFNbeta-1a. RESULTS: Of 3,361 women in the studies, 69 pregnancies were reported, of which 41 were patients receiving (or who had stopped receiving within 2 weeks prior to conception) IFNbeta-1a (in utero exposure group), 22 were patients who discontinued IFNbeta-1a treatment more than 2 weeks before conception (previous exposure group), and six were patients receiving placebo. The 41 in utero exposure pregnancies resulted in 20 healthy full-term infants, one healthy premature infant, nine induced abortions, eight spontaneous abortions, one fetal death, and one congenital anomaly (hydrocephalus). One patient was lost to follow-up. The 22 previous exposure pregnancies resulted in 20 full-term healthy infants, one healthy premature infant, and one birth-related congenital anomaly (Erb palsy). CONCLUSIONS: The majority (21/31) of pregnancies that had the potential to go to full term produced healthy infants. The rate of spontaneous abortion was higher, but not significantly so, in the in utero exposure group compared to general population estimates. Until more exposure data become available, patients remain advised to stop IFNbeta therapy before becoming pregnant.

Abnormalities, Drug-Induced↗
PubMed2001

Psychological factors and hyperemesis gravidarum.

Hyperemesis gravidarum (HG) is a condition of severe, intractable nausea and vomiting during pregnancy. It has long been held that HG is a psychosomatic illness reflective of a long-term psychological trait, that is, conversion disorder. We investigated this possibility by conducting a two-phase study: (1) a comparison of women with (n = 9) and without (n = 10) HG during pregnancy and (2) a comparison of nonpregnant women who did (n = 10) and did not (n = 12) have HG during their most recent pregnancies. The pattern of findings differed between experiments 1 and 2. During pregnancy, women with HG scored significantly higher on three scales associated with conversion disorder (all p values <0.01) than did women without HG. There were no significant differences between HG subjects and controls after pregnancy. We find no support for the theory that HG is a psychosomatic condition. Rather, it appears to be a complex interaction of biological, psychological, and sociocultural factors.

Adult↗
PubMed2001

Oral misoprostol vs. intravaginal prostaglandin E2 for preinduction cervical ripening. A randomized trial.

OBJECTIVE: To compare orally administered misoprostol with intravaginal prostaglandin E2 for cervical ripening and labor induction. STUDY DESIGN: Patients presenting with medical or obstetric indications for labor induction whose Bishop's score was < or = 6 were randomly allocated to receive either 50 micrograms of oral misoprostol or 4 mg of intravaginal prostaglandin E2. If adequate cervical ripening (Bishop score of 9 or cervical dilatation of 3) or active labor did not ensue, repeat doses of each medication were administered every four hours. A maximum of six doses of either oral misoprostol or intravaginal prostaglandin E2 was permitted. Intravenous oxytocin was subsequently administered according to a standardized infusion protocol. RESULTS: Sixty patients were enrolled, with 29 randomized to the oral misoprostol arm and 31 to the prostaglandin E2 group. The data on 58 patients were eligible for analysis. Delivery occurred within 48 hours in 96.4% (27/28) of those administered oral misoprostol as compared to 76.7% (23/30) of those who received intravaginal prostaglandin E2 (P = .03). The mean time intervals from the start of induction to delivery were similar between the two groups (1,496 +/- 120 vs. 1,723 +/- 230 minutes, P = .40). No statistically significant differences existed between the two groups with respect to intrapartum complications, tachysystole, uterine hyperstimulation or adverse neonatal outcomes. CONCLUSION: Oral administration of misoprostol is an effective alternative to intravaginal prostaglandin E2 for preinduction cervical ripening.

Administration, Intravaginal↗
PubMed2000

Serial salivary estriol to detect an increased risk of preterm birth.

OBJECTIVE: To evaluate serial measurements of salivary estriol (E3) to detect increased risk of spontaneous preterm labor and preterm birth. METHODS: A masked, prospective, multicenter trial of 956 women with singleton pregnancies was completed at eight United States medical centers. Saliva was collected weekly, beginning at the 22nd week of gestation until birth, and tested for unconjugated E3 by enzyme-linked immunosorbent assay. Women were separated into high-risk and low-risk groups using the Creasy scoring system. RESULTS: A single, positive (at or above 2.1 ng/mL) salivary E3 test predicted an increased risk of spontaneous preterm labor and delivery in the total population (relative risk [RR] 4.0, P <.005), in the low-risk population (RR 4.0, P < or =.05), and in the high-risk population (RR 3.4, P =.05). Two consecutive positive tests significantly increased the RR in all study groups, with a dramatic improvement in test specificity and positive predictive value but only a modest decrease in sensitivity. In women who presented with symptomatic preterm labor, salivary E3 identified 61% of those who delivered within 2 weeks, using a threshold of 1.4 ng/mL. CONCLUSION: Elevated salivary E3 is associated with increased risk of preterm birth in asymptomatic women and symptomatic women who present for evaluation of preterm labor.

Adult↗
PubMed2000

Analysis of McRoberts' maneuver by x-ray pelvimetry.

OBJECTIVE: To document radiographically the changes in pelvic dimensions created by McRoberts' maneuver. METHODS: Women at least 37 weeks' pregnant who presented to labor and delivery were eligible for study entry. Anterior-posterior and lateral x-rays were taken with women in the dorsal lithotomy position and after application of McRoberts' maneuver, in which the maternal legs were hyperflexed 45 degrees onto the maternal abdomen. A two-tailed paired t test was used to assess the changes in the pelvic diameters, with P < .05 considered statistically significant. RESULTS: Thirty-six subjects were enrolled in the study and 34 x-rays were suitable for analysis. McRoberts' maneuver was associated with an increase in the mean angle of inclination between the symphysis pubis and the sacral promontory (51.53 +/- 2.03 versus 38.07 +/- 1.96 degrees, P < .001). There was a 24% decrease in the angle created by drawing a line bisecting the symphysis pubis relative to the horizontal (P < .001). With McRoberts' maneuver the angle created by a line bisecting the longitudinal axis of the fifth lumbar vertebra and the longitudinal axis of the upper sacrum also increased (133.75 +/- 2.25 to 140.14 +/- 2.12 degrees, P = .04). CONCLUSION: Ours are the first systematic observations of pelvic changes associated with McRoberts' maneuver, confirming the traditional thinking that the maneuver causes a significant cephalad rotation of the symphysis pubis and subsequent flattening of the sacrum.

Adult↗
PubMed2000

Unstable angina during pregnancy in two patients with premature coronary atherosclerosis and aortic stenosis in association with familial hypercholesterolemia.

Obstructive atherosclerotic coronary artery disease is uncommon in women during childbearing age, and the occurrence of myocardial ischemia during pregnancy has therefore been anecdotal. Two young patients with premature coronary artery disease in association with familial hypercholestrolemia had unstable angina in the second trimester of pregnancy. Workup revealed coronary artery disease and aortic stenosis. One patient opted for abortion at the twentieth week of gestation, and the other decided to continue pregnancy and was delivered by cesarean at 28 weeks' gestation. Coronary artery bypass grafting was performed after pregnancy in both patients. In addition, one of the patients underwent aortic valve replacement, and other had replacement of the narrowed ascending aorta with uneventful recovery. Our report describes an uncommon presentation of unstable angina during pregnancy in 2 young women with premature coronary artery disease and aortic valvular and supravalvular stenosis as a result of familial hypercholesterolemia. The management of these conditions during pregnancy is influenced by the effects of available therapeutic modalities on both maternal and fetal outcome.

Adolescent↗
PubMed2000

An oxytocin receptor antagonist (atosiban) in the treatment of preterm labor: a randomized, double-blind, placebo-controlled trial with tocolytic rescue.

OBJECTIVES: This study was designed to evaluate the efficacy and safety of the oxytocin receptor antagonist atosiban in the treatment of preterm labor. STUDY DESIGN: A multicenter, double-blind, placebo-controlled trial with tocolytic rescue was designed. Five hundred thirty-one patients were randomized to receive, and 501 received, either intravenous atosiban (n = 246) or placebo (n = 255), followed by subcutaneous maintenance with the assigned agent. Standard tocolytics as rescue tocolysis were permitted after 1 hour of either placebo or atosiban if preterm labor continued. The primary end point was the time from the start of study drug to delivery or therapeutic failure. Secondary end points were the proportion of patients who remained undelivered and did not receive an alternate tocolytic at 24 hours, 48 hours, and 7 days. RESULTS: No significant difference was found in the time from start of treatment to delivery or therapeutic failure between atosiban and placebo (median, 25.6 days vs 21.0 days, respectively; P =.6). The percentages of patients remaining undelivered and not requiring an alternate tocolytic at 24 hours, 48 hours, and 7 days were significantly higher in the atosiban group than in the control group (all P < or =.008). A significant treatment-by-gestational age interaction existed for the 48-hour and 7-day end points. Atosiban was consistently superior to placebo at a gestational age of > or =28 weeks. Fourteen atosiban-treated patients and 5 placebo-treated patients were randomized at <24 weeks; the incidence of fetal-infant deaths was higher for the atosiban group at <24 weeks. Maternal-fetal adverse events were similar except for injection-site reactions, which occurred more often with atosiban. CONCLUSIONS: In this trial the treatment of patients in preterm labor with atosiban resulted in prolongation of pregnancy for up to 7 days for those at a gestational age > or =28 weeks, and this occurred with a low rate of maternal-fetal adverse effects. In addition, at a gestational age > or =28 weeks, the infant morbidity and mortality of atosiban-initiated standard care were similar to those with placebo-initiated standard care. Given that all patients in this study were eligible for tocolysis and that, in practice, nearly all patients who are eligible for a tocolytic receive one, the benefit of using atosiban is the placebo-like maternal-fetal side effect profile. These observations support the use of this oxytocin receptor antagonist in the treatment of patients in preterm labor with intact membranes. Efficacy and infant outcome data at <28 weeks are inconclusive.

Double-Blind Method↗
PubMed2000

Obstetric implications of activated protein C resistance and factor V Leiden mutation.

An increasing number of reports have focused on activated protein C resistance (APCR) as it has been shown not only to be the most common genetic factor predisposing patients to thromboembolic disease but the most common identifiable cause overall. More than 90 percent of the cases of APCR are caused by the factor V Leiden mutation, in which a guanine to adenine substitution in the factor V gene at nucleotide position 1691 results in a glutamine to arginine switch at position 506. Recent studies have also pointed to evidence of an association between APCR/factor V Leiden mutation and hypertensive disorders of pregnancy, first and second trimester miscarriage, placental infarction, and placental abruption.

Activated Protein C Resistance↗
PubMed1999

Favorable response of Eisenmenger syndrome to inhaled nitric oxide during pregnancy.

OBJECTIVE: Our goal was to evaluate the effectiveness of therapy with a specific pulmonary vasodilator, nitric oxide, in a woman with Eisenmenger syndrome during pregnancy. STUDY DESIGN: Eisenmenger syndrome consists of a congenital communication between the systemic and pulmonary circulation with secondary pulmonary hypertension causing reversal of flow through the shunt. Maternal morbidity is approximately 50% with the greatest risk of death being in the peripartum period. Pharmacologic therapy to relieve worsening pulmonary hypertension is confounded by the undesired effects of vasodilators on the systemic circulation. Therapy with a specific pulmonary vasodilator, nitric oxide, was attempted. RESULTS: A 27-year-old woman with Eisenmenger syndrome at 36 weeks' gestation was treated with inhaled nitric oxide during the second stage of labor and the postpartum period when she experienced progressive refractory hypoxemia. Administration of nitric oxide was followed by improved oxygenation and lowering of pulmonary artery pressures. A brief episode of methemoglobinemia responded to lowering of the nitric oxide concentration and administration of intravenous methylene blue. Nitric oxide was discontinued after 48 hours. The patient died 2 days later despite continued vasodilator therapy including intra-pulmonary artery prostacyclin. CONCLUSION: Inhaled nitric oxide can be used to correct the hypoxemia of Eisenmenger syndrome. Nitric oxide inhalation is easily performed, and pulmonary vasodilatory effects commence within minutes after administration.

Administration, Inhalation↗
PubMed1999

Reversible peripartum liver failure: a new perspective on the diagnosis, treatment, and cause of acute fatty liver of pregnancy, based on 28 consecutive cases.

OBJECTIVE: We sought to describe our experience with the clinical diagnosis, management, and course of patients with acute fatty liver of pregnancy. STUDY DESIGN: Twenty-eight cases of acute fatty liver of pregnancy at the Los Angeles County and University of Southern California Medical Center from 1982 to June 1997 were identified, and presenting symptoms, clinical course, laboratory values, maternal complications, and neonatal outcomes were studied. RESULTS: The incidence of acute fatty liver of pregnancy was 1 in 6659 births. There were no maternal deaths. Initial presentation was at an average of 37 weeks of gestation with a characteristic prodrome of malaise, nausea, vomiting, and abdominal pain. No patient was admitted with the diagnosis of acute fatty liver of pregnancy. The condition was diagnosed most commonly on the second hospital day after laboratory results indicated coagulopathy, renal insufficiency, and liver function abnormalities. One patient underwent liver biopsy at cesarean delivery. Radiologic studies did not aid with the diagnosis. Twenty-one patients were admitted in spontaneous labor, and 16 labors were complicated by abnormal fetal heart rate patterns or meconium. There was 1 stillbirth and 1 neonatal death as a result of perinatal asphyxia. Maternal morbidity consisted of hypoglycemia, infection, renal insufficiency, coagulopathy, encephalopathy, and wound complications. All patients had evidence of disseminated intravascular coagulopathy with profoundly decreased antithrombin levels. All patients recovered normal liver function post partum. CONCLUSIONS: Reversible peripartum liver failure may be diagnosed and managed on the basis of clinical and laboratory criteria. With adequate support, these patients may have full recovery of hepatic function.

Acute Disease↗
PubMed1999

Brachial plexus palsy: an in utero injury?

Acquired brachial plexus injury historically has been linked with excessive lateral traction applied to the fetal head, usually in association with shoulder dystocia. Recent reports in the obstetric literature, however, have suggested that in utero forces may underlie a significant portion of these injuries. Brachial plexus palsies may therefore precede the delivery itself and may occur independent of the actions of the accoucheur. Thus we propose that the long-held notions of a traction-mediated pathophysiologic mechanism for all brachial plexus injuries warrant critical reappraisal.

Brachial Plexus↗
PubMed1999

A role for estriol in human labor, term and preterm.

Although estriol has been studied as an indicator of fetal well-being in the past, its broader biologic role has not been elucidated. Estriol in the maternal compartment closely reflects fetal adrenal activity, and increased fetal adrenal activity prior to the onset of labor is a common link in mammalian parturition. In humans, estriol increases before spontaneous labor and may be a clinically useful marker for some cases of preterm labor.

Animals↗
PubMed1999

Serial betamethasone administration: effect on maternal salivary estriol levels.

OBJECTIVE: Maternal salivary estriol levels are an indirect measure of fetal adrenal activity, which may be affected by administration of betamethasone. The objective was to compare sequential salivary estriol levels in patients receiving serial betamethasone therapy with those of healthy pregnant patients. STUDY DESIGN: Ten patients at high risk for preterm delivery were asked to obtain salivary specimens before and 1 to 2 days after each administration of weekly betamethasone treatments between 24 and 32 weeks' gestation. These values were compared with those of specimens obtained throughout gestation in healthy women who were not delivered preterm. Unconjugated salivary estriol was measured with a sensitive and specific enzyme-linked immunoassay (Biex, Inc, Dublin, Calif). RESULTS: The effect of betamethasone on salivary estriol levels did not change with time, showing an average of 23.1% drop from pretreatment to posttreatment levels but rebounding to the same starting level before the next dose. When weekly pretreatment values were looked at across time, the geometric mean of the individual patients' slopes did not differ significantly from no change. The same was true of the posttreatment values. The rate of change with advancing gestation was compared between 182 control subjects and the 10 study subjects. The average change was +8.8% per week in the control subjects and -1.3% per week in the study patients (P =.003). CONCLUSIONS: Maternal administration of betamethasone significantly suppressed salivary estriol levels. These levels returned to pretreatment values each week before the next dose; however, the rise normally associated with advancing gestational age was not observed.

Betamethasone↗
PubMed1999

Incidence, clinical characteristics, and timing of objectively diagnosed venous thromboembolism during pregnancy.

OBJECTIVE: To estimate the incidence, timing, and associated clinical characteristics of objectively diagnosed pregnancy-associated venous thromboembolism. METHODS: We retrospectively reviewed venous thromboembolism cases (deep venous thrombosis and pulmonary embolism) that occurred between 1978 and 1996. Study inclusion criteria required the objective diagnosis with either Doppler ultrasound, venography, impedance plethysmography, pulmonary angiography, ventilation-perfusion scanning, or computed tomography or magnetic resonance imaging. RESULTS: Among 268,525 deliveries there were 165 (0.06%) episodes of venous thromboembolism (one per 1627 births). There were 127 cases of deep venous thrombosis and 38 cases of pulmonary embolism. Only 14% (23 of 165 patients) had a history of venous thromboembolism. Most cases of deep venous thrombosis were in the left leg (104 of 127, 81.9%), with nearly three quarters of them (94 of 127, 74.8%) occurring during the antepartum period. Among cases of antepartum deep venous thrombosis, half were detected before 15 weeks' gestation (47 of 95, 49.5%), and only 28 cases occurred after 20 weeks (P < .001). Most of the pulmonary embolisms occurred in the postpartum period (23 of 38, 60.5%) and were strongly associated with cesarean delivery (19 of 36,470 compared with four of 232,032, P < .001). CONCLUSION: The incidence of venous thromboembolism during pregnancy is lower than has been previously described. Most cases occurred in the antepartum period, with the risk of deep venous thrombosis appearing to begin even before the second trimester.

Adolescent↗
PubMed1999

Pregnancy, the postpartum, and steroid hormones: effects on cognition and mood.

The effects of pregnancy on cognition and mood were examined using a repeated-measures design. Nineteen women, average age 33, were tested with a comprehensive neuropsychological battery during their last 2 months of pregnancy and again within 2 months of delivery. Blood samples were obtained from all subjects and assayed for a variety of steroid hormones implicated in cognitive and mood functioning. Most participants also completed several self-report measures of mood. In comparison with performance after delivery, women showed significantly more impairment in aspects of verbal memory during pregnancy and also tended to report more negative mood states. Memory deficits were not explained by mood disturbances. No hormone assayed consistently related to cognitive performance during pregnancy. During pregnancy, higher levels of progesterone (P) were associated with greater mood disturbances and higher levels of dehydroepiandrosterone (DHEA) with better mood. After delivery, testosterone (T) was strongly and consistently associated with greater reported mood disturbances. Our results confirm a peripartal memory deficit, which cannot be explained by the dramatic rise in circulating steroid hormones, or by mood status during pregnancy. Steroidal hormones, namely P, DHEA and T, appear to play a role in mood disturbances during, and after, pregnancy. Studies beginning earlier in pregnancy and continuing for an extended period of time after delivery are needed to confirm and expand these observations.

Adult↗