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Biomedical subjects

J A Bofill

Publications and source records attributed to J A Bofill.

26 records · Page 2Linked to original sources

A randomized prospective trial of the obstetric forceps versus the M-cup vacuum extractor.

OBJECTIVE: Our purpose was to determine the efficacy of the obstetric forceps versus the M-cup, a new vacuum extractor cup, and maternal-neonatal complication rates. STUDY DESIGN: Over a 10-month period operative vaginal deliveries were randomized between the obstetric forceps and the M-cup vacuum extractor cup. Maternal demographics, indication for intervention, analgesia, position, station, degree of asynclitism, fetal caput-molding, and time from application to delivery were prospectively recorded. Episiotomy and extensions, lacerations, and the reason for abandonment of the randomized instrument were noted in both groups. Fetal weight, Apgar scores, cord arterial gases, hyperbilirubinemia, phototherapy, and any evidence of fetal trauma were documented at delivery or in the nursery. RESULTS: Six hundred thirty-seven women were randomized, 315 in the forceps group and 322 in the M-cup group. There were no differences in maternal demographic variables. The station, position, degree of asynclitism, or requirement for rotation was not different between the groups. The corrected efficacy rates were forceps 92% and M-cup 94% (p = 0.217). The M-cup deliveries were accomplished more rapidly than forceps deliveries (p < 0.001) and were associated with a lower rate of episiotomy (p < 0.001), third-degree (p < 0.001) and fourth-degree (p = 0.002) lacerations, but blood loss as clinically estimated (p = 0.232) or as measured by hemoglobin levels (p = 0.166) was not significantly different. Forceps deliveries were associated with fewer clinically diagnosed cephalhematomas (p = 0.015) than M-cup deliveries were, but there were no differences in the number of neonates diagnosed with hyperbilirubinemia (p = 0.377) or in the number of infants treated with phototherapy (p = 0.660). CONCLUSIONS: The M-cup vacuum extractor cup appears to be as efficient (and faster) than the obstetric forceps but is associated with significantly more fetal cephalhematomas, whereas maternal injuries are more common with the forceps.

Adult↗

The clinical efficacy of oral tocolytic therapy.

OBJECTIVE: Our purpose was to determine whether maintenance oral tocolytic therapy after preterm labor stabilization decreases uterine activity, reduces the rate of recurrent preterm labor and subsequent preterm birth, or improves neonatal outcome. STUDY DESIGN: Women with documented idiopathic preterm labor stabilized with acute tocolytic therapy were randomized to three groups: placebo, terbutaline 5 mg, or magnesium chloride 128 mg, all given orally every 4 hours. Patients and providers were blinded to group assignment. All subjects were enrolled in a comprehensive system of preterm birth prevention that included preterm labor education, weekly clinic visits, home uterine contraction assessment, daily phone contact, and 24-hour perinatal nurse access. RESULTS: Of the 248 patients who were randomized, 39 were delivered before discharge and 4 were lost to follow-up, leaving 205 for final analysis: 68 placebo, 72 terbutaline, and 65 magnesium. The terbutaline group had significantly more side effects than the placebo group did. All groups had otherwise similar perinatal outcomes when confounding variables were controlled for. Overall, the three groups had a preterm birth rate < 37 weeks of 55.6% delivery, < 34 weeks of 15.6%, a 20.4% rate of newborn intensive care unit admission, and a mean neonatal length of stay of 6.3 days. CONCLUSIONS: Maintenance oral tocolytic therapy did not decrease uterine activity, reduce the rate of recurrent preterm labor or preterm birth, or improve perinatal outcome. Overall improvement in perinatal outcome may be achieved with a comprehensive program of preterm birth prevention without the use of maintenance oral tocolytic therapy.

Administration, Oral↗

Lowering the threshold for the diagnosis of gestational diabetes.

OBJECTIVE: Our purpose was to determine whether lowering the diagnostic threshold for gestational diabetes mellitus on 3-hour 100 gm oral glucose tolerance testing will select a population at risk for adverse perinatal outcome. STUDY DESIGN: In this retrospective study 434 patients with an abnormal 50 gm glucose screen result (> or = 140 mg/dl) underwent a standardized 3-hour oral glucose tolerance test. The results were stratified according to maternal weight and the criteria recommended by Sacks or Carpenter. Birth weight and rate of macrosomia were the primary perinatal outcome variables analyzed. RESULTS: Analysis of the data set stratified according to the Sacks criteria revealed results very similar to the Carpenter criteria data set. Patients who would have been newly diagnosed with gestational diabetes mellitus only if the lowered criteria were used (group 2) were older and heavier. No other variable comparisons achieved statistical significance. When the same patients were stratified according to prepregnancy weight, overweight patients were older, gained less weight during the third trimester, underwent cesarean section more often, and had higher cumulative maternal morbidity. Regression analysis showed that the degree of hyperglycemia did not predict macrosomia or influence birth weight, but prepregnant maternal body mass index was associated with macrosomia. CONCLUSIONS: Fetal macrosomia is influenced by maternal prepregnant body mass index. Lowering the glucose tolerance test threshold would result in overdiagnosis of gestational diabetes mellitus without improving perinatal outcome.

Birth Weight↗

Operative vaginal delivery: a survey of fellows of ACOG.

OBJECTIVE: To document operative vaginal delivery rates of ACOG Fellows and to stratify practice patterns with regard to mid-pelvic delivery and deep transverse arrest by the time elapsed since residency. METHODS: A survey was mailed to a random sample of 1600 ACOG Fellows. Of the 597 respondents (37%), 558 who still practice obstetrics formed the study group. Selection bias regarding recipients of the survey was reduced by randomization by an uninvolved third party. The length of time since residency was categorized as 10 years or fewer ("recent," 31%), 11-20 years ("intermediate," 43%), and more than 20 years ("remote," 26%). RESULTS: The majority of respondents (338 of 558, 61%) reported an operative vaginal delivery rate of 15% or less. One hundred forty-two (25%) use only forceps, whereas 78 (14%) use vacuum extraction exclusively. More than half have abandoned mid-pelvic operative vaginal deliveries, and of the 41% who still perform these operations, about half use forceps. In cases of deep transverse arrest, about 25% perform cesarean delivery, whereas 26% and 42% use forceps or vacuum, respectively. Resident training and practice in vacuum delivery were more common in the recently trained groups (recent > intermediate > remote; P < .001). There were no differences among the groups with respect to attempting mid-pelvic operative vaginal delivery (P = .29), but the remote group was more likely to use forceps, whereas the recent group was more likely to use vacuum (P = .039). A large disparity existed among the groups regarding the management of deep transverse arrest, with vacuum use associated with group assignment (P < .001). CONCLUSIONS: The majority of respondents have an operative vaginal delivery rate of no more than 15%. Most respondents have abandoned mid-pelvic operative vaginal delivery. Practice patterns reflect differences in residency training; the more recently trained Fellows more often were taught and use vacuum for delivery.

Data Collection↗

Shoulder dystocia and operative vaginal delivery.

Our objective was to determine the factors involved in the development of shoulder dystocia in association with operative vaginal delivery. In this prospective study, patients who were candidates for operative vaginal delivery were randomized either to forceps (N = 315) or vacuum with M-cup (N = 322) and timed from initial placement of instrument to final delivery. Data were gathered prior to and after instrumental delivery. Statistics used were Pearson chi square, Fisher's exact, analysis of variance, and multiple logistic regression. There were a total of 21 patients with shoulder dystocia in both groups (3.3% incidence). Discriminant factors that did nor meet significance included use of epidural analgesia (P = .12), station (P = .99), previous vaginal delivery (P = .99), fetal gender (P = .54), indication for operative vaginal delivery (P = .63), > 45 degrees rotation (P = .68), use of episiotomy (P = .62), maternal weight (P = .26), and maternal diabetes (P = .08). Nearly attaining significance in univariate analysis was randomization to vacuum (P = .052). Significant factors included gestational age (P = .03), time required to effect delivery (P = .007), and birthweight (P = .0001). When these factors were subjected to stepwise multiple logistic regression, three factors remained as significant associations with shoulder dystocia: randomization to vacuum (P = .04), time for delivery (P = .03), and birthweight (P = .0001). In this operative vaginal delivery trial, shoulder dystocia was strongly associated with large fetal size, longer time to delivery, and the use of vacuum for delivery.

Birth Injuries↗

Maternal hypoglycemia: is it associated with adverse perinatal outcome?

OBJECTIVE: To determine if maternal hypoglycemia is associated with adverse perinatal outcome, particularly low birth weight. STUDY DESIGN: In this prospective study, all patients after 24 weeks' gestation were screened for gestational diabetes using 50 gm of glucola (oral) followed by a 1-hour plasma glucose measurement and hypoglycemia was defined as < or = 88 mg/dl. RESULTS: In these 426 women the mean (+/- SD) 1-hour plasma glucose value was 99.8 +/- 22.7 mg/dl. Of these, 16 were diagnosed with gestational diabetes and 46 were lost to follow-up leaving 364 patients; 116 with hypoglycemia and 248 with euglycemia. Women with hypoglycemia weighed less at the beginning of pregnancy and at delivery, but total weight gain during pregnancy was similar between both groups. There was no difference between groups in maternal symptomatology, birth weight, or the rate of fetal growth restriction. CONCLUSION: Hypoglycemia on the 1-hour glucola screen is not predictive of fetal growth restriction or other adverse perinatal consequence.

Birth Weight↗

Two-hour postprandial test versus one-hour, fifty-gram glucola test as screening tools for gestational diabetes: a critical analysis.

OBJECTIVE: The objective of this study was to compare 2-hour postprandial glucose measurements with the standard 1-hour, 50 gm glucola screen as a predictor of gestational diabetes. STUDY DESIGN: In this prospective study, 448 patients were screened for gestational diabetes mellitus after 20 weeks' gestation. Each patient was instructed to ingest a meal containing at least 100 gm of carbohydrate, and 2 hours later a plasma glucose level was obtained. Shortly after, each patient was given 50 gm glucola followed by a 1-hour glucose measurement. If either screen showed a result of 140 mg/dl or more, a formal 3-hour glucose tolerance test was done. Data were analyzed with use of the receiver operating characteristic curve. RESULTS: Of the 448 patients screened, 39 (8.7%) had a screening result of 140 mg/dl or greater and 16 (3.6%) of these had gestational diabetes mellitus. The receiver operating characteristic curve showed that the 1-hour glucose screen was more predictive of gestational diabetes than the postmeal assessment. The area under the receiver operating characteristic curve (plus or minus the SEM) for the 1-hour glucose test was 0.746 +/- 0.086 (p < 0.005) whereas the 2-hour postprandial test produced an area of 0.524 +/- 0.097 (p = NS). The range of optimal 1-hour glucola discriminatory values was 182 to 190 mg/dl. Thus the critical cutoff value of the 1-hour glucola test that minimizes false-positive results and maximizes true-positive screening for gestational diabetes is 182 mg/dl or greater. CONCLUSIONS: The 1-hour glucola test is a reliable screening test for gestational diabetes mellitus whereas the 2-hour post-prandial test is not.

Adult↗