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Biomedical subjects

M E Hannah

Publications and source records attributed to M E Hannah.

At least 37 records · Page 2Linked to original sources

The effect of indomethacin tocolysis in preterm labour on perinatal outcome: a randomised placebo-controlled trial.

OBJECTIVE: To determine whether indomethacin tocolysis in preterm labour is associated with a better perinatal outcome than placebo. DESIGN: A randomised placebo-controlled trial. SETTING: Two university teaching hospitals with level three neonatal intensive care units. POPULATION: Women in preterm labour with intact membranes between 23 and 30 weeks of gestation. METHODS: Random allocation to tocolysis with indomethacin (50 mg followed by 25 mg 6 hourly for 48 hours) or placebo in a double-blind fashion. MAIN OUTCOME MEASURES: The primary outcome, perinatal mortality or severe neonatal morbidity, was defined as perinatal death, necrotising enterocolitis, bronchopulmonary dysplasia, intraventricular haemorrhage or peri-ventricular leucomalacia. Data were analysed using odds ratios (OR) and 95% confidence intervals (95% CI). RESULTS: Between March 1995 and February 1996, 34 women (39 babies) were recruited. The baseline characteristics of the two groups were similar. No patient was lost to follow up. In the indomethacin group, gestation was prolonged by > 48 hours in 13/16 (81%) of women vs 10/18 (56%) in the placebo group. The incidence of perinatal mortality or severe neonatal morbidity was not significantly different between the groups, but occurred in twice as many babies in the indomethacin group as in the placebo group--6/19 (32%) vs 3/20 (15%) OR (95% CI) 2.62 (0.44-18.8). There was one perinatal death, of a baby delivered at 24 weeks of gestation. This occurred in the indomethacin group. CONCLUSION: There is no evidence that indomethacin tocolysis is beneficial, and further trials are needed to assess the impact of indomethacin tocolysis in preterm labour.

Adult↗

Prediction of perinatal outcome in fetuses suspected to have intrauterine growth restriction: Doppler US study of fetal cerebral, renal, and umbilical arteries.

PURPOSE: To determine and compare the diagnostic performance of fetal middle cerebral (MCA), renal (RA), and umbilical (UA) arterial Doppler ultrasonography (US) for prediction of adverse perinatal outcome in suspected intrauterine growth restriction (IUGR). MATERIALS AND METHODS: Two hundred ninety-three small-for-gestational age fetuses (24-39 weeks at recruitment and US-estimated weight or abdominal circumference below 10th percentile) were prospectively examined with Doppler US of the UA, MCA, and RA. Clinicians were blinded to MCA and RA Doppler measurements. RESULTS: Seventy-six fetuses (25.9%) had at least one major or minor adverse perinatal outcome. Major outcomes included stillbirth, neonatal death, neurologic complication, and necrotizing enterocolitis. The MCA pulsatility index (PI), compared with the UA PI and RA PI, was more sensitive (72.4% vs 44.7% and 8.3%) but less specific (58.1% vs 86.6% and 92.6%) in predicting adverse outcome. The UA PI had the highest positive likelihood ratio (ratio, 3.3); the MCA PI had the lowest negative likelihood ratio (ratio, 0.48). When gestational age at the first Doppler US examination was less than 32 weeks, the MCA PI had a sensitivity of 95.5% and negative predictive value of 97.7% for major adverse outcome (negative likelihood ratio, 0.10). CONCLUSION: In suspected IUGR, while an abnormal UA PI is a better predictor of adverse perinatal outcome than an abnormal MCA or RA PI, a normal MCA PI may help to identify fetuses without major adverse perinatal outcome, especially before 32 weeks gestational age.

Brain↗

Competence and adjustment of siblings of children with mental retardation.

Adjustment and competence of siblings who had a brother or sister with mental retardation were compared to those of control siblings who had brothers or sisters with no disabilities. Results indicated no overall differences for internalizing disorders, externalizing disorders, or for self-esteem and competence based on group membership, gender, or gender match. However, boys with a brother or sister with mental retardation had difficulty in school functioning. In addition, a greater number of girls with brothers and sisters with mental retardation expressed their distress through internalization.

Achievement↗

International multicenter term PROM study: evaluation of predictors of neonatal infection in infants born to patients with premature rupture of membranes at term. Premature Rupture of the Membranes.

OBJECTIVE: Our objective was to determine significant predictors for the development of neonatal infection in infants born to patients with premature rupture of membranes at term. STUDY DESIGN: Multivariate analysis was used to determine the significant predictors of neonatal infection in infants born to women with premature rupture of the membranes who were enrolled in the Term PROM Study. In a randomized, controlled trial, the Term PROM Study recently compared induction of labor with expectant management for premature rupture of membranes at term. RESULTS: The following variables were identified as independent predictors of neonatal infection: clinical chorioamnionitis (odds ratio 5.89, P < .0001), positive maternal group B streptococcal status (vs negative or unknown, odds ratio 3.08, P < .0001), 7 to 8 vaginal digital examinations (vs 0 to 2, odds ratio 2.37, P = .04), 24 to < 48 hours from membrane rupture to active labor (vs < 12 hours, odds ratio 1.97, P = .02), > or = 48 hours from membrane rupture to active labor (vs < 12 hours, odds ratio 2.25, P = .01), and maternal antibiotics before delivery (odds ratio 1.63, P = .05). CONCLUSIONS: Among infants born to patients with premature rupture of membranes at term, clinical chorioamnionitis and maternal colonization with group B streptococci are the most important predictors of subsequent neonatal infection.

Adult↗

An early labor assessment program: a randomized, controlled trial.

BACKGROUND: Approximately 31 percent of cesarean deliveries in the United States and Canada are performed for dystocia. The aim of this study was to determine the effectiveness of early labor assessment to reduce cesarean birth rates for low-risk nulliparous women. METHODS: Two hundred and nine low-risk nulliparous women were randomly allocated to either the early labor assessment group or the direct admission to hospital group. Women in the early labor assessment group were evaluated and, if found to be in false or latent labor, were encouraged to go home or walk before admission to the labor unit. Those in the direct admission group were admitted to the labor unit without an assessment. Data were collected and analyzed about method of delivery, duration of labor, intrapartum interventions, and neonatal well-being. Women completed an evaluation of their experience in the early postpartum period. RESULTS: Significant decreases occurred in duration of labor, use of epidural analgesia for pain, and use of oxytocin to augment labor in the early labor assessment group. These women evaluated their labor and birth experience more positively than women in the direct admission group. No significant differences were found in the frequency of cesarean section or instrumental vaginal delivery for the two groups. CONCLUSIONS: Early labor assessment has the potential to reduce the number of women receiving oxytocin for augmentation, the rate of epidural analgesia for pain relief, and the duration of the active and second stages of labor, and to improve women's evaluations of their labor and birth experiences.

Adult↗

Fetal fibronectin as a predictor of preterm birth: an overview.

The objective of this study was to determine if cervicovaginal fibronectin is predictive of preterm birth. Articles involving human subjects published in English between January 1976 and December 1997 were retrieved from MEDLINE using the keywords: fibronectin, fetal fibronectin, oncofetal fibronectin, preterm, PROM, preterm birth, and preterm labor. We included studies that were prospective, enrolled women at less than 37 weeks' gestation and blinded caregivers to the fetal fibronectin test results. Of the 24 studies meeting the inclusion criteria, 15 included symptomatic women; 8 included asymptomatic women; and 1 study included both. Data were abstracted independently by two authors and a meta-analysis of results of test characteristics, using summary values, was undertaken where possible. For symptomatic women, the sensitivity for delivery within 7 to 10 days of sampling was excellent (summary value [95% confidence interval ¿CI¿]: 98% [95%, 100%]). For delivery within 14 days, the sensitivity was somewhat lower (summary value [95% CI]: 82% [74%, 90%]) and lower still for delivery within 21 days (summary value [95% CI]: 73% [67%, 80%]). For delivery less than 34 weeks the sensitivity was good, but poor for delivery less than 37 weeks (summary value [95% CI]: 87% [81%, 94%], 54% [51%, 58%] respectively). For asymptomatic women, the sensitivity of fetal fibronectin for delivery less than 34 and less than 37 weeks was poor (summary value [95% CI]: 43% [36%, 50%] and 64%[57%, 71%] respectively). The specificity of fetal fibronectin for symptomatic and asymptomatic women was over 80% for all outcomes. For symptomatic women, a negative test for fetal fibronectin should be useful at ruling out the likelihood of delivery within 7 to 10 days of sampling. For asymptomatic women, testing for fetal fibronectin is unlikely to be useful as many women at risk will be misclassified as normal.

Body Fluids↗

Induction of labour versus expectant management for prelabour rupture of the membranes at term: an economic evaluation. TERMPROM Study Group. Term Prelabour Rupture of the Membranes.

BACKGROUND: As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection. Recently the TERMPROM (Term Prelabor Rupture of the Membranes) Study Group reported the results of a randomized controlled trial comparing 4 management strategies: induction with oxytocin (IwO), induction with prostaglandin (IwP), and expectant management and induction with either oxytocin (EM-O) or prostaglandin (EM-P) if complications developed. The study found no statistically significant differences in neonatal infection and cesarean section rates between any of the 4 groups. OBJECTIVE: To conduct an economic evaluation comparing the cost of (a) IwO and EM-O, (b) IwP and EM-P and (c) IwO and IwP. DESIGN: An economic analysis, conducted alongside the clinical trial, using a third-party payer perspective. Analysis included all treatment costs incurred for both the mother and the baby. Information on health care utilization and outcomes was collected for all study participants. Three countries (Canada, the United Kingdom and Australia), corresponding to the largest study recruitment, were chosen for calculation of unit costs. For each country, the base, low and high estimates of unit cost for each service item were generated. Intention-to-treat analysis. Extensive statistical and sensitivity analyses were performed. RESULTS: The median cost of IwO per patient was significantly lower statistically than that of EM-O and IwP. This result held in all 3 countries compared -$114 and -$46 in Canada, -113 Pounds and -63 Pounds in the UK, and -A$30 and -A$49 in Australia) and after an extensive sensitivity analysis. There was no statistically significant difference in median cost per patient between IwP and EM-P. CONCLUSION: Although the clinical results of the TERMPROM study did not find IwO to be preferable to the other treatment alternatives, the economic evaluation found it to be less costly. However, these cost differences, even though statistically significant, are not likely to be important in many countries. When this is the case, the authors recommend that women be offered a choice between management strategies.

Australia↗

Prednisone and aspirin in women with autoantibodies and unexplained recurrent fetal loss.

BACKGROUND: Recurrent fetal loss has been well described in women with antiphospholipid antibodies. Such women also often have other autoantibodies commonly found in patients with systemic lupus erythematosus. Treating them with prednisone and aspirin may reduce the risk of fetal loss. METHODS: We screened 773 nonpregnant women who had the unexplained loss of at least two fetuses for antinuclear, anti-DNA, antilymphocyte, and anticardiolipin antibodies and for the lupus anticoagulant. Of 385 women with at least one autoantibody, 202 who later became pregnant were randomly assigned in equal numbers to receive either prednisone (0.5 to 0.8 mg per kilogram of body weight per day) and aspirin (100 mg per day) or placebo for the duration of the pregnancy. The women were stratified according to age (18 to 34 years or 35 to 39 years) and the week of gestation at which the previous fetal losses had occurred (< or = 12 or > 12 weeks). The primary outcome measure was a successful pregnancy. RESULTS: Live infants were born to 66 women in the treatment group (65 percent) and 57 women in the placebo group (56 percent, P=0.19). More infants were born prematurely in the treatment group than in the placebo group (62 percent vs. 12 percent, P<0.001). The major side effects of therapy in the mothers were hypertension (treatment group, 13 percent; placebo group, 5 percent; P=0.05) and diabetes mellitus (15 percent and 5 percent, P=0.02). CONCLUSIONS: Treating women who have autoantibodies and recurrent fetal loss with prednisone and aspirin is not effective in promoting live birth, and it increases the risk of prematurity.

Abortion, Habitual↗

International Multicentre Term Prelabor Rupture of Membranes Study: evaluation of predictors of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term.

OBJECTIVES: Our purpose was to determine significant predictors for the development of clinical chorioamnionitis and postpartum fever in patients with prelabor rupture of membranes at term. STUDY DESIGN: Logistic regression analysis with odds ratios and 95% confidence intervals was used to determine the significant predictors of clinical chorioamnionitis and postpartum fever in women with prelabor rupture of membranes at term enrolled in this study. The study recently compared in a randomized controlled trial four strategies of management: induction with oxytocin, induction with prostaglandin, expectant management, and, if failed, induction with oxytocin or prostaglandin. RESULTS: The following variables were significantly associated with clinical chorioamnionitis: (1) number of digital vaginal examinations: > 8, 7 to 8, 5 to 6, 3 to 4 (vs 0 to 2) (odds ratio 5.07, 3.80, 2.62, 2.06); (2) duration of active labor: > or = 12, 9 to < 12, 6 to < 9 hours (vs < 3 hours) (odds ratio 4.12, 2.94, 1.97); (3) meconium-stained amniotic fluid (odds ratio 2.28); (4) parity of 0 (odds ratio 1.80); (5) time from membrane rupture to active labor: > or = 48, 24 to < 48 hours (vs < 12 hours) (odds ratio 1.76, 1.77); and (6) group B streptococcal colonization (odds ratio 1.71). Variables significantly associated with postpartum fever were (1) clinical chorioamnionitis (odds ratio 5.37), (2) duration of active labor: > or = 12, 9 to < 12, 6 to < 9, 2 to < 6 hours (vs < 3 hours) (odds ratio 4.86, 3.53, 3.46, 3.04), (3) cesarean section, operative vaginal delivery (odds ratio 3.97, 1.86), (4) group B streptococcal colonization (odds ratio 1.88), and (5) maternal antibiotics before delivery (odds ratio 1.94). CONCLUSIONS: Increasing numbers of digital vaginal examinations, longer duration of active labor, and meconium staining of the amniotic fluid were the most important risk factors for the development of clinical chorioamnionitis in women with prelabor rupture of membranes at term. The most important risk factors for the development of postpartum fever were clinical chorioamnionitis, increasing duration of active labor, and cesarean section delivery.

Adult↗

Maternal colonization with group B Streptococcus and prelabor rupture of membranes at term: the role of induction of labor. TermPROM Study Group.

OBJECTIVES: Our purpose was to determine the effect of induction of labor on neonatal infection if mothers are group B streptococci positive and have prelabor rupture of membranes at term. STUDY DESIGN: In the TermPROM study 5041 women were randomized to induction with intravenous oxytocin, induction with vaginal prostaglandin E2 gel, or expectant management with induction, if needed. Of these, 4834 women had vaginal or introital swabs for group B streptococci taken at entry. We used logistic regression to test for effects of treatment within group B streptococci subgroups. RESULTS: Group B streptococci were predictive of neonatal infection for the induction with vaginal prostaglandin E2 gel and expectant groups but not for the induction with oxytocin group. For women positive for group B streptococci the rates of neonatal infection were 2.5% for the induction with oxytocin group and > 8% for all other groups. CONCLUSIONS: Induction of labor with intravenous oxytocin may be preferable for group B streptococci-positive women with prelabor rupture of membranes at term.

Administration, Intravaginal↗

Women's evaluations of induction of labor versus expectant management for prelabor rupture of the membranes at term. TermPROM Study Group.

BACKGROUND: Induction of labor has become common practice in many Western countries, but few studies have assessed women's views. METHODS: A randomized, controlled trial was conducted at 72 hospitals in six countries. Five thousand forty-one women meeting eligibility criteria, with no contraindications for induction of labor or expectant management, were randomly assigned to four groups: induction with intravenous oxytocin, induction with vaginal prostaglandin E2 gel, or expectant management followed by induction with either oxytocin or with prostaglandin E2 gel if complications developed. The three main outcome measures were evaluations of the treatment received, perceived control during childbirth, and evaluations of the experience of trial participation. RESULTS: Questionnaires were completed by 81.9 percent of the sample. No significant differences occurred between the two induction groups. Compared with the expectant management groups, induced women were less likely to report there was nothing they liked about their treatment and less likely to report that the treatment caused additional worry. No between-group differences occurred in experienced control during childbirth. Women in the induction groups were more likely to be willing to participate in the study again and to feel reassured. CONCLUSIONS: Women's preferences should be considered when making decisions about their method of management when membranes rupture before labor. Obtaining participants' views is both feasible and worthwhile when evaluating forms of medical care.

Adult↗

Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group.

BACKGROUND: As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection. It is not known whether inducing labor will reduce this risk or whether one method of induction is better then another. METHODS: We studied 5041 women with prelabor rupture of the membranes at term. The women were randomly assigned to induction of labor with intravenous oxytocin; induction of labor with vaginal prostaglandin E2 gel; or expectant management for up to four days, with labor induced with either intravenous oxytocin or vaginal prostaglandin E2 gel if complications developed. The primary outcome was neonatal infection. Secondary outcomes were the need for cesarean section and women's evaluations of their treatment. RESULTS: The rates of neonatal infection and cesarean section were not significantly different among the study groups. The rates of neonatal infection were 2.0 percent for the induction-with-oxytocin group, 3.0 percent for the induction-with-prostaglandin group, 2.8 percent for the expectant-management (oxytocin) group, and 2.7 percent for the expectant-management (prostaglandin) group. The rates of cesarean section ranged from 9.6 to 10.9 percent. Clinical chorioamnionitis was less likely to develop in the women in the induction-with-oxytocin group than in those in the expectant-management (oxytocin) group (4.0 percent vs. 8.6 percent, P<0.001), as was postpartum fever (1.9 percent vs. 3.6 percent, P=0.008). Women in the induction groups were less likely to say they liked "nothing" about their treatment than those in the expectant-management groups. CONCLUSIONS: In women with prelabor rupture of the membranes at term, induction of labor with oxytocin or prostaglandin E2 and expectant management result in similar rates of neonatal infection and cesarean section. Induction of labor with intravenous oxytocin results in a lower risk of maternal infection than does expectant management. Women view induction of labor more positively than expectant management.

Adult↗

Postterm pregnancy: putting the merits of a policy of induction of labor into perspective.

BACKGROUND: Several randomized, controlled trials compared the policies of induction of labor and expectant management for women who reach 41 weeks' gestation, and although they suggest a better outcome for mothers and infants with such a policy in place, controversy continues as to which is the better form of care. The Canadian Multicenter Postterm Pregnancy Trial (CMPPT) enrolled 3407 women, of whom 1701 were randomized to a policy of induction of labor (induced group) and 1706 were randomized to a policy of expectant management (expectant group). Secondary analyses of data from the CMPPT were undertaken to explore a number of controversial issues. METHODS: We used data from the CMPPT to explore further the timing of delivery for women enrolled between 41 0/7 and 41 6/7 weeks' gestation, the potential impact of more liberal use of prostaglandins on cesarean section rates, and the relative merits of induced versus spontaneous labor in the two groups. RESULTS: Most women in the CMPPT (89%) were enrolled at 41 0/7 to 41 6/7 weeks' gestation, of whom 86.2 percent in the induced group and 63.6 percent in the expectant group gave birth before 42 weeks' gestation. Assuming that administration of prostaglandins would reduce the likelihood of cesarean section by 12 to 15 percent, cesarean section rates were reduced in the induction group from 21.2 percent to 20.8 to 20.9 percent, and in the expectant group from 24.5 percent 23.3 to 24.2 percent. If labor was induced as part of a policy of expectant management, the cesarean section rate was much higher (33.5%) than if labor was either spontaneous or induced as part of a policy of induction (18.5%, 22.4%). CONCLUSIONS: Women should be informed of the benefits and risks associated with the policies of induction of labor and expectant management, and their preferences regarding these policies should be respected.

Adult↗