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1.
Zootaxa ; 4780(2): zootaxa.4780.2.5, 2020 May 25.
Article in English | MEDLINE | ID: mdl-33055746

ABSTRACT

Humid tropical forests in Mesoamerica are distributed along the Atlantic slope and, in scattered locations, along the Mexican Pacific slope. These poorly explored Mexican forests include microendemic bird species. Two species in the genus Dendrocolaptes occur in lowland and foothill humid tropical forests of Mesoamerica. One of these, D. sanctithomae, is comprised of four subspecies, of which the two that occur in Mexico, D. s. sanctithomae and D. s. sheffleri, are distinctly different morphologically, and the latter is a poorly known microendemic taxon of the Mexican Pacific humid tropical forest in the Sierra Madre del Sur. We used both nuclear (nDNA) and mitochondrial DNA (mtDNA) to evaluate the genetic variation of D. sanctithomae in Mexico, and complemented this with a quantitative analysis of phenotypic traits. We also conducted analyses of environmental niche models to test the hypothesis of niche differentiation of D. s. sheffleri from other taxa of D. sanctithomae. Our phylogenetic reconstructions of mtDNA consistently recovered D. s. sheffleri and D. s. sanctithomae as reciprocally monophyletic, while they shared alleles of nDNA. These mtDNA differences are comparable with differences reported between other Dendrocolaptes sister-taxa pairs. Our analysis of phenotypic traits also indicated that the taxa differ in measurements of hallux and feather barring. In contrast, niche differentiation tests suggest that the niches of both taxa are more similar than expected by chance. Our evidence leads us to propose species status for D. sheffleri. This is an additional example of recent speciation in Mexico that indicates active and peripatric evolutionary differentiation in the northern Neotropics.


Subject(s)
Genetic Variation , Passeriformes , Animals , DNA, Mitochondrial , Mexico , Phylogeny
2.
BJOG ; 122(4): 468-76, 2015 Mar.
Article in English | MEDLINE | ID: mdl-24989790

ABSTRACT

BACKGROUND: The optimal dose of misoprostol for the induction of labour remains uncertain. OBJECTIVES: To compare the efficacy and safety of 25 versus 50 micrograms of intravaginal misoprostol tablets for the induction of labour and cervical ripening. SEARCH STRATEGY: We performed electronic and manual searches to identify relevant randomised trials. SELECTION CRITERIA: The efficacy outcomes assessed were rates of vaginal delivery within 24 hours, delivery within one dose, and oxytocin augmentation, and interval to delivery. The safety outcomes assessed were incidences of tachysystole, hyperstimulation, caesarean delivery, cesarean delivery for non-reassuring fetal heart rate (FHR), operative vaginal delivery, abnormal 5-minute Apgar score, abnormal cord gas values, admission to a neonatal intensive care unit (NICU), and meconium passage. DATA COLLECTION AND ANALYSIS: Thirteen studies (1945 women) were included. Relative risk (RR) and 95% confidence intervals (CI) were calculated using fixed-effects and random-effects models. MAIN RESULTS: We found that 25 micrograms was less efficacious, with lower rates of delivery after one dose (RR 0.59; 95% CI 0.39-0.88) and vaginal delivery within 24 hours (RR 0.88; 95% CI 0.79-0.96), and with increased rates of oxytocin augmentation (RR 1.54, 95% CI 1.36-1.75). We noted an improved safety profile with 25 micrograms, however, with decreased rates of tachysystole (RR 0.46; 95% CI 0.35-0.61), hyperstimulation (RR 0.5; 95% CI 0.31-0.78), caesarean deliveries for non-reassuring FHR (RR 0.67; 95% CI 0.52-0.87), NICU admissions (RR 0.63; 95% CI 0.4-0.98), and meconium passage (RR 0.65; 95% CI 0.45-0.96). CONCLUSIONS: Although 50 micrograms of intravaginal misoprostol may be more efficacious, safety concerns make the 25-microgram dose preferable.


Subject(s)
Cervical Ripening/drug effects , Delivery, Obstetric/methods , Labor, Induced/methods , Misoprostol/administration & dosage , Oxytocics/administration & dosage , Administration, Intravaginal , Adult , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Humans , Infant, Newborn , Pregnancy , Pregnancy Outcome , Pregnancy Trimester, Third , Randomized Controlled Trials as Topic , Risk
4.
ENFURO: Rev. Asoc. Esp. A.T.S. Urol ; (104): 36-39, oct.-dic. 2007. tab
Article in Spanish | IBECS | ID: ibc-137186

ABSTRACT

Es frecuente ver en los centros asistenciales que las estimaciones de las necesidades de personal de cuidados en las áreas de hospitalización se lleva a cabo en base a la consideración del número de pacientes ingresados; sin embargo, son las condiciones particulares de cada paciente las que determinan los recursos necesarios para su cuidado. El objetivo principal de este estudio es identificar poblaciones con un mayor consumo de cuidados en el momento de su ingreso como medio de optimizar la asignación de personal (AU)


It is frequent to see in the existential centres, that the estimations of the needs for staff of cares, in the areas of hospitalization it is carried out following the consideration of the number of admitted patients, however those that determine the necessary resources for their care are the particular conditions of every patient. The main goal of this study is to identify the populations with a bigger consumption of cares at the moment of their admission as means of optimizing the assignment of staff (AU)


Subject(s)
Humans , Urologic Diseases/epidemiology , Disabled Persons/statistics & numerical data , Disability Evaluation , Severity of Illness Index , Risk Factors , Personal Autonomy
5.
J Perinatol ; 27(12): 749-53, 2007 Dec.
Article in English | MEDLINE | ID: mdl-17762846

ABSTRACT

OBJECTIVE: To investigate the relationship between cervical length (CL) at 37 to 40 weeks and delivery within 7 days and delivery by 41 weeks. STUDY DESIGN: We performed transvaginal ultrasound to measure CL in women with singleton gestations at 37 to 40 weeks. We then used a receiver operating characteristic curve (ROC) to assess the relationship between CL and delivery within 7 days and delivery by 41 weeks. RESULT: For the 120 women included in the analysis, the mean CL (+/-s.d.) was 25.3+/-9.8 mm. The logistic regression model to predict each of the outcomes includes gestational age at ultrasound (GA-US) and CL. Neither birthweight, nor parity seems to affect the probability of delivery within 7 days. The ROC curve was used to assess the probability of spontaneous labor within 7 days at each CL measurement. The likelihood ratio of delivery within 7 days when CL is < or = 10 mm is 12. CONCLUSION: CL measurement at 37-40 weeks is an independent predictor of delivery within 7 days and delivery by 41 weeks regardless of GA-US. This information can be utilized when counseling patients regarding the management of term pregnancies.


Subject(s)
Cervical Ripening/physiology , Cervix Uteri/diagnostic imaging , Labor Onset/physiology , Pregnancy Trimester, Third/physiology , Female , Humans , Predictive Value of Tests , Pregnancy , Ultrasonography
6.
Int J Gynaecol Obstet ; 88(2): 108-11, 2005 Feb.
Article in English | MEDLINE | ID: mdl-15694083

ABSTRACT

OBJECTIVE: Within the obstetric community, several studies suggest that cervical ripening and labor induction after 40 weeks' gestation leads to improved maternal and neonatal outcomes. The most effective drug regimen to safely promote labor has not been determined. METHOD: Forty-nine subjects followed in an outpatient obstetrical clinic with pregnancies of at least 40 weeks' gestation, and an unfavorable Bishop score were assigned randomly to receive oral misoprostol 50 or 25 microg every 3 days for a maximum of three doses. RESULTS: Twenty-three subjects received misoprostol 25 microg and 26 received 50 microg. The mean interval (+/-standard deviation) from start of cervical ripening to delivery was 2.4 days +/-0.3 vs. 3.9 days +/-0.7 for the 50 and 25 microg groups (P<0.05). No adverse events were noted. However, due to small sample size, less frequent adverse events may be missed. Type II errors cannot be excluded. CONCLUSION: In the prevention of postdate pregnancy, outpatients use of oral misoprostol 50 microg appears to result in earlier delivery, as compared to 25 microg.


Subject(s)
Cervical Ripening/drug effects , Misoprostol/administration & dosage , Oxytocics , Adult , Ambulatory Care , Dose-Response Relationship, Drug , Female , Humans , Pregnancy , Pregnancy, Prolonged
7.
Int J Gynaecol Obstet ; 83(2): 151-7, 2003 Nov.
Article in English | MEDLINE | ID: mdl-14550589

ABSTRACT

OBJECTIVES: To determine whether human chorionic gonadotropin (hCG) detected in cervicovaginal secretions of patients with symptoms suggestive of preterm labor is a predictor of preterm birth. METHODS: Women presenting to labor and delivery with symptoms of preterm labor were invited to participate. After collecting secretions with a cotton-tipped applicator from the posterior fornix and endocervical canal, we placed the swab in a test tube containing 1 ml of normal saline. From this solution, we performed qualitative and quantitative hCG measurements. Qualitative and quantitative hCG results from women who delivered at term were compared with those delivering prior to 37 weeks' gestation. RESULTS: Samples were obtained and analyzed from 86 women at a mean (+/- standard deviation) gestational age of 30.7+/-2.9 weeks. Of the 86 subjects enrolled, 28 (32.6%) delivered preterm. A positive rapid qualitative assay from cervicovaginal secretions between 24 and 34 weeks' gestation was associated with a significant increase in the incidence of preterm delivery (relative risk 2.62, 95% confidence interval (CI) 1.38, 4.98). The likelihood ratios for a positive and negative test were 2.19 (95% CI 1.35, 3.56) and 0.51 (95% CI 0.30, 0.85) respectively. Using a cut-off of 19 mIU/ml, similar diagnostic accuracy for predicting preterm birth was obtained with the quantitative test 1.93 (95% CI 1.14, 3.26) and 0.62 (95% CI 0.40, 0.98). CONCLUSIONS: Qualitative and quantitative hCG measurements from cervicovaginal secretions may be useful predictors of preterm birth in symptomatic patients. The qualitative hCG test can be used at the bedside with results obtained in minutes.


Subject(s)
Chorionic Gonadotropin/analysis , Genitalia, Female/metabolism , Obstetric Labor, Premature/diagnosis , Vaginal Discharge/metabolism , Adult , Bodily Secretions/chemistry , Female , Humans , Predictive Value of Tests , Pregnancy , United States
8.
Int J Gynaecol Obstet ; 82(2): 143-52, 2003 Aug.
Article in English | MEDLINE | ID: mdl-12873774

ABSTRACT

OBJECTIVES: To systematically review the efficacy of misoprostol compared with placebo or other uterotonics in preventing maternal morbidity associated with the third stage of labor. METHODS: We identified, retrieved, evaluated, abstracted data, and assessed the quality of all published studies (from January 1996 to May 2002) which assessed misoprostol's efficacy in minimizing uterine blood loss during the third stage of labor. Seventeen studies included 28170 subjects; of these, approximately one-half received misoprostol with the remainder receiving either a placebo or another uterotonic agent. An estimate of the odds ratio (OR) and risk difference for dichotomous outcomes was calculated using a random- and fixed-effects model. Continuous outcomes were pooled using a variance-weighted average of within-study difference in means. RESULTS: In assessing studies comparing misoprostol with placebo, those who received oral misoprostol had a decreased risk of needing additional uterotonics (OR 0.64, 95% confidence interval 0.46, 0.90). Compared with placebo, use of misoprostol was associated with an increased risk for shivering and pyrexia. In contrast, in studies comparing misoprostol with oxytocin, oxytocin was associated with significantly lower rates of postpartum hemorrhage, maternal shivering and pyrexia. In studies comparing misoprostol with Syntometrine, misoprostol was associated with higher rates of the need for additional uterotonic agent as well as shivering. CONCLUSIONS: Misoprostol was inferior to oxytocin and other uterotonics with regard to any of the third stage of labor outcomes assessed. However, when compared to placebo, misoprostol had a decreased risk of needing additional uterotonics. Thus, in less-developed countries where administration of parenteral uterotonic drugs may be problematic, misoprostol represents a reasonable agent for the management of the third stage of labor. Additional randomized clinical trials examining objective outcome measures (i.e. need for blood transfusion or 10% hemoglobin change) may further define benefits and risks of misoprostol use during the third stage of labor.


Subject(s)
Labor Stage, Third , Labor, Obstetric/drug effects , Misoprostol/therapeutic use , Oxytocics/therapeutic use , Postpartum Hemorrhage/drug therapy , Postpartum Hemorrhage/prevention & control , Female , Fever/etiology , Fever/prevention & control , Humans , Misoprostol/adverse effects , Oxytocics/adverse effects , Placebo Effect , Pregnancy , Pregnancy Outcome , Randomized Controlled Trials as Topic , Shivering , Treatment Outcome
9.
Obstet Gynecol ; 98(5 Pt 1): 745-50, 2001 Nov.
Article in English | MEDLINE | ID: mdl-11704163

ABSTRACT

OBJECTIVE: To estimate the efficacy of preoperative administration of intravaginal metronidazole for the prevention of postcesarean endometritis. METHODS: This double-masked, placebo-controlled randomized trial included patients of at least 24 weeks' gestation undergoing cesarean deliveries for various indications. Patients were randomized to receive either 5 g of metronidazole gel intravaginally or matching placebo before the initiation of the cesarean. All patients underwent surgical cleansing of the abdomen, and most received prophylactic antibiotics after cord clamping. Patients with chorioamnionitis and/or suspected allergy to metronidazole were excluded. For a two-sided alpha of 0.05 and beta of 0.20 (80% power), 120 subjects were required in each group. The main outcome variable was the incidence of postcesarean endometritis. Secondary outcome variables included presence of febrile morbidity, wound infection, days on antibiotics, and length of postpartum hospitalization. Neonatal outcomes included birth weight, Apgar scores less than 7 at 5 minutes, umbilical arterial pH less than 7.16, admission and length of stay in the neonatal intensive care unit, and length of hospital stay. RESULTS: Of 112 patients receiving metronidazole, eight (7%) developed postcesarean endometritis, compared with 19 of 112 (17%) of those receiving placebo gel (relative risk 0.42, 95% confidence interval 0.19, 0.92). No significant differences were noted between treatment groups with respect to the other outcome variables. CONCLUSION: The preoperative administration of 5 g of intravaginal metronidazole gel appears to reduce the incidence of postcesarean endometritis.


Subject(s)
Anti-Infective Agents/therapeutic use , Cesarean Section , Endometritis/prevention & control , Metronidazole/therapeutic use , Postoperative Complications/prevention & control , Premedication , Administration, Intravaginal , Adult , Double-Blind Method , Endometritis/epidemiology , Female , Gels , Humans , Incidence , Postoperative Complications/epidemiology , Pregnancy
11.
Am J Obstet Gynecol ; 185(2): 308-17, 2001 Aug.
Article in English | MEDLINE | ID: mdl-11518884

ABSTRACT

OBJECTIVE: We sought to evaluate the cytologic diagnosis and sample adequacy of the liquid-based cervical cytologic smear (ThinPrep) compared with that of the conventional Papanicolaou smear. STUDY DESIGN: Prospective studies of ThinPrep and conventional Papanicolaou smears were analyzed for cytologic diagnosis and sample adequacy. Computerized databases, references in published studies, and index reviews published in English were used to identify direct-to-vial and split-sample clinical trials of cervical smears performed by conventional and liquid-based techniques. Only published studies that used the Bethesda system nomenclature with clearly documented outcome data were included. Each trial was assessed for the quality of its method, inclusion and exclusion criteria, adequacy of randomization, sampling protocols, definition of outcome, and statistical analyses. RESULTS: Twenty-five studies met inclusion criteria for this review. Odds ratios with 95% confidence intervals were calculated for each outcome. Estimates of odds ratios and risk differences for dichotomous outcomes were calculated by use of random and fixed-effects models. Homogeneity was tested across the studies. Results indicate that the ThinPrep test is as good as or superior to the conventional Papanicolaou smear in diagnosing uterine cervical premalignant abnormalities. Also the ThinPrep test provides improved sample adequacy when compared with the conventional Papanicolaou test. CONCLUSION: The ThinPrep test improved sample adequacy and led to improved diagnosis of low-grade and high-grade squamous intraepithelial lesions. However, there is no difference in the rate of atypical cells of undetermined significance diagnosis between ThinPrep and conventional smear groups. The added cost of ThinPrep cytologic screening and, hence, its cost-effectiveness are not evaluated in this study.


Subject(s)
Cytodiagnosis/methods , Papanicolaou Test , Vaginal Smears , Female , Humans , Odds Ratio , Prospective Studies , Sensitivity and Specificity , Solutions , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Dysplasia/diagnosis
12.
Int J Gynaecol Obstet ; 73(1): 7-14, 2001 Apr.
Article in English | MEDLINE | ID: mdl-11336715

ABSTRACT

OBJECTIVE: To compare maternal and neonatal outcomes in elective cesarean vs. attempted vaginal delivery for breech presentation at or near term. METHODS: We reviewed the maternal and neonatal charts of all singleton breech deliveries of at least 35 weeks' gestation or 2000 g delivered between 1986 and 1997 at our institution. Patients delivered by elective cesarean were compared to those attempting a vaginal delivery. The neonatal outcomes analyzed were: corrected mortality; Apgar scores less than 7 at 5 min; abnormal umbilical cord blood gases; birth trauma; and admissions to the intensive care nursery. Maternal morbidity was also assessed and compared. RESULTS: Of 848 women meeting criteria for evaluation, 576 were delivered by elective cesarean while 272 attempted a vaginal delivery. Of 272 women undergoing a trial of labor, 203 (74.6%) were delivered vaginally, while 69 (25.4%) failed an attempt at vaginal delivery and underwent a cesarean. When comparing patients delivered by elective cesarean with those attempting a vaginal delivery, no significant differences were noted in neonatal outcomes. However, maternal morbidity was higher among women delivered by cesarean, regardless of the indications for the procedure. Similar neonatal and maternal results were noted when nulliparous patients were analyzed separately. CONCLUSIONS: Cesarean delivery of selected near-term infants presenting as breech is associated with increased maternal morbidity without corresponding improvement in neonatal outcomes.


Subject(s)
Breech Presentation , Cesarean Section/adverse effects , Delivery, Obstetric , Infant, Newborn, Diseases/epidemiology , Puerperal Disorders/epidemiology , Adult , Apgar Score , Cesarean Section/mortality , Female , Florida/epidemiology , Humans , Infant, Newborn , Infant, Newborn, Diseases/etiology , Medical Records , Pregnancy , Pregnancy Outcome , Puerperal Disorders/etiology , Retrospective Studies
14.
Obstet Gynecol ; 96(5 Pt 2): 861-6, 2000 Nov.
Article in English | MEDLINE | ID: mdl-11094242

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by oligohydramnios. DATA SOURCES: Randomized controlled trials of prophylactic amnioinfusion in women with oligohydramnios were identified using computerized databases, index reviews, and references cited in original studies and review articles. METHODS OF STUDY SELECTION: We evaluated, abstracted data from, and analyzed randomized studies of prophylactic intrapartum amnioinfusion in women with oligohydramnios. In every study the group allocation was based exclusively on presence of oligohydramnios. Only published studies with clearly documented outcome data were included. The quality of each trial was evaluated for methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. The trials were evaluated concerning cesarean deliveries for fetal heart rate (FHR) abnormalities, overall cesarean rates, acidemia at birth, intrapartum fetal heart rate abnormalities, Apgar scores under 7 at 5 minutes, and postpartum endometritis. TABULATION, INTEGRATION, AND RESULTS: Thirty-five studies were identified, of which 14 met the inclusion criteria for this systematic review. They included 1533 patients, 793 in the amnioinfusion group, and 740 controls. Odds ratios (OR) with their 95% confidence intervals (CI) for each outcome were calculated. We calculated an estimate of the OR and risk difference for dichotomous outcomes using random and fixed-effects models. A test of homogeneity was done across studies. Women with oligohydramnios who received intrapartum amnioinfusion had lower incidence of cesarean for FHR abnormalities (OR 0.23; 95% CI 0.15, 0.35). Intrapartum amnioinfusion also was associated with lower overall rates of cesarean deliveries (OR 0.52; 95% CI 0.40, 0. 68), acidemia at birth (OR 0.40; 95% CI 0.30, 0.55), FHR abnormalities during labor (OR 0.24; 95% CI 0.17, 0.34), and Apgar scores under 7 at 5 minutes (OR 0.52; 95% CI 0.29, 0.91). Postpartum endometritis rates were similar among the study groups. CONCLUSION: In the presence of oligohydramnios, prophylactic intrapartum amnioinfusion significantly improves neonatal outcome and lessens the rate of cesarean delivery, without increasing the rate of postpartum endometritis.


Subject(s)
Amniotic Fluid , Oligohydramnios/therapy , Pregnancy Outcome , Apgar Score , Cesarean Section , Female , Heart Rate, Fetal , Humans , Infant, Newborn , Oligohydramnios/prevention & control , Pregnancy , Randomized Controlled Trials as Topic
17.
Obstet Gynecol ; 95(6 Pt 2): 1051-6, 2000 Jun.
Article in English | MEDLINE | ID: mdl-10808033

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid. DATA SOURCES: We identified prospective clinical trials of amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid (AF) published in English by using computerized databases, references in published studies, and index reviews. METHODS OF STUDY SELECTION: We analyzed prospective studies of intrapartum amnioinfusion for meconium-stained AF. In every case, group allocation was based exclusively on meconium in AF. Only published studies with clearly documented outcome data were included. The trials were evaluated for meconium below the vocal cords, meconium aspiration syndrome, fetal acidemia, cesarean delivery, and postpartum endometritis. Each trial was evaluated for the quality of its methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. TABULATION, INTEGRATION, AND RESULTS: Thirteen studies met inclusion criteria for our systematic review. Odds ratios (ORs) with their 95% confidence intervals (CIs) were calculated for each outcome. Estimates of ORs and risk differences for dichotomous outcomes were calculated using random and fixed-effects models. We tested for homogeneity across the studies. We found that intrapartum amnioinfusion significantly reduced the frequency of meconium aspiration syndrome (OR 0.30; 95% CI 0.19, 0. 46), of meconium below the vocal cords, and neonatal acidemia. Subjects allocated to receive amnioinfusion also had a significantly lower overall cesarean rate (OR 0.74, 95% CI 0.59, 0.93) without increased postpartum endometritis. CONCLUSION: Amnioinfusion in cases of meconium-stained fluid significantly improves neonatal outcome, lowers the cesarean delivery rate, and does not increase the postpartum endometritis rate.


Subject(s)
Amnion , Meconium Aspiration Syndrome/prevention & control , Meconium , Obstetric Labor Complications/prevention & control , Amniotic Fluid , Cesarean Section/statistics & numerical data , Clinical Trials as Topic , Female , Humans , Infant, Newborn , Pregnancy , Prospective Studies
18.
Am J Obstet Gynecol ; 182(5): 1050-1, 2000 May.
Article in English | MEDLINE | ID: mdl-10819824

ABSTRACT

OBJECTIVE: This study was undertaken to examine the effect of obstetric resident physician gender on the forceps delivery rate. STUDY DESIGN: Analysis was based on >350,000 deliveries performed by >800 residents in obstetrics and gynecology throughout the United States from 1994 to 1998. A chi(2) analysis was performed on resident statistics from residency review committee report forms. RESULTS: The percentage of total deliveries performed with forceps during residency was significantly higher among male residents (P <. 0001), as was the percentage of vaginal deliveries performed with forceps during residency (P <.0001). The percentage of overall operative vaginal deliveries (vacuum plus forceps) was significantly higher for male residents (P <.0001); however, the percentage of vacuum deliveries did not vary according to gender of the resident when considered independently. CONCLUSION: These results strongly suggest that resident gender affects performance of forceps delivery.


Subject(s)
Delivery, Obstetric/methods , Internship and Residency , Obstetrical Forceps/statistics & numerical data , Obstetrics/statistics & numerical data , Sex Factors , Female , Humans , Male , Practice Patterns, Physicians'/statistics & numerical data , Pregnancy
19.
Am J Obstet Gynecol ; 182(5): 1173-83, 2000 May.
Article in English | MEDLINE | ID: mdl-10819855

ABSTRACT

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.


Subject(s)
Obstetric Labor, Premature/drug therapy , Tocolysis , Tocolytic Agents/therapeutic use , Vasotocin/analogs & derivatives , Double-Blind Method , Female , Fetal Death , Fetal Distress , Gestational Age , Humans , Placebos , Pregnancy , Time Factors , Tocolytic Agents/adverse effects , Treatment Outcome , Vasotocin/adverse effects , Vasotocin/therapeutic use
20.
Am J Obstet Gynecol ; 182(5): 1184-90, 2000 May.
Article in English | MEDLINE | ID: mdl-10819856

ABSTRACT

OBJECTIVES: Patients admitted with an acute episode of preterm labor who respond to early intravenously administered tocolysis remain at risk of having subsequent episodes of preterm labor and preterm delivery. Several pharmacologic agents have been used in an attempt to reduce subsequent episodes of preterm labor, and all are associated with significant side effects. Atosiban, an oxytocin receptor antagonist, is effective in the treatment of an acute episode of preterm labor. This study was designed to compare the efficacy and safety of atosiban with those of placebo maintenance therapy in women with preterm labor who achieved uterine quiescence with intravenous atosiban. STUDY DESIGN: A multicenter, double-blind, placebo-controlled trial was designed for patients in preterm labor who responded to early intravenous treatment with atosiban. Five hundred thirteen patients were randomly assigned to receive maintenance therapy, 252 to receive atosiban, and 251 to receive matching placebo. Maintenance therapy was administered as a continuous subcutaneous infusion, via pump, of 30 microg/min to the end of 36 weeks' gestation. The primary end point was the number of days from the start of maintenance therapy until the first recurrence of labor. A secondary end point was the percentage of patients receiving subsequent intravenous atosiban therapy. RESULTS: The time (median) from the start of maintenance treatment to the first recurrence of labor was 32.6 days with atosiban and 27.6 days with placebo (P =.02). At least one subsequent intravenous atosiban treatment was needed by 61 atosiban patients (23%) and 77 placebo patients (31%). Except for injection site reactions, adverse event profiles of atosiban and placebo were comparable. There were 4 neonatal deaths reported in the atosiban group and 5 in the placebo group after the start of maintenance therapy. Infant outcomes (including birth weight) were comparable between maintenance and treatment groups. CONCLUSIONS: Maintenance therapy with the oxytocin receptor antagonist atosiban can prolong uterine quiescence after successful treatment of an acute episode of preterm labor with atosiban. Treatment was well tolerated.


Subject(s)
Hormone Antagonists/therapeutic use , Obstetric Labor, Premature/drug therapy , Oxytocin/antagonists & inhibitors , Vasotocin/analogs & derivatives , Adult , Double-Blind Method , Female , Gestational Age , Hormone Antagonists/adverse effects , Humans , Placebos , Pregnancy , Time Factors , Tocolytic Agents/adverse effects , Tocolytic Agents/therapeutic use , Treatment Outcome , Vasotocin/adverse effects , Vasotocin/therapeutic use
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