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Fetal Heart Tracing

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861. Management of prolonged pregnancy

amniotic fluid, non-reassuring foetal heart rate tracing, Caesarean section rates). Test operating characteristics were also reported in the review. How were decisions on the relevance of primary studies made? Two reviewers independently screened references and any disagreements were resolved by consensus. Assessment of study quality The included studies were evaluated in terms of the following: randomisation, description and generalisability of the study population; description of the interventions (...) to reduce the risks of adverse outcomes of conditions associated with prolonged pregnancy. The tests reviewed were as follows: tests to determine the risk of stillbirth or compromise related to prolonged gestation included maternal measurement of foetal movement, nonstress test, contraction stress test using either nipple stimulation or oxytocin, amniotic fluid measurements, and Doppler measurements of umbilical or foetal cerebral blood flow; tests to determine the risk of macrosomia included estimation

2002 DARE.

862. Vaginal misoprostol for induction of labor: a randomized controlled trial

presentation and intact membranes. Exclusion criteria were non-reassuring foetal heart rate tracing (FHR), prior uterine surgery, known hypersensitivity to misoprostol or other PGs or contraindication to vaginal birth. The number of patients not meeting this criteria was not stated. Patients had to give informed consent and no patients were reported to have refused. When induction began, the next sequentially numbered opaque envelope was opened indicating study allocation (misoprostol or standard therapy (...) September 1994 and the prices of the drugs used appear to be from the same time period. Source of effectiveness data The effectiveness data were derived from a single study. Link between effectiveness and cost data Costing was limited to the costs of the drug used. This costing appears to have been done retrospectively. Study sample Patients were eligible for inclusion in this study if they had an indication for induction of labour, a single live foetus, gestation greater than 37 weeks, cephalic

1996 NHS Economic Evaluation Database.

863. Management of prolonged pregnancy

outcomes is the main "driver" of high negative predictive values, and if sensitivity and specificity do not change appreciably with gestational age, that negative predictive value -- the likelihood that a fetus with a normal test will have a normal outcome -- decreases with advancing gestational age. Thus, false negative results will increase with advancing gestational age. The most sensitive tests to assess the risks to the fetus of prolonged pregnancy appear to be combinations of fetal heart rate (...) power to detect differences in categorical outcomes, such as cesarean section rates and adverse maternal or perinatal outcomes. There is a consistent pattern of tradeoffs between efficacy of interventions for induction, especially as measured by time to induction or delivery within a predetermined period of time, and uterine hyperactivity, with possible increased risks of surrogate markers of fetal compromise, such as nonreassuring fetal heart rate tracings. Misoprostol appears most consistently

2002 Health Technology Assessment (HTA) Database.

864. Neuraxial Versus Systemic Analgesia for Latent Phase Labor Effect on Rate of Operative Delivery

continuous external electronic fetal heart rate (FHR) monitoring and tocodynamometry. Internal fetal scalp electrodes were placed when the external tracing was not interpretable, and intrauterine pressure catheters were used to measure the intensity of contractions when deemed necessary by the obstetricians. Artificial rupture of membranes was performed, and nurses titrated oxytocin infusions according to institutional protocol. Indication for Cesarean Delivery [ Time Frame: At time of decision (...) delivery rate. Condition or disease Intervention/treatment Phase Labor Pain Pregnancy Procedure: combined spinal epidural analgesia Procedure: late analgesia (systemic) Not Applicable Detailed Description: Women in early labor frequently request pain medication. Obstetricians may prescribe narcotics (administered as an intravenous (IV) or intramuscular (IM) injection). However, IV or IM narcotics provide incomplete pain relief and have maternal and fetal/neonatal side effects, e.g., maternal drowsiness

2006 Clinical Trials

865. Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum

are done before and after each depsipeptide infusion and 3 more times for the next 24 hours, and at various times over 4 days during the flavopiridol infusion to evaluate the effects of the medicines. Samples are also drawn periodically throughout the treatment cycle to evaluate safety. Heart function is monitored with several EKGs before and during the depsipeptide doses. The drug has shown effects on EKG tracings, but does not appear to injure the heart muscle. Tumor biopsies are done before (...) will be excluded. Patients with potentially treatable pulmonary metastases from lymphomas or germ cell tumors will be excluded. Patients who have received three or more systemic cytotoxic treatment regimens will be excluded due to possible cumulative marrow suppression. Cardiac exclusion criteria, patients with known cardiac abnormalities such as: Uncontrolled arrhythmias History of serious ventricular arrhythmias not controlled by coronary artery bypass surgery. Patients with a history of sustained VT, VF

2004 Clinical Trials

866. Cisplatin, Irinotecan, and Bevacizumab, in Treating Patients With Small Cell Lung Cancer

fracture Patients with a history of significant bleeding episodes (e.g., hemoptysis, bleeding diathesis, upper or lower GI bleeding) are not eligible; patients with trace blood in the sputum ("blood tinged sputum") are eligible No myocardial infarction or significant change in anginal pattern within one year or current congestive heart failure (NYHA Class 2 or higher) Patients with a history of hypertension must be well controlled (< 150/90) on a stable regimen of anti-hypertensive therapy No HIV (...) as there may be an increased bleeding risk with bevacizumab No current and/or recent (within 1 month) use of a thrombolytic agent; low dose thrombolytic therapy for maintenance of central venous catheter is allowed No clinically significant peripheral arterial disease Non-pregnant and non-nursing; the effect of the combination of bevacizumab, cisplatin, and irinotecan on the fetus and infant is unknown Granulocytes >= 1,500/μl Platelets >= 100,000/μl Serum Creatinine =< ULN Total Bilirubin < 2.0 mg/dl SGOT

2005 Clinical Trials

867. Sublingual Versus Vaginal Misoprostol for Labor Induction at Term

: Live singleton pregnancy at a gestational age of 36 wks or more with a medical or obstetric indication for induction Both nulliparous and multiparous women A cephalic presentation An unfavorable cervix (Bishop's score less than 8) A reassuring fetal heart tracing. Exclusion Criteria: Rupture of membranes Multiple gestation Malpresentation (presentation other than cephalic) Previous cesarean delivery Known contraindications to the use of prostaglandins (e.g. asthma) Grandmultiparity (more than 5 (...) Outcome Measures : The interval of induction to delivery [ Time Frame: Within 24 hours of induction ] Number of doses of misoprostol given [ Time Frame: Within 24 hours of induction ] Number of unsuccessful inductions [ Time Frame: Within 24 hours of induction ] Number of cesarean deliveries for fetal concerns [ Time Frame: Within 24 hours of randomization ] The incidence of tachysystole [ Time Frame: within 24 hours of randomization ] Eligibility Criteria Go to Information from the National Library

2005 Clinical Trials

868. Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury

with cerebral white matter injury. The researchers' hypothesis is that this new imaging technique will help us better understand how these devastating injuries occur. Condition or disease Intervention/treatment Brain Injury, Fetus and Neonate Procedure: Diffusion-tensor imaging Detailed Description: Maternal and neonatal data will be collected as well as the umbilical arterial gas results and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound at 24-72 hours, 10-14 days (...) Hopkins University Collaborator: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Information provided by: Johns Hopkins University Study Details Study Description Go to Brief Summary: The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants diagnosed with cerebral white matter injury during the neonatal period and identify antenatal risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial gas results that are associated

2005 Clinical Trials

869. Biomarkers of Intra-amniotic Infection in Women With Preterm Premature Ruptured Amniotic Membranes

is enrolled and has an amniocentesis within 24 hours of membrane rupture Subject is a candidate for expectant management as evidenced by the following: Absence of labor (defined by absence of painful uterine contractions) No clinical signs of infection (maternal fever of 37.9 C or greater, fetal heart rate greater than 160 bpm, uterine tenderness, purulent aminorrhea) presence of non-reassuring heart tracing Subject is a candidate for amniocentesis as evidenced by the following: Ultrasound reveals pocket (...) of fluid likely to result in successful amniocentesis Physician believes that the subject shoudl undergo amniocentesis as part of their routine evaluation of their current problem of PPROM to rule out infection and/or to test for lung maturity Exclusion Criteria: Subject has a fetus with major fetal anomaly (life threatening or requires surgical intervention) or chromosomal aneuploidy Subject has pre-existing medical indication for preterm delivery (e.g., pre-eclampsia, refractory hypertension

2008 Clinical Trials

870. Tocolysis for Preterm Labor

, chorioamnionitis, non-reassuring fetal tracing - physician judgement); AND Able and willing to consent to the study protocol. Exclusion Criteria: Failure to meet admission criteria; Known serious fetal malformations; Severe maternal/obstetric disease affecting the mother or fetus (severe cardiac disease, placental abruption/previa, severe diabetes, severe preeclampsia, etc. - physician judgment); Allergic to magnesium, antiprostaglandin or calcium channel antagonist; Refusal or inability to consent (...) in stopping uterine activity, but particularly when used for >48 hours have been associated with both maternal and fetal sides effects. Lastly, calcium channel antagonists are effective in stopping contractions and have very little in the way of maternal and fetal side effects, but less data is available in the United States on their use. Because there is no FDA approved drug to stop preterm labor, we purpose to randomize all women with preterm labor (20-34 weeks) to receive one of the above three methods

2008 Clinical Trials

871. Indomethacin Versus Nifedipine for Preterm Labor Tocolysis

contractions at least every 5 minutes, or at least 2 cm cervical dilation and 80% effacement Exclusion Criteria: Ruptured amniotic membranes Signs/symptoms of chorioamnionitis (maternal temperature greater than 100.4 F/38.0 C, fetal tachycardia, uterine tenderness) Non-reassuring fetal heart rate tracings Contra-indications to indomethacin or nifedipine Contra-indications to tocolysis Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your (...) . Both the patient and primary medical provider will be blinded to the identity of the study drug. An abdominal ultrasound will be performed in the labor and delivery unit prior to the administration of the tocolytic in order to assess fetal position and fluid level, and to document fetal cardiac activity and movement, and will be repeated at 48 hours post-randomization. Following randomization, the patient will be given either 50 mg oral indomethacin with two pills of placebo, or 3 pills each

2007 Clinical Trials

872. Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM)

/3 diagnostic tests (pooling, ferning and nitrazine positivity) Exclusion Criteria: Membrane rupture greater than 72 hours Persistent labor characterized by regular painful contractions with cervical change and/or cervix visually greater than 5 cm Chorioamnionitis defined by having 2 or more of the following: maternal temperature > 100.4, persistent fetal tachycardia (>170bpm), maternal tachycardia (>110bpm) in the absence of other likely cause, uterine tenderness. Non-reassuring fetal heart rate (...) tracing or biophysical testing Vaginal hemorrhage Lethal fetal anomalies Intrauterine fetal demise Maternal conditions which precludes expectant management Fetal condition which precludes expectant management Maternal allergy to indomethacin Maternal active gastritis Multiple gestations HIV with viral load >1000 HSV with active herpetic lesions Cervical cerclage Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact

2007 Clinical Trials

873. Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation

heart rate tracings Rate of postpartum hemorrhage Incidence of NICU admissions Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages (...) : University of Florida Information provided by (Responsible Party): University of Florida Study Details Study Description Go to Brief Summary: The purpose of this study is to compare the time to delivery of two different cervical ripening methods on the preterm gestation. Condition or disease Intervention/treatment Phase Premature Birth Cervical Ripening Drug: Misoprostol Device: Foley bulb Phase 2 Detailed Description: Labor induction for the preterm gestation is indicated for various maternal and fetal

2006 Clinical Trials

874. Randomized Trial of ATN-224 and Temozolomide in Advanced Melanoma

illness preventing informed consent or with the potential to interfere with assessment of safety or efficacy of ATN-224 treatment Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients known to be positive for HIV or infectious hepatitis type A, B or C No other prior malignancy (...) ≥1,500/uL platelets ≥100,000/uL hemoglobin ≥9 g/dL total bilirubin ≤2 X institutional upper limit of normal (ULN) AST(SGOT) and ALT(SGPT) ≤2 X ULN creatinine clearance (measured or calculated) ≥30 mL/min Patients are allowed to receive erythropoietin or blood transfusions before receiving their first dose of ATN-224 to bring the hemoglobin level to >9 g/dL to meet eligibility criteria. Use of adequate contraception. Temozolomide has the potential to cause fetal harm. The effects of ATN 224

2006 Clinical Trials

875. Trial of Magnesium Sulfate Tocolysis Versus Nifedipine Tocolysis in Women With Preterm Labor

for eligibility information Ages Eligible for Study: 15 Years to 50 Years (Child, Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Women in preterm labor between 24 to 32 6/7 weeks' gestation with intact membranes with an age range of 15 to 50 years old. Exclusion Criteria: Cervical dilatation of ≥ 6 cm Maternal contraindication to tocolysis Known fetal anomalies Suspected chorioamnionitis Nonreassuring fetal heart tracing Vaginal bleeding due to placenta

2006 Clinical Trials

876. Iodine I 131 Monoclonal Antibody 3F8 and Bevacizumab in Treating Patients With Relapsed or Refractory Neuroblastoma

safety restrictions during therapy period. Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after MIBG treatment. The minimum dose for hematopoietic stem cells is 2 X106 CD34+ cells/kg. Minimum life expectancy of four weeks. Signed informed consent indicating awareness of the investigational nature of this program. Subject Exclusion Criteria: Severe major organ toxicity. Renal, cardiac, hepatic, pulmonary, gastrointestinal (...) , Chinese hamster ovary cells products or other recombinant human antibodies Active serious infections not controlled by antibiotics. Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period. Inability or unwillingness to comply with radiation safety procedures or protocol requirements. Contacts and Locations Go to Information from the National Library

2007 Clinical Trials

877. Pilot Study to Evaluate a Prototype Electronic Uterine Inhibitor to Prevent Preterm Contractions

Actual Study Completion Date : April 2012 Arms and Interventions Go to Arm Intervention/treatment Experimental: Electrical Intervention Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst (...) is delivered at expected contraction times; and a post-EI control period (C2). Device: Electrical Intervention (EI) Electrical intervention (EI) is bipolar, constant-current (1-20 mA), square-wave pulses in 20% duty cycles. Women in preterm labor have an electrode placed vaginally; tocodynamometric contraction timing and fetal heart rate are monitored continuously. Successive 20-minute periods include pre-control period (C1); the EI period, in which a 10-second current burst is delivered at expected

2005 Clinical Trials

878. Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

such as chorioamnionitis, nonreassuring fetal heart rate tracing, metabolic acidosis, or hypotonia at birth. Exclusion Criteria: Major congenital or chromosomal abnormalities in fetus Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00375908 Locations Layout table (...) of chorioamnionitis during labor, nonreassuring fetal heart rate tracing at the time of delivery, or a 5 minute Apgar < 7. For the infants born at < 34 weeks the brain injured infants will be compared to gestational age matched controls without brain injury. For the infants born at > 34 weeks, each infant later confirmed to have neurologic morbidity will be compared to a gestational age matched noninjured control. The investigators hope to use proteomic analysis to determine if there are measurable differences

2006 Clinical Trials

879. A Study of ATN-224 and Bortezomib in Patients With Multiple Myeloma

, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Women who are pregnant or lactating Known history of HIV History of another prior cancer, except basal cell carcinoma or carcinoma in situ of the cervix (or if there has been no evidence of recurrence for at least 5 years) Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study (...) (measured or calculated) Patients are allowed to receive blood transfusions before receiving their first dose of ATN-224 to bring the hemoglobin level to ≥8 g/dL to meet eligibility criteria. Use of adequate contraception. The effects of ATN 224 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because antiangiogenic agents are known to be teratogenic, women of child-bearing potential and men with partners of child-bearing potential must agree to use

2006 Clinical Trials

880. Therapeutic Zinc in Infant Bacterial Illness

in the first two months of life. Almost 90% of all low birth weight (LBW) babies are born in developing countries, particularly in the Indian subcontinent. Nearly 70% of these are small for gestational age unlike in the developed world where the bulk of low birth weight babies are preterms. Zinc deficiency during fetal development is documented to cause intra-uterine growth retardation and also impaired postnatal immune functions making these babies more susceptible to severe infections. Studies have shown (...) suspicion of necrotising enterocolitis. Congenital heart disease. Any CVS malformation: Congenital heart disease. Cyanosis before present episode. Presence of murmur > grade 3/6. Ambiguous genitalia. Known chromosomal abnormality. Infants requiring exchange transfusion. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer

2006 Clinical Trials

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