Role of mifepristone in pre-induction cervical ripening: a double blind placebo-controlled study

Background: Mifepristone has been used for cervical priming and labour induction for long with modest success. This double-blind study compares mifepristone with placebo in causing cervical ripening and inducing spontaneous labour in women past their expected date of delivery.Methods: 200 women at 40 weeks gestation received mifepristone or placebo after Bishop score was assessed. 48 hours later, cervical score was rechecked. Improvement in Bishop score was noted as primary outcome measure. Incidence of spontaneous labour, cesarean delivery and meconium staining of liquor during labour was also monitored.Results: 16 women went into labour before 48 hours and 184 were evaluable. Improvement in Bishop score was noted in significantly more women in mifepristone group (82/94 versus 42/90, p<0.0001). Mean change in Bishop score was 3.22 in mifepristone group and 1.61 in placebo group. This advantage in cervical ripening with mifepristone did not translate into better obstetric outcome. The incidence of spontaneous labour (64/94 mifepristone versus 60/90 placebo), cesarean section (4/94 versus 12/90) and MSL (8/94 versus 10/90) was comparable in the two groups and did not reach statistical significance.Conclusions: Mifepristone has a beneficial effect on cervical ripening in term pregnancies but does not offer obstetric advantage in terms of higher rates of spontaneous labour or vaginal delivery.

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Profiling cervical ripening for induction of labour with Foley’s balloon catheter in Ebonyi state, Nigeria: a randomized controlled trial

International Journal of Research in Medical Sciences ◽

10.18203/2320-6012.ijrms20215030 ◽

2021 ◽

Vol 10 (1) ◽

pp. 22

Author(s):

Nnabugwu Alfred Adiele ◽

Christian C. Mgbafulu ◽

Arinze Chidiebere Ikeotuonye ◽

Christian Chidebe Anikwe ◽

Joshua Adeniyi Adebayo ◽

...

Keyword(s):

Controlled Trial ◽

Foley Catheter ◽

Balloon Catheter ◽

Active Phase ◽

Induction Of Labour ◽

Cervical Ripening ◽

Labour Induction ◽

Controlled Study ◽

Bishop Score ◽

Randomized Controlled

Background: The ripeness of the cervix is an important prerequisite to a successful labour induction. Use of extra-amniotic Foley catheter is a mechanical method of cervical ripening with proven efficacy. This study compared the difference in efficacy between 30 ml and 60 ml of water for inflation of Foley catheter balloon when used for cervical ripening during induction of labour.Methods: A single-blind randomized controlled study where 260 term pregnant women with intact membranes and unfavourable cervix were selected for induction of labour and randomized into two equal groups (30 ml- and 60 ml- groups) from October, 2019 to July 2020. Each participant had cervical ripening with the catheter bulb inflated with either 30 ml or 60 ml of sterile water (as assigned to the individual). After achieving favourable cervix (BS ≥6), oxytocin titration was commenced and the labour monitored with the outcomes well documented and statistically analysed.Results: Mean duration to favourable Bishop Score significantly reduced in the 60 ml group (10.8 hours±2.99) as against 12.7 hours±10.0 in 30ml group (p=0.038). Mean duration of active phase of labour was significantly reduced in 60 ml group (5.6 hours±2.4) as against 8.4 hours±3.2 in 30 ml group (p=0.010). Caesarean delivery rate was significantly reduced in the 60 ml groups (p=0.027).Conclusions: The use of 60 ml inflated Foley’s balloon catheter when compared with 30mls to ripen the cervix effectively reduced the duration to favourable Bishop Score, duration of the active phase of labour and the rate of Caesarean sections.

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Cow's Milk Formula as a Cause of Infantile Colic: A Double-Blind Study

PEDIATRICS ◽

10.1542/peds.70.1.7 ◽

1982 ◽

Vol 70 (1) ◽

pp. 7-10 ◽

Cited By ~ 3

Author(s):

Lasse Lothe ◽

Tor Lindberg ◽

Irene Jakobsson

Keyword(s):

Gastrointestinal Symptoms ◽

Dietary Treatment ◽

Blind Study ◽

Cow’S Milk ◽

Milk Formula ◽

Double Blind Study ◽

Infantile Colic ◽

Double Blind ◽

Cow's Milk

The role of cow's milk in infantile colic in formula-fed infants was estimated in a double-blind study. Sixty colicky infants were given a cow's milk-containing formula (Enfamil) and a cow's milk-free formula based on soy (ProSobee). Eleven infants (18%) were free of symptoms while receiving soy formula. Symptoms of 32 infants (53%) were unchanged or worse when they were fed cow's milk formula and soy formula, but symptoms disappeared when they were fed a formula containing hydrolyzed casein (Nutramigen). Symptoms of 17 infants (29%) could not be related to the diet; these infants were permitted to continue on a cow's milk-based formula. A challenge with cow's milk-based formula after one month (at approximately age 3 months) produced symptoms of infantile colic in 22 infants (36%). At age 6 months, a challenge with cow's milk was positive in 11 infants (18%) with epidermal and gastrointestinal symptoms. Eight infants (13%) at 12 months of age and five infants (8%) at 16 months of age were still intolerant to cow's milk. Cow's milk seems to be a major cause of infantile colic in formula-fed infants. A dietary treatment is suggested for moderate or severe forms of the colic. Cow's milk protein intolerance is common later in infancy in these infants.

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Abstract 8: A Phase IIb Double-blind, Randomized, Placebo Controlled Study of GSK249320 for Stroke Recovery

Stroke ◽

10.1161/str.48.suppl_1.8 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Steven C Cramer ◽

Lori A Enney ◽

Colleen K Russell ◽

Monica Simeoni ◽

Thomas R Thompson

Keyword(s):

Monoclonal Antibody ◽

Substantial Reduction ◽

Indirect Evidence ◽

Primary Outcome Measure ◽

Clinical Findings ◽

Stroke Recovery ◽

Gait Velocity ◽

Controlled Study ◽

Double Blind ◽

Target Binding

Introduction: One class of potential post-stroke restorative therapy focuses on promoting axon outgrowth by blocking myelin-based inhibitory proteins such as myelin-associated glycoprotein (MAG). The aim of the current study was to extend preclinical and clinical findings of GSK249320, an IgG1-type monoclonal antibody to MAG, to explore effects on motor outcomes after stroke. Methods: This was a phase IIb double-blind, randomized, placebo controlled study (GSK funded; clinicaltrials.gov # NCT01808261). At 30 international sites, patients with ischemic stroke 24-72 hours prior and deficits in gait were randomized to two IV infusions of GSK249320 or placebo. Primary outcome measure was change in gait velocity from baseline to Day 90. Results: A total of 134 subjects were randomized. The two groups were overall well matched at baseline. The study was stopped at the pre-specified interim analysis because the treatment difference met the predefined futility criteria cutoff. Secondary endpoints, including gait analyzed categorically and upper extremity function (Box & Blocks score), were concordant. The two IV infusions of GSK249320 were well tolerated. Although direct evidence that the therapy reached the biological target was not available, indirect evidence of target binding was suggested by the substantial reduction in free MAG plasma levels with GSK249320 treatment. Conclusions: The monoclonal antibody GSK249320 administered IV within 72 hours of stroke onset demonstrated no improvement in gait velocity as compared to placebo. The antibody was well tolerated and showed low immunogenicity, findings that may prove useful to future studies aiming to use a monoclonal antibody to modify activity in specific biological pathways in order to improve recovery from stroke.

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Role of ketamine and tramadol as adjuncts to bupivacaine 0.5% in paravertebral block for breast surgery: A randomized double-blind study

Egyptian Journal of Anaesthesia ◽

10.1016/j.egja.2011.04.002 ◽

2011 ◽

Vol 27 (2) ◽

pp. 101-105 ◽

Cited By ~ 6

Author(s):

Ahmed M. Omar ◽

Mohamed A. Mansour ◽

Hisham H. Abdelwahab ◽

Ossama H. Aboushanab

Keyword(s):

Breast Surgery ◽

Paravertebral Block ◽

Blind Study ◽

Double Blind Study ◽

Double Blind

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Effect of cholecystokinin-A receptor blockade on lipid-induced gastric relaxation in humans

AJP Gastrointestinal and Liver Physiology ◽

10.1152/ajpgi.1997.273.1.g118 ◽

1997 ◽

Vol 273 (1) ◽

pp. G118-G123 ◽

Cited By ~ 6

Author(s):

M. A. Mesquita ◽

D. G. Thompson ◽

L. E. Troncon ◽

M. D'Amato ◽

L. C. Rovati ◽

...

Keyword(s):

Double Blind Study ◽

Receptor Blockade ◽

Intragastric Pressure ◽

Double Blind ◽

Perception Threshold ◽

Threshold Control ◽

Gastric Pressure ◽

Induced Changes ◽

Perception Score

The purpose of this study was to assess the role of endogenous cholecystokinin (CCK) in regulating fat-induced changes in human gastric relaxation. Proximal gastric pressure-volume relationships were determined in 12 healthy volunteers during a series of gastric distensions, both fasting and after intragastric instillation of 250 ml of 10% Intralipid. All subjects were studied twice, in a randomized, double-blind study, during intravenous infusion of either loxiglumide (CCK-A antagonist) or saline. For each distension, intragastric pressure and compliance were determined together with perception intensity. During saline infusion, Intralipid reduced intragastric pressure (prelipid, 11.7 +/- 0.8; postlipid, 9.7 +/- 0.6 mmHg; P = 0.002) and increased compliance (pressure-volume slope values: prelipid, 87.6 +/- 9.7; postlipid, 47.2 +/- 7; P < 0.01). Loxiglumide infusion during fasting exerted no effect on either intragastric pressure or compliance. After lipid, however, loxiglumide abolished the expected postlipid reduction in intragastric pressure (prelipid, 12.1 +/- 0.7; postlipid, 11.5 +/- 0.8 mmHg; P = 0.4) but did not consistently abolish the postlipid increase in compliance. Loxiglumide exerted no effect on the cumulative perception score or on the volume at perception threshold, although it prevented the fat-induced reduction in pressure at perception threshold [control: prelipid, 15.4 +/- 1.1; postlipid, 10.7 +/- 0.5 (P < 0.05); loxiglumide: prelipid, 13.8 +/- 1.5; postlipid, 12.2 +/- 0.9 (P > 0.05)]. Endogenous CCK or CCK-A receptors therefore play a role in the fat-induced reduction of intragastric pressure and might also modulate gastric perception after lipid.

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Duloxetine augmentation in resistant obsessive compulsive disorder: Surveying a new medication for challenges in treatment of OCD

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.361 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S415-S415

Author(s):

A. Mowla

Keyword(s):

Obsessive Compulsive Disorder ◽

Primary Outcome Measure ◽

Controlled Clinical Trial ◽

Double Blind Study ◽

Obsessive Compulsive ◽

Double Blind ◽

Compulsive Disorder ◽

Significant Difference ◽

Competing Interest ◽

To Receive

IntroductionUp to 50% of patients with OCD have failed to respond in SSRI trials, so looking for pharmacological alternatives in treatment of obsessive compulsive disorder (OCD) seems necessary.ObjectivesSurveying duloxetine augmentation in treatment of resistant OCD.AimsStudy the effects of serotonin-norepinephrine enhancers for treatment of OCD.MethodsThis augmentation trial was designed as an 8-week randomized controlled, double blind study. Forty-six patients suffering from OCD who had failed to respond to at least 12 weeks of treatment with a selective serotonin reuptake inhibitor (fluoxetine, citalopram or fluvoxamine) were randomly allocated to receive duloxetine or sertraline plus their current anti OCD treatment. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was the primary outcome measure.ResultsForty-six patients (24 of 30 in duloxetine group and 22 of 27 in sertraline group) completed the trial. Both groups showed improvement over the 8-week study period (mean Y-BOCS total score at week 8 as compared with baseline: P < 0.001 and P < 0.001) without significant difference (P = 0.861). Those receiving duloxetine plus their initial medications experienced a mean decrease of 33.0% in Y-BOCS score and the patients with sertraline added to their initial medication experienced a mean decrease of 34.5% in Y-BOCS.ConclusionsOur double blind controlled clinical trial showed duloxetine to be as effective as sertraline in reducing obsessive and compulsive symptoms in resistant OCD patients. However, it needs to be noted that our study is preliminary and larger double blind placebo controlled studies are necessary to confirm the results.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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A randomised placebo-controlled double-blind multicentre trial comparing antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis: APPAC III trial study protocol

BMJ Open ◽

10.1136/bmjopen-2018-023623 ◽

2018 ◽

Vol 8 (11) ◽

pp. e023623 ◽

Cited By ~ 12

Author(s):

Suvi Sippola ◽

Juha Grönroos ◽

Ville Sallinen ◽

Tero Rautio ◽

Pia Nordström ◽

...

Keyword(s):

Acute Appendicitis ◽

Antibiotic Therapy ◽

Ct Scan ◽

Symptomatic Treatment ◽

Spontaneous Resolution ◽

University Hospital ◽

Controlled Study ◽

Double Blind ◽

Uncomplicated Acute Appendicitis

IntroductionRecent studies show that antibiotic therapy is safe and feasible for CT-confirmed uncomplicated acute appendicitis. Spontaneous resolution of acute appendicitis has already been observed over a hundred years ago. In CT-confirmed uncomplicated acute diverticulitis (left-sided appendicitis), studies have shown no benefit from antibiotics compared with symptomatic treatment, but this shift from antibiotics to symptomatic treatment has not yet been widely implemented in clinical practice. Recently, symptomatic treatment of uncomplicated acute appendicitis has been demonstrated in a Korean open-label study. However, a double-blinded placebo-controlled study to illustrate the role of antibiotics and spontaneous resolution of uncomplicated acute appendicitis is still lacking.Methods and analysisThe APPAC III (APPendicitis ACuta III) trial is a multicentre, double-blind, placebo-controlled, superiority randomised study comparing antibiotic therapy with placebo in the treatment CT scan-confirmed uncomplicated acute appendicitis aiming to evaluate the role of antibiotics in the resolution of uncomplicated acute appendicitis. Adult patients (18–60 years) with CT scan-confirmed uncomplicated acute appendicitis (the absence of appendicolith, abscess, perforation and tumour) will be enrolled in five Finnish university hospitals.Primary endpoint is success of the randomised treatment, defined as resolution of acute appendicitis resulting in discharge from the hospital without surgical intervention within 10 days after initiating randomised treatment (treatment efficacy). Secondary endpoints include postintervention complications, recurrent symptoms after treatment up to 1 year, late recurrence of acute appendicitis after 1 year, duration of hospital stay, sick leave, treatment costs and quality of life. A decrease of 15 percentage points in success rate is considered clinically important difference. The superiority of antibiotic treatment compared with placebo will be analysed using Fisher’s one-sided test and CI will be calculated for proportion difference.Ethics and disseminationThis protocol has been approved by the Ethics Committee of Turku University Hospital and the Finnish Medicines Agency (FIMEA). The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT03234296; Pre-results.

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Role of pre–extubation fentanyl in mastectomy: a randomized, controlled, double–blind study

Anaesthesia, Pain & Intensive Care ◽

10.35975/apic.v25i2.1462 ◽

2021 ◽

Vol 25 (2) ◽

Author(s):

Ahmed Salman ◽

Norma Osama Zayed ◽

Ahmed Mansour ◽

Ramy Howaidi ◽

Ahmed Gamaleldin Foly ◽

...

Keyword(s):

Short Form ◽

Cardiovascular Responses ◽

Blind Study ◽

Double Blind Study ◽

Double Blind ◽

Randomized Controlled ◽

Arterial Blood ◽

Extubation Time ◽

Significant Difference

Background: Both tracheal intubation and extubation are associated with dangerous consequences such as tachycardia, hypertension, myocardial ischemia and arrhythmias. The aim was to evaluate pre–extubation two different doses of fentanyl on hemodynamic stabilization and delayed recovery in mastectomy. Methodology: The randomized controlled double–blind study was conducted on 126 patients aged 16–60 years, with controlled hypertension, receiving chemotherapy before surgery and underwent mastectomy for breast cancer. Patients were randomly allocated into 3 equal groups. Before extubation, patients received 10 ml saline in group (C), 1 µg/kg fentanyl in Group–F1: and 2 µg/kg fentanyl in Group–F2. Mean arterial blood pressure (MAP) and heart rate (HR) were recorded at T1 (after maintenance of anesthesia), T2 (after giving the test drug), T3 (immediately after extubation), T4 (5 min. after extubation) and T5 (15 min after extubation). Results: MAP was significantly lower in fentanyl groups compared to Group–C at T2 and T3 without significant deference between fentanyl groups. HR was significantly lower in fentanyl groups compared to Group–C and in Group–F2 compared to Group–F1 at T3, T4 and T5. Time of extubation was significantly prolonged in Group–F2 compared to Group–F1 and Group–C without a significant difference between Group–F1 and Group–C. Conclusions: Pre–extubation fentanyl 1 µg/kg blunted cardiovascular responses to extubation without respiratory depression or prolonged recovery. Pre–extubation fentanyl 2 µg/kg provide more control in HR but with delay in the extubation time compared to 1 µg/kg of fentanyl. Key words: Pre–Extubation, Fentanyl, Mastectomy, Hemodynamics, Recovery Preregistration: The study was registered in the Ethical Committee of Faculty of Medicine, Cairo University, Cairo, Egypt (approval number: 281) Citation: Salman A, Zayed NO, Mansour A, Howaidi R, Foly AG, ElSharkawy MS, Abdelgalil AS. Role of pre–extubation fentanyl in mastectomy: a randomized, controlled, double–blind study. Anaesth. pain intensive care 2021;25(2):143-149. DOI: 10.35975/apic.v25i2.1462. Abbreviations: CST=Craniosacral therapy; SMT=Sensorimotor training; NCLBP=Nonspecific chronic low back pain; VAS=Visual analogue scale; ODI=Oswestry disability index, BDI-II=Beck depression inventory-II, and SF-36=Short Form-36; CSF=cerebral spinal fluid; CSS=craniosacral system; PRM=primary respiratory movements Received: 27 June 2020, Reviewed: 24 July 2020, Accepted: 27 July 2020

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The role of tolvaptan in prevention of hyponatremia in patients undergoing transurethral resection of prostate surgery- A randomized double blind study

Indian Journal of Clinical Anaesthesia ◽

10.18231/j.ijca.2021.059 ◽

2021 ◽

Vol 8 (2) ◽

pp. 321-325

Author(s):

Dinesh Kumar Singh ◽

B B Baj ◽

Vipin Goyal

Keyword(s):

Transurethral Resection ◽

Blind Study ◽

Transurethral Resection Of Prostate ◽

Double Blind Study ◽

Double Blind ◽

Significant Difference ◽

Group A ◽

The Mean ◽

Group B

The aim of our study to determine the role of tolvaptan in prevention of hyponatremia in transurethral resection of prostate surgery. This is randomized double-blind study conducted in 60 ASA grade status 1 and 2 patients age group between 45-80 yrs undergoing TURP under spinal anaesthesia in urology operation theatre in Mahatma Gandhi hospital Jaipur after receiving permission from hospital ethical committee. A detailed history, complete physical examination and routine investigation were done for all patients followed by informed written consent was obtained. Patients are randomly divided into 2 groups. In group A -30 patients who received orally tab tolvaptan 15 mg and group B-30 patients who received orally tab multivitamin 2 hrs before surgery after doing electrolytes of the patients in the morning. In both groups age (in yrs), wt (in kg), ASA grade, volume of irrigating fluid (in litres), volume of prostate resected (in gm) and duration of surgery (in minutes) all demographic and surgical details data were compared. Electrolytes were compared in both groups pre and post-operatively and statistical analysis was done.There was significant difference in post-operative sodium level between the two groups (A and B). The mean level of sodium significantly reduced post-operatively in group –B (control grp). The mean level of sodium significantly increased post-operatively in group –A (tolvaptan grp). We conclude single dose of tolvaptan -15 mg found to effective in prevention of hyponatremia in patients undergoing TURP.

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EFFECTIVENESS AND TOLERABILITY OF CV-3988, A SELECTIVE PAF ANTAGONIST, AFTER INTRAVENOUS ADMINISTRATION TO MAN

10.1055/s-0038-1642878 ◽

1987 ◽

Author(s):

J Arnout ◽

A Van Hecken ◽

I Delepeleire ◽

Y Miyamoto ◽

I Holmes ◽

...

Keyword(s):

Light Transmission ◽

Platelet Rich Plasma ◽

Biological Activities ◽

Wide Spectrum ◽

Platelet Activating Factor ◽

Controlled Study ◽

Dependent Manner ◽

Double Blind ◽

Health And Disease

Platelet activating factor (PAF) is a naturally occurring phospholipid with a wide spectrum of biological activities. Although PAF has been ascribed a potential role in various conditions including inflammation, asthma, glomerulonephritis and thrombosis, its precise function in physiologic/pathophysiologic processes remains unclear. The introduction of selective PAF receptor antagonists could represent a useful tool to extend our knowledge of the role of this mediator in health and disease.We have investigated the efficacy and tolerability of (RS)-2-methoxy-3-(octadecylcarbomoyloxy)propy1 2-(3-thiazolio)-ethyIphosphate (CV-3988, Takeda Chem. Ind), a selective PAF antagonist with structural analogies with PAF, after intravenous infusion in man in a double-blind, placebo-controlled study. The compound, in doses from 750 to 2,000 pg/kg, significantly reduced platelet sensitivity to PAF. The threshold aggregating concentration (TAC) of PAF was defined as the minimal concentration causing an irreversible aggregation with a maximal amplitude of at least 50% of the difference in light transmission between platelet rich plasma and platelet poor plasma. It increased in a dose-dependent manner reaching 3.6 times the basal TAC (p<0.0005) at the end and 2.60 times the basal TAC (p<0.0005) 4 hours after infusion of the highest dose. The TAC of PAF returned to the basal value within 24 hours after the end of the infusion.CV-3988 did not cause major side effects nor changes in blood pressure, pulse or respiratory rate. However, small but clinically insignificant changes in plasma haemoglobin and serum haptoglobin were seen at the end and four hours after the end of the infusion, indicating a slight haemolysis probably by high local concentrations at the infusion site.Our results indicate that, when adequate infusion volumes and infusion rates are used, CV-3988 can be safely administered to man and should be useful in elucidating the role of PAF in health and disease.

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