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Paediatric and Perinatal Epidemiology Jan 2021Although nausea and vomiting of pregnancy (NVP) is common, the secular and demographic trends of NVP and its treatments are not well-studied.
BACKGROUND
Although nausea and vomiting of pregnancy (NVP) is common, the secular and demographic trends of NVP and its treatments are not well-studied.
OBJECTIVES
To describe the prevalence and patterns of first-trimester NVP and selected treatments among controls in the National Birth Defects Prevention Study (NBDPS).
METHODS
National Birth Defects Prevention Study is a population-based case-control study of birth defects in the United States (1997-2011). We collected self-reported data about NVP and use of commonly reported pharmacological and herbal/natural treatments (ondansetron, promethazine, pyridoxine, metoclopramide, doxylamine succinate, ginger, phosphorated carbohydrate solution, and prochlorperazine) from mothers of non-malformed control infants. We estimated the prevalence of NVP and selected treatments and examined secular and demographic trends (education, race/ethnicity, and maternal age) for such use, adjusting for study centre.
RESULTS
Among 10 540 mothers of controls, 7393 women (70.1%) reported first-trimester NVP, and 12.2% of those used one or more of the commonly reported treatments. Specific treatment use varied after adjustment for study centre (ondansetron: 3.4%; promethazine: 4.2%; pyridoxine: 3.2%; metoclopramide: 0.7%; doxylamine succinate: 1.7%; ginger: 1.0%; phosphorated carbohydrate solution: 0.4%; and prochlorperazine: 0.3%). Treatment use increased for each agent over the study period. Women with more years of education reported more NVP and treatment use. White (72%), Hispanic (71%), and other race (73%) women reported more NVP than Black women (67%); White women used selected NVP treatments most frequently, and Black women used them more than Hispanic women. Though women aged 25-34 years reported more NVP (72%) than younger (69%) or older (67%) women, the frequency of medication use was similar among women aged 25-34 and ≥35, and lower among women aged <25 years.
CONCLUSIONS
National Birth Defects Prevention Study controls reported NVP at frequencies similar to those previously reported. Of note, we observed an increase in use of selected treatments over time, and variations in NVP and treatments by study site and demographic factors.
Topics: Antiemetics; Case-Control Studies; Female; Humans; Infant; Nausea; Pregnancy; Pregnancy Complications; Pregnancy Trimester, First; Vomiting
PubMed: 32623767
DOI: 10.1111/ppe.12705 -
Iranian Journal of Allergy, Asthma, and... Apr 2020No Abstract.
No Abstract.
Topics: Allergens; Anaphylaxis; Basophil Degranulation Test; Basophils; Doxylamine; Drug Hypersensitivity; HLA-DR Antigens; Histamine H1 Antagonists; Humans; Immunophenotyping; Interleukin-3 Receptor alpha Subunit; Leukocyte Common Antigens; Male; Middle Aged
PubMed: 32372634
DOI: 10.18502/ijaai.v19i2.2774 -
PloS One 2019We aimed to describe medication use in pregnancies that resulted in births and abortions, as well as use after a pregnancy-related visit to characterize the receipt of...
We aimed to describe medication use in pregnancies that resulted in births and abortions, as well as use after a pregnancy-related visit to characterize the receipt of medication after knowledge of pregnancy. Abortions included both spontaneous and induced abortions. Rates of medication use among women with a pregnancy outcome (2001-2013) were described using the Manitoba Population Research Data Repository at the Manitoba Centre for Health Policy. Use was determined as ≥ 1 prescription filled during pregnancies that resulted in births (livebirth/stillbirth) and abortions. Rates were calculated at any time during pregnancy and after a pregnancy-related visit. Rates were additionally characterized by risk in pregnancy using Briggs classification (2017). Of 174,848 birth pregnancies, overall 64.9% filled ≥ 1 prescription during pregnancy (a significant increase from 62.3% to 68.8% from 2001-2013, p<0.0001); 55.4% filled ≥ 1 prescription after a pregnancy-related visit. Of 71,967 abortions, 44.7% filled ≥ 1 prescription (a significant increase from 42.6% to 46.8% from 2001-2013, p<0.0001). Only 3.7% of birth pregnancies had at least one prescription for a contraindicated medication (according to Briggs classification), whereas 10.8% of abortions filled a prescription for a contraindicated medication. The most common drugs used in pregnancy were amoxicillin, doxylamine, codeine combinations, nitrofurantoin, cephalexin, salbutamol and ranitidine. Fewer women filled prescriptions for undesirable medications according to Briggs classification during pregnancy after a pregnancy-related visit.
Topics: Abortion, Spontaneous; Adult; Canada; Female; Humans; Manitoba; Parturition; Pregnancy; Pregnancy Outcome; Prescription Drugs; Prescriptions; Retrospective Studies
PubMed: 30840711
DOI: 10.1371/journal.pone.0211319 -
Journal of Investigational Allergology... Dec 2018
Topics: Adult; Basophils; Doxylamine; Female; Humans; Hypersensitivity; Pregnancy
PubMed: 30530395
DOI: 10.18176/jiaci.0311 -
Drug Testing and Analysis May 2019Untargeted toxicological screening is an analytical challenge, given the high number of molecules and metabolites to be detected and the constant appearance of new...
Untargeted toxicological screening is an analytical challenge, given the high number of molecules and metabolites to be detected and the constant appearance of new psychoactive substances (NPS). The combination of liquid chromatography with high-resolution tandem mass spectrometry (HRMS/MS) in a data-dependent acquisition mode generates a large volume of high quality spectral data. Commercial software for processing MS data acquired during untargeted screening experiments usually compare measured features (mass, retention time, and fragmentation spectra) against a predefined list of analytes. However, there is a lack of tools for visualizing and organizing MS data of unknown compounds. Here, we applied molecular networking to untargeted toxicological screening. This bioinformatic tool allows the exploration and organization of MS/MS data without prior knowledge of the sample's chemical composition. The organization of spectral data is based on spectral similarity. Hence, important information can be obtained even before the annotation step. The link established between molecules enables the propagation of structural information. We applied this approach to three clinical and forensic cases with various matrices: (a) blood and a syringe content in a forensic case of death by self-injection, (b) hair segments in a case of drug-facilitated assault, and (c) urine and blood samples in a case of 3-methoxyphencyclidine intoxication. Data preprocessing with MZmine allows sample-to-sample comparison and generation of multisample molecular networks. Our present study shows that molecular networking can be a useful complement to conventional approaches for untargeted screening interpretation, for example for xenobiotics identification or NPS metabolism elucidation.
Topics: Adolescent; Antiemetics; Chlormequat; Designer Drugs; Doxylamine; Female; Forensic Toxicology; Humans; Male; Middle Aged; Phencyclidine; Tandem Mass Spectrometry; Young Adult
PubMed: 30468699
DOI: 10.1002/dta.2550 -
American Family Physician Nov 2018Women often see their primary care physicians for common acute conditions during pregnancy. These conditions may be caused by pregnancy (obstetric problems) or worsened... (Review)
Review
Women often see their primary care physicians for common acute conditions during pregnancy. These conditions may be caused by pregnancy (obstetric problems) or worsened by pregnancy (obstetrically aggravated problems), or they may require special consideration during pregnancy because of maternal or fetal risks (nonobstetric problems). Primary care physicians should know the differential diagnosis for common conditions during pregnancy and recognize the important findings of obstetric and urgent nonobstetric problems. The family physician can evaluate and treat most nonobstetric problems, although obstetric problems require referral to a primary maternity care clinician. A tiered approach, including routinely looking for all-cause red flag symptoms and signs, while remaining aware of estimated gestational age, allows for high-quality care and shared decision making between the family physician and the pregnant patient. When treating common causes of nausea and epigastric pain/gastroesophageal reflux, lifestyle modifications are considered the safest and first-choice therapy, followed by well-established low-risk therapies, such as vitamin B6 (pyridoxine) and doxylamine for nausea, and antacids not containing salicylates (found in bismuth combination products) for gastroesophageal reflux. Other common conditions during pregnancy are best treated with low-risk therapies, such as using antihistamines or topical steroids for rashes, first-generation cephalosporins or amoxicillin for cystitis, and physical therapy and acetaminophen for low back pain and headaches.
Topics: Acute Disease; Diagnosis, Differential; Female; Humans; Pregnancy; Pregnancy Complications; Primary Health Care
PubMed: 30325641
DOI: No ID Found -
Drugs in R&D Jun 2018Doxylamine tablets are approved as an over-the-counter sleep aid. We developed a doxylamine succinate intranasal metered-dose delivery system with the expectation of a... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Doxylamine tablets are approved as an over-the-counter sleep aid. We developed a doxylamine succinate intranasal metered-dose delivery system with the expectation of a more rapid onset of action with reduced side-effect potential compared with the oral tablet.
METHODS
This phase I study randomized 24 adults with chronic intermittent sleep impairment to receive either single doses of intranasal doxylamine succinate 3.2, 6.3, or 12.7 mg or doxylamine succinate 25-mg oral tablet. Doxylamine pharmacokinetics were assessed using noncompartmental methods; pharmacodynamics were evaluated using the Karolinska Sleepiness Scale (KSS) and numerous psychomotor tests. Adverse events (AEs) were monitored.
RESULTS
None of the intranasal dose levels produced a mean maximum plasma concentration (C) above the 50 ng/mL target level or a time to maximum concentration shorter than that of the oral tablet. At the highest intranasal dose, C and area under the doxylamine concentration-time curve were approximately 25% of the values achieved with the oral dose. Variation in most pharmacokinetic parameters was higher with intranasal compared with oral dosing. A relationship between plasma doxylamine concentration and KSS change from baseline was evident for the 25-mg tablet and, to a lesser extent, for the 12.7-mg intranasal dose. Changes from baseline in psychomotor parameters did not show a relationship to intranasal dose, and did not distinguish between intranasal versus oral dosing. The most common AEs with intranasal dosing were nasal congestion, nasal dryness, and frontal headache.
CONCLUSION
The nasal spray did not increase doxylamine absorption or systemic bioavailability compared with the oral tablet.
Topics: Administration, Intranasal; Administration, Oral; Adolescent; Adult; Biological Availability; Cross-Over Studies; Dose-Response Relationship, Drug; Doxylamine; Female; Histamine H1 Antagonists; Humans; Male; Metered Dose Inhalers; Middle Aged; Sleep Initiation and Maintenance Disorders; Young Adult
PubMed: 29671128
DOI: 10.1007/s40268-018-0232-1 -
Acta Pharmaceutica (Zagreb, Croatia) Mar 2018The prediction power of partial least squares (PLS) and multivariate curve resolution-alternating least squares (MCR-ALS) methods have been studied for simultaneous...
The prediction power of partial least squares (PLS) and multivariate curve resolution-alternating least squares (MCR-ALS) methods have been studied for simultaneous quantitative analysis of the binary drug combination - doxylamine succinate and pyridoxine hydrochloride. Analysis of first-order UV overlapped spectra was performed using different PLS models - classical PLS1 and PLS2 as well as partial robust M-regression (PRM). These linear models were compared to MCR-ALS with equality and correlation constraints (MCR-ALS-CC). All techniques operated within the full spectral region and extracted maximum information for the drugs analysed. The developed chemometric methods were validated on external sample sets and were applied to the analyses of pharmaceutical formulations. The obtained statistical parameters were satisfactory for calibration and validation sets. All developed methods can be successfully applied for simultaneous spectrophotometric determination of doxylamine and pyridoxine both in laboratory-prepared mixtures and commercial dosage forms.
Topics: Calibration; Doxylamine; Drug Compounding; Least-Squares Analysis; Multivariate Analysis; Pyridoxine; Spectrophotometry
PubMed: 29453910
DOI: 10.2478/acph-2018-0008 -
PloS One 2018Doxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed. We re-analysed the findings of a... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Doxylamine-pyridoxine is recommended as a first line treatment for nausea and vomiting during pregnancy and it is commonly prescribed. We re-analysed the findings of a previously reported superiority trial of doxylamine-pyridoxine for the treatment of nausea and vomiting during pregnancy using the clinical study report obtained from Health Canada.
METHODS AND FINDINGS
We re-analysed individual level data for a parallel arm randomized controlled trial that was conducted in six outpatient obstetrical practices in the United States. Pregnant women between 7 and 14 weeks of gestation with moderate nausea and vomiting of pregnancy symptoms. The active treatment was a tablet containing both doxylamine 10 mg and pyridoxine 10 mg taken between 2 and 4 times per day for 14 days depending on symptoms. The control was an identical placebo tablet taken using the same instructions. The primary outcome measure was improvement in nausea and vomiting of symptoms scores using the 13-point pregnancy unique quantification of emesis scale between baseline and 14 days using an ANCOVA. 140 participants were randomized into each group. Data for 131 active treatment participants and 125 control participants were analysed. On the final day of the trial, 101 active treatment participants and 86 control participants provided primary outcome measures. There was greater improvement in symptoms scores with doxylamine-pyridoxine compared with placebo (0.73 points; 95% CI 0.21 to 1.25) when last observation carried forward imputation was used for missing data but the difference is not statistically significant using other approaches to missing data (e.g. 0.38; 95% CI -0.08 to 0.84 using complete data).
CONCLUSIONS
There is a trend towards efficacy for nausea and vomiting symptoms with doxylamine-pyridoxine compared with placebo but the statistical significance of the difference depends on the method of handling missing data and the magnitude of the difference suggests that there is no clinically important benefit employing the prespecified minimal clinically important difference or "expected difference" of 3 points.
TRIAL REGISTRATION
Clinical Trial NCT00614445.
Topics: Doxylamine; Drug Therapy, Combination; Female; Humans; Morning Sickness; Placebos; Pregnancy; Pyridoxine
PubMed: 29342163
DOI: 10.1371/journal.pone.0189978