scholarly journals WOMAN-PharmacoTXA trial: Study protocol for a randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral administration of tranexamic acid in women giving birth by caesarean section

2021 ◽  
Vol 6 ◽  
pp. 157
Author(s):  
Monica Arribas ◽  
Ian Roberts ◽  
Rizwana Chaudhri ◽  
Amber Geer ◽  
Danielle Prowse ◽  
...  
Keyword(s):  
Caesarean Section ◽  
Oral Administration ◽  
Tranexamic Acid ◽  
Pregnant Women ◽  
Umbilical Cord ◽  
Controlled Trial ◽  
Maternal Blood ◽  
Oral Solution ◽  
Adult Women ◽  
Intravenous And Oral Administration

Background: Intravenous tranexamic acid (TXA) within 3 hours of birth significantly reduces death due to bleeding in women with postpartum haemorrhage (PPH). Most PPH deaths occur in the first hours after giving birth and treatment delay decreases survival.  One barrier to rapid TXA treatment is the need for intravenous injection. Intramuscular injection and oral solution of TXA would be easier and faster to administer and would require less training. However, the pharmacokinetics (PK), pharmacodynamics and safety of TXA administered by different routes in pregnant women have not been established. The main aim of this study is to ascertain whether IM and oral solution of TXA will be absorbed at levels sufficient to inhibit fibrinolysis in pregnant women. Methods: WOMAN-PharmacoTXA is a prospective, randomised, open label trial to be conducted in Zambia and Pakistan.  Adult women undergoing caesarean section with at least one risk factor for PPH will be included.  Women will be randomised to receive one of the following about 1 hour prior to caesarean section: 1-gram TXA IV, 1-gram TXA IM, 4-grams TXA oral solution or no TXA. Randomisation will continue until 120 participants with at least six post randomisation PK samples are included. TXA concentration in maternal blood samples will be measured at baseline and at different time points during 24 hours after receipt of intervention. Blood TXA concentration will be measured from the umbilical cord and neonate. The primary endpoint is maternal blood TXA concentrations over time. Secondary outcomes include umbilical cord and neonate TXA concentration D-dimer concentration, blood loss and clinical diagnosis of PPH, injection site reactions and maternal and neonate adverse events. Discussion: The WOMAN-PharmacoTXA trial will provide important data on pharmacokinetics, pharmacodynamics and safety of TXA after IV, intramuscular and oral administration in women giving birth by caesarean section. Trial registration: ClincalTrials.gov, NCT04274335 (18/02/2020).

scholarly journals Oral administration of maternal vaginal microbes at birth to restore gut microbiome development in infants born by caesarean section: A pilot randomised placebo-controlled trial

EBioMedicine ◽  
2021 ◽  
Vol 69 ◽  
pp. 103443
Author(s):  
Brooke C. Wilson ◽  
Éadaoin M. Butler ◽  
Celia P. Grigg ◽  
José G.B. Derraik ◽  
Valentina Chiavaroli ◽  
...  
Keyword(s):  
Caesarean Section ◽  
Oral Administration ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Microbiome Development

scholarly journals Vitamin A intake of Brazilian mothers and retinol concentrations in maternal blood, human milk, and the umbilical cord

2018 ◽  
Vol 46 (4) ◽  
pp. 1555-1569 ◽  
Author(s):  
Thalia Manfrin Martins Deminice ◽  
Ivan Savioli Ferraz ◽  
Jacqueline Pontes Monteiro ◽  
Alceu Afonso Jordão ◽  
Lívia Maria Cordeiro Simões Ambrósio ◽  
...  
Keyword(s):  
Breast Milk ◽  
Vitamin A ◽  
Human Milk ◽  
Pregnant Women ◽  
Umbilical Cord ◽  
Maternal Blood ◽  
Maternal Serum ◽  
Serum Retinol ◽  
Cross Sectional ◽  
Blood Samples

Objectives To analyse intake of vitamin A (VA) and retinol concentrations in maternal blood, breast milk (BM), and the umbilical cord (UC) of newborns, and to determine the associations among these variables. Methods We performed a cross-sectional, epidemiological study of 180 mother–newborn dyads. Maternal and UC blood samples and BM were collected. VA intake by the mother over 30 days was assessed using a questionnaire. Results Mean retinol concentrations in maternal serum, the UC, and BM were 0.65 ± 0.27, 0.36 ± 0.18, and 2.95 ± 2.70 µmol/L, respectively. Retinol concentrations <0.70 µmol/L were found in 57.2% of maternal blood samples and in 94.9% of UC samples. A total of 27.9% of BM samples showed retinol concentrations <1.05 µmol/L. Mean VA intake by the mothers was 1041.33 ± 1187.86 µg retinol activity equivalents/day and was inadequate (<550 µg retinol activity equivalents/day) in 44.7%. Conclusions High proportions of insufficient retinol concentrations were observed in the UC, maternal blood, and BM. A high percentage of pregnant women had inadequate VA intake. Mothers with insufficient serum retinol concentrations had newborns with lower retinol concentrations in the UC. Higher retinol concentrations were observed in maternal blood and the UC with a higher VA intake.

A Randomized Controlled Trial of Oral Administration of Tetanus Toxoid (TT) Versus Tetanus and Reduced Diphtheria (Td) in Pregnant Women

2009 ◽  
Vol 29 (4) ◽  
pp. 524-531 ◽  
Author(s):  
Maha M. Salama ◽  
Osama A. W. Hady ◽  
Wael Ashour ◽  
Amal Mostafa ◽  
Sahar El Alkamy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Oral Administration ◽  
Pregnant Women ◽  
Tetanus Toxoid ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals Congenital, Intrapartum and Postnatal Maternal-Fetal-Neonatal SARS-CoV-2 Infections: A Narrative Review

Nutrients ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3570
Author(s):  
Rafael A. Caparros-Gonzalez ◽  
María Angeles Pérez-Morente ◽  
Cesar Hueso-Montoro ◽  
María Adelaida Álvarez-Serrano ◽  
Alejandro de la Torre-Luque
Keyword(s):  
Amniotic Fluid ◽  
Pregnant Women ◽  
Umbilical Cord ◽  
Case Reports ◽  
Controlled Trial ◽  
Case Series ◽  
Narrative Review ◽  
Before And After ◽  
Positive Results ◽  
Cervical Secretion

Background: There is inconclusive evidence regarding congenital, intrapartum, and postnatal maternal-fetal-neonatal SARS-CoV-2 infections during the COVID-19 pandemic. A narrative review was conducted with the aim of guiding clinicians on the management of pregnant women with respect to congenital, intrapartum, and postnatal maternal-fetal-neonatal SARS-CoV-2 infections and breastfeeding during the COVID-19 pandemic. Methods: Searches were conducted in Web of Science, PubMed, Scopus, Dialnet, CUIDEN, Scielo, and Virtual Health Library to identify observational, case series, case reports, and randomized controlled trial studies assessing the transmission of SARS-CoV-2 from mother to baby and/or through breastfeeding during the COVID-19 pandemic. Results: A total of 49 studies was included in this review, comprising 329 pregnant women and 331 neonates (two pregnant women delivered twins). The studies were performed in China (n = 26), USA (n = 7), Italy (n = 3), Iran (n = 2), Switzerland (n = 1), Spain (n = 1), Turkey (n = 1), Australia (n = 1), India (n = 1), Germany (n = 1), France (n = 1), Canada (n = 1), Honduras (n = 1), Brazil (n = 1), and Peru (n = 1). Samples from amniotic fluid, umbilical cord blood, placenta, cervical secretion, and breastmilk were collected and analyzed. A total of 15 placental swabs gave positive results for SARS-CoV-2 ribonucleic acid (RNA) on the fetal side of the placenta. SARS-CoV-2 RNA was found in seven breastmilk samples. One umbilical cord sample was positive for SARS-CoV-2. One amniotic fluid sample tested positive for SARS-CoV-2. Conclusions: This study presents some evidence to support the potential of congenital, intrapartum, and postnatal maternal-fetal-neonatal SARS-CoV-2 infections during the COVID-19 pandemic. Mothers should follow recommendations including wearing a facemask and hand washing before and after breastfeeding.

Higher Levels of Triglyceride, Fatty Acid Translocase, and Toll-Like Receptor 4 and Lower Level of HDL-C in Pregnant Women with GDM and Their Close Correlation with Neonatal Weight

2021 ◽  
pp. 1-7
Author(s):  
Jianli Zhou ◽  
Jie Bai ◽  
Yanjuan Guo ◽  
Lijun Fu ◽  
Jun Xing
Keyword(s):  
Cord Blood ◽  
Pregnant Women ◽  
Umbilical Cord ◽  
Umbilical Cord Blood ◽  
Venous Blood ◽  
Density Lipoprotein ◽  
Maternal Blood ◽  
Control Group ◽  
Case Group ◽  
Toll Like Receptor 4

<b><i>Objectives:</i></b> In this study, we aimed to compare the levels of maternal blood lipids, placental and venous blood lipid transporters, and inflammatory factor receptors in pregnant women with and without gestational diabetes mellitus (GDM). We also aimed to figure out the relationship between these values and neonatal weight. <b><i>Methods:</i></b> Fifty pregnant women with GDM under blood glucose control belong to the case group, and 50 pregnant women with normal glucose tolerance in concurrent delivery belong to the control group. Fasting venous blood of these pregnant women was taken 2 weeks before delivery, and umbilical cord blood was collected after delivery. The levels of triglyceride (TG), serum total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol (HDL-C) in maternal blood and umbilical cord blood were tested in the laboratory department of our hospital. The level of toll-like receptor 4 (TLR4) in serum of umbilical veins was detected by the double-antibody sandwich ELISA. Western blot and RT-PCR were used to detect the protein and mRNA expressions of TLR4, LPL, and FAT/CD36 in the placenta. <b><i>Results:</i></b> The level of TG in maternal blood in the case group was remarkably higher than that in the control group, which was opposite to the level of HDL-C. In the umbilical cord blood of women with GDM, the expression of TLR4 increased and was closely correlated with neonatal weight. In the placenta of women with GDM, the expressions of FAT/CD36 and TLR4 increased, and both of them were closely correlated with neonatal weight. Besides, TLR4 in umbilical cord blood increased and was closely correlated with neonatal weight. Although the expression of LPL in the placenta decreased, it had no obvious correlation with neonatal weight. <b><i>Conclusions:</i></b> TG in maternal blood, TLR4 in the placenta and umbilical cord blood, and FAT/CD36 in the placenta were positively correlated with neonatal weight. However, HDL-C in maternal blood was negatively correlated with neonatal weight. Although the expression of LPL in the placenta reduced due to GDM, it had no correlation with neonatal weight.

scholarly journals Influence of timing of maternal antibiotic administration during caesarean section on infant microbial colonisation: a randomised controlled trial

Gut ◽  
2021 ◽  
pp. gutjnl-2021-324767
Author(s):  
Thomas Dierikx ◽  
Daniel Berkhout ◽  
Anat Eck ◽  
Sebastian Tims ◽  
Johan van Limbergen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Caesarean Section ◽  
Umbilical Cord ◽  
Controlled Trial ◽  
Skin Incision ◽  
Control Group ◽  
Antibiotic Administration ◽  
Cord Clamping ◽  
Umbilical Cord Clamping ◽  
Randomised Controlled

ObjectiveRevised guidelines for caesarean section (CS) advise maternal antibiotic administration prior to skin incision instead of after umbilical cord clamping, unintentionally exposing the infant to antibiotics antenatally. We aimed to investigate if timing of intrapartum antibiotics contributes to the impairment of microbiota colonisation in CS born infants.DesignIn this randomised controlled trial, women delivering via CS received antibiotics prior to skin incision (n=20) or after umbilical cord clamping (n=20). A third control group of vaginally delivering women (n=23) was included. Faecal microbiota was determined from all infants at 1, 7 and 28 days after birth and at 3 years by 16S rRNA gene sequencing and whole-metagenome shotgun sequencing.ResultsCompared with vaginally born infants, profound differences were found in microbial diversity and composition in both CS groups in the first month of life. A decreased abundance in species belonging to the genera Bacteroides and Bifidobacterium was found with a concurrent increase in members belonging to the phylum Proteobacteria. These differences could not be observed at 3 years of age. No statistically significant differences were observed in taxonomic and functional composition of the microbiome between both CS groups at any of the time points.ConclusionWe confirmed that microbiome colonisation is strongly affected by CS delivery. Our findings suggest that maternal antibiotic administration prior to CS does not result in a second hit on the compromised microbiome. Future, larger studies should confirm that antenatal antibiotic exposure in CS born infants does not aggravate colonisation impairment and impact long-term health.

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