Comparative Evaluation of Anaesthetic Efficacy of conventional Lignocaine, sodium Bicarbonate-Buffered Lignocaine, lignocaine with Magnesium Sulphate in Inferior Alveolar Nerve Block for Patients with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial - CCT

Start Date03 Mar 2026

Sponsor / Collaborator-

100 Clinical Results associated with Magnesium Sulfate

100 Translational Medicine associated with Magnesium Sulfate

100 Patents (Medical) associated with Magnesium Sulfate

20,301

Literatures (Medical) associated with Magnesium Sulfate

31 Dec 2026·Journal of Maternal-Fetal & Neonatal Medicine

Does magnesium sulfate affect duration of labor for nulliparous patients undergoing induction of labor for hypertensive disorders of pregnancy at term? ^#

Article

Author: Lee, Daniel ; Negi, Masaru ; Mei, Jenny Y.

OBJECTIVE:

Magnesium sulfate is administered intrapartum for seizure prophylaxis in patients with preeclampsia with severe features. We aimed to quantify the effect of magnesium sulfate on duration of labor induction in nulliparous patients undergoing induction of labor for hypertensive disorders of pregnancy at term gestation.

METHODS:

This retrospective cohort study was a secondary analysis from the Consortium on Safe Labor, a multicenter cohort study of 228,438 deliveries in 19 U.S. hospitals. The analysis included nulliparous patients ≥ 18 years old with singleton gestation undergoing induction of labor for hypertensive disorders of pregnancy with delivery at ≥37 weeks gestation. Primary outcome was duration of labor induction, defined as time in hours (h) from initiation of induction to delivery, between patients who received magnesium sulfate and those who did not. Secondary outcomes were rate of cesarean delivery and perinatal outcomes.

RESULTS:

Total 5,886 patients met inclusion criteria, of whom 2102 (35.7%) received magnesium sulfate intrapartum. Median duration of labor induction was significantly longer in the magnesium cohort (16.8h, IQR 10.3h-25.3h vs 15.0h, IQR 9.0h-22,9h; p < 0.001). Multivariate logistic regression controlling for baseline characteristics different between groups found that magnesium use was significantly associated with labor length over 12 h (adjusted odds ratio [aOR] 1.36; 95% confidence interval [CI] 1.21-1.54; p < 0.001) as well as over 24 h (aOR, 1.44; 95% CI, 1.26-1.64; p < 0.001). The overall rate of CD was 39.2% in the cohort. Magnesium use was not associated with higher rate of CD (p = 0.58) but was associated with longer maternal length of stay (p < 0.001) and higher rate of endometritis (p < 0.001). Magnesium use was associated with higher rates of neonatal intensive care unit admission (p < 0.001), 5-minute APGAR ≤ 7 (p < 0.001), respiratory distress syndrome (p < 0.001), and composite neonatal morbidity (p < 0.001).

CONCLUSION:

Magnesium sulfate administration is significantly associated with longer induction of labor length amongst patients undergoing induction for hypertension, though it did not impact mode of delivery. Appropriate care should be taken in expeditiously managing labor for this high-risk patient cohort.

01 Mar 2026·Case reports in women's health

Bradycardia in the setting of postpartum preeclampsia and influenza A: A case report

Article

Author: Deighton-Collins, Sarah ; Rahmon, Dalia ; Dubay, Kelly

Postpartum bradycardia is a rare clinical finding, with limited guidance regarding its evaluation and management. Prior literature suggests that postpartum bradycardia is most commonly associated with preeclampsia, underlying cardiac disease, medication effects, or neuraxial anesthesia. In patients with preeclampsia, management may be particularly challenging, as magnesium sulfate-used for seizure prophylaxis-is theorized to exacerbate bradycardia. This report concerns the case of a 33-year-old woman (G3P3003) with an otherwise uncomplicated pregnancy and cesarean delivery who was diagnosed with Influenza A on postpartum day 1 and treated with oseltamivir. She was readmitted on postpartum day 7 with epigastric pain and shortness of breath and was found to have severe sinus bradycardia (heart rate 32-42 beats per minute) and highly elevated blood pressure, consistent with new-onset postpartum preeclampsia with severe features. Cardiac evaluation, including electrocardiography and transthoracic echocardiography, revealed no structural or ischemic abnormalities. The patient was treated with magnesium sulfate for seizure prophylaxis and antihypertensive therapy. Despite persistent bradycardia, she remained hemodynamically stable, and her heart rate gradually normalized over three days without additional intervention. She was discharged in stable condition and remained asymptomatic at follow-up. This case highlights postpartum bradycardia as a potential presenting sign of delayed-onset preeclampsia, even following a normotensive pregnancy. Although magnesium sulfate and recent influenza infection were considered as contributing factors, the clinical course supported preeclampsia as the primary etiology. Postpartum bradycardia is often benign and self-limited; however, thorough evaluation is essential to exclude cardiac pathology and guide appropriate management.

01 Mar 2026·HUMAN IMMUNOLOGY

Modulatory effect of magnesium sulfate on NLRP3 inflammasome expression by human monocytes stimulated in vitro with monosodium urate

Article

Author: Peracoli, Maria Terezinha Serrao ; Franco, Gabriela de Oliveira ; de Oliveira, Larissa Ragozo Cardoso ; Peracoli, José Carlos ; Ribeiro-Vasques, Vanessa Rocha ; Braga da Silva, Patricia ; Romao-Veiga, Mariana

The NLRP3 inflammasome contributes to inflammation in preeclampsia (PE), a hypertensive pregnancy disorder associated with immune imbalance. Magnesium sulfate (MgSO₄), the standard therapy for eclampsia, also exhibits anti-inflammatory properties linked to intracellular calcium regulation. This study investigated the modulatory effect of MgSO₄ on NLRP3 inflammasome expression in monocytes from 16 healthy non-pregnant women stimulated with monosodium urate (MSU). Monocytes were cultured in vitro with or without MSU and MgSO₄. Gene and protein expression of NLRP3, caspase-1, and gasdermin D were assessed by RT-qPCR and flow cytometry. The concentrations of IL-1β, IL-18, TNF-α, and IL-10 in culture supernatants were measured using ELISA. MSU stimulation increased the expression of NLRP3 and its components, confirming the activation of the inflammasome. Treatment with MgSO₄ significantly reduced the expression of NLRP3, caspase-1, gasdermin D, IL-1β, and TNF-α, while increasing IL-10 levels. Additionally, MSU induced intracellular calcium elevation, whereas MgSO₄ significantly decreased calcium concentration. These findings demonstrate that MgSO₄ exerts an immunomodulatory effect on MSU-activated monocytes by downregulating NLRP3 inflammasome activation, pyroptosis, and proinflammatory cytokine production through a calcium-dependent mechanism. This suggests that MgSO₄ may contribute to reducing the exaggerated inflammatory response associated with PE, supporting its therapeutic actions beyond seizure prevention.

News (Medical) associated with Magnesium Sulfate

25 Nov 2025

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New IV Solutions Manufacturing Plant Setup Report 2025 Released: Step-by-Step Investment Guide for Entrepreneurs

BROOKLYN, NY, UNITED STATES, November 25, 2025 / EINPresswire.com / -- Setting up IV solutions manufacturing plant presents an excellent opportunity for entrepreneurs, investors, and MSMEs aiming to tap into the rapidly growing pharmaceutical, healthcare, hospital, clinical, and emergency medical sectors. IV solutions (intravenous solutions), essential for fluid replacement, electrolyte balance, medication delivery, nutritional support, and critical care treatment in hospitals, clinics, emergency care facilities, and various medical applications, are critical products with consistent demand worldwide. With the rising demand for advanced healthcare infrastructure, increased hospital admissions, growing chronic disease prevalence, expanding surgical procedures, and the expansion of the pharmaceutical and healthcare industry, establishing IV solutions manufacturing unit can be both profitable and sustainable. IMARC Group's report, " IV Solutions Manufacturing Plant Project Report 2025: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue," offers a comprehensive guide for establishing a manufacturing plant. The IV solutions manufacturing plant report offers insights into the manufacturing process, financials, capital investment, expenses, ROI, and more for informed business decisions. What are IV Solutions? IV solutions are sterile pharmaceutical preparations designed for administration directly into the bloodstream via intravenous infusion, enabling rapid fluid replacement, electrolyte correction, drug delivery, and nutritional support in medical and clinical settings. IV solutions are fundamental pharmaceutical products in health care due to their exceptional purity, sterility, precise composition and biocompatibility. Modern IV solutions are typically manufactured from pharmaceutical-grade water, electrolytes, dextrose, and active pharmaceutical ingredients obtained from certified suppliers, which are processed under strictly controlled aseptic conditions to ensure quality and safety compliance. IV solutions provide superior therapeutic efficacy and patient safety while providing excellent stability for a variety of medical and clinical applications. They are classified into various types including crystalloid solutions, colloid solutions, isotonic solutions, hypotonic solutions, hypertonic solutions, dextrose solutions, normal saline, Ringer lactate, parenteral nutrition solutions and special formulations for rehydration therapy, shock management, surgical procedures, critical care, paediatric care and chemotherapy administration. Understanding IV Solutions and Their Growing Demand IV solutions are manufactured through processes involving water purification, ingredient preparation, compounding and mixing, filtration, sterilization, aseptic filling, container sealing, inspection, quality testing, and packaging. The process combines pharmaceutical engineering expertise with aseptic processing technologies to create high-quality, sterile products suitable for demanding medical and diagnostic applications. Commonly produced varieties include normal saline (0.9% sodium chloride), dextrose solutions (5%, 10%, 25%, 50%), Ringer's lactate, Ringer's solution, dextrose-saline combinations, electrolyte replacement solutions, parenteral nutrition formulations, and custom pharmaceutical formulations for specific medical indications in hospitals, clinics, ambulatory care centers, and emergency medical services. The global demand for IV solutions is increasing rapidly due to the expansion of healthcare infrastructure across the globe, increasing hospital admissions, increase in surgical procedures, increasing prevalence of chronic diseases requiring intravenous therapy and expansion of emergency medical services. Health care providers and medical facilities demand high-quality IV solutions offering superior sterility, precise formulation, excellent stability and compliance with international pharmaceutical quality and safety standards. With advances in IV solution technology, including ready-to-use multi-chamber bags, non-PVC containers, preservative-free formulations, and closed-system transfer devices, the IV solutions industry has become important to the pharmaceutical, health care, hospital, emergency medicine, and home health care sectors. Ask Analyst for Customization: https://www.imarcgroup.com/request?type=report&id=12020&flag=C Raw Material Requirements for IV Solutions Production Understanding raw material requirements is the foundation of setting up IV solutions manufacturing plant. The quality and type of materials directly influence the sterility, safety, and therapeutic efficacy of the final product. 1. Primary Raw Materials Purified Water for Injection (WFI): Ultra-pure, pyrogen-free water meeting USP/EP standards serving as the primary solvent for all IV solution formulations. Sodium Chloride: Pharmaceutical-grade sodium chloride (USP/BP) for normal saline and electrolyte solutions. Dextrose (Glucose): Pharmaceutical-grade anhydrous or monohydrate dextrose for energy-providing solutions. Electrolyte Compounds: Pharmaceutical-grade potassium chloride, calcium chloride, magnesium sulfate, sodium lactate, and sodium acetate for electrolyte replacement solutions. 2. Secondary Raw Materials and Components • Buffer Systems: Phosphate buffers, citrate buffers, and pH adjusters for maintaining solution stability and physiological pH. • Amino Acids: Pharmaceutical-grade amino acid solutions for parenteral nutrition formulations. • Lipid Emulsions: Sterile lipid preparations for total parenteral nutrition (TPN) solutions. • Vitamins and Trace Elements: Pharmaceutical-grade vitamin complexes and trace mineral additives for nutritional solutions. • Active Pharmaceutical Ingredients: Various medications for medicated IV solutions (antibiotics, analgesics, antiemetics) as per formulation requirements. • Packaging Materials: Medical-grade PVC bags, non-PVC bags, glass bottles, polyethylene containers with sterile closures and administration sets. • Rubber Stoppers and Closures: Pharmaceutical-grade elastomeric closures meeting sterility and extractables requirements. • Overpouch Materials: Protective aluminum or polyester-based overwraps for moisture and oxygen barrier. • Labels and Documentation: Pharmaceutical-grade labels with batch information, expiry dates, and regulatory compliance markings. A consistent supply of high-quality pharmaceutical-grade raw materials is essential to ensure uniform quality, sterility standards, and cost-effective production. Machinery Requirements for IV Solutions Manufacturing Choosing the right machinery ensures efficient production, sterility assurance, and minimal contamination risk. The level of automation (semi-automatic or fully automatic) depends on production capacity and budget. 1. Water Purification Systems - Multi-stage water treatment including reverse osmosis, ultrafiltration, electrodeionization, and distillation producing pharmaceutical-grade WFI. 2. Compounding and Mixing Vessels - Jacketed stainless steel mixing tanks with automated ingredient addition, temperature control, and homogenization systems. 3. Filtration Systems - Multiple-stage filtration including depth filters, membrane filters, and final sterilizing-grade 0.22-micron filters ensuring solution clarity and sterility. 4. Sterilization Equipment - High-capacity autoclaves or steam sterilizers with validated cycles for terminal sterilization of filled containers. 5. Aseptic Filling Lines - Automated filling machines operating in cleanroom environments with HEPA filtration, laminar airflow, and environmental monitoring. 6. Container Washing and Sterilization - Automated washing, rinsing, and depyrogenation tunnels for glass bottles and containers. 7. Sealing and Capping Machines - Automated sealing equipment for bags, bottles, and vials ensuring hermetic closure and container integrity. 8. Inspection Systems - Automated visual inspection equipment, particle detection systems, and leak testing machines ensuring product quality. 9. Labeling and Packaging Lines - Automated labeling machines, overwrap packaging equipment, and carton packaging systems. 10. Environmental Monitoring Systems - Cleanroom monitoring equipment including particle counters, microbial samplers, temperature and humidity monitors ensuring GMP compliance. 11. Testing and Quality Control Equipment - pH meters, osmometers, endotoxin testing systems, sterility testing isolators, HPLC systems, spectrophotometers, and analytical instruments ensuring consistent quality and regulatory compliance. Efficient machinery selection ensures higher output, minimal contamination risk, and consistent quality suitable for domestic and export markets. Production Process Overview The IV solutions manufacturing process involves several key stages to ensure quality, sterility, and consistency: 1. Raw Material Reception: Pharmaceutical-grade materials are received, quarantined, sampled, tested for quality and compliance, and approved for use. 2. Water Purification: Municipal or pre-treated water undergoes multi-stage purification producing pharmaceutical-grade Water for Injection (WFI) meeting USP/EP specifications. 3. Ingredient Preparation: Electrolytes, dextrose, and other ingredients are weighed accurately in controlled environments following validated procedures. 4. Compounding and Mixing: Ingredients are dissolved in WFI under controlled conditions with continuous mixing, temperature control, and pH adjustment. 5. Bulk Solution Filtration: Compounded solutions undergo multiple filtration stages removing particles and ensuring solution clarity. 6. Container Preparation: Containers (bags, bottles, vials) are washed, rinsed, depyrogenated, and sterilized before filling operations. 7. Aseptic Filling: Solutions are filled into sterile containers in aseptic processing areas under HEPA-filtered laminar airflow conditions. 8. Container Sealing: Filled containers are immediately sealed using validated heat-sealing or capping processes ensuring hermetic closure. 9. Terminal Sterilization: Sealed containers undergo autoclave sterilization using validated cycles achieving sterility assurance level (SAL) of 10⁻⁶. 10. Post-Sterilization Cooling: Sterilized containers are cooled under controlled conditions preventing thermal shock and container damage. 11. Visual Inspection: Each container undergoes automated and manual inspection for particulate matter, container integrity, fill volume, and seal quality. 12. Leak Testing: Random samples undergo leak testing ensuring container integrity and sterility maintenance. 13. Labeling: Approved containers receive pharmaceutical labels with batch numbers, manufacturing dates, expiry dates, and regulatory information. 14. Secondary Packaging: Labeled containers are placed in protective overwraps, packaged in cartons with product information and handling instructions. 15. Quality Testing: Comprehensive testing including sterility testing, bacterial endotoxin testing, pH testing, osmolality measurement, chemical analysis, and stability studies. 16. Quarantine and Release: Finished products are quarantined pending quality control approval and released after passing all specifications. 17. Storage and Distribution: Released products are stored in temperature-controlled warehouses and distributed through validated cold chain logistics. This comprehensive process ensures high-quality, sterile products with consistent quality and pharmaceutical regulatory compliance. Request for a Sample Report: https://www.imarcgroup.com/iv-solutions-manufacturing-plant-project-report/requestsample Cost Breakdown for Setting Up an IV Solutions Manufacturing Plant A well-planned cost breakdown helps assess project feasibility and profitability. The overall investment depends on plant size, automation level, and product range. 1. Land and Building - Space for raw material storage, water purification plant, compounding area, aseptic processing cleanrooms (Grade A/B/C/D), sterilization facility, quality control laboratory, warehouse facilities with proper HVAC systems, environmental controls, and GMP infrastructure. 2. Machinery and Equipment - Major investment areas include water purification systems, compounding vessels, filling lines, sterilization autoclaves, cleanroom facilities, inspection systems, and analytical instruments. Automation enhances sterility assurance but increases initial investment. 3. Raw Material Procurement - Pharmaceutical-grade electrolytes, dextrose, WFI, and packaging materials are sourced from certified suppliers. Long-term contracts with pharmaceutical ingredient manufacturers, chemical suppliers, or specialty material suppliers stabilize costs and ensure quality. 4. Utilities and Infrastructure - Electricity, purified water systems, HVAC for cleanrooms, compressed air, steam generation, chilled water, and waste treatment facilities are required for aseptic processing, sterilization, and environmental compliance. Efficient energy systems and water recycling reduce long-term operational costs. 5. Labor and Workforce - Includes skilled and semi-skilled labor for compounding operations, aseptic filling operations, quality control, microbiology, validation, regulatory affairs, and engineering support. 6. Maintenance and Spare Parts - Regular maintenance ensures smooth functioning of filling machines, autoclaves, water systems, and cleanroom facilities. 7. Administrative and Overhead Costs - Covers quality assurance, regulatory compliance, management, marketing, logistics, R&D, pharmaceutical validation, and export operations. A detailed cost analysis with ROI projections helps entrepreneurs identify investment opportunities and achieve optimal financial planning. Setup Cost Analysis and Financial Planning Conducting a thorough setup cost analysis allows investors to evaluate capital requirements and operating expenses. Fixed costs (machinery, land, building, cleanrooms) must be separated from variable costs (raw materials, labor, utilities). Financial projections, including break-even analysis and ROI, are essential for decision-making and funding strategies. Government incentives under pharmaceutical manufacturing schemes, MSME development, make in India, Amenabar Bharat, Production Linked Incentive (PLI) schemes for pharmaceuticals, and manufacturing promotion programs can significantly reduce project costs. Adopting energy-efficient manufacturing technologies, automated aseptic processing systems, water recycling, and lean manufacturing practices enhances profitability and competitiveness. Key Considerations for Setting Up IV Solutions Manufacturing Plant 1. Location: Choose proximity to pharmaceutical hubs, healthcare clusters, or industrial zones with reliable infrastructure to reduce transportation costs and ensure market access. 2. Quality Standards: Follow WHO GMP guidelines, ISO 13485, US FDA 21 CFR Part 210/211, European Pharmacopoeia standards, USP standards, and international pharmaceutical quality specifications. 3. Automation: Semi-automatic or fully automatic aseptic processing setups ensure better sterility assurance, consistency, productivity, and reduced contamination risk. 4. Market Analysis: Understand healthcare industry trends, hospital infrastructure growth, pharmaceutical market demand, emergency medical services expansion, and export opportunities. 5. Sustainability: Implement eco-friendly manufacturing processes, energy-efficient equipment, water recycling systems, waste minimization, and responsible material sourcing. 6. Product Diversification: Offer multiple product lines such as crystalloid solutions, colloid solutions, parenteral nutrition, paediatric formulations, and specialized medical solutions to expand market reach. 7. Technology and R&D: Invest in advanced aseptic processing technology, automated filling systems, and formulation development processes. 8. Supply Chain Management: Establish reliable sourcing relationships with certified pharmaceutical ingredient suppliers, packaging material manufacturers, and medical device vendors. Browse Related Reports: • Peanut Butter Manufacturing Plant: https://www.imarcgroup.com/peanut-butter-manufacturing-plant-project-report • Mushroom Farming Project Report: https://www.imarcgroup.com/mushroom-farming-project-report • Aluminium Recycling Plant: https://www.imarcgroup.com/aluminium-recycling-plant-project-report • Uranium Hexafluoride Production Plant Cost: https://www.imarcgroup.com/uranium-hexafluoride-manufacturing-plant-project-report • PVC Panel Manufacturing Plant: https://www.imarcgroup.com/pvc-panel-manufacturing-plant-project-report How IMARC Can Help IMARC Group is a global management consulting firm that helps the world's most ambitious changemakers to create a lasting impact. The company provide a comprehensive suite of market entry and expansion services. IMARC offerings include thorough market assessment, feasibility studies, company incorporation assistance, factory setup support, regulatory approvals and licensing navigation, branding, marketing and sales strategies, competitive landscape and benchmarking analyses, pricing and cost research, and procurement research. Elena Anderson IMARC Services Private Limited +1 201-971-6302 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

07 Nov 2025

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Project PROTECT Milestone: Angels for Change and STAQ Pharma Strengthen U.S. Supply of Magnesium Sulfate

Angels for Change announces a significant milestone in Project PROTECT that aims to anticipate and mitigate critical U.S. drug shortages through partnerships “We must stay ahead of shortages,” said Laura Bray, Founder of Angels for Change. “Project PROTECT is building a reliable, onshore, ready-to-activate safety net for patients.” — Laura Bray TAMPA, FLORIDA, UNITED STATES, November 6, 2025 / EINPresswire.com / -- Angels for Change is proud to announce a significant milestone in Project PROTECT, a program that aims to anticipate and mitigate critical U.S. drug shortages of essential medicines through non-profit partnership. STAQ Pharma, a hospital-owned 503B outsourcing facility and recipient of a 2025 Project PROTECT grant, has completed the Preparation and Protective phases for Magnesium Sulfate IV bags. Magnesium Sulfate is a lifesaving medication used in emergency care, maternal-fetal medicine, and critical care settings. Production readiness scheduled for December 1, 2025 will ensure rapid, U.S.-made, on-demand supply to protect patients during shortage. Magnesium Sulfate frequently appears on national drug shortage lists and is vital for treating severe asthma attacks, eclampsia, pre-eclampsia, and cardiac emergencies. Ensuring continuous access is essential for emergency departments, labor and delivery units, and intensive care teams nationwide. “We must stay ahead of shortages,” said Laura Bray, Founder of Angels for Change. “Project PROTECT is building a reliable, onshore, ready-to-activate safety net for patients. STAQ Pharma’s increased capacity and readiness strengthens the US supply chain and ensures care for mothers, infants, and emergency patients throughout the nation during shortage.” Strengthening the Medicine Supply Chain Against Shortages Launched in 2022, Project PROTECT proactively builds U.S. manufacturing capacity for patient-critical medicines at risk of shortage. The program has already helped ensure over 750,000 patient treatments during three national shortages and was named one of CNN’s top healthcare stories of 2023. STAQ Pharma’s Magnesium Sulfate readiness builds on earlier Project PROTECT awards to secure supplies of Furosemide and Bumetanide, medications vital for cardiac and renal care. Together, these efforts reinforce emergency preparedness and strengthen hospital readiness during supply chain disruptions. “By working with Angels for Change, we can prepare, anticipate, and close gaps before patients feel the impact of shortage,” said Mark Spiecker, President of STAQ Pharma. A key focus of Project PROTECT includes protecting vulnerable patient groups who face heightened risks from a delay in care. Ensuring stable access to Magnesium Sulfate is especially critical in maternal-fetal medicine, where timely treatment for eclampsia can prevent life-threatening complications for mothers and newborns. The impact of this work is deeply personal for Angels for Change Founder Laura Bray, who, like more than 50,000 mothers each year, relied on Magnesium Sulfate during childbirth — underscoring why proactive preparedness saves lives. About Project PROTECT Project PROTECT is a national program that provides grants to U.S.-based 503B outsourcing facilities to proactively prepare essential medicines at risk of shortage. By establishing ready-to-activate domestic capacity, the program strengthens national preparedness and protects patient access vulnerable therapies. Learn more: www.angelsforchange.org/project-protect About Angels for Change Angels for Change is a nonprofit patient-advocacy organization dedicated to ending drug shortages through advocacy, awareness, and a resilient supply chain. Angels for Change partners across healthcare, supply chain, manufacturing, and government to ensure patients receive lifesaving medicines when they need them. Learn more: www.angelsforchange.org About STAQ Pharma STAQ Pharma is a hospital-owned 503B outsourcing facility that supplies sterile injectable medications nationwide to support continuity of care and help providers navigate drug shortages. With two FDA-registered facilities, STAQ delivers high-quality ready-to-administer sterile injectables, IV bags, and syringes to healthcare systems across the United States. Learn more: www.staqpharma.com Shelby Trieu Angels for Change +1 813-501-7742 email us here Visit us on social media: LinkedIn Instagram Facebook Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

16 Sep 2025

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Novocuff Announces IDE Approval for the RETAIN Study

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Novocuff, Inc., a clinical-stage, maternal health medical device company, today announced approval from the U.S. Food and Drug Administration of its Investigational Device Exemption (IDE) application for the RETAIN Study. The study is a randomized, multicenter, pivotal trial evaluating the Novocuff Cervical Control System™ (CCS). The RETAIN study evaluates the safety and effectiveness of the Novocuff CCS, a medical device intended to retain amniotic fluid and extend gestation in singleton pregnancies complicated by preterm prelabor rupture of membranes (PPROM) as early as 24 weeks. The trial will be conducted at leading research hospitals across the U.S., enrolling up to 272 participants. Dr. Lisa Zuckerwise, Maternal Fetal Medicine (MFM) Specialist and Associate Professor, Department of OB/GYN, and Division Director of the MFM Program at the University of Virginia School of Medicine, and Dr. Dwight Rouse, MFM Specialist at Women’s & Infants Hospital of Rhode Island and faculty at the Warren Alpert Medical School at Brown University, are the Co-Principal Investigators for RETAIN. Dr. Zuckerwise explained, "RETAIN is an essential evaluation of a potential new treatment option for patients with PPROM, and I look forward to getting this important research underway.” PPROM, defined as prelabor rupture of the amniotic sac before 37 weeks gestation, affects 3-4% of pregnancies in the U.S. and accounts for nearly one-third of preterm births. It carries high risks for mothers and babies, including infection and many short and long-term complications of prematurity. Current treatment for PPROM includes antibiotics, corticosteroids, magnesium sulfate as appropriate, and inpatient monitoring. No treatment options for PPROM are intended to retain amniotic fluid. Participants allocated to the Novocuff CCS group will receive standard treatment in addition to the device. Additional therapies for PPROM are urgently needed. Dr. Rouse stated, "This approval marks a significant milestone in evaluating a potential new option for a condition where historically there has been a dearth of innovation." “IDE approval represents a foundational step toward our mission to improve outcomes for mothers and babies,” said Amelia Degenkolb, CEO of Novocuff. “We are committed to generating high-quality clinical evidence to evaluate the potential of this therapy to redefine the standard of care.” About Novocuff Novocuff, Inc., a privately held medical device company in residence at Fogarty Innovation, is pioneering an innovative treatment option for the condition of PPROM.

Clinical Study

100 Deals associated with Magnesium Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	D11AX05 A06AD04 A12CC02	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Electrolyte imbalance	Japan	Otsuka Pharmaceutical Factory, Inc.	13 Mar 2008
Pre-Eclampsia	United States	Hospira, Inc.	24 Jun 1994
Hypomagnesemia	Australia	Pfizer Australia Pty Ltd.	08 Oct 1991
Seizures	Australia	Pfizer Australia Pty Ltd.	08 Oct 1991
Hypomagnesemia 2, Renal	United States	Fresenius Kabi USA LLC	08 Sep 1986

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Localized swelling	Phase 1	China	Shijiazhuang Penghai Pharmaceutical Co., Ltd.	29 Dec 2023
Localized swelling	Phase 1	China	Shijiazhuang Xingze Pharmaceutical Technology Co., Ltd.	29 Dec 2023
Wounds and Injuries	IND Approval	China	Guangdong Maiheng Pharmaceutical R&D Co., Ltd.	12 Jun 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FAST-MAG (ISC2026)	Phase 3	Stroke	485	Magnesium sulfate	mxqenwmfvv(xvkzkwcwrq) = lbyjcclqua fnxandutgz (aieadmszas ) View more	Positive	04 Feb 2026
NCT06675500 (Magnesium AF, CTgov)	Phase 3	Atrial Fibrillation	130	Magnesium sulphate (Group A (Study Group))	lxkrgjnwad = abgzdixsqp trylrjcffm (hjukkglpml, ngiyhhmkhe - sfgcvxyekj) View more	-	17 Aug 2025
				Placebo (Group B (Control Group))	lxkrgjnwad = hrcnnelfrg trylrjcffm (hjukkglpml, nptaqwycvp - ivghhxormy) View more
NCT06603766 (PPHN, CTgov)	Phase 2/3	Pulmonary Arterial Hypertension	40	Inhalational magnesium sulfate (Nebulized Magnesium (NebMag) Group 1)	ubifweihzb(mircgsieci) = ieadnbtqxx oumztpbjxf (nvrtfuulgr, 1.29) View more	-	05 Feb 2025
				IV Magnesium Sulfate (Intravenous Magnesium (IVMag) Group 2)	ubifweihzb(mircgsieci) = wwwyfhlfvt oumztpbjxf (nvrtfuulgr, 1.18) View more
NCT05166811 (IMPACT-ED, CTgov)	Phase 2	Asthma	52	0.9% saline (Placebo)	qqbidmrdmd = dezilppfvh jqnxwvcijf (wzzkdhdgui, ktreywbhpe - rztrgequdu) View more	-	18 Dec 2024
				Magnesium Sulfate, Heptahydrate (50 mg/kg)	qqbidmrdmd = hrdzfwvgee jqnxwvcijf (wzzkdhdgui, cgssbcrcbd - qunuknlqql) View more
NCT05967442 (MAGraine, CTgov)	Phase 3	Acute migraine \| Headache	157	Magnesium sulfate (Magnesium)	abtpfazutz(ymykozyyqh) = eqxtuhanni pnxbkqnyna (aifzeydbdv, bosanbnrdq - fzomdojzgm) View more	-	01 Oct 2024
				Metoclopramide 10mg (Metoclopramide)	abtpfazutz(ymykozyyqh) = zepjjrshwv pnxbkqnyna (aifzeydbdv, avrumomebc - qrhjtetiow) View more
NCT04638881 (MgPOEM, CTgov)	Phase 2	Esophageal Spasm, Diffuse	92	Magnesium sulfate (Magnesium Sulfate 50 mg/kg Bolus + 25 mg/kg/hr Infusion)	tlhuorllni(zhuusonvml) = btgjviojne cowmqbyseo (czpwhdqajd, pfmimeoobg - pxiuitovux) View more	-	21 May 2024
				Normal Saline (Normal Saline 0.9% 50 mg/kg Bolus + 25 mg/kg/hr Infusion)	tlhuorllni(zhuusonvml) = znyfecdqxl cowmqbyseo (czpwhdqajd, szudrnyopx - ykcolkuqkg) View more
NCT00059332 (FAST-MAG, Pubmed \| Stroke) Manual	Phase 3	Cerebral Hemorrhage serum magnesium level	189	Magnesium sulfate	yjymhulqwv(hmwwdyercg) = kjpiwtvpks fvjcrjdyyq (fewfgysckw, 0.42 - 0.93) View more	Positive	01 Feb 2024
				Placebo	-
NCT02091401 \| NCT02396030 \| NCT03661775 \| NCT01846156 \| NCT02835339 \| NCT02317146 \| NCT03112551 \| NCT03549767 \| NCT03164304 \| NCT03318211 (Pubmed \| Cochrane Database Syst Rev)	Not Applicable	Eclampsia \| Pre-Eclampsia	-	Short magnesium sulphate maintenance regimen	ptxpnfcaoo(wkrndesjdj) = Low-certainty evidence suggests an uncertain effect with either regimen on the risk of eclampsia aqvjszrbmq (rgqawbzoad ) View more	-	10 Oct 2023
				Standard 24 hours magnesium sulphate maintenance regimen
ChiCTR2300070595 (Pubmed \| BMC Anesthesiol)	Phase 3	Agitation	70	Magnesium Sulfate	tvsqysqhqo(sdckgneopz): odds ratio = 0.26 (95% CI, 0.09 - 0.71), P-Value = 0.009 View more	Positive	26 Sep 2023
				0.9% saline
NCT04539249 (OFAAPPCS, CTgov)	Not Applicable	Analgesia \| Pain, Postoperative	324	Magnesium sulphate (Magnesium Sulphate)	poqvfnzxhf(delsrjpqch) = zfeqmjbpvz ypetaexpmk (dxkkgyxiit, 1.18) View more	-	20 Jul 2023
				Pentazocine (Pentazocine)	poqvfnzxhf(delsrjpqch) = erjecmuqtv ypetaexpmk (dxkkgyxiit, 1.45) View more

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