A Double-blind Randomized Placebo-controlled Four-arm Trial to Assess the Efficacy of Oral Bicarbonate and Intravenous Butylscopolamine Bromide to Facilitate Spontaneous (Non-operative) Delivery in Pregnant Female Participants With Induction of Labor

Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy.
At the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH < 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery.
Given that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted.
Bicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events.
The rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.

开始日期2023-01-03

申办/合作机构

Oslo universitetssykehus HF

EUCTR2021-000392-37-NO / Not yet recruiting临床3期IIT

A double-blind randomized placebo-controlled four-arm trial to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide to facilitate spontaneous (non-operative) delivery in pregnant female participants with induction of labor.

开始日期2021-11-02

申办/合作机构

Oslo universitetssykehus HF

EUCTR2018-002338-19-NO / Unknown status临床3期IIT

BUSCLAB - A DOUBLE BLIND RANDOMIZED PLACEBO-CONTROLLED TRIAL INVESTIGATING THE EFFECT OF INTRAVENOUS BUTYLSCOPOLAMINE BROMIDE TO TREAT SLOW PROGRESS IN LABOR - BUSCLAB

开始日期2019-01-22

申办/合作机构

Oslo universitetssykehus HF

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100 项与 Butylscopolamine 相关的转化医学

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100 项与 Butylscopolamine 相关的专利（医药）

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369

项与 Butylscopolamine 相关的文献（医药）

2024-02-01·Journal of Obstetrics and Gynaecology Canada

The Effect of Hyoscine N-Butyl Bromide Rectal on the Duration of Labour and Rate of Cervical Dilatation: A Systematic Review and Meta-Analysis

Review

作者: Larki, Mona ; Makvandi, Somayeh ; Rasti, Afarin

OBJECTIVEThe current meta-analysis was designed to investigate the impact of Hyoscine N-butyl bromide (HBB) rectal on labour duration and the rate of cervical dilatation by consolidating the available data.METHODSThe search of Medline through the PubMed interface, Scopus, ScienceDirect, and the Cochrane Central Register of Controlled Trials (CENTRAL) was performed for original articles concerning the effects of HBB rectal on the duration of labour published prior to 26 June 2023. Search terms were based on Medical Subject Headings without time and language restrictions. They included: Hyoscine, Scopolamine, HBB, Buscopan, Buscolysin, Buscapine, rectal, suppository, childbirth, delivery, active phase, second stage, cervical dilatation, labour, labour, and duration of labour. The Comprehensive Meta-Analysis V3 software was used for all analyses.RESULTSFive randomized control trials and 1 non-randomized study involving 1310 women were included in the systematic review. Two studies were excluded from the meta-analysis because of heterogeneous interventions and a lack of mean and SD results. The results determined that HBB rectal administration significantly decreased the duration of the active phase (pooled mean difference -193.893; 95% CI -229.173 to -158.613, P < 0.001; I² squares = 90.097%) and second stage of labour (pooled mean difference -2.911; 95% CI -5.486 to -0.336, P = 0.027; I² squares = 90.097%). Also, the cervical dilatation rate in the active phase of labour was 0.981 cm/h higher than in the control group (I² = 0.0%; P < 0.001).CONCLUSIONThis meta-analysis found that HBB rectal administration shortened the active labour phase and second stage and increased the rate of cervix dilatation; consequently, it can be used as a cost-effective intervention for low-risk pregnant women during labour. However, our findings also suggest that more robust clinical trials are required to generate evidence and confirm the use of HBB during labour for clinical practice guidelines.

2024-01-01·Endoscopy International Open

Provider-reported use of butylscopolamine in gastrointestinal endoscopy in Germany

Article

作者: Georgiadou, Ekaterini ; von Hahn, Thomas ; Ranti, Daniel ; Ullmann, Octavia ; Hillemacher, Thomas ; Schmidt, Arthur

Abstract Introduction The anti-cholinergic agent hyoscine-N-butylbromide (HBB) is used in gastrointestinal (GI) endoscopy to decrease motility and facilitate endoscopic procedures. Data from clinical studies to support this practice is limited especially for therapeutic procedures. Likewise, patterns of use among endoscopist are largely unclear. This study sought to assess usage of HBB among German-speaking endoscopists. Material and Methods We conducted an anonymous online survey among endoscopists in German-speaking countries. Results A total of 207 physicians participated in the survey. The majority (76.9%) were experienced endoscopists and 92.3% of respondents use HBB at least occasionally during procedures. The reported median stated frequency of HBB use varied greatly between different types of procedures and increased with the complexity of the procedure being performed. HBB was rarely used in diagnostic esophagogastroduodenoscopies (EGD) (median stated frequency 1% of procedures), while use frequency was significantly higher in EGD with endoscopic mucosal resection (EMR) (10%; p=0.002) and EGD with endoscopic submucosal dissection (ESD) (20%; p<0.001). Similarly, use frequency during diagnostic colonoscopy was lower (5%) compared to colonoscopy with EMR (20%, p=0.005) or ESD (42.5%, p<0.001). The highest use frequency was reported for ERCP (50%). The most frequently stated reason to use HBB was facilitation of the procedure (80.6%) followed by increasing diagnostic yield (58.3%). Conclusion German-speaking endoscopists commonly use HBB, most frequently to facilitate complex therapeutic procedures. Given there is almost no data supporting HBB use in therapeutic endoscopy, we suggest that more research is needed to evaluate benefits and risks of this practice.

2024-01-01·Talanta

Determination of scopolamine and butylscopolamine in beverages, urine and Buscopan® tablets samples using electrophoresis microchip with integrated contactless conductivity detection

Article

作者: Santos, Hellen I ; Pinheiro, Kemilly M P ; Richter, Eduardo M ; Coltro, Wendell K T

The number of cases in which scopolamine (SCO) was used for both recreational and predatory purposes has increased dramatically in recent decades. Linked to this, there is a concern about obtaining SCO through thermal degradation of butylscopolamine (BSCO) - an active ingredient of Buscopan® - a drug sold without a medical prescription. In this study, mixtures containing SCO and BSCO were separated and detected on a microchip electrophoresis (ME) device with integrated capacitively coupled contactless conductivity detection (C⁴D) using a running buffer composed of 40 mmol L^-1 of butyric acid and 25 mmol L^-1 of sodium hydroxide (pH 5.0). The separation was performed within ca. 115 s with a resolution of 1.3 and separation efficiency ranging from 1.4 × 10⁵ to 1.5 × 10⁵ theoretical plates m^-1. A detection limit of 1.1 μmol L^-1 was achieved for both species and the developed method revealed satisfactory repeatability with relative standard deviation (RSD) values for forty-eight injections between 4.8 and 9.4% for peak areas and lower than 3.3% for migration times. Furthermore, inter-day precision was evaluated for sixteen injections (a sequence of four injections performed over four days), and RSD values were less than 6.6% for peak areas and 2.2% for migration times. Satisfactory recovery values (95-114%) were obtained for all evaluated beverage samples (cachaça, vodka, whiskey, beer, Coca-Cola, and grape juice) as well as for artificial urine samples (95-107%). Finally, the conversion of BSCO into SCO was observed after simple heating procedure of Buscopan® sample (not subject to medical prescription), which was successfully confirmed through analysis by capillary electrophoresis coupled to the mass spectrometry (CE-MS). Based on the reported results, the use of ME-C⁴D devices has demonstrated a huge potential for applications in the forensic chemistry field.

项与 Butylscopolamine 相关的新闻（医药）

2022-06-27

·GlobeNewswire-Health Care

High-Quality Botanical Ingredient Producer Linnea SA Celebrates 40 Years of Innovation

RIAZZINO, Switzerland, June 27, 2022 (GLOBE NEWSWIRE) -- Linnea SA (“Linnea” or “the Company”), is proud to announce that it is celebrating the Company’s 40th anniversary in 2022. Linnea has been manufacturing high quality botanical ingredients at their GMP certified facility in Ticino, Switzerland since 1982. Today Linnea produces a suite of natural beneficial botanical ingredients including: Bilberry, Ginkgo Biloba, Red Clover, 5 HTP, HMR Lignan™, Vinpocetine, Vincamine, Butylscopolamine and Cannabinoids. Since 2016 Linnea has been focusing on producing valuable non-psychoactive cannabinoids. Linnea Cannabinoids delivers innovative trustworthy CBD ingredients for the pharmaceutical, dietary ingredients and cosmetics industries. Their CBD is available as a GMP-certified full spectrum extract and a 99% pure isolate. It is rare to find a company in the cannabinoid industry producing GMP-certified pharmaceutical-grade products with decades of experience. Linnea’s newest product is a standardized full spectrum CBG (Cannabigerol) extract which is available for the food and cosmetics market. “We are thrilled to be celebrating our 40 year anniversary and it is due to this experience that we are proud to have been able to create some of the only GMP certified pharmaceutical grade cannabinoid ingredients for companies to use in their product formulations. We believe quality and high standards are vital for cannabis companies and consumers,” said Susanne Caspar, the CEO of Linnea. Linnea’s mission since its founding has been to improve people's lives with high-quality standardized products, and they continue to live by this mission today. The company is constantly innovating new products and investing in sustainability projects. For more information about Linnea’s mission or to view their cannabinoid product line, please visit their websites: https://www.linneacannabinoids.ch or www.linnea.ch About Linnea: Linnea has been providing gold-standard botanical ingredients for use in the pharmaceutical, cosmetics and dietary supplement industries for 40 years. Having expanded into the cannabis and cannabinoid industries in 2016, they helped pave the way in research, standardization and a pharmaceutical level of quality for this emerging global industry. Contact: Lucas Wentworthlucas@nisonco.com

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