P10 Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review

BackgroundAccording to international guidelines clinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for both the mother and her offspring. Consolidated Standards of Reporting Trials (CONSORT) reporting criteria apply to these trials and should include safety data on the offspring. The safety of maternal treatments is a key issue for health care professionals and parents. Diabetes, human immunodeficiency virus (HIV) infection and hypertension are among the most frequent chronic diseases worldwide in women of child bearing potential. The objective of this systematic review was to analyse offspring data reported in clinical trials conducted in pregnant women receiving chronic drug treatment for one of these conditions.MethodsPubmed and Embase (01/01/1997–31/12/2017) were searched for drug trials in pregnant women with diabetes, HIV infection or hypertension. Titles and abstracts were screened, followed by a full text review of eligible articles. Inclusion criteria were interventional clinical trials in pregnant women treated with chronic medication and full text in English. Trial characteristics, maternal and offspring data were extracted. Data was summarised by disease and study. Twelve key items were considered for the offspring. The protocol was registered on PROSPERO (CRD42017057024).ResultsOverall, 196 articles reporting 132 clinical trials (diabetes n=55; HIV n=59; hypertension n=18) were included. The number of births were frequently not reported (diabetes 40%; HIV 24%; hypertension 56%). Congenital malformations were infrequently reported with sufficient detail (diabetes 27%; HIV 34%; hypertension 6%). Similar observations were made for other key items (e.g. foetal losses, neonatal deaths, birth weight corrected for gestational age).ConclusionsUnderreporting of key data for the offspring was frequent in publications of clinical trials in pregnant women with diabetes, HIV infection or hypertension making the assessment of the benefit-risk ratio of treatment options during pregnancy difficult.Disclosure(s)Nothing to disclose

Download Full-text

Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2019-316982 ◽

2019 ◽

Vol 105 (2) ◽

pp. 215-221

Author(s):

Beate Aurich ◽

Tania Martin-Montoya ◽

Daolun Zhang ◽

Evelyne Jacqz-Aigrain

Keyword(s):

Clinical Trials ◽

Hiv Infection ◽

Pregnant Women ◽

Full Text ◽

Treatment Options ◽

Neonatal Deaths ◽

Sufficient Detail ◽

Mother And Child ◽

Full Text Review ◽

Registration Number

BackgroundClinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for mother and child. The safety of maternal treatments is a key issue for healthcare professionals and parents.ObjectiveTo analyse offspring data reported in clinical trials in pregnant women with diabetes, HIV infection or hypertension (three of the most common diseases in women of childbearing potential) and either treated prior to pregnancy for these chronic diseases or diagnosed and treated during pregnancy.MethodsPubMed and Embase (1 January 1997 to 31 December 2017) were searched for drug trials in pregnant women with diabetes, HIV infection or hypertension. Titles and abstracts were screened, followed by a full-text review of eligible articles. Inclusion criteria were interventional clinical trials in pregnant women treated with medication and full text in English. Trial characteristics, maternal and offspring data were extracted. Data were summarised by disease and study. Twelve key items were considered for the offspring.ResultsOverall, 196 articles reporting 132 clinical trials (diabetes n=55; HIV n=59; hypertension n=18) were included. Key offspring data were frequently not reported, for example, number of births (diabetes: 22/55, 40%; HIV: 14/59, 24%; hypertension: 10/18, 56%). Congenital malformations were often not reported with sufficient detail (diabetes: 40/55, 73%; HIV: 39/59, 66%; hypertension: 17/18, 94%). Similar observations were made for other key items (eg, fetal losses, neonatal deaths).ConclusionUnder-reporting of key data for the offspring was frequent in publications of clinical trials in pregnant women with diabetes, HIV infection or hypertension making the assessment of the benefit-risk ratio of treatment options during pregnancy difficult.Trial registration numberCRD42017057024.

Download Full-text

Management of carcinoid syndrome (CS): A systematic review of systemic treatment options.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.4_suppl.516 ◽

2018 ◽

Vol 36 (4_suppl) ◽

pp. 516-516

Author(s):

Edward M. Wolin ◽

Al Bowen Benson

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Systemic Treatment ◽

Treatment Options ◽

Symptom Relief ◽

Safety Data ◽

Significant Heterogeneity ◽

Carcinoid Heart Disease ◽

Systemic Treatments ◽

Symptom Response

516 Background: CS is a major cause of symptom burden (diarrhea/flushing) in patients (pts) with neuroendocrine tumors and is associated with shortened survival and severe complications such as carcinoid heart disease. We performed a systematic review of clinical evidence for CS systemic treatments. Methods: PubMed, Embase, and Cochrane databases were searched. Large ( > 60 pt) prospective clinical trials investigating the efficacy/safety of systemic treatment options for pts with CS were eligible for inclusion. Data extracted included study design, pt population, interventions, prior treatments, permitted concomitant medications, study endpoints/statistical analyses, and efficacy/safety outcomes. Results: Six large prospective clinical trials (total 953 pts) were identified from 144 search results. Significant heterogeneity existed in pt populations, control groups (placebo vs active comparator), duration of therapy, study endpoints, and efficacy/safety data reporting. Interventions assessed were long-acting and subcutaneous octreotide (OCT & OCT SC), lanreotide (LAN), telotristat ethyl (TE)+somatostatin analogues (SSA), pasireotide (PAS), and everolimus (EVE)+OCT. Symptom response was variably assessed by the frequency of diarrhea/flushing and/or receipt of rescue short-acting SSA in 5/6 studies; a significant improvement in at least one of these measures occurred in 4 studies (OCT and OCT SC; LAN; TE+SSA). Failure to meet symptom response criteria ranged from 29-82% in the studies. Reported reductions in CgA and/or 5-HIAA reached statistical significance in 3 studies (LAN; EVE+OCT; TE+SSA). Interventions were generally well tolerated. Two phase 3 trials focused specifically on management of CS symptoms refractory to SSA; strategies included switching to PAS or an increased dose of OCT (40 mg q28d) for refractory diarrhea/flushing, or receipt of TE with continued SSA for refractory diarrhea. Conclusions: SSA provide substantial symptom relief for pts with CS. For refractory symptoms, TE can be added, SSA dose increased, and metastasis debulking can be used (with surgery, hepatic artery embolization, ablation, and PRRT). The addition of biologic agents to SSA can further improve CS management.

Download Full-text

Frontotemporal Dementia: A systematic review

10.21203/rs.3.rs-1156339/v1 ◽

2021 ◽

Author(s):

Samar Khalifa

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Frontotemporal Dementia ◽

Full Text ◽

Common Type ◽

Functional Measures ◽

The Future ◽

Clinical Measures

Abstract Background: Frontotemporal dementia is a common type of dementia and is a group of progressive neurodegenerative syndromes usually caused by the accumulation of pathological tau or TDP-43 proteins. The review is identifying the clinical measures including neuropsychological scores and functional measures. Methods: A systematic review was conducted covering the clinical trials done to investigate the Frontotemporal Dementia. The sample was taken from Pubmed library. 28 results were found in a range of time from 2016 to 2021. The excluded papers were 17. Results: A total of 10,349 articles were identified at the first stage of papers selecting. All records were screened in order to include and exclude by title/abstract and then based on full text. After excluding articles by year and type of papers, a total of 28 articles were identified through the databases. Following this, the irrelevant papers from databases were removed from original articles, and finally 11 articles were included based on their title/abstract. Full articles were then sourced for about 600 references. It included 732 patients and 195 controls as a total. Conclusions: The review describes the clinical and RCT trials for FTD in the last five years so it can be very updated information for the researchers to cover information required for their researches in the future ones.

Download Full-text

Pregnancy and Breastfeeding During COVID-19 Pandemic: A Systematic Review of Published Pregnancy Cases

Frontiers in Public Health ◽

10.3389/fpubh.2020.558144 ◽

2020 ◽

Vol 8 ◽

Author(s):

Carina Rodrigues ◽

Inês Baía ◽

Rosa Domingues ◽

Henrique Barros

Keyword(s):

Systematic Review ◽

Adverse Effects ◽

Pregnant Women ◽

Pregnancy Outcomes ◽

Web Of Science ◽

Study Quality ◽

Neonatal Deaths ◽

Live Births ◽

Milk Samples ◽

The Impact

Background: The COVID-19 pandemic is an emerging concern regarding the potential adverse effects during pregnancy. This study reviews knowledge on the impact of COVID-19 on pregnancy and describes the outcome of published cases of pregnant women diagnosed with COVID-19.Methods: Searches were conducted in PubMed®, Scopus®, Web of Science®, and MedRxiv® up to 26th June 2020, using PRISMA standards, to identify original published studies describing pregnant women at any gestational age diagnosed COVID-19. There were no date or language restrictions on the search. All identified studies were included irrespective of assumptions on study quality.Results: We identified 161 original studies reporting 3,985 cases of pregnant women with COVID-19 (1,007 discharged while pregnant). The 2,059 published cases with pregnancy outcomes resulted in 42 abortions, 21 stillbirths, and 2,015 live births. Preterm birth occurred in 23% of cases. Around 6% of pregnant women required admission to an intensive care unit and 28 died. There were 10 neonatal deaths. From the 163 cases with amniotic fluid, placenta, and/or cord blood analyzed for the SARS-CoV-2 virus, 10 were positive. Sixty-one newborns were positive for SARS-CoV-2. Four breast milk samples from 92 cases showed evidence of SARS-CoV-2.Conclusion: Emerging evidence suggests that vertical transmission is possible, however, there is still a limited number of reported cases with intrapartum samples. Information, counseling and adequate monitoring are essential to prevent and manage adverse effects of SARS-CoV-2 infection during pregnancy.

Download Full-text

Remotely delivered interventions to support women with symptoms of anxiety in pregnancy: a mixed methods systematic review of quantitative and qualitative evidence (Preprint)

10.2196/preprints.28093 ◽

2021 ◽

Author(s):

Kerry Evans ◽

Stefan Rennick-Egglestone ◽

Serena Cox ◽

Yvonne Kuipers ◽

Helen Spiby

Keyword(s):

Systematic Review ◽

Pregnant Women ◽

Quantitative Data ◽

Meta Analysis ◽

Treatment Options ◽

Social Science Citation Index ◽

Cochrane Library ◽

Access To Treatment ◽

On Line ◽

In Pregnancy

BACKGROUND Symptoms of anxiety are common in pregnancy, with severe symptoms associated with negative outcomes for women and babies. Low level psychological therapy is recommended as first line treatment options for women with mild to moderate anxiety, with the aim to prevent an escalation of symptoms and provide women with coping strategies. Remotely delivered interventions have been suggested to improve access to treatment and support for women in pregnancy and provide a cost-effective, flexible and timely solution. OBJECTIVE To identify and evaluate remotely delivered, digital or on-line interventions to support women with symptoms of anxiety in pregnancy. METHODS A mixed method systematic review following a convergent segregated approach to synthesise the qualitative and quantitative data. The ACM Digital Library, AMED, ASSIA, CRD, CENTRAL, the Cochrane Library, CINAHL, EMBASE, HTA, IEEE Xplore, JBI, Maternity and Infant Care, Medline, PsycINFO and the Social Science Citation Index were searched in October 2020. Quantitative or qualitative primary research including pregnant women which evaluated remotely delivered interventions reporting measures of anxiety, fear, stress, distress, women’s views, feedback and opinions were included in the review. RESULTS Three qualitative and 14 were quantitative studies included. Populations included a general antenatal population, and pregnant women with anxiety and depression, fear of childbirth, insomnia and pre-term labour. Interventions included CBT, Problem Solving, Mindfulness and Educational designs. Most interventions were delivered via on-line platforms and 8 included direct contact from trained therapists or coaches. A meta-analysis of the quantitative data found for I-CBT and facilitated interventions there was observed beneficial effect in relation to the reduction of anxiety scores (SMD=-0.49; 95% CI=-0.75 to -0.22; SMD=-0.48; 95% CI=-0.75 to -0.22). However, due to limitations in the amount of available data and study quality, the findings should be interpreted with caution. Synthesised findings from quantitative and qualitative data found some evidence to suggest that interventions are more effective when women are motivated to maintain regular participation in interventions. Participation may be enhanced by providing regular contact with therapists, targeting interventions for women with anxiety symptoms; providing peer support forums; including components of relaxation and cognitive based skills; and providing sufficient sessions to develop new skills without being too time consuming. CONCLUSIONS There is limited evidence to suggest that pregnant women may benefit from remotely delivered interventions. The synthesised findings highlighted components of interventions which may improve the effectiveness and acceptability of remotely delivered interventions. These include providing women with contact with a therapist, healthcare professional or peer community. Women may be more motivated to complete interventions which are perceived as relevant or tailored to their needs and situations. Remote interventions may also provide women with greater anonymity to help them feel more confident in disclosing their symptoms.

Download Full-text

A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus

Vaccine ◽

10.1016/j.vaccine.2013.01.045 ◽

2013 ◽

Vol 31 (35) ◽

pp. 3628-3635 ◽

Cited By ~ 3

Author(s):

Cindy Tamminga ◽

Michael Kavanaugh ◽

Charlotte Fedders ◽

Santina Maiolatesi ◽

Neethu Abraham ◽

...

Keyword(s):

Systematic Review ◽

Human Immunodeficiency Virus ◽

Clinical Trials ◽

Safety Data ◽

Data Reporting ◽

Immunodeficiency Virus

Download Full-text

The efficacy of topical, oral and surgical interventions for the treatment of tungiasis: A systematic review of the literature

PLoS Neglected Tropical Diseases ◽

10.1371/journal.pntd.0009722 ◽

2021 ◽

Vol 15 (8) ◽

pp. e0009722

Author(s):

Ana Carolina Tardin Martins ◽

Amanda Ramos de Brito ◽

Patrícia Shu Kurizky ◽

Rodrigo Gurgel Gonçalves ◽

Yago Ranniere Teixeira Santana ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Observational Studies ◽

Treatment Options ◽

Sufficient Evidence ◽

Tissue Destruction ◽

Adequate Treatment ◽

Surgical Interventions ◽

Surgical Extraction ◽

Quantitative Descriptive

Background Tungiasis is a neglected disease caused by Tunga penetrans that can be complicated by secondary infections and local tissue destruction. Adequate treatment is important, especially in vulnerable populations; potential treatment options proposed range from surgical extraction to the use of oral and topical medications. We aimed to perform a systematic review to assess the efficacy of topical, oral and surgical interventions for the treatment of tungiasis. Methodology/Principal findings The present review is registered in PROSPERO (CRD42021234741). On September 1, 2020, we searched PubMed, EMBASE, Scopus, Web of Science, Science Direct, Scielo and LILACS BVS. We included clinical trials and longitudinal observational studies that evaluated any topical, systemic or mechanical treatment for tungiasis. We used the Revised Cochrane Risk of Bias (RoB) Tool for Randomized Trials for clinical trial analysis. Qualitative and quantitative descriptive syntheses were performed. Our search strategy resulted in 3376 references. Subsequently, 2568 titles/abstracts and 114 full texts were screened. We finally included 19 articles; 9 were classified as clinical trials. Two and 3 articles presented low and some RoB, respectively, according to the tool. Only two articles tested the efficacy of oral medications (niridazole, ivermectin), with discouraging results. Six clinical trials evaluated topical products for the treatment of tungiasis; 2 evaluated dimeticone-based compounds and reported positive results in lesion reduction and cure. None reported significant adverse reactions. Surgical extraction was evaluated only in observational studies. Conclusions/Significance We conclude that, although surgical extraction is the most commonly used treatment, there is sufficient evidence supporting the use of occlusive agents, especially manufactured dimeticone-based products.

Download Full-text

Glecaprevir/Pibrentasvir: The First 8-Week, Pangenotypic HCV Treatment Regimen for Patients 12 Years of Age and Older

Annals of Pharmacotherapy ◽

10.1177/1060028019877128 ◽

2019 ◽

Vol 54 (3) ◽

pp. 262-276

Author(s):

Jamie Huff ◽

Rebecca Andersen

Keyword(s):

Clinical Trials ◽

Hepatitis C ◽

English Language ◽

Data Extraction ◽

Treatment Options ◽

Safety Data ◽

Hcv Treatment ◽

Cost Information ◽

Additional Information ◽

Compensated Cirrhosis

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, dosing, and cost information of glecaprevir/pibrentasvir in the treatment of hepatitis C virus (HCV). Data Sources: A literature search was conducted between September 2018 and July 2019 using PubMed and Google Scholar with the search terms glecaprevir, pibrentasvir, Mavyret, Maviret, and hepatitis C. Clinicaltrials.gov was searched using the same terms. References of published articles were assessed for additional information. Study Selection and Data Extraction: English-language preclinical and clinical studies on the chemistry, pharmacology, pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir were evaluated. Data Synthesis: Food and Drug Administration–approved glecaprevir/pibrentasvir is considered both safe and efficacious for the treatment of HCV genotypes 1 to 6 and in several patient populations, such as those with treatment-naïve or treatment-experienced HCV; with or without compensated cirrhosis, HIV-1 coinfection, or renal impairment; post–liver or post–kidney transplant; and ≥12 years of age. Sustained virological response rates ranged from 83% to 100% in clinical trials, and safety outcomes appear similar to other guideline-recommended HCV treatment options. Relevance to Patient Care and Clinical Practice: This review discusses the pharmacological, efficacy, and safety data found in glecaprevir/pibrentasvir clinical trials and relates this to guideline recommendations and the practical use of this medication for treatment of HCV. Conclusions: With HCV infection rates remaining elevated, it is important to have safe and efficacious treatment options. Glecaprevir/pibrentasvir is a safe and efficacious guideline-recommended, 8-week treatment for HCV in several patient populations, with these populations likely growing in the near future given ongoing and future studies.

Download Full-text

Heparin Does Not Increase Live Births in Pregnant Women with Previous Unexplained Recurrent Miscarriages: A Systematic Review and Meta-Analysis

Blood ◽

10.1182/blood.v120.21.504.504 ◽

2012 ◽

Vol 120 (21) ◽

pp. 504-504

Author(s):

Murtadha K. Al-Khabori ◽

Zainab S. Al-Hosni ◽

Hajer M. Al Ghaithi ◽

Altaf M. Al Maamari ◽

Wafa S. Bessiso ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Pregnant Women ◽

Antiphospholipid Antibodies ◽

Odds Ratio ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Inherited Thrombophilia ◽

Recurrent Miscarriages ◽

Live Births

Abstract Abstract 504 Background: The impact of heparin in pregnant women with previous unexplained recurrent miscarriages remains uncertain. The use of heparin in this patient population has been increasing with the hope of improving the rate of live births. We performed a systematic review of the randomized clinical trials addressing this question. Methods: We searched MEDLINE (searched July 1st 2012), CENTRAL (Issue 7 of 12, July 2012), American Society of Hematology (searched July 1st 2012), clinical trials registries (http://clinicaltrials.gov/, searched July 1st 2012), and bibliographies of relevant studies for randomized clinical trials comparing heparin (unfractionated or low molecular weight) to other best care approaches. Use of aspirin was allowed in either study arms. Included patients were pregnant women over 18 years of age with previous recurrent unexplained miscarriages (at least two at any trimester). We performed a meta-analysis using random effects models to estimate the pooled odds ratio. Statistical heterogeneity was calculated by using the I2 statistic. Results: Eight trials proved eligible, five of which provided data from 1141 patients that could be included in the meta-analysis and three of which remain unpublished. Only the subgroup of patients with no antiphospholipid antibodies or inherited thrombophilia was included. There was a total of 839 live births observed. Enoxaparin was used in four trials and nadroparin was used in one trial. All trials randomized patients before the 8th week of gestation. There were 430 live births (among a total of 561 pregnancies) and 409 live births (among a total of 580 pregnancies) in the heparin and other best care treatment arms respectively. The difference between the two treatment arms was not statistically significant with a pooled odds ratio of 1.49 (95% confidence interval: 0.84, 2.66; P = 0.17). There was a substantial heterogeneity among the results of different trials (Chi2 = 14.91, P = 0.005; I2 = 73%). Conclusions: Available evidence suggests that heparin does not increase live births in pregnant women with previous unexplained recurrent miscarriages with no evidence of antiphospholipid antibodies or inherited thrombophilia. Future trials should explore new treatment strategies. Disclosures: No relevant conflicts of interest to declare.

Download Full-text