scholarly journals A study protocol for the cardiac effects of a single dose of either oxytocin 2.5 IU or carbetocin 100 µg after caesarean delivery: a prospective randomized controlled multi-centre trial in Norway

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 973
Author(s):  
Maria Bekkenes ◽  
Marte Morin Jørgensen ◽  
Anne Flem Jacobsen ◽  
Morten Wang Fagerland ◽  
Helene Rakstad-Larsen ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Drug Administration ◽  
Caesarean Delivery ◽  
Troponin I ◽  
Study Drug ◽  
University Hospital ◽  
Study Drug Administration ◽  
Randomized Controlled ◽  
Estimated Blood Loss ◽  
Increased Risk

Background: Both oxytocin and carbetocin are used to prevent uterine atony and post-partum haemorrhage after caesarean delivery in many countries, including Norway. Oxytocin causes dose-dependent ST-depression, troponin release, prolongation of QT-time and arrythmia, but little is known about myocardial effects of carbetocin. We have previously demonstrated comparable vasodilatory effects of oxytocin and carbetocin and are now undertaking a Phase 4 trial to investigate whether carbetocin causes similar changes to myocardial markers compared with oxytocin. Methods: Our randomized controlled trial will be conducted at three obstetrics units at Oslo University Hospital and Akershus University Hospital, Norway. Planned enrolment will be of 240 healthy, singleton pregnant women aged 18 to 50 years undergoing planned caesarean delivery. Based on pilot study data, each participant will receive a one-minute intravenous injection of either oxytocin 2.5 IU or carbetocin 100 µg during caesarean delivery. The prespecified primary outcome is the change from baseline in high-sensitive troponin I plasma concentrations at 6–10 hours after study drug administration. Secondary outcomes include uterine tone grade at 2.5 and five minutes after study drug administration, adverse events for up to 48 hours after study drug administration, estimated blood loss within eight hours of delivery, need for rescue treatment and direct/indirect costs. Enrolment and primary analysis are expected to be completed by the end of 2021. Discussion: Women undergoing caesarean delivery should be assessed for cardiovascular risk particularly as women with an obstetric history of pregnancy induced hypertension, gestational diabetes mellitus, preterm birth, placental abruption, and stillbirth are at increased risk of future cardiovascular disease. Any additional ischaemic myocardial risk from uterotonic agents will need to be balanced with the benefit of reducing the risk of postpartum haemorrhage. Any potential cardiotoxicity difference between oxytocin and carbetocin will help inform treatment decisions for pregnant women. Registration: Clinicaltrials.gov NCT03899961 (02/04/2019).

scholarly journals Association between Pre-pregnant Overweight and Obesity and Periodontal Disease during Pregnancy: A Cross Sectional Study

2017 ◽  
Vol 3 (1) ◽  
pp. 1
Author(s):  
Eman Ali Abd El Moaty Sheha ◽  
Hanan Elzeblawy Hassan ◽  
Wafaa Mostafa Ahmed Gamel
Keyword(s):  
Periodontal Disease ◽  
Pregnant Women ◽  
Cross Sectional Study ◽  
Overweight And Obesity ◽  
University Hospital ◽  
Public Health Issue ◽  
Obese Women ◽  
Sectional Study ◽  
Cross Sectional ◽  
Increased Risk

Background: Obesity is considered а noteworthy public health issue in both developed & developing countries. Among the 1.5 billion overweight individuals worldwide, 300 million of them were obese women. In the general, the prevalence of maternal obesity has increased 60% in the previous two decades with nearly 1 in 3 women now entering pregnancy obese. Also, the periodontаl disease has been observed to be prevalent in pregnant women with the prevalence ranging from 20% to more than 50%, especially economically disadvantaged women.Aim: explore the relation between pre-pregnant overweight and obesity with periodontal disease during pregnancy.Subjects & Methods: cross-sectional study among 400 pregnant women were booked in the high-risk obstetric departments and the antenatal outpatient clinics at governmental general hospitals in El-Fayoum City and governmental university hospital in El-Mansoura city.Results: The mean age of pregnant women was 29.9 ± 6.2 with increase the prevalence of periodontal disease in pregnant women (83.5%). Statistically significant correlation was found between prenatal weight and periodontаl disease during pregnancy (p ≤ 0.0001) with increasing the prevalence of periodontal disease in prenatal obese women (53.2%) and over weight (39.7%) were observed in women who were in their 3rd trimester (р = 0.011). Increase prevalence of periodontal with poor oral hygiene and sedentary activity.Conclusion: increased pre-pregnancy obesity & overweight are positively correlated with periodontal disease prevalence among pregnant women, and Pregnancy itself may also be associated with аn increased risk of periodontal disease.Recommendations: Activating the role of the maternity and community health nurse in branches of Obstetrics and antenatal clinics to enhance pregnant women's knowledge regarding oral health risks of obesity & overweight.

Abstract 11817: The Effect of Time to Treatment With Antiarrhythmic Drugs on Return of Spontaneous Circulation in Shock Refractory Out-of-Hospital Cardiac Arrest: A Secondary Analysis of the ALPS Randomized Controlled Trial

Circulation ◽  
2021 ◽  
Vol 144 (Suppl_2) ◽  
Author(s):  
Mahbod Rahimi ◽  
Paul Dorian ◽  
Sheldon Cheskes ◽  
Gerald Lebovic ◽  
Steve Lin
Keyword(s):  
Cardiac Arrest ◽  
Drug Administration ◽  
Controlled Trial ◽  
Group Versus ◽  
Study Drug ◽  
Spontaneous Circulation ◽  
Study Drug Administration ◽  
Time To Treatment ◽  
Return Of Spontaneous Circulation ◽  
Hospital Cardiac Arrest

Purpose: The effects of amiodarone and lidocaine on the return of spontaneous circulation (ROSC), relative to time to treatment in out of hospital cardiac arrest (OHCA) patients is unknown. We conducted a post-hoc analysis of the Resuscitation Outcomes Consortium Amiodarone, Lidocaine, Placebo (ROC ALPS) randomized trial examining the association of time to treatment with ROSC at emergency department (ED) arrival. Method: In the ROC ALPS trial, adults with non-traumatic OHCA with initial VF/pVT after ≥ 1 shock were randomized to receive amiodarone, lidocaine or placebo. We used logistic regression to examine the association of time to treatment (911 call to study drug administration interval) with ROSC at ED arrival. Results: Overall, 1112 (36.7%) patients had ROSC at ED arrival. Time to treatment data were available for 2994 (99%) of the patients. The proportion of patients with ROSC at ED arrival decreased as time to drug administration increased, in amiodarone (OR 0.92, 95% CI 0.90-0.94 per min increase), lidocaine (OR 0.95, 95% CI: 0.93-0.96) and placebo (OR 0.95, 95% CI: 0.93-0.96) arms. The odds of ROSC at ED in the amiodarone group (versus placebo) changed in relation to the time of drug administration (OR 0.96, 95% CI: 0.93-0.99). With short times to drug administration, ROSC was higher in amiodarone versus placebo recipients, whereas ROSC was higher with placebo at later times. Comparing lidocaine to placebo, ROSC rate increased at all times (OR 1.29, 95% CI: 1.07-1.59); there was no time to drug administration effect (OR 1.00, 95% CI: 0.97-1.03). Among all patients, survival at hospital discharge was 21.0%, 24.4%, and 23.7% for placebo, amiodarone and lidocaine respectively. Conclusion: Amiodarone’s efficacy in restoring ROSC declined with longer duration of arrest, potentially due to its adverse hemodynamic effects. Overall, amiodarone and lidocaine had similar effects on mortality; in this study, ROSC at ED arrival trend did not reflect the overall survival rate

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

Economic evaluation of DVd versus VAd in the treatment of multiple myeloma: Results from a phase III multicenter randomized clinical trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6050-6050
Author(s):  
R. M. Rifkin ◽  
M. Hussein ◽  
R. Iskandar ◽  
A. O’Sullivan ◽  
D. Thompson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Multiple Myeloma ◽  
Economic Evaluation ◽  
Drug Administration ◽  
Study Drug ◽  
Phase Iii ◽  
Study Drug Administration ◽  
Reduced Dose ◽  
Hospitalization Costs

6050 Background: A randomized Phase III clinical trial of pegylated liposomal doxorubicin, vincristine, and reduced-dose dexamethasone (DVd) versus conventional doxorubicin, vincristine, and reduced-dose dexamethasone (VAd) found similar efficacy in the treatment of newly-diagnosed multiple myeloma (Cancer, in press). However, observed clinical advantages of DVd included less toxicity and supportive care. (Cancer In press). Methods: This economic evaluation was conducted as a piggyback to the clinical trial. Utilization data were collected prospectively for enrolled patients (DVd = 97; VAd = 95). Costs were estimated by applying standard US unit costs in 2004 to observed utilization. We compared resource utilization and costs for study drug administration, other care (hospitalizations due to AEs, tests, transfusions, and concomitant medications), and total costs during follow-up for patients receiving DVd versus VAd using 2-sided t-tests. Results: DVd patients required significantly fewer hospital (1.5 vs 8.5; p < 0.01) and clinic days (4.8 vs 14.4; p < 0.01) for study drug administration. Costs of study drug were significantly higher for DVd patients ($16,181 vs $788; p < 0.01), but lower hospitalization costs ($3,311 vs $18,492; p < 0.01) and clinic costs ($797 vs $2,412; p < 0.01) for drug administration more than offset these costs, resulting in nominally lower overall study drug administration costs for DVd versus VAd ($20,289 vs $21,692; p = 0.64). No other component of care differed significantly between the two groups (costs of other care: $14,152 for DVd vs $14,154 for VAd; p = 0.99) and overall treatment costs ($34,442 for DVd vs $35,846 for VAd; p = 0.76) were similar in the two groups. DVd patients had approximately 10 additional days of follow-up over the trial period (149.4 vs 139.2) versus VAd patients. Conclusions: Despite higher drug acquisition costs, use of DVd did not increase the overall cost of treatment compared to VAd. [Table: see text]

scholarly journals Assessment of the understanding of informed consent including participants’ experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research

2018 ◽  
Vol 1 ◽  
pp. 12 ◽  
Author(s):  
Shubham Atal ◽  
Fidelma Dunne
Keyword(s):  
Diabetes Mellitus ◽  
Informed Consent ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Pregnant Women ◽  
Decision Aid ◽  
Controlled Trial ◽  
Study Drug ◽  
University Hospital ◽  
Microsoft Office

Background: Informed consent is a basic ethical requirement of clinical research, yet deficiencies have been documented in the comprehension of its components among trial participants. Pregnancy research is sparsely conducted. Assessment of understanding of the informed consent among pregnant women suffering from Gestational Diabetes Mellitus enrolled in a randomized controlled trial, and their experiences was planned. Methodology: A prospective observational cohort study was conducted among participants of EMERGE clinical trial at the University Hospital, Galway. Willing participants allowed observation of their consent encounters. They completed the standard QuIC questionnaire at follow up visits for assessment of objective and subjective understanding of informed consent, and reasons to participate and level of satisfaction. Data was entered and analysed using Microsoft Office Excel and Minitab version 18. Results: The most commonly asked questions asked in the twenty consent encounters observed were focused upon the safety of the study drug for the developing foetuses and women. The general attitude of the women was positive towards participation. The mean objective understanding score was 72.43 ± 7 and the subjective understanding score was 91.67 ± 8.68 (out of 100). Critical components of consent like voluntarism, randomisation, withdrawal, and benefit to others were well understood. The domains related to nonstandard nature of treatment, additional risks/discomforts and compensation were poorly understood. The women cited the desire to provide benefit to future patients as the most common reason to participate, and most were satisfied with the consent process. Conclusion: Comprehension of informed consent is good in most aspects, but the grasp of certain concepts is poor among the pregnant women. Efforts are needed to improve informed consent through engagement of investigators, research nurses and possibly, the use of a decision aid.

scholarly journals Challenges and threats of investigator-initiated multicenter randomized controlled trials: the BACE trial experience

2019 ◽  
Vol 6 (4) ◽  
pp. 175
Author(s):  
Kristina Vermeersch ◽  
Bénédicte Demeyere ◽  
Karen Denaux ◽  
Katelijne De Nys ◽  
Thierry Troosters ◽  
...  
Keyword(s):  
Clinical Research ◽  
Controlled Trial ◽  
Study Drug ◽  
Research Field ◽  
University Hospital ◽  
Chronic Obstructive ◽  
Included Trial ◽  
Local Study ◽  
Randomized Controlled ◽  
Trial Experience

<p class="abstract"><strong>Background:</strong> Investigator-initiated clinical research has become a complex environment. Increasing administrative tasks and costs, imposed by stringent regulatory demands, risk to reduce this creative, independent and indispensable research field. The objective of the present study was to illustrate the burden of non-scientific challenges associated with an investigator-initiated multicentre randomized controlled trial, based on the Belgian trial with azithromycin for Chronic obstructive pulmonary disease (COPD) Exacerbations requiring hospitalization (BACE) trial experience.</p><p class="abstract"><strong>Methods:</strong> The trial enrolled 301 patients with COPD, hospitalized for an acute exacerbation between 2014-2017, and assessed the potential of azithromycin, an off-patent antibiotic. Key experienced challenges were complemented with registry data from the Clinical Trial Centre of the University Hospital Leuven to outline the local clinical respiratory research field, quotations for the trial protocol obtained from 3 pharmaceutical companies to provide insight into the budget restraints and a participation survey to capture the consortium’s perspective.</p><p class="abstract"><strong>Results:</strong> 60% of the required sample size was enrolled. Key challenges included trial implementation, study drug and database management. Industry-initiated trials dominated the local research field (61%), whereas investigator-initiated prospective interventional and multicenter trials accounted for 19% and 13%, respectively. The triple quotation revealed the BACE trial to require 1.6 to 2.1-fold the amount when executed by the pharmaceutical industry. The survey identified the lack of a local study team as an important obstacle for participation, along with inadequate financial compensation and excessive administrative workload.</p><p class="abstract"><strong>Conclusions: </strong>Without an adaptation of current regulatory and funding policies to overcome non-scientific challenges, investigator-initiated clinical research is risking to further decline.</p>

Abstract 15287: Evolocumab Inhibits the Acute Rise in Lipoprotein(a) in Patients With Non-ST Elevation Myocardial Infarction (NSTEMI)- Results From the EVACS Study

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Michael Vavuranakis ◽  
Michael J Blaha ◽  
Steven R Jones ◽  
Thomas Schindler ◽  
Marlene S Williams ◽  
...  
Keyword(s):  
Acute Coronary Syndrome ◽  
Troponin I ◽  
Study Drug ◽  
Optimal Level ◽  
Distributed Data ◽  
Early Administration ◽  
Lipoprotein A ◽  
Coronary Syndrome ◽  
Increased Risk ◽  
Normally Distributed

Introduction: Elevated Lipoprotein(a) [Lp(a)] is associated with an increased risk of coronary heart disease (CHD). Although Lp(a) is mostly heritable, and controlled by the apo(a) gene, acute increases are described in small studies following acute coronary syndrome (ACS). PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibition modestly reduces Lp(a) in people with stable CHD but its effects during the early phase of an ACS are unknown. Hypothesis: Early administration of a PCSK9 inhibitor prevents a rise in Lp(a) following an ACS/NSTEMI. Methods: Participants from the EVACS trial (Evolocumab in Acute Coronary Syndrome; NCT03515304), all with a NSTEMI and a troponin-I of > 5 ng/ml were randomized to placebo or to evolocumab. Serum Lp(a) was obtained at study entry prior to study drug and at 30 days. Normally distributed data were summarized using means and standard deviations and non-normally distributed data using medians and interquartile ranges. Results: Fifty-six participants were randomized to placebo (27) or to evolocumab (29). Mean age was 55±13 years, 41% were women and 27% were African American. The Scatterplots (Fig.1) demonstrate for those with a baseline Lp(a) of ≤75 nmol/L (the previously described optimal level) there was no increase in Lp(a) over the 30-day study period in either group. However, for those with a baseline Lp(a) of >75 nmol/L there was a significant increase in the placebo group (Panel A), from a baseline of 176.5 nmol/L [131.5, 245.0] to 266 nmol/L [195.8, 302.5] at 30 days, p=0.02, but no increase in the evolocumab group (Panel B; baseline of 142 nmol/L [93, 177] to 137 nmol/L [96.8, 178.3], p=NS). The baseline values of those with Lp(a) of >75 nmol/L did not differ between the groups; at 30 days, however, Lp(a) was higher in the placebo than in the evolocumab group (p=0.02; Panel C). Conclusions: Early administration of evolocumab prevents the acute increase in Lp(a) in those with a baseline Lp(a) of over 75 nmol/L following an ACS/NSTEMI.

Effectiveness of Terbutaline and Theophylline Alone and in Combination in Exercise-Induced Bronchospasm

PEDIATRICS ◽  
1981 ◽  
Vol 67 (4) ◽  
pp. 508-513
Author(s):  
Gail G. Shapiro ◽  
Joseph J. McPhillips ◽  
Kevin Smith ◽  
Clifton T. Furukawa ◽  
William E. Pierson ◽  
...  
Keyword(s):  
Drug Administration ◽  
Study Drug ◽  
Forced Expiratory Volume ◽  
Exercise Tests ◽  
Double Blind ◽  
Study Drug Administration ◽  
Before And After ◽  
Forced Expiratory Flow ◽  
Exercise Induced ◽  
Better Than

Theophylline and terbutaline, alone and in combination, were evaluated for effectiveness in treating exercise-induced bronchospasm (EIB) when used at doses that should be tolerated by adolescents taking them intermittently: theophylline, 250 mg (fast release), and terbutaline, 2.5 mg. Twenty-one subjects, 12 to 19 years of age, with EIB performed standardized exercise tests on four separate days and received either theophylline, terbutaline, the combination, or placebo in a prerandomized double-blind manner prior to exercise. Exercise tests were performed two and five hours after each study drug administration. Blood samples were drawn before and again two and five hours after drug administration for theophylline level. Pulmonary function [forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and forced expiratory flow rate (FEF25% to 75%)] was recorded before and after exercise. All of the active treatments were better than placebo in diminishing EIB. The combination was statistically better than terbutaline or theophylline alone. The effect of theophylline was not significantly different from that of terbutaline. The combination induced significantly more tremor than either agent individually. Either drug alone or the two in combination is effective for diminishing EIB. Although the combination may have additive properties for some patients, the increased incidence of tremor may diminish its appeal. Either drug alone or in combination is effective in decreasing EIB for at least five hours, which makes them practical choices for treatment of school-aged children.

Cesarean Birth Morbidity among Women with SARS-CoV-2

2021 ◽  
Author(s):  
Rodney McLaren ◽  
Viktoriya London ◽  
Sujatha Narayanamoorthy ◽  
Fouad Atallah ◽  
Michael Silver ◽  
...  
Keyword(s):  
Pregnant Women ◽  
Surgical Outcomes ◽  
Primary Outcome ◽  
Postoperative Fever ◽  
Cesarean Birth ◽  
Estimated Blood Loss ◽  
Increased Risk ◽  
Key Points ◽  
Significant Difference ◽  
Cesarean Births

Objective The objective of this study was to compare maternal outcomes of women with and without severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections who underwent cesarean births. Study Design This was a matched cohort study of pregnant women who had a cesarean birth between March 15, 2020, and May 20, 2020. Cases included women who tested positive for SARS-CoV-2. For every case, two patients who tested negative for SARS-CoV-2 were matched by maternal age, gestational age, body mass index, primary or repeat cesarean birth, and whether the procedure was scheduled or unscheduled. We compared rates of adverse postcesarean complications (intraoperative bladder or bowel injury, estimated blood loss more than or equal to 1,000 mL, hemoglobin drop more than 3 g/dL, hematocrit drop more than 10%, need for blood transfusion, need for hysterectomy, maternal intensive care unit admission, postoperative fever, and development of surgical site infection), with the primary outcome being a composite of those outcomes. We also assessed duration of postoperative stay. Fisher's exact tests were performed to compare the primary outcome between both groups. Results Between March and May 2020, 202 women who subsequently underwent cesarean birth were tested for SARS-CoV-2. Of those 202, 43 (21.3%) patients were positive. They were matched to 86 patients who tested negative. There was no significant difference in the rate of composite adverse surgical outcomes between the groups (SARS-CoV-2 infected 27.9%, SARS-CoV-2 uninfected 25.6%; p = 0.833). There was a higher rate of postoperative fevers (20.9 vs. 5.8%; p = 0.015), but that did not result in a longer length of stay (p = 0.302). Conclusion Pregnant women with SARS-CoV-2 who underwent a cesarean birth did not have an increased risk of adverse surgical outcomes, other than fever, compared with pregnant women without SARS-CoV-2. Key Points

Risk and other factors associated with toxoplasmosis and toxocariasis in pregnant women from southern Brazil

2016 ◽  
Vol 91 (5) ◽  
pp. 534-538 ◽  
Author(s):  
P.C. Santos ◽  
P.L. Telmo ◽  
L.M. Lehmann ◽  
G.T. Mattos ◽  
G.B. Klafke ◽  
...  
Keyword(s):  
Risk Factors ◽  
Pregnant Women ◽  
Total Population ◽  
University Hospital ◽  
Risk Of Infection ◽  
Southern Brazil ◽  
Factors Associated ◽  
Modes Of Transmission ◽  
Increased Risk ◽  
Serology Test

AbstractToxoplasmosis causes complications during pregnancy that have serious effects on fetal development. Thus far, toxocariasis has been reported to spread only via vertical transmission. Nonetheless, the population of pregnant women is also exposed to this infection. Co-infection with both Toxoplasma gondii and Toxocara spp. has been reported in children, but there are no reports of co-infection in the population of pregnant women. The aim of this study was to determine the prevalence of co-infection with T. gondii and Toxocara spp. in pregnant women at a university hospital in southern Brazil, and to identify the risk factors associated with infection by both parasites. Two hundred pregnant women were tested for the presence of anti-T. gondii and anti-Toxocara spp. antibodies and were asked to complete an epidemiological questionnaire. In this study, the co-infection rate observed in the total population of pregnant women was 8%. In addition, women with a positive result for a serology test for Toxocara spp. were at increased risk of infection by T. gondii (P = 0.019). Co-infection with both parasites in pregnant women was associated with low birth weights in neonates. The similar modes of transmission of both parasites could explain the co-infection. Only a few previous studies have investigated this phenomenon. The findings of the present study emphasize the importance of serological diagnosis during prenatal care and further research in this area to identify risk factors associated with this co-infection, and the possible implications of this co-infection during pregnancy and on the health of newborns.

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