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Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis.

ABSTRACT: BACKGROUND:In clinical trials, pregnant women are potentially vulnerable, and the fetus is exposed to the intervention. This study aimed to identify the reasons that led pregnant women at a high risk of premature delivery to participate in a randomized clinical trial. METHODS:The women participating in the main trial were contacted by telephone postpartum and invited to answer an open questionnaire in a cross-sectional study. Data were collected by telephone and analyzed using thematic analysis. After the analysis categories were defined, all the answers were reviewed, categorized and grouped. A descriptive summary of the content of each category was then made. RESULTS:Overall, 208 women from different geographical regions of the country agreed to participate. Four categories were identified: 1) The risk of losing the baby; 2) A previous experience of premature delivery; 3) The role of the doctor and other health professionals, and 4) The availability of quality medical care and free medication. The main reason given for agreeing to participate was to reduce the risks associated with the baby being born prematurely, particularly when the woman herself or someone close to her had already experienced premature delivery. Other reasons were having received clear guidance and explanations from the doctor regarding prematurity and about the study and being given the opportunity to receive free treatment with greater access to the public healthcare system. CONCLUSIONS:The decision to participate in a clinical trial is not easy, particularly when the individual is vulnerable and in a critical situation as in the case of a pregnant woman at a high risk of delivering prematurely. Fears and uncertainties regarding the pregnancy outcome, as well as the woman's previous experiences and her awareness of the actual risks she faces will affect her decision regarding whether or not to participate. Recruitment challenges could be overcome by ensuring that the research team provides adequate information and support, thus creating a bond with participants that would foster a sense of safety and trust in the study proposals.

SUBMITTER: Monteiro TM

PROVIDER: S-EPMC6425624 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis.

Monteiro Thaís M TM Katz Leila L Bento Silvana F SF Amorim Melania M MM Moriel Patrícia C PC Pacagnella Rodolfo C RC

BMC pregnancy and childbirth 20190320 1

<h4>Background</h4>In clinical trials, pregnant women are potentially vulnerable, and the fetus is exposed to the intervention. This study aimed to identify the reasons that led pregnant women at a high risk of premature delivery to participate in a randomized clinical trial.<h4>Methods</h4>The women participating in the main trial were contacted by telephone postpartum and invited to answer an open questionnaire in a cross-sectional study. Data were collected by telephone and analyzed using the ...[more]

PMID: 30894167

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Project description:BackgroundPremature birth rates have slightly increased globally, making its prevention critical for both short-term and long-term health outcomes. Various interventions have been developed in response to the multifaceted risk factors for premature birth, including internet-based programs. These programs offer accessibility and enhanced engagement; however, their overall efficacy in preventing premature births requires thorough evaluation.ObjectiveThis systematic review aims to identify the study designs and assess the effectiveness of internet-based interventions in preventing premature birth among pregnant women.MethodsA comprehensive search of the MEDLINE, Embase, CINAHL, and Cochrane Library databases was conducted to identify randomized trials and quasi-experimental studies evaluating internet-based interventions for premature birth prevention in pregnant women. The search was inclusive, with no restrictions based on language or geographical location, allowing for a comprehensive global perspective. The time frame for the inclusion of studies extended until February 2023. The risk of bias (RoB) in each study was independently assessed by 3 authors forming pairs, using the revised Cochrane RoB tool (RoB 2) for randomized trials, as per the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Owing to heterogeneity in populations, measurements, and interventions, a meta-analysis was not conducted.ResultsThis review included 26 articles, comprising 12 intention-to-treat and 14 per-protocol studies. The overall RoB was high in most intention-to-treat studies and of some concern in most per-protocol studies. The target populations varied, including nonspecific pregnant women, those with gestational diabetes mellitus (GDM) or those at risk of GDM, individuals with anxiety or depression, and those experiencing preterm labor. Psychosocial, physiological, and wellness health outcomes were evaluated. Internet-based interventions effectively reduced stress/distress in nonspecific pregnant women but not in those experiencing preterm labor. Their effectiveness in reducing anxiety and depression varied, with inconsistent results among different groups. In women with GDM or those at risk of GDM, interventions successfully controlled fasting plasma glucose and 2-hour postprandial plasma glucose levels but did not consistently manage glycated hemoglobin levels. These interventions did not reduce the incidence of premature births across the various populations studied. The effectiveness of these internet-based interventions in addressing substance or alcohol abuse and insomnia also varied.ConclusionsInternet-based interventions show promise in improving psychosocial health and managing blood sugar to prevent premature birth, highlighting variability in effectiveness across different risk factors. Further research, including clinical trials, is vital for developing, evaluating, and disseminating effective, safe internet-based interventions. Establishing standardized measurement tools and rigorous evaluation processes is crucial for enhancing these interventions' effectiveness and reliability in clinical practice, significantly contributing to preventing premature births and improving maternal health outcomes.Trial registrationPROSPERO CRD42021278847; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021278847.

Project description:BACKGROUND:Electronic cigarettes (ECs) are increasingly used for reducing or stopping smoking, with some studies showing positive outcomes. However, little is known about views on ECs during pregnancy or postpartum and previous studies have nearly all been conducted in the US and have methodological limitations, such as not distinguishing between smokers and ex/non-smokers. A greater understanding of this topic will help to inform both clinicians and EC interventions. We elicited views and experiences of ECs among UK pregnant or recently pregnant women. METHODS:We conducted semi-structured telephone interviews, using topic guides, with pregnant or recently pregnant women, who were current or recent ex-smokers. To ensure broad views of ECs were obtained, recruitment was from several geographical locations and via various avenues of recruitment. This included stop smoking services, antenatal and health visitor clinics, a pregnancy website and an informal network. Participants were 15 pregnant and 15 postpartum women, including nine current EC users, 11 ex-users, and 10 never-users. Five women who were interviewed in pregnancy were later interviewed in postpartum to explore if their views had changed. Audio data was transcribed verbatim and framework analysis was applied. RESULTS:Five main themes emerged: motivations for use (e.g., for stopping or reducing smoking), social stigma (e.g., avoiding use in public, preferring 'discrete' NRT), using the EC (e.g., mostly used at home); consumer aspects (e.g., limited advice available), and harm perceptions (e.g., viewed as less harmful than smoking; concerns about safety and addiction). CONCLUSIONS:ECs were viewed positively by some pregnant and postpartum women and seen as less harmful than smoking and useful as aids for reducing and stopping smoking. However, due to perceived social stigma, some women feel uncomfortable using ECs in public, especially during pregnancy, and had concerns about safety and nicotine dependence. Health professionals and designers of EC interventions need to provide women with up-to-date and consistent information and advice about safety and dependence, as well as considering the influence of social stigma.

Project description:BackgroundThe EVERREST Prospective Study is a multicentre observational cohort study of pregnancies affected by severe early-onset fetal growth restriction. The study recruits women with singleton pregnancies where the estimated fetal weight is less than the 3rd centile and below 600 g, between 20 + 0 and 26 + 6 weeks of pregnancy, in the absence of a known chromosomal, structural or infective cause.MethodThe reported study was retrospective descriptive qualitative interview study of women who had participated in the EVERREST Prospective Study. The aim of this study was to explore the experiences and perceptions of pregnant women taking part in research during a pregnancy affected by severe early-onset fetal growth restriction. Audio-recorded semi-structured telephone interviews were conducted with a purposive sample of 12 women, at least 1 year after delivery of their baby. Two of these pregnancies had ended in stillbirth and one in neonatal death, reflecting the outcomes seen in the EVERREST Prospective Study. Participants gave informed consent, were 16 years or older and were interviewed in English. A topic guide was used to ensure a consistent approach. Questions focused on pregnancy experiences, involvement with the EVERREST study and potential involvement in future research. Recordings were transcribed verbatim for thematic analysis using NVivo10.ResultsFour broad themes were identified; 'before joining the EVERREST Prospective Study', 'participating in research', 'information and support' and 'looking back and looking forwards'. Each broad theme incorporated several subthemes. All participants recalled their reaction to being told their baby was smaller than expected. The way this news was given had a lasting impact. A range of benefits of participation in the EVERREST Prospective Study were described and the participants were positive about the way it was conducted. As a consequence, they were receptive to participating in future research. However, the findings suggest that research teams should be sensitive when approaching families at a difficult time or when they are already participating in other research.ConclusionsThis study highlights the willingness of pregnant women to participate in research and identifies strategies for researchers to engage participants.

Project description:BackgroundThere is sufficient meta-analytic evidence that antenatal interventions for women at risk (selective prevention) or for women with severe psychological symptoms (indicated prevention) are effective in reducing postpartum distress. However, women without risk or severe psychological symptoms might also experience distress. This meta-analysis focused on the effectiveness of preventive psychological interventions offered to universal populations of pregnant women on symptoms of depression, anxiety, and general stress. Paternal and infant outcomes were also included.MethodWe included 12 universal prevention studies in the meta-analysis, incorporating a total of 2559 pregnant women.ResultsOverall, ten studies included depression as an outcome measure, five studies included stress, and four studies anxiety. There was a moderate effect of preventive interventions implemented during pregnancy on the combined measure of maternal distress (d = .52), on depressive symptoms (d = .50), and on stress (d = .52). The effect on anxiety (d = .30) was smaller. The effects were not associated with intervention timing, intervention type, intervention delivery mode, timing of post-test, and methodological quality. The number of studies including partner and/or infant outcomes was too low to assess their effectiveness.ConclusionsThis meta-analysis suggests that universal prevention during pregnancy is effective on decreasing symptoms of maternal distress compared to routine care, at least with regard to depression. While promising, the results with regard to anxiety and stress are based on a considerably lower number of studies, and should thus be interpreted with caution. More research is needed on preventing other types of maternal distress beyond depression. Furthermore, there is a lack of research with regard to paternal distress. Also, given the large variety in interventions, more research is needed on which elements of universal prevention work. Finally, as maternal distress symptoms can affect infant development, it is important to investigate whether the positive effects of the preventive interventions extend from mother to infant.Systematic review registration numberInternational prospective register of systematic reviews (PROSPERO) registration number: CRD42018098861.

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Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis.

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Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis.

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