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E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial

Intimate partner violence (IPV) during pregnancy, a condition as common as obstetrics conditions like gestational diabetes, is associated with maternal and neonatal complications. Systematic detection of IPV is not well established in antenatal screening probably because the effectiveness of protect...

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Autores principales: Zapata-Calvente, Antonella Ludmila, Martín-de-las-Heras, Stella, Bueno Cavanillas, Aurora, Andreasen, Karen, Rasch, Vibeke, Khan, Khalid S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10022801/
https://www.ncbi.nlm.nih.gov/pubmed/36930616
http://dx.doi.org/10.1371/journal.pone.0282997
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author Zapata-Calvente, Antonella Ludmila
Martín-de-las-Heras, Stella
Bueno Cavanillas, Aurora
Andreasen, Karen
Rasch, Vibeke
Khan, Khalid S.
author_facet Zapata-Calvente, Antonella Ludmila
Martín-de-las-Heras, Stella
Bueno Cavanillas, Aurora
Andreasen, Karen
Rasch, Vibeke
Khan, Khalid S.
author_sort Zapata-Calvente, Antonella Ludmila
collection PubMed
description Intimate partner violence (IPV) during pregnancy, a condition as common as obstetrics conditions like gestational diabetes, is associated with maternal and neonatal complications. Systematic detection of IPV is not well established in antenatal screening probably because the effectiveness of protective interventions has not been evaluated. E-health interventions may be beneficial among mothers exposed to IPV. Prior to performing a full-scale effectiveness trial for such an intervention, a pilot study is required to assess the feasibility of randomising a sufficiently large number of women exposed to IPV during pregnancy. The eIPV trial is a randomised pilot study nested within a cohort of consenting mothers who screen positive for IPV in the first antenatal visit at <12 weeks’ gestation and accept an e-health package (psychological counselling by videoconference) in Spain and Denmark. Twenty eligible mothers from the above cohort will be randomised to either intervention or control. The intervention group will receive the e-health package as part of the cohort. The control group will be invited to accept a delay in the intervention (e-health package eight weeks later). After consenting to delay, the control group will provide comparative data without losing the opportunity of obtaining the intervention. We will determine estimates of rates of informed consent to randomization, and the rates of adherence and dropout following randomization. Qualitative interviews will be conducted to examine the women’s perception about the benefit of the intervention, reasons for acceptability and non-adherence, and obstacles to recruitment, randomisation and consent. The results will inform the trial feasibility and variance of key clinical outcome measures for estimation of sample size of the full-scale effectiveness trial.
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spelling pubmed-100228012023-03-18 E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial Zapata-Calvente, Antonella Ludmila Martín-de-las-Heras, Stella Bueno Cavanillas, Aurora Andreasen, Karen Rasch, Vibeke Khan, Khalid S. PLoS One Study Protocol Intimate partner violence (IPV) during pregnancy, a condition as common as obstetrics conditions like gestational diabetes, is associated with maternal and neonatal complications. Systematic detection of IPV is not well established in antenatal screening probably because the effectiveness of protective interventions has not been evaluated. E-health interventions may be beneficial among mothers exposed to IPV. Prior to performing a full-scale effectiveness trial for such an intervention, a pilot study is required to assess the feasibility of randomising a sufficiently large number of women exposed to IPV during pregnancy. The eIPV trial is a randomised pilot study nested within a cohort of consenting mothers who screen positive for IPV in the first antenatal visit at <12 weeks’ gestation and accept an e-health package (psychological counselling by videoconference) in Spain and Denmark. Twenty eligible mothers from the above cohort will be randomised to either intervention or control. The intervention group will receive the e-health package as part of the cohort. The control group will be invited to accept a delay in the intervention (e-health package eight weeks later). After consenting to delay, the control group will provide comparative data without losing the opportunity of obtaining the intervention. We will determine estimates of rates of informed consent to randomization, and the rates of adherence and dropout following randomization. Qualitative interviews will be conducted to examine the women’s perception about the benefit of the intervention, reasons for acceptability and non-adherence, and obstacles to recruitment, randomisation and consent. The results will inform the trial feasibility and variance of key clinical outcome measures for estimation of sample size of the full-scale effectiveness trial. Public Library of Science 2023-03-17 /pmc/articles/PMC10022801/ /pubmed/36930616 http://dx.doi.org/10.1371/journal.pone.0282997 Text en © 2023 Zapata-Calvente et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Study Protocol
Zapata-Calvente, Antonella Ludmila
Martín-de-las-Heras, Stella
Bueno Cavanillas, Aurora
Andreasen, Karen
Rasch, Vibeke
Khan, Khalid S.
E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial
title E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial
title_full E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial
title_fullStr E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial
title_full_unstemmed E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial
title_short E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial
title_sort e-health psychological intervention in pregnant women exposed to intimate partner violence (eipv): a protocol for a pilot randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10022801/
https://www.ncbi.nlm.nih.gov/pubmed/36930616
http://dx.doi.org/10.1371/journal.pone.0282997
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