The Response Study: A French registry on pregnancy in women with MS and related disorders and their children up to 6 years—Protocol, recruitment status, and baseline characteristics
Background: Counseling on pregnancy is still challenging, particularly regarding the use of disease-modifying treatments (DMTs). We are lacking long-term outcomes in children exposed to DMTs. Objectives: This study aimed to set up a French pregnancy registry for women with multiple sclerosis (MS) an...
Gespeichert in:
| Veröffentlicht in: | Multiple sclerosis 2024-02, Vol.30 (2), p.216-226 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 226 |
|---|---|
| container_issue | 2 |
| container_start_page | 216 |
| container_title | Multiple sclerosis |
| container_volume | 30 |
| creator | Vukusic, Sandra Bourre, Bertrand Casey, Romain Deiva, Kumaran Guennoc, Anne-Marie Lebrun-Frenay, Christine Leray, Emmanuelle Rollot, Fabien Benyahya, Lakhdar Girod, Catherine Marignier, Romain Maillart, Elisabeth |
| description | Background:
Counseling on pregnancy is still challenging, particularly regarding the use of disease-modifying treatments (DMTs). We are lacking long-term outcomes in children exposed to DMTs.
Objectives:
This study aimed to set up a French pregnancy registry for women with multiple sclerosis (MS) and related disorders nested within the Observatoire Français de la Sclérose en Plaques (OFSEP) cohort.
Methods:
Prospective, observational, multicentric, epidemiological study in France. Neurological visits are organized according to routine practice. Data are collected on the OFSEP minimal datasheet. Auto-questionnaires on pregnancy are completed by patients at Months 5–6 and 8 during pregnancy, and Months 3, 6, and 12 postpartum. A specific survey on analgesia is completed by anesthesiologists. Pediatric data are collected from the child’s health book, where visits on Day 8, Month 9, and 24 are mandatory. Parents complete neurodevelopmental questionnaires at Year 1, Years 2 and 6.
Results:
The RESPONSE study started in August 2019. On 7 April 2023, 515 women were included. Baseline demographics are presented.
Conclusions:
RESPONSE will provide rich information on the global management of pregnancy in France and prospective data on children until the age of 6 years, exposed or not to a DMT, including data on neurodevelopment that can be compared to the general population.
Study funding:
EDMUS and ARSEP Foundation, Biogen, Roche. |
| doi_str_mv | 10.1177/13524585231223390 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_hal_p</sourceid><recordid>TN_cdi_hal_primary_oai_HAL_hal_04432657v1</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_13524585231223390</sage_id><sourcerecordid>2913450425</sourcerecordid><originalsourceid>FETCH-LOGICAL-c354t-fe43be7779a3dbbefbf33d731bc8d65a1e9bc5e2005004e9ff8daca122c779b23</originalsourceid><addsrcrecordid>eNp1ks1u1DAQxyMEoqXwAFyQJS4gNcUf8TrhtqoorbQIRMs5cuxJ4yprb20HlBsPwbvwPjxJZ7ulSCAu_hj__n-PPVMUzxk9YkypN0xIXslacsE4F6KhD4p9VilV0kbRh7jG83IL7BVPUrqilCol5ONiT9Scypqx_eLnxQDkM6RN8AnIeZ7s_JYsyUkEbwYS4dKlHGcSPNngxmtvZuI8-RbWgKPLA_lwTrS3iI46gyXWpRAtxHQbzQO4SMzgRouOZNqQHMiCzKBj-vX9x6cYcjBhPES5iZPL6JpJyjpP6fDWoNMJRucBPXTUJkPEhJxJT4tHvR4TPLubD4ovJ-8ujk_L1cf3Z8fLVWmErHLZQyU6UEo1Wtiug77rhbBKsM7UdiE1g6YzEjilktIKmr6vrTYav9OgpuPioHi98x302G6iW-s4t0G79nS5arcxWlWCL6T6ypB9tWM3MVxPkHK7dsnAOGoPYUotb5ioJK24RPTlX-hVmKLHlyCFpWS8abaGbEeZGFKK0N9nwGi77YD2nw5AzYs756lbg71X_C45Akc7IOlL-HPt_x1vABACu5g</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2923312991</pqid></control><display><type>article</type><title>The Response Study: A French registry on pregnancy in women with MS and related disorders and their children up to 6 years—Protocol, recruitment status, and baseline characteristics</title><source>MEDLINE</source><source>SAGE Complete A-Z List</source><creator>Vukusic, Sandra ; Bourre, Bertrand ; Casey, Romain ; Deiva, Kumaran ; Guennoc, Anne-Marie ; Lebrun-Frenay, Christine ; Leray, Emmanuelle ; Rollot, Fabien ; Benyahya, Lakhdar ; Girod, Catherine ; Marignier, Romain ; Maillart, Elisabeth</creator><creatorcontrib>Vukusic, Sandra ; Bourre, Bertrand ; Casey, Romain ; Deiva, Kumaran ; Guennoc, Anne-Marie ; Lebrun-Frenay, Christine ; Leray, Emmanuelle ; Rollot, Fabien ; Benyahya, Lakhdar ; Girod, Catherine ; Marignier, Romain ; Maillart, Elisabeth</creatorcontrib><description>Background:
Counseling on pregnancy is still challenging, particularly regarding the use of disease-modifying treatments (DMTs). We are lacking long-term outcomes in children exposed to DMTs.
Objectives:
This study aimed to set up a French pregnancy registry for women with multiple sclerosis (MS) and related disorders nested within the Observatoire Français de la Sclérose en Plaques (OFSEP) cohort.
Methods:
Prospective, observational, multicentric, epidemiological study in France. Neurological visits are organized according to routine practice. Data are collected on the OFSEP minimal datasheet. Auto-questionnaires on pregnancy are completed by patients at Months 5–6 and 8 during pregnancy, and Months 3, 6, and 12 postpartum. A specific survey on analgesia is completed by anesthesiologists. Pediatric data are collected from the child’s health book, where visits on Day 8, Month 9, and 24 are mandatory. Parents complete neurodevelopmental questionnaires at Year 1, Years 2 and 6.
Results:
The RESPONSE study started in August 2019. On 7 April 2023, 515 women were included. Baseline demographics are presented.
Conclusions:
RESPONSE will provide rich information on the global management of pregnancy in France and prospective data on children until the age of 6 years, exposed or not to a DMT, including data on neurodevelopment that can be compared to the general population.
Study funding:
EDMUS and ARSEP Foundation, Biogen, Roche.</description><identifier>ISSN: 1352-4585</identifier><identifier>EISSN: 1477-0970</identifier><identifier>DOI: 10.1177/13524585231223390</identifier><identifier>PMID: 38205811</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Analgesia ; Child ; Children ; Epidemiology ; Female ; France - epidemiology ; Humans ; Life Sciences ; Multiple sclerosis ; Multiple Sclerosis - epidemiology ; Multiple Sclerosis - therapy ; Neurodevelopment ; Pediatrics ; Population studies ; Postpartum Period ; Pregnancy ; Prospective Studies ; Questionnaires ; Registries</subject><ispartof>Multiple sclerosis, 2024-02, Vol.30 (2), p.216-226</ispartof><rights>The Author(s), 2024</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c354t-fe43be7779a3dbbefbf33d731bc8d65a1e9bc5e2005004e9ff8daca122c779b23</cites><orcidid>0000-0001-7699-0328 ; 0000-0002-3713-2416 ; 0000-0002-5967-2800 ; 0000-0002-5918-9261 ; 0000-0001-7337-7122 ; 0000-0001-8424-4499 ; 0000-0002-2459-2480 ; 0000-0002-5752-2331 ; 0000-0002-8409-2365</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://journals.sagepub.com/doi/pdf/10.1177/13524585231223390$$EPDF$$P50$$Gsage$$H</linktopdf><linktohtml>$$Uhttps://journals.sagepub.com/doi/10.1177/13524585231223390$$EHTML$$P50$$Gsage$$H</linktohtml><link.rule.ids>230,314,780,784,885,21818,27923,27924,43620,43621</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38205811$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04432657$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Vukusic, Sandra</creatorcontrib><creatorcontrib>Bourre, Bertrand</creatorcontrib><creatorcontrib>Casey, Romain</creatorcontrib><creatorcontrib>Deiva, Kumaran</creatorcontrib><creatorcontrib>Guennoc, Anne-Marie</creatorcontrib><creatorcontrib>Lebrun-Frenay, Christine</creatorcontrib><creatorcontrib>Leray, Emmanuelle</creatorcontrib><creatorcontrib>Rollot, Fabien</creatorcontrib><creatorcontrib>Benyahya, Lakhdar</creatorcontrib><creatorcontrib>Girod, Catherine</creatorcontrib><creatorcontrib>Marignier, Romain</creatorcontrib><creatorcontrib>Maillart, Elisabeth</creatorcontrib><title>The Response Study: A French registry on pregnancy in women with MS and related disorders and their children up to 6 years—Protocol, recruitment status, and baseline characteristics</title><title>Multiple sclerosis</title><addtitle>Mult Scler</addtitle><description>Background:
Counseling on pregnancy is still challenging, particularly regarding the use of disease-modifying treatments (DMTs). We are lacking long-term outcomes in children exposed to DMTs.
Objectives:
This study aimed to set up a French pregnancy registry for women with multiple sclerosis (MS) and related disorders nested within the Observatoire Français de la Sclérose en Plaques (OFSEP) cohort.
Methods:
Prospective, observational, multicentric, epidemiological study in France. Neurological visits are organized according to routine practice. Data are collected on the OFSEP minimal datasheet. Auto-questionnaires on pregnancy are completed by patients at Months 5–6 and 8 during pregnancy, and Months 3, 6, and 12 postpartum. A specific survey on analgesia is completed by anesthesiologists. Pediatric data are collected from the child’s health book, where visits on Day 8, Month 9, and 24 are mandatory. Parents complete neurodevelopmental questionnaires at Year 1, Years 2 and 6.
Results:
The RESPONSE study started in August 2019. On 7 April 2023, 515 women were included. Baseline demographics are presented.
Conclusions:
RESPONSE will provide rich information on the global management of pregnancy in France and prospective data on children until the age of 6 years, exposed or not to a DMT, including data on neurodevelopment that can be compared to the general population.
Study funding:
EDMUS and ARSEP Foundation, Biogen, Roche.</description><subject>Analgesia</subject><subject>Child</subject><subject>Children</subject><subject>Epidemiology</subject><subject>Female</subject><subject>France - epidemiology</subject><subject>Humans</subject><subject>Life Sciences</subject><subject>Multiple sclerosis</subject><subject>Multiple Sclerosis - epidemiology</subject><subject>Multiple Sclerosis - therapy</subject><subject>Neurodevelopment</subject><subject>Pediatrics</subject><subject>Population studies</subject><subject>Postpartum Period</subject><subject>Pregnancy</subject><subject>Prospective Studies</subject><subject>Questionnaires</subject><subject>Registries</subject><issn>1352-4585</issn><issn>1477-0970</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1ks1u1DAQxyMEoqXwAFyQJS4gNcUf8TrhtqoorbQIRMs5cuxJ4yprb20HlBsPwbvwPjxJZ7ulSCAu_hj__n-PPVMUzxk9YkypN0xIXslacsE4F6KhD4p9VilV0kbRh7jG83IL7BVPUrqilCol5ONiT9Scypqx_eLnxQDkM6RN8AnIeZ7s_JYsyUkEbwYS4dKlHGcSPNngxmtvZuI8-RbWgKPLA_lwTrS3iI46gyXWpRAtxHQbzQO4SMzgRouOZNqQHMiCzKBj-vX9x6cYcjBhPES5iZPL6JpJyjpP6fDWoNMJRucBPXTUJkPEhJxJT4tHvR4TPLubD4ovJ-8ujk_L1cf3Z8fLVWmErHLZQyU6UEo1Wtiug77rhbBKsM7UdiE1g6YzEjilktIKmr6vrTYav9OgpuPioHi98x302G6iW-s4t0G79nS5arcxWlWCL6T6ypB9tWM3MVxPkHK7dsnAOGoPYUotb5ioJK24RPTlX-hVmKLHlyCFpWS8abaGbEeZGFKK0N9nwGi77YD2nw5AzYs756lbg71X_C45Akc7IOlL-HPt_x1vABACu5g</recordid><startdate>20240201</startdate><enddate>20240201</enddate><creator>Vukusic, Sandra</creator><creator>Bourre, Bertrand</creator><creator>Casey, Romain</creator><creator>Deiva, Kumaran</creator><creator>Guennoc, Anne-Marie</creator><creator>Lebrun-Frenay, Christine</creator><creator>Leray, Emmanuelle</creator><creator>Rollot, Fabien</creator><creator>Benyahya, Lakhdar</creator><creator>Girod, Catherine</creator><creator>Marignier, Romain</creator><creator>Maillart, Elisabeth</creator><general>SAGE Publications</general><general>Sage Publications Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0001-7699-0328</orcidid><orcidid>https://orcid.org/0000-0002-3713-2416</orcidid><orcidid>https://orcid.org/0000-0002-5967-2800</orcidid><orcidid>https://orcid.org/0000-0002-5918-9261</orcidid><orcidid>https://orcid.org/0000-0001-7337-7122</orcidid><orcidid>https://orcid.org/0000-0001-8424-4499</orcidid><orcidid>https://orcid.org/0000-0002-2459-2480</orcidid><orcidid>https://orcid.org/0000-0002-5752-2331</orcidid><orcidid>https://orcid.org/0000-0002-8409-2365</orcidid></search><sort><creationdate>20240201</creationdate><title>The Response Study: A French registry on pregnancy in women with MS and related disorders and their children up to 6 years—Protocol, recruitment status, and baseline characteristics</title><author>Vukusic, Sandra ; Bourre, Bertrand ; Casey, Romain ; Deiva, Kumaran ; Guennoc, Anne-Marie ; Lebrun-Frenay, Christine ; Leray, Emmanuelle ; Rollot, Fabien ; Benyahya, Lakhdar ; Girod, Catherine ; Marignier, Romain ; Maillart, Elisabeth</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c354t-fe43be7779a3dbbefbf33d731bc8d65a1e9bc5e2005004e9ff8daca122c779b23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Analgesia</topic><topic>Child</topic><topic>Children</topic><topic>Epidemiology</topic><topic>Female</topic><topic>France - epidemiology</topic><topic>Humans</topic><topic>Life Sciences</topic><topic>Multiple sclerosis</topic><topic>Multiple Sclerosis - epidemiology</topic><topic>Multiple Sclerosis - therapy</topic><topic>Neurodevelopment</topic><topic>Pediatrics</topic><topic>Population studies</topic><topic>Postpartum Period</topic><topic>Pregnancy</topic><topic>Prospective Studies</topic><topic>Questionnaires</topic><topic>Registries</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vukusic, Sandra</creatorcontrib><creatorcontrib>Bourre, Bertrand</creatorcontrib><creatorcontrib>Casey, Romain</creatorcontrib><creatorcontrib>Deiva, Kumaran</creatorcontrib><creatorcontrib>Guennoc, Anne-Marie</creatorcontrib><creatorcontrib>Lebrun-Frenay, Christine</creatorcontrib><creatorcontrib>Leray, Emmanuelle</creatorcontrib><creatorcontrib>Rollot, Fabien</creatorcontrib><creatorcontrib>Benyahya, Lakhdar</creatorcontrib><creatorcontrib>Girod, Catherine</creatorcontrib><creatorcontrib>Marignier, Romain</creatorcontrib><creatorcontrib>Maillart, Elisabeth</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Multiple sclerosis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vukusic, Sandra</au><au>Bourre, Bertrand</au><au>Casey, Romain</au><au>Deiva, Kumaran</au><au>Guennoc, Anne-Marie</au><au>Lebrun-Frenay, Christine</au><au>Leray, Emmanuelle</au><au>Rollot, Fabien</au><au>Benyahya, Lakhdar</au><au>Girod, Catherine</au><au>Marignier, Romain</au><au>Maillart, Elisabeth</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The Response Study: A French registry on pregnancy in women with MS and related disorders and their children up to 6 years—Protocol, recruitment status, and baseline characteristics</atitle><jtitle>Multiple sclerosis</jtitle><addtitle>Mult Scler</addtitle><date>2024-02-01</date><risdate>2024</risdate><volume>30</volume><issue>2</issue><spage>216</spage><epage>226</epage><pages>216-226</pages><issn>1352-4585</issn><eissn>1477-0970</eissn><abstract>Background:
Counseling on pregnancy is still challenging, particularly regarding the use of disease-modifying treatments (DMTs). We are lacking long-term outcomes in children exposed to DMTs.
Objectives:
This study aimed to set up a French pregnancy registry for women with multiple sclerosis (MS) and related disorders nested within the Observatoire Français de la Sclérose en Plaques (OFSEP) cohort.
Methods:
Prospective, observational, multicentric, epidemiological study in France. Neurological visits are organized according to routine practice. Data are collected on the OFSEP minimal datasheet. Auto-questionnaires on pregnancy are completed by patients at Months 5–6 and 8 during pregnancy, and Months 3, 6, and 12 postpartum. A specific survey on analgesia is completed by anesthesiologists. Pediatric data are collected from the child’s health book, where visits on Day 8, Month 9, and 24 are mandatory. Parents complete neurodevelopmental questionnaires at Year 1, Years 2 and 6.
Results:
The RESPONSE study started in August 2019. On 7 April 2023, 515 women were included. Baseline demographics are presented.
Conclusions:
RESPONSE will provide rich information on the global management of pregnancy in France and prospective data on children until the age of 6 years, exposed or not to a DMT, including data on neurodevelopment that can be compared to the general population.
Study funding:
EDMUS and ARSEP Foundation, Biogen, Roche.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>38205811</pmid><doi>10.1177/13524585231223390</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-7699-0328</orcidid><orcidid>https://orcid.org/0000-0002-3713-2416</orcidid><orcidid>https://orcid.org/0000-0002-5967-2800</orcidid><orcidid>https://orcid.org/0000-0002-5918-9261</orcidid><orcidid>https://orcid.org/0000-0001-7337-7122</orcidid><orcidid>https://orcid.org/0000-0001-8424-4499</orcidid><orcidid>https://orcid.org/0000-0002-2459-2480</orcidid><orcidid>https://orcid.org/0000-0002-5752-2331</orcidid><orcidid>https://orcid.org/0000-0002-8409-2365</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1352-4585 |
| ispartof | Multiple sclerosis, 2024-02, Vol.30 (2), p.216-226 |
| issn | 1352-4585 1477-0970 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_04432657v1 |
| source | MEDLINE; SAGE Complete A-Z List |
| subjects | Analgesia Child Children Epidemiology Female France - epidemiology Humans Life Sciences Multiple sclerosis Multiple Sclerosis - epidemiology Multiple Sclerosis - therapy Neurodevelopment Pediatrics Population studies Postpartum Period Pregnancy Prospective Studies Questionnaires Registries |
| title | The Response Study: A French registry on pregnancy in women with MS and related disorders and their children up to 6 years—Protocol, recruitment status, and baseline characteristics |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-09T06%3A36%3A17IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_hal_p&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=The%20Response%20Study:%20A%20French%20registry%20on%20pregnancy%20in%20women%20with%20MS%20and%20related%20disorders%20and%20their%20children%20up%20to%206%20years%E2%80%94Protocol,%20recruitment%20status,%20and%20baseline%20characteristics&rft.jtitle=Multiple%20sclerosis&rft.au=Vukusic,%20Sandra&rft.date=2024-02-01&rft.volume=30&rft.issue=2&rft.spage=216&rft.epage=226&rft.pages=216-226&rft.issn=1352-4585&rft.eissn=1477-0970&rft_id=info:doi/10.1177/13524585231223390&rft_dat=%3Cproquest_hal_p%3E2913450425%3C/proquest_hal_p%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2923312991&rft_id=info:pmid/38205811&rft_sage_id=10.1177_13524585231223390&rfr_iscdi=true |