{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T23:42:52Z","timestamp":1793058172829,"version":"4.5.0"},"reference-count":62,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"unspecified","delay-in-days":29,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000292","name":"Cystic Fibrosis Trust","doi-asserted-by":"publisher","award":["SRC 027"],"award-info":[{"award-number":["SRC 027"]}],"id":[{"id":"10.13039\/501100000292","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013342","name":"NIHR Imperial Biomedical Research Centre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013342","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Resp Res"],"accepted":{"date-parts":[[2026,5,28]]},"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Cystic fibrosis transmembrane conductance regulator (CFTR) modulators (CFTRm) have altered the landscape of pregnancy and parenthood in cystic fibrosis (CF). As pregnant and breastfeeding females with CF (FwCF) were excluded from pivotal CFTRm trials, evidence to guide management and counsel families on maternal and child outcomes is limited. While CFTRm are unlicensed for use in pregnancy, substantial clinical benefit means most continue therapy. Early studies indicate that CFTRm cross the placenta and are detectable in breastmilk; reported associations include infant liver dysfunction and cataracts but risks remain poorly characterised. We describe the protocol for the first UK-based prospective study evaluating pregnancy and parenthood in FwCF and health outcomes in their children in the CFTRm era.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A single protocol underpins three linked prospective observational substudies in the MATRIARCH_CF research programme. The \u2018Mama\u2019 cohort recruits FwCF planning pregnancy or pregnant, with follow-up from preconception to 24\u2009months postpartum, assessing physical and psychological health, lung function and CF-related complications. \u2018Mini\u2019 recruits children aged 0\u201324\u2009months born to a parent with CF and compares offspring exposed and unexposed to CFTRm in utero and\/or through breastfeeding; measures include birth outcomes, congenital anomalies, liver biochemistry, growth and neurodevelopment. \u2018Midi\u2019 recruits children aged 3\u20136 years from the same exposure groups and assesses neurodevelopment and lung function. Longitudinal data across cohorts will strengthen the evidence base, support risk\u2013benefit discussions and inform clinical guidance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The protocol was approved by NHS ethics HSC REC A committee (25\/NI\/0027 19 March 2025). Assessments align with routine care where possible. Visit windows are flexible and participants may decline individual assessments. The research team does not influence CFTRm initiation, cessation or dose adjustment. People with CF contributed throughout study design to ensure acceptability. Findings will be disseminated through PhD theses, conference presentations and peer-reviewed publications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06797206\">NCT06797206<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjresp-2026-004270","type":"journal-article","created":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:39:00Z","timestamp":1782844740000},"page":"e004270","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Maternal, Infant, Reproductive and Child Health in Cystic Fibrosis (MATRIARCH_CF): a prospective, observational study to evaluate pregnancy and parenthood in females with cystic fibrosis and health of the offspring in the CFTR-modulator era"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct06797206","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-0726-9508","authenticated-orcid":false,"given":"Amy","family":"Downes","sequence":"first","affiliation":[{"name":"Imperial College London Institute of Reproductive and Developmental Biology, London, UK"},{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Idan","family":"Bokobza","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"},{"name":"Imperial College London National Heart and Lung Institute, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ladina","family":"Weitnauer","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Scott","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"},{"name":"Chelsea and Westminster Hospital, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Dobra","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"},{"name":"Imperial College London National Heart and Lung Institute, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Short","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"},{"name":"Imperial College London National Heart and Lung Institute, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Semple","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"},{"name":"Imperial College London National Heart and Lung Institute, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olivia","family":"Beaumont","sequence":"additional","affiliation":[{"name":"King\u2019s College Hospital NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Williamson","sequence":"additional","affiliation":[{"name":"Imperial College London Institute of Reproductive and Developmental Biology, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane C","family":"Davies","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"},{"name":"Imperial College London National Heart and Lung Institute, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Imogen","family":"Felton","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital, Guy's and St Thomas\u2019 NHS Foundation Trust, London, UK"},{"name":"Imperial College London National Heart and Lung Institute, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,6,30]]},"reference":[{"key":"2026063007050746000_13.1.e004270.1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202108-1986OC"},{"key":"2026063007050746000_13.1.e004270.2","unstructured":"Vertex Pharmaceuticals . 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