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2. Neonatal and maternal outcomes following SARS-CoV-2 infection and COVID-19 vaccination: a population-based matched cohort study

Author

Lindsay, Laura, Calvert, Clara, Shi, Ting, Carruthers, Jade, Denny, Cheryl, Donaghy, Jack, Hopcroft, Lisa E. M., Hopkins, Leanne, Goulding, Anna, McLaughlin, Terry, Moore, Emily, Taylor, Bob, Bhaskaran, Krishnan, Katikireddi, Srinivasa Vittal, McCabe, Ronan, McCowan, Colin, Simpson, Colin R., Robertson, Chris, Sheikh, Aziz, Wood, Rachael, and Stock, Sarah J.

Published
2023
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3. A population-based matched cohort study of major congenital anomalies following COVID-19 vaccination and SARS-CoV-2 infection

Author

Calvert, Clara, Carruthers, Jade, Denny, Cheryl, Donaghy, Jack, Hopcroft, Lisa E. M., Hopkins, Leanne, Goulding, Anna, Lindsay, Laura, McLaughlin, Terry, Moore, Emily, Taylor, Bob, Loane, Maria, Dolk, Helen, Morris, Joan, Auyeung, Bonnie, Bhaskaran, Krishnan, Gibbons, Cheryl L., Katikireddi, Srinivasa Vittal, O’Leary, Maureen, McAllister, David, Shi, Ting, Simpson, Colin R., Robertson, Chris, Sheikh, Aziz, Stock, Sarah J., and Wood, Rachael

Published
2023
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4. Changes in preterm birth and stillbirth during COVID-19 lockdowns in 26 countries

Author

Calvert, Clara, Brockway, Meredith (Merilee), Zoega, Helga, Miller, Jessica E., Been, Jasper V., Amegah, Adeladza Kofi, Racine-Poon, Amy, Oskoui, Solmaz Eradat, Abok, Ishaya I., Aghaeepour, Nima, Akwaowo, Christie D., Alshaikh, Belal N., Ayede, Adejumoke I., Bacchini, Fabiana, Barekatain, Behzad, Barnes, Rodrigo, Bebak, Karolina, Berard, Anick, Bhutta, Zulfiqar A., Brook, Jeffrey R., Bryan, Lenroy R., Cajachagua-Torres, Kim N., Campbell-Yeo, Marsha, Chu, Dinh-Toi, Connor, Kristin L., Cornette, Luc, Cortés, Sandra, Daly, Mandy, Debauche, Christian, Dedeke, Iyabode Olabisi F., Einarsdóttir, Kristjana, Engjom, Hilde, Estrada-Gutierrez, Guadalupe, Fantasia, Ilaria, Fiorentino, Nicole M., Franklin, Meredith, Fraser, Abigail, Gachuno, Onesmus W., Gallo, Linda A., Gissler, Mika, Håberg, Siri E., Habibelahi, Abbas, Häggström, Jonas, Hookham, Lauren, Hui, Lisa, Huicho, Luis, Hunter, Karen J., Huq, Sayeeda, KC, Ashish, Kadambari, Seilesh, Kelishadi, Roya, Khalili, Narjes, Kippen, Joanna, Le Doare, Kirsty, Llorca, Javier, Magee, Laura A., Magnus, Maria C., Man, Kenneth K. C., Mburugu, Patrick M., Mediratta, Rishi P., Morris, Andrew D., Muhajarine, Nazeem, Mulholland, Rachel H., Bonnard, Livia Nagy, Nakibuuka, Victoria, Nassar, Natasha, Nyadanu, Sylvester D., Oakley, Laura, Oladokun, Adesina, Olayemi, Oladapo O., Olutekunbi, Olanike A., Oluwafemi, Rosena O., Ogunkunle, Taofik O., Orton, Chris, Örtqvist, Anne K., Ouma, Joseph, Oyapero, Oyejoke, Palmer, Kirsten R., Pedersen, Lars H., Pereira, Gavin, Pereyra, Isabel, Philip, Roy K., Pruski, Dominik, Przybylski, Marcin, Quezada-Pinedo, Hugo G., Regan, Annette K., Rhoda, Natasha R., Rihs, Tonia A., Riley, Taylor, Rocha, Thiago Augusto Hernandes, Rolnik, Daniel L., Saner, Christoph, Schneuer, Francisco J., Souter, Vivienne L., Stephansson, Olof, Sun, Shengzhi, Swift, Emma M., Szabó, Miklós, Temmerman, Marleen, Tooke, Lloyd, Urquia, Marcelo L., von Dadelszen, Peter, Wellenius, Gregory A., Whitehead, Clare, Wong, Ian C. K., Wood, Rachael, Wróblewska-Seniuk, Katarzyna, Yeboah-Antwi, Kojo, Yilgwan, Christopher S., Zawiejska, Agnieszka, Sheikh, Aziz, Rodriguez, Natalie, Burgner, David, Stock, Sarah J., and Azad, Meghan B.

Published
2023
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5. Pregnancy outcomes after SARS-CoV-2 infection in periods dominated by delta and omicron variants in Scotland: a population-based cohort study

Author

Stock, Sarah J, Moore, Emily, Calvert, Clara, Carruthers, Jade, Denny, Cheryl, Donaghy, Jack, Hillman, Sam, Hopcroft, Lisa E M, Hopkins, Leanne, Goulding, Anna, Lindsay, Laura, McLaughlin, Terry, Taylor, Bob, Auyeung, Bonnie, Katikireddi, Srinivasa Vittal, McCowan, Colin, Ritchie, Lewis D, Rudan, Igor, Simpson, Colin R, Robertson, Chris, Sheikh, Aziz, and Wood, Rachael

Published
2022
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7. SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland

Author

Stock, Sarah J., Carruthers, Jade, Calvert, Clara, Denny, Cheryl, Donaghy, Jack, Goulding, Anna, Hopcroft, Lisa E. M., Hopkins, Leanne, McLaughlin, Terry, Pan, Jiafeng, Shi, Ting, Taylor, Bob, Agrawal, Utkarsh, Auyeung, Bonnie, Katikireddi, Srinivasa Vittal, McCowan, Colin, Murray, Josie, Simpson, Colin R., Robertson, Chris, Vasileiou, Eleftheria, Sheikh, Aziz, and Wood, Rachael

Published
2022
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8. A population-based matched cohort study of early pregnancy outcomes following COVID-19 vaccination and SARS-CoV-2 infection

Author

Calvert, Clara, Carruthers, Jade, Denny, Cheryl, Donaghy, Jack, Hillman, Sam, Hopcroft, Lisa E. M., Hopkins, Leanne, Goulding, Anna, Lindsay, Laura, McLaughlin, Terry, Moore, Emily, Pan, Jiafeng, Taylor, Bob, Almaghrabi, Fatima, Auyeung, Bonnie, Bhaskaran, Krishnan, Gibbons, Cheryl L., Katikireddi, Srinivasa Vittal, McCowan, Colin, Murray, Josie, O’Leary, Maureen, Ritchie, Lewis D., Shah, Syed Ahmar, Simpson, Colin R., Robertson, Chris, Sheikh, Aziz, Stock, Sarah J., and Wood, Rachael

Published
2022
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12. COVID-19 hospital admissions and deaths after BNT162b2 and ChAdOx1 nCoV-19 vaccinations in 2·57 million people in Scotland (EAVE II): a prospective cohort study

Author

Agrawal, Utkarsh, Katikireddi, Srinivasa Vittal, McCowan, Colin, Mulholland, Rachel H, Azcoaga-Lorenzo, Amaya, Amele, Sarah, Fagbamigbe, Adeniyi Francis, Vasileiou, Eleftheria, Grange, Zoe, Shi, Ting, Kerr, Steven, Moore, Emily, Murray, Josephine L K, Shah, Syed Ahmar, Ritchie, Lewis, O'Reilly, Dermot, Stock, Sarah J, Beggs, Jillian, Chuter, Antony, Torabi, Fatemah, Akbari, Ashley, Bedston, Stuart, McMenamin, Jim, Wood, Rachael, Tang, Ruby S M, de Lusignan, Simon, Hobbs, F D Richard, Woolhouse, Mark, Simpson, Colin R, Robertson, Chris, and Sheikh, Aziz

Published
2021
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15. Direct on-swab metabolic profiling of vaginal microbiome host interactions during pregnancy and preterm birth

Author

Pruski, Pamela, Correia, Gonçalo D. S., Lewis, Holly V., Capuccini, Katia, Inglese, Paolo, Chan, Denise, Brown, Richard G., Kindinger, Lindsay, Lee, Yun S., Smith, Ann, Marchesi, Julian, McDonald, Julie A. K., Cameron, Simon, Alexander-Hardiman, Kate, David, Anna L., Stock, Sarah J., Norman, Jane E., Terzidou, Vasso, Teoh, T. G., Sykes, Lynne, Bennett, Phillip R., Takats, Zoltan, and MacIntyre, David A.

Published
2021
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18. Piloting the Use of Federated Analysis to Enhance Privacy and Enable Trustworthy Access to Covid-19 Research Data

Author

Eradat Oskoui, Solmaz, primary, Barnes, Rodrigo, additional, Forde, Eoghan, additional, Retford, Matthew, additional, Postlethwaite, Neil, additional, Hunter, Karen J., additional, Wozencraft, Anne, additional, Thompson, Simon, additional, Orton, Chris, additional, Ford, D.V., additional, Heys, Sharon, additional, Kennedy, Julie, additional, McNerney, Cynthia, additional, Peng, Jeffrey, additional, Ghanbariadolat, Hamed, additional, Rees, Sarah, additional, Mulholland, Rachel H., additional, Sheikh, Aziz, additional, Burgner, David, additional, Brockway, Meredith Lee, additional, Azad, Meghan B., additional, Rodriguez, Natalie, additional, Zoega, Helga, additional, Stock, Sarah J., additional, Calvert, Clara, additional, Miller, Jessica, additional, Fiorentino, Nicole, additional, Racine, Amy, additional, and Haggstrom, Jonas, additional

Published
2024
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19. Associations between low Apgar scores and mortality by race in the United States: A cohort study of 6,809,653 infants

Author

Gillette, Emma, Boardman, James P., Calvert, Clara, John, Jeeva, and Stock, Sarah J.

Subjects
Anencephaly -- Risk factors -- Diagnosis -- Care and treatment, Infants -- Patient outcomes, Apgar score -- Health aspects, Infants (Newborn) -- Health aspects -- Genetic aspects, Biological sciences
Abstract

Background Apgar scores measure newborn health and are strongly associated with infant outcomes, but their performance has largely been determined in primarily white populations. Given the majority of the global population is not white, we aim to assess whether the association between low Apgar score and mortality in infants varies across racial groups. Methods and findings Population-based cohort study using 2016 to 2017 United States National Vital Statistics System data. The study included singleton infants born between 37.sup.+0 and 44.sup.+6 weeks to mothers over 15 years, without congenital abnormalities. We looked at 3 different mortality outcomes: (1) early neonatal mortality; (2) overall neonatal mortality; and (3) infant mortality. We used logistic regression to assess the association between Apgar score (categorized as low, intermediate, and normal) and each mortality outcome, and adjusted for gestational age, sex, maternal BMI, education, age, previous number of live births, and smoking status, and stratified these models by maternal race group (as self-reported on birth certificates). The cohort consisted of 6,809,653 infants (52.8% non-Hispanic white, 23.7% Hispanic, 13.8% non-Hispanic black, 6.6% non-Hispanic Asian, and 3.1% non-Hispanic other). A total of 6,728,829 (98.8%) infants had normal scores, 63,467 (0.9%) had intermediate scores, and 17,357 (0.3%) had low Apgar scores. Compared to infants with normal scores, low-scoring infants had increased odds of infant mortality. There was strong evidence that this association varied by race (p < 0.001) with adjusted odds ratios (AORs) of 54.4 (95% confidence interval [CI] 49.9 to 59.4) in non-Hispanic white, 70.02 (95% CI 60.8 to 80.7) in Hispanic, 23.3 (95% CI 20.3 to 26.8) in non-Hispanic black, 100.4 (95% CI 74.5 to 135.4) in non-Hispanic Asian, and 26.8 (95% CI 19.8 to 36.3) in non-Hispanic other infants. The main limitation was missing data for some variables, due to using routinely collected data. Conclusions The association between Apgar scores and mortality varies across racial groups. Low Apgar scores are associated with mortality across racial groups captured by United States (US) records, but are worse at discriminating infants at risk of mortality for black and non-Hispanic non-Asian infants than for white infants. Apgar scores are useful clinical indicators and epidemiological tools; caution is required regarding racial differences in their applicability., Author(s): Emma Gillette 1,2,*, James P. Boardman 3,4, Clara Calvert 2,5, Jeeva John 4, Sarah J. Stock 2,3 Introduction The Apgar score has been used for nearly 70 years to [...]

Published
2022
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20. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

Author

Norman, Jane E, Heazell, Alexander E P, Rodriguez, Aryelly, Weir, Christopher J, Stock, Sarah J E, Calderwood, Catherine J, Cunningham Burley, Sarah, Frøen, J Frederik, Geary, Michael, Breathnach, Fionnuala, Hunter, Alyson, McAuliffe, Fionnuala M, Higgins, Mary F, Murdoch, Edile, Ross-Davie, Mary, Scott, Janet, and Whyte, Sonia

Published
2018
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22. Natural antimicrobials in pregnancy

Author

Stock, Sarah J. E., Kelly, Rodney., and Riley, Simon

Subjects
572, natural antimicrobials, defensins, secretory leucocyte protease inhibitor, SLPI, elafin, pregnancy
Abstract

Natural antimicrobials are peptides that are essential components of the innate immune system, providing broad-spectrum protection against bacteria, yeasts and some viruses. In addition to their innate immune activity, they exhibit properties suggesting they interact with the adaptive immune system. These functions imply they may be of particular importance in pregnancy. Intrauterine infection is responsible for approximately one third of cases of preterm labour, and normal labour is considered an inflammatory process, associated with leukocyte invasion of the uterine tissues and increased cytokine production. Little is known, however, about natural antimicrobial expression in pregnant reproductive tract. The aim of this thesis was thus to characterize natural antimicrobial production in pregnancy. The study focused on two main areas - the lower genital tract, comprised of the vagina and cervix; and the innermost fetal membrane, the amnion. In the lower genital tract, levels of natural antimicrobials were determined in samples of cervicovaginal secretions collected from pregnant women, using enzyme linked immunosorbance assay (ELISA). In addition Taqman quantitative PCR and ELISAs were used to investigate natural antimicrobial production by cell lines derived from endocervical, ectocervical and vaginal epithelium. It was found that elafin and secretory leucocyte protease inhibitor (SLPI) were found at high concentrations in cervicovaginal secretions, but levels were diminished in women with the common vaginal infection bacterial vaginosis (p<0.05). Cells derived from the vaginal epithelium expressed greater amounts of elafin than cervically derived cells. However, elafin and SLPI production could be stimulated in endocervical cells by the bacterial product lipopolysaccharide, a response that was not seen in the vaginal cell line. Natural antimicrobial production in the amnion was examined in tissue explants and primary cultured amnion cells, using a combination of Taqman PCR and ELISAs. In addition, cDNA microarray was carried out to investigate factors controlling amniotic antimicrobial production, and the involvement of signalling pathways was studied using specific pathway inhibitors. It was shown that the amnion expressed five antimicrobials: human beta defensins (HBD) 1, 2 and 3, SLPI and elafin. Expression of HBD2 was significantly upregulated following normal labour (p<0.05), with production in primary amnion epithelial cells dramatically increased by IL-1ß. The pattern of HBD2 expression in response to IL-1ß was biphasic, which suggested involvement of a secondary gene product. Several putative influential factors were identified by cDNA micorarray, including the NF-kappaB cofactor NFkappaBinhibitorζ. Its relationship to HBD2 was explored. The involvement of both NF-kappaB and mitogen activated protein (MAP) kinase p38 signalling appeared crucial in the response. This work has shown that natural antimicrobials are expressed by both the lower genital tract, where infections that are associated with preterm labour originate, and in the amnion, which is the fetus last line of defence to infection. They may have an important role in the prevention of infection associated preterm labour. Further characterization of these responses may increase understanding of the physiology, and pathophysiology of labour, and lead to strategies for the prevention of premature delivery.

Published
2008

23. Author Correction: SARS-CoV-2 infection and COVID-19 vaccination rates in pregnant women in Scotland

Author

Stock, Sarah J., Carruthers, Jade, Calvert, Clara, Denny, Cheryl, Donaghy, Jack, Goulding, Anna, Hopcroft, Lisa E. M., Hopkins, Leanne, McLaughlin, Terry, Pan, Jiafeng, Shi, Ting, Taylor, Bob, Agrawal, Utkarsh, Auyeung, Bonnie, Katikireddi, Srinivasa Vittal, McCowan, Colin, Murray, Josie, Simpson, Colin R., Robertson, Chris, Vasileiou, Eleftheria, Sheikh, Aziz, and Wood, Rachael

Published
2022
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25. Low-dose aspirin for the prevention of preterm birth: More questions than answers

Author

Hodgetts Morton, Victoria and Stock, Sarah J.

Subjects
Aspirin -- Dosage and administration, Premature birth -- Prevention -- Risk factors, Biological sciences
Abstract

Author(s): Victoria Hodgetts Morton 1, Sarah J. Stock 2,* Preterm birth (birth before 37 weeks gestation) is the leading cause of neonatal mortality, is associated with long-term disability in survivors, [...]

Published
2022
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29. Development and validation of a risk prediction model of preterm birth for women with preterm labour symptoms (the QUIDS study): A prospective cohort study and individual participant data meta-analysis

Author

Stock, Sarah J., Horne, Margaret, Bruijn, Merel, White, Helen, Boyd, Kathleen A., Heggie, Robert, Wotherspoon, Lisa, Aucott, Lorna, Morris, Rachel K., Dorling, Jon, Jackson, Lesley, Chandiramani, Manju, David, Anna L., Khalil, Asma, Shennan, Andrew, van Baaren, Gert-Jan, Hodgetts-Morton, Victoria, Lavender, Tina, Schuit, Ewoud, Harper-Clarke, Susan, Mol, Ben W., Riley, Richard D., Norman, Jane E., and Norrie, John

Subjects
Premature labor -- Complications and side effects, Obstetrics -- Diagnosis, Premature birth -- Risk factors, Biological sciences
Abstract

Background Timely interventions in women presenting with preterm labour can substantially improve health outcomes for preterm babies. However, establishing such a diagnosis is very challenging, as signs and symptoms of preterm labour are common and can be nonspecific. We aimed to develop and externally validate a risk prediction model using concentration of vaginal fluid fetal fibronectin (quantitative fFN), in combination with clinical risk factors, for the prediction of spontaneous preterm birth and assessed its cost-effectiveness. Methods and findings Pregnant women included in the analyses were 22.sup.+0 to 34.sup.+6 weeks gestation with signs and symptoms of preterm labour. The primary outcome was spontaneous preterm birth within 7 days of quantitative fFN test. The risk prediction model was developed and internally validated in an individual participant data (IPD) meta-analysis of 5 European prospective cohort studies (2009 to 2016; 1,783 women; mean age 29.7 years; median BMI 24.8 kg/m.sup.2 ; 67.6% White; 11.7% smokers; 51.8% nulliparous; 10.4% with multiple pregnancy; 139 [7.8%] with spontaneous preterm birth within 7 days). The model was then externally validated in a prospective cohort study in 26 United Kingdom centres (2016 to 2018; 2,924 women; mean age 28.2 years; median BMI 25.4 kg/m.sup.2 ; 88.2% White; 21% smokers; 35.2% nulliparous; 3.5% with multiple pregnancy; 85 [2.9%] with spontaneous preterm birth within 7 days). The developed risk prediction model for spontaneous preterm birth within 7 days included quantitative fFN, current smoking, not White ethnicity, nulliparity, and multiple pregnancy. After internal validation, the optimism adjusted area under the curve was 0.89 (95% CI 0.86 to 0.92), and the optimism adjusted Nagelkerke R.sup.2 was 35% (95% CI 33% to 37%). On external validation in the prospective UK cohort population, the area under the curve was 0.89 (95% CI 0.84 to 0.94), and Nagelkerke R.sup.2 of 36% (95% CI: 34% to 38%). Recalibration of the model's intercept was required to ensure overall calibration-in-the-large. A calibration curve suggested close agreement between predicted and observed risks in the range of predictions 0% to 10%, but some miscalibration (underprediction) at higher risks (slope 1.24 (95% CI 1.23 to 1.26)). Despite any miscalibration, the net benefit of the model was higher than 'treat all' or 'treat none' strategies for thresholds up to about 15% risk. The economic analysis found the prognostic model was cost effective, compared to using qualitative fFN, at a threshold for hospital admission and treatment of [greater than or equal to]2% risk of preterm birth within 7 days. Study limitations include the limited number of participants who are not White and levels of missing data for certain variables in the development dataset. Conclusions In this study, we found that a risk prediction model including vaginal fFN concentration and clinical risk factors showed promising performance in the prediction of spontaneous preterm birth within 7 days of test and has potential to inform management decisions for women with threatened preterm labour. Further evaluation of the risk prediction model in clinical practice is required to determine whether the risk prediction model improves clinical outcomes if used in practice. Trial registration The study was approved by the West of Scotland Research Ethics Committee (16/WS/0068). The study was registered with ISRCTN Registry (ISRCTN 41598423) and NIHR Portfolio (CPMS: 31277)., Author(s): Sarah J. Stock 1,2,*, Margaret Horne 2, Merel Bruijn 2, Helen White 3, Kathleen A. Boyd 4, Robert Heggie 4, Lisa Wotherspoon 2, Lorna Aucott 5, Rachel K. Morris [...]

Published
2021
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31. Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis

Author

Norman, Jane E., Norrie, John, MacLennan, Graeme, Cooper, David, Whyte, Sonia, Chowdhry, Sue, Cunningham-Burley, Sarah, Mei, Xue W., Smith, Joel B. E., Shennan, Andrew, Robson, Stephen C., Thornton, Steven, Kilby, Mark D., Marlow, Neil, Stock, Sarah J., Bennett, Phillip R., and Denton, Jane

Subjects
Prevention, Complications and side effects, Risk factors, Equipment and supplies, Obstetrics -- Equipment and supplies, Multiple pregnancy -- Complications and side effects, Premature birth -- Risk factors -- Prevention, Pregnancy, Multiple -- Complications and side effects
Abstract

Author(s): Jane E. Norman 1,*, John Norrie 2, Graeme MacLennan 3, David Cooper 3, Sonia Whyte 4, Sue Chowdhry 5, Sarah Cunningham-Burley 5, Xue W. Mei 6, Joel B. E. [...], Background Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix. Methods and findings We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length [less than or equal to] 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55-1.38], p = 0.54). The primary neonatal outcome-a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery-was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54-1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix ([less than or equal to]35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50-1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses. Conclusions These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out. Trial registration ISRCTN Registry ISRCTN 02235181. ClinicalTrials.gov NCT02235181.

Published
2021
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33. Awareness of Fetal Movements and Care Package to Reduce Fetal Mortality (AFFIRM): A Stepped Wedge, Cluster-Randomised Trial

Author

Norman, Jane E., Heazell, Alexander E. P., Rodriguez, Aryelly, Weir, Christopher J., Stock, Sarah J. E., Calderwood, Catherine J., Burley, Sarah Cunningham, Frøen, J. Frederik, Geary, Michael, Breathnach, Fionnuala, Hunter, Alyson, McAuliffe, Fionnuala M., Higgins, Mary F., Murdoch, Edile, Ross-Davie, Mary, Scott, Janet, and Whyte, Sonia

Published
2019
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34. Cathelicidins and the Onset of Labour

Author

Boeckel, Sara R. van, Hrabalkova, Lenka, Baker, Tina L., MacPherson, Heather, Frew, Lorraine, Boyle, Ashley K., McHugh, Brian J., Wilson, Kirsten, Norman, Jane E., Dorin, Julia R., Davidson, Donald J., and Stock, Sarah J.

Published
2019
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35. Consortium for the Study of Pregnancy Treatments (Co-OPT):An international birth cohort to study the effects of antenatal corticosteroids

Author

Frier, Emily M, Lin, Chun, Reynolds, Rebecca M, Allegaert, Karel, Been, Jasper V, Fraser, Abigail, Gissler, Mika, Einarsdóttir, Kristjana, Florian, Lani, Jacobsson, Bo, Vogel, Joshua P, Zoega, Helga, Bhattacharya, Sohinee, Krispin, Eyal, Henning Pedersen, Lars, Roberts, Devender, Kuhle, Stefan, Fahey, John, Mol, Ben W, Burgner, David, Schuit, Ewoud, Sheikh, Aziz, Wood, Rachael, Gyamfi-Bannerman, Cynthia, Miller, Jessica E, Duhig, Kate, Lahti-Pulkkinen, Marius, Hadar, Eran, Wright, John, Murray, Sarah R, Stock, Sarah J, Frier, Emily M, Lin, Chun, Reynolds, Rebecca M, Allegaert, Karel, Been, Jasper V, Fraser, Abigail, Gissler, Mika, Einarsdóttir, Kristjana, Florian, Lani, Jacobsson, Bo, Vogel, Joshua P, Zoega, Helga, Bhattacharya, Sohinee, Krispin, Eyal, Henning Pedersen, Lars, Roberts, Devender, Kuhle, Stefan, Fahey, John, Mol, Ben W, Burgner, David, Schuit, Ewoud, Sheikh, Aziz, Wood, Rachael, Gyamfi-Bannerman, Cynthia, Miller, Jessica E, Duhig, Kate, Lahti-Pulkkinen, Marius, Hadar, Eran, Wright, John, Murray, Sarah R, and Stock, Sarah J

Abstract

BACKGROUND: Antenatal corticosteroids (ACS) are widely prescribed to improve outcomes following preterm birth. Significant knowledge gaps surround their safety, long-term effects, optimal timing and dosage. Almost half of women given ACS give birth outside the "therapeutic window" and have not delivered over 7 days later. Overtreatment with ACS is a concern, as evidence accumulates of risks of unnecessary ACS exposure.METHODS: The Consortium for the Study of Pregnancy Treatments (Co-OPT) was established to address research questions surrounding safety of medications in pregnancy. We created an international birth cohort containing information on ACS exposure and pregnancy and neonatal outcomes by combining data from four national/provincial birth registers and one hospital database, and follow-up through linked population-level data from death registers and electronic health records.RESULTS AND DISCUSSION: The Co-OPT ACS cohort contains 2.28 million pregnancies and babies, born in Finland, Iceland, Israel, Canada and Scotland, between 1990 and 2019. Births from 22 to 45 weeks' gestation were included; 92.9% were at term (≥ 37 completed weeks). 3.6% of babies were exposed to ACS (67.0% and 77.9% of singleton and multiple births before 34 weeks, respectively). Rates of ACS exposure increased across the study period. Of all ACS-exposed babies, 26.8% were born at term. Longitudinal childhood data were available for 1.64 million live births. Follow-up includes diagnoses of a range of physical and mental disorders from the Finnish Hospital Register, diagnoses of mental, behavioural, and neurodevelopmental disorders from the Icelandic Patient Registers, and preschool reviews from the Scottish Child Health Surveillance Programme. The Co-OPT ACS cohort is the largest international birth cohort to date with data on ACS exposure and maternal, perinatal and childhood outcomes. Its large scale will enable assessment of important rare outcomes such as perinatal m

Published
2023

36. Consortium for the Study of Pregnancy Treatments (Co-OPT): An international birth cohort to study the effects of antenatal corticosteroids

Author

Epi Methoden Team 4, JC onderzoeksprogramma Methodologie, Frier, Emily M, Lin, Chun, Reynolds, Rebecca M, Allegaert, Karel, Been, Jasper V, Fraser, Abigail, Gissler, Mika, Einarsdóttir, Kristjana, Florian, Lani, Jacobsson, Bo, Vogel, Joshua P, Zoega, Helga, Bhattacharya, Sohinee, Krispin, Eyal, Henning Pedersen, Lars, Roberts, Devender, Kuhle, Stefan, Fahey, John, Mol, Ben W, Burgner, David, Schuit, Ewoud, Sheikh, Aziz, Wood, Rachael, Gyamfi-Bannerman, Cynthia, Miller, Jessica E, Duhig, Kate, Lahti-Pulkkinen, Marius, Hadar, Eran, Wright, John, Murray, Sarah R, Stock, Sarah J, Epi Methoden Team 4, JC onderzoeksprogramma Methodologie, Frier, Emily M, Lin, Chun, Reynolds, Rebecca M, Allegaert, Karel, Been, Jasper V, Fraser, Abigail, Gissler, Mika, Einarsdóttir, Kristjana, Florian, Lani, Jacobsson, Bo, Vogel, Joshua P, Zoega, Helga, Bhattacharya, Sohinee, Krispin, Eyal, Henning Pedersen, Lars, Roberts, Devender, Kuhle, Stefan, Fahey, John, Mol, Ben W, Burgner, David, Schuit, Ewoud, Sheikh, Aziz, Wood, Rachael, Gyamfi-Bannerman, Cynthia, Miller, Jessica E, Duhig, Kate, Lahti-Pulkkinen, Marius, Hadar, Eran, Wright, John, Murray, Sarah R, and Stock, Sarah J

Published
2023

40. Consortium for the Study of Pregnancy Treatments (Co-OPT): An international birth cohort to study the effects of antenatal corticosteroids

Author

Frier, Emily M., primary, Lin, Chun, additional, Reynolds, Rebecca M., additional, Allegaert, Karel, additional, Been, Jasper V., additional, Fraser, Abigail, additional, Gissler, Mika, additional, Einarsdóttir, Kristjana, additional, Florian, Lani, additional, Jacobsson, Bo, additional, Vogel, Joshua P., additional, Zoega, Helga, additional, Bhattacharya, Sohinee, additional, Krispin, Eyal, additional, Henning Pedersen, Lars, additional, Roberts, Devender, additional, Kuhle, Stefan, additional, Fahey, John, additional, Mol, Ben W., additional, Burgner, David, additional, Schuit, Ewoud, additional, Sheikh, Aziz, additional, Wood, Rachael, additional, Gyamfi-Bannerman, Cynthia, additional, Miller, Jessica E., additional, Duhig, Kate, additional, Lahti-Pulkkinen, Marius, additional, Hadar, Eran, additional, Wright, John, additional, Murray, Sarah R., additional, and Stock, Sarah J., additional

Published
2023
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41. The need for appropriate language in the debate on medicalisation of pregnancy

Author

Cluver, Catherine, primary, de Groot, Christianne, additional, Mol, Ben W, additional, Murphy, Kellie E, additional, Norman, Jane E, additional, Pacagnella, Rodolfo, additional, Palmer, Kirsten, additional, Poon, Liona C, additional, Rolnik, Daniel L, additional, Spong, Catherine Y, additional, Stock, Sarah J, additional, Thangaratinam, Shakila, additional, Tong, Stephen, additional, Verhoeven, Corine, additional, Vuong, Lan N, additional, Walker, Sue P, additional, and Xiaohua, Liu, additional

Published
2023
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42. Implementation of a novel ultrasound training programme for midwives in Malawi: A mixed methods evaluation using the RE-AIM framework

Author

Viner, Alexandra C., primary, Malata, Monica P., additional, Mtende, Medrina, additional, Membe-Gadama, Gladys, additional, Masamba, Martha, additional, Makwakwa, Enita, additional, Bamuya, Catherine, additional, Lissauer, David, additional, Stock, Sarah J., additional, Norman, Jane E., additional, Reynolds, Rebecca M., additional, Magowan, Brian, additional, Freyne, Bridget, additional, Gadama, Luis, additional, Cunningham-Burley, Sarah, additional, Nyondo-Mipando, Linda, additional, and Chipeta, Effie, additional

Published
2023
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43. Baby and Maternal Outcomes Following SARS-CoV-2 Infection and COVID-19 Vaccination During Pregnancy: A National Population-Based Matched Cohort Study

Author

Lindsay, Laura, primary, Calvert, Clara, additional, Shi, Ting, additional, Carruthers, Jade, additional, Denny, Cheryl, additional, Donaghy, Jack, additional, Hopcroft, Lisa EM, additional, Hopkins, Leanne, additional, Goulding, Anna, additional, McLaughlin, Terry, additional, Moore, Emily, additional, Taylor, Bob, additional, Bhaskaran, Krishnan, additional, Katikireddi, Srinivasa Vittal, additional, McCabe, Ronan, additional, McCowan, Colin, additional, Simpson, Colin, additional, Robertson, Chris, additional, Sheikh, Aziz, additional, Wood, Rachael, additional, and Stock, Sarah J., additional

Published
2023
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48. Preterm Birth Therapies to Target Inflammation

Author

Pavlidis, Ioannis and Stock, Sarah J E

Subjects
Inflammation, Pharmacology, Pregnancy, Inflammation/drug therapy, Infant, Newborn, Humans, Premature Birth, Premature Birth/metabolism, Female, Pharmacology (medical), Child
Abstract

Preterm birth (PTB; defined as delivery before 37 weeks of pregnancy) is the leading cause of morbidity and mortality in infants and children aged5 years, conferring potentially devastating short- and long-term complications. Despite extensive research in the field, there is currently a paucity of medications available for PTB prevention and treatment. Over the past few decades, inflammation in gestational tissues has emerged at the forefront of PTB pathophysiology. Even in the absence of infection, inflammation alone can prematurely activate the main components of parturition resulting in uterine contractions, cervical ripening and dilatation, membrane rupture, and subsequent PTB. Mechanistic studies have identified critical elements of the complex inflammatory molecular pathways involved in PTB. Here, we discuss therapeutic options that target such key mediators with an aim to prevent, postpone, or treat PTB. We provide an overview of more traditional therapies that are currently used or being tested in humans, and we highlight recent advances in preclinical studies introducing novel approaches with therapeutic potential. We conclude that urgent collaborative action is required to address the unmet need of developing effective strategies to tackle the challenge of PTB and its complications.

Published
2022
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