Oxfordshire Women and Their Children's Health (OxWATCH): protocol for a prospective cohort feasibility study

S Harrison, G Petkovic, A Chevassut, L Brook, N Higgins, Y Kenworthy, M Selwood, T Snelgar, L Arnold, H Boardman, C Heneghan, P Leeson, C Redman, I Granne, S Harrison, G Petkovic, A Chevassut, L Brook, N Higgins, Y Kenworthy, M Selwood, T Snelgar, L Arnold, H Boardman, C Heneghan, P Leeson, C Redman, I Granne

Abstract

Introduction: Some specific pregnancy disorders are known to be associated with increased incidence of long-term maternal ill health (eg, gestational diabetes with late onset type 2 diabetes; pre-eclampsia with arterial disease). To what degree these later health conditions are a consequence of the woman's constitution prior to pregnancy rather than pregnancy itself triggering changes in a woman's health is unknown. Additionally, there is little prospective evidence for the impact of pre-pregnancy risk factors on the outcome of pregnancy. To understand the importance of pre-pregnancy health requires the recruitment of women into a long-term cohort study before their first successful pregnancy. The aim of this feasibility study is to test recruitment procedures and acceptability of participation to inform the planning of a future large-scale cohort study.

Methods: The prospective cohort feasibility study will recruit nulliparous women aged 18-40 years. Women will be asked to complete a questionnaire to assess the acceptability of our recruitment and data collection procedures. Baseline biophysical, genetic, socioeconomic, behavioural and psychological assessments will be conducted and samples of blood, urine, saliva and DNA will be collected. Recruitment feasibility and retention rates will be assessed. Women who become pregnant will be recalled for pregnancy and postpregnancy assessments.

Ethics and dissemination: The study protocol was approved by South Central Portsmouth REC (Ref: 12/SC/0492). The findings from the study will be disseminated through peer reviewed journals, national and international conference presentations and public events.

Trial registration number: http://www.clinicaltrials.gov; NCT02419898.

Keywords: maternal health; pre-pregnancy; pregnancy.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
Flow chart of study recruitment.

References

    1. Godfrey KM, Barker DJ. Fetal nutrition and adult disease. Am J Clin Nutr 2000;71(5 Suppl):1344S–52S.
    1. Bellamy L, Casas JP, Hingorani AD et al. . Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet 2009;373:1773–9. 10.1016/S0140-6736(09)60731-5
    1. Lazdam M, Davis EF, Lewandowski AJ et al. . Prevention of vascular dysfunction after preeclampsia: a potential long-term outcome measure and an emerging goal for treatment. J Pregnancy 2012;2012:704146 10.1155/2012/704146
    1. Leigh B, Milgrom J. Risk factors for antenatal depression, postnatal depression and parenting stress. BMC Psychiatry 2008;8:24 10.1186/1471-244X-8-24
    1. Redman CW, Sargent IL. Immunology of pre-eclampsia. Am J Reprod Immunol 2010;63:534–43. 10.1111/j.1600-0897.2010.00831.x
    1. Magnussen EB, Vatten LJ, Lund-Nilsen TI et al. . Prepregnancy cardiovascular risk factors as predictors of pre-eclampsia: population based cohort study. BMJ 2007;335:978 10.1136/
    1. Sattar N, Greer IA. Pregnancy complications and maternal cardiovascular risk: opportunities for intervention and screening? BMJ 2002;325:157–60. 10.1136/bmj.325.7356.157
    1. Ness RB, Roberts JM. Heterogeneous causes constituting the single syndrome of preeclampsia: a hypothesis and its implications. Am J Obstet Gynecol 1996;175:1365–70. 10.1016/S0002-9378(96)70056-X
    1. Poston L, Harthoorn LF, Van Der Beek EM. Obesity in pregnancy: implications for the mother and lifelong health of the child. A consensus statement. Pediatr Res 2011;69:175–80. 10.1203/PDR.0b013e3182055ede
    1. Berge LN, Arnesen E, Forsdahl A. Pregnancy related changes in some cardiovascular risk factors. Acta Obstet Gynecol Scand 1996;75:439–42. 10.3109/00016349609033350
    1. Llurba E, Gratacós E, Martín-Gallán P et al. . A comprehensive study of oxidative stress and antioxidant status in preeclampsia and normal pregnancy. Free Radic Biol Med 2004;37:557–70. 10.1016/j.freeradbiomed.2004.04.035
    1. Bodnar LM, Catov JM, Simhan HN et al. . Maternal vitamin D deficiency increases the risk of preeclampsia. J Clin Endocrinol Metab 2007;92:3517–22. 10.1210/jc.2007-0718
    1. Wen SW, Chen XK, Rodger M et al. . Folic acid supplementation in early second trimester and the risk of preeclampsia. Am J Obstet Gynecol 2008;198:45.e1–7. 10.1016/j.ajog.2007.06.067
    1. Mistry HD, Broughton Pipkin F, Redman CW et al. . Selenium in reproductive health. Am J Obstet Gynecol 2012;206:21–30. 10.1016/j.ajog.2011.07.034
    1. Levine RJ, Vatten LJ, Horowitz GL et al. . Pre-eclampsia, soluble fms-like tyrosine kinase 1, and the risk of reduced thyroid function: nested case-control and population based study. BMJ 2009;339:b4336 10.1136/bmj.b4336
    1. Powe CE, Levine RJ, Karumanchi SA. Preeclampsia, a disease of the maternal endothelium: the role of antiangiogenic factors and implications for later cardiovascular disease. Circulation 2011;123:2856–69. 10.1161/CIRCULATIONAHA.109.853127
    1. Agrawal A, Scherrer JF, Grant JD et al. . The effects of maternal smoking during pregnancy on offspring outcomes. Prev Med 2010;50:13–18. 10.1016/j.ypmed.2009.12.009
    1. Patra J, Bakker R, Irving H et al. . Dose-response relationship between alcohol consumption before and during pregnancy and the risks of low birthweight, preterm birth and small for gestational age (SGA)-a systematic review and meta-analyses. BJOG 2011;118:1411–21. 10.1111/j.1471-0528.2011.03050.x
    1. Elsenbruch S, Benson S, Rücke M et al. . Social support during pregnancy: effects on maternal depressive symptoms, smoking and pregnancy outcome. Hum Reprod 2007;22:869–77. 10.1093/humrep/del432
    1. Hobel CJ, Goldstein A, Barrett ES. Psychosocial stress and pregnancy outcome. Clin Obstet Gynecol 2008;51:333–48. 10.1097/GRF.0b013e31816f2709
    1. Andersson L, Sundström-Poromaa I, Bixo M et al. . Point prevalence of psychiatric disorders during the second trimester of pregnancy: a population-based study. Am J Obstet Gynecol 2003;189:148–54. 10.1067/mob.2003.336
    1. Alder J, Fink N, Bitzer J et al. . Depression and anxiety during pregnancy: a risk factor for obstetric, fetal and neonatal outcome? A critical review of the literature. J Matern Fetal Neonatal Med 2007;20:189–209. 10.1080/14767050701209560
    1. Board NC. Commissioning maternity services. A resoirce pack to support clinical commisioning groups 2012.
    1. Mahendru AA, Everett TR, Wilkinson IB et al. . A longitudinal study of maternal cardiovascular function from preconception to the postpartum period. J Hypertens 2014;32:849–56. 10.1097/HJH.0000000000000090
    1. te Velde ER, Eijkemans R, Habbema HD. Variation in couple fecundity and time to pregnancy, an essential concept in human reproduction. Lancet 2000;355:1928–9. 10.1016/S0140-6736(00)02320-5
    1. Wilcox AJ, Weinberg CR, O'Connor JF et al. . Incidence of early loss of pregnancy. N Engl J Med 1988;319:189–94. 10.1056/NEJM198807283190401
    1. Arain M, Campbell MJ, Cooper CL et al. . What is a pilot or feasibility study? A review of current practice and editorial policy . BMC Med Res Methodol 2010;10:67 10.1186/1471-2288-10-67
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract 2004;10:307–12. 10.1111/j.2002.384.doc.x

Source: PubMed

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