The effectiveness of extended postpartum comprehensive health care bundle selected outcomes of women with preeclampsia at 6 months: protocol of a randomized controlled trial

Authors

  • Venkadalakshmi V. National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Manju Dhandapani National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Shalini Gainder Department of Obstetrics and gynaecology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Vikas Suri Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Karobi Das National Institute of Nursing Education, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Rajesh Vejeyvergiya Department of Cardiology, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Abhishek Ghosh Department of Psychiatry, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Poonam Khanna School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Rajan Chellappa Department of Physiotherapy, Postgraduate Institute of Medical Education and Research, Chandigarh, India
  • Babina Department of Physiotherapy, Postgraduate Institute of Medical Education and Research, Chandigarh, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20240044

Keywords:

EP CHC bundle, Preeclampsia, Postpartum women cardiovascular risk in women

Abstract

Background: Women who have experienced pre-eclampsia (PE) may also face additional health problems in later life, as the condition is associated with an increased risk of death from 2-fold increased risk of long-term cardiovascular disease (CVD), hypertension, stroke, an approximate 5-12-fold increased risk of end-stage renal disease (ESRD), metabolic syndrome, and diabetes.

Methods: Method was randomized controlled trial. Women with PE who delivered in PGIMER will be enrolled and will be allocated into experimental ad control group using a computer random table with allocation concealment. Enrolment will be done at the time of discharge; baseline assessment will be done 6 weeks and the intervention bundle will be implemented to the women in experimental group. The women in control group will receive routine care. Women in both the groups will be followed up at 6 months.

Conclusions: This study aims to determine the effectiveness of “extended postpartum comprehensive health care bundle (EP CHC bundle)” on selected outcomes of women with preeclampsia at 6 months. The comprehensive health care bundle will be designed with the inputs from all stakeholders, has the potential to suit the dynamic nature of management of women with preeclampsia after delivery.

CTRI registration number: CTRI/2021/04/032749 ON 12/4/2021

References

World Health Organization. WHO recommendations for prevention and treatment of pre-eclampsia and eclampsia. 2011. Available at: http://whqlibdoc.who.int/publications/2011/9789241548335_eng.pdf. Accessed on 20 May 2023.

Preeclampsia in 2018: Revisiting Concepts, Physiopathology, and Prediction. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6304478/. Accessed on 14 May 2023.

Sibai BM. Etiology and management of postpartum hypertension-preeclampsia. Am J Obstet Gynecol. 2012;206(6):470-75.

Magee LA, Pels A, Helewa M, Evelyne R, Peter VD, Canadian Hypertensive Disorders of Pregnancy (HDP) Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014;4(2):105-45.

El-Sayed AAF. Preeclampsia: A review of the pathogenesis and possible management strategies based on its pathophysiological derangements. Taiwan J Obstet Gynecol. 2017;56(5):593-8.

Lisonkova S, Joseph KS. Incidence of preeclampsia: risk factors and outcomes associated with early- versus late-onset disease. Am J Obstet Gynecol. 2013;209(6):544.e1-12.

Ditisheim A, Sibai BM. Diagnosis and Management of HELLP Syndrome Complicated by Liver Hematoma. Clin Obstet Gynecol. 2017;60(1):190-97.

Hermes W, Franx A, van Pampus MG, Kitty WB, Joris A van der Post, Martina P et al. 10-Year cardiovascular event risks for women who experienced hypertensive disorders in late pregnancy: the HyRAS study. BMC Pregnancy Childbirth. 2010;10:28.

Hermes W, Tamsma JT, Grootendorst DC, Arie F, Joris Van DP, Maria GP et al. Cardiovascular risk estimation in women with a history of hypertensive pregnancy disorders at term: a longitudinal follow-up study. BMC Pregnancy Childbirth. 2013;13:126-6.

Mayama M, Uno K, Tano S, Masato Y, Mayu U, Yasuyuki K et al. Incidence of posterior reversible encephalopathy syndrome in eclamptic and patients with preeclampsia with neurologic symptoms. Am J Obstet Gynecol 2016;215(2):239.e1-5.

Fang X, Liang Y, Chen D, Fang H, Jia C, Fami H. A study on clinicoradiological characteristics and pregnancy outcomes of reversible posterior leukoencephalopathy syndrome in preeclampsia or eclampsia. Hypertens Res. 2017;40(12):982-7.

Tsigas E. Advocacy is essential to supporting women with pre-eclampsia. Obstet Med. 2017;10(1):33-5.

Xiong C, Zhou A, Cao Z, Yaqi Z, Lin Q, Cong Y et al. Association of pre-pregnancy body mass index, gestational weight gain with cesarean section in term deliveries of China. Sci Rep. 2016;6:37168.

Thangaratinam S, Ismail KMK, Sharp S, A Coomarasamy, Khan KS, Tests in Prediction of Pre-eclampsia Severity review group. Accuracy of serum uric acid in predicting complications of pre-eclampsia: a systematic review. BJOG Int J Obstet Gynaecol. 2006;113(4):369-78.

Lui NA, Jeyaram G, Henry A. Postpartum Interventions to Reduce Long-Term Cardiovascular Disease Risk in Women After Hypertensive Disorders of Pregnancy: A Systematic Review. Front Cardiovasc Med. 2019;6:160.

Preeclampsia Foundation. Preeclampsia and Racial and Ethnic Disparities. Available at: https://www.preeclampsia.org/public/frontend/assets/img/gallery/patient_information_sheet_02.20.20_ FINAL.pdf. Accessed 20 May 2023.

You WB, Wolf MS, Bailey SC. Improving patient understanding of preeclampsia: a randomized controlled trial. Am J Obstet Gynecol. 2012;206(2):431.e1-5.

Seely EW, Rich-Edwards J, Lui J, Nicklas JM, Saxena A, Tsigas E et al. Risk of future cardiovascular disease in women with prior preeclampsia: a focus group study. BMC Pregnancy Childbirth. 2013;13:240.

Stern C, Trapp E-M, Mautner E, Maria D, Uwe L, Mila C-Z. The impact of severe preeclampsia on maternal quality of life. Qual Life Res. 2014;23(3):1019-26.

Benschop L, Duvekot JJ, Roeters van Lennep JE. Future risk of cardiovascular disease risk factors and events in women after a hypertensive disorder of pregnancy. Heart. 2019;105(16):1273.

Skurnik G, Roche AT, Stuart JJ, Janet RE, Eleni T, Sue EL et al. Improving the postpartum care of women with a recent history of preeclampsia: a focus group study. Hypertens Pregnancy. 2016;35(3):371-81.

Podymow T, August P. Postpartum Course of Gestational Hypertension and Preeclampsia. Hypertens Pregnancy. 2010;29(3):294-300.

Eastabrook G, Aksoy T, Bedell S, Debbie P, Barbra DV. Preeclampsia biomarkers: An assessment of maternal cardiometabolic health. Pregnancy Hypertens. 2018;13:204-13.

Paauw ND, Luijken K, Franx A, Marianne CV, Titia AL. Long-term renal and cardiovascular risk after preeclampsia: towards screening and prevention. Clin Sci. 2016;130(4):239-46.

Hermes W, Franx A, van Pampus MG. Cardiovascular risk factors in women who had hypertensive disorders late in pregnancy: a cohort study. Am J Obstet Gynecol. 2013;208:474.e1-8.

Di X, Mai H, Zheng Z, Kaimin G, Abraham NM, Huishu L. Neuroimaging findings in women who develop neurologic symptoms in severe preeclampsia with or without eclampsia. Hypertens Res. 2018;41(8):598-604.

Xiaobo F, Yanling L, Dunjin C, He F, Chen J, Zhong Y et al. Effect of blood pressure on reversible posterior leukoencephalopathy syndrome in pre-eclampsia or eclampsia. Hypertens Res. 2018;41(2):112-7.

Weissgerber TL, Mudd LM. Preeclampsia and diabetes. Curr Diab Rep. 2015;15(3):9-9.

Wang L, Leng J, Liu H, Zhang S, Wang J, Li W et al. Association between hypertensive disorders of pregnancy and the risk of postpartum hypertension: a cohort study in women with gestational diabetes. J Hum Hypertens. 2017;31(11):725-30.

Mogos MF, August EM, Salinas-Miranda AA, Dawood HS, Hamisu MS. A Systematic Review of Quality of Life Measures in Pregnant and Postpartum Mothers. Appl Res Qual Life. 2013;8(2):219-50.

Hernández- Martínez A, Rodríguez-Almagro J, Molina-Alarcón M, Nuria I-T, Miriam DM, Juan MM-G. Postpartum post-traumatic stress disorder: Associated perinatal factors and quality of life. J Affect Disord. 2019;249:143-50.

Martínez-Galiano JM, Hernández-Martínez A, Rodríguez-Almagro J, Miguel DR, Ana RA, Juan GS. Women’s Quality of Life at 6 Weeks Postpartum: Influence of the Discomfort Present in the Puerperium. Int J Environ Res Public Health 2019;16(2):253.

Machado MS, Bertagnolli TV, Machado JS, Cristine H, Geraldo D, Ricardo CC. [239-POS]: Assessment of quality of life of women with preeclampsia compared with healthy pregnant women. ResearchGate. 2015;5:120-21.

Caprini Score Accurately Predicts Risk of Venous Thromboembolism in Critically Ill Surgical Patients | The Hospitalist, Available at: https://www.the-hospitalist.org/hospitalist/article/121924/caprini-score-accurately-predicts-risk-venous-thromboembolism-critically. Accessed on 28 May 2023).

Cronin M, Dengler N, Krauss E, Ayal S, Nicole W, Madison D et al. Completion of the Updated Caprini Risk Assessment Model (2013 Version). Clin Appl Thromb. 2019;25:107602961983805.

FINAL_PE_CVD_POSITION-PAPER_1578569237.pdf, Available at: https://www.preeclampsia.org/frontend/assets/img/advocacy_resource/FINAL_PE_CVD_POSITION-PAPER_1578569237.pdf. Accessed on 20 May 2023.

Guidelines on mental health promotive and preventive interventions for adolescents. Available at: https://www.who.int/mental_health/media/ en/76.pdf?ua=1. Accessed on 29 May 2023.

Linne Y, Dye L, Barkeling B, Rossner S. Long-term weight development in women: A 15-year follow-up of the effects of pregnancy. Obesity Res. 2004;12:1166-78.

Kew S, Ye C, Hanley AJ, Connelly PW, Sermer M, Zinman B et al. Cardiometabolic implications of postpartum weight changes in the first year after delivery. Diabetes Care. 2014;37:1998-2006.

Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: Systematic review and meta-analysis. BMJ. 2007;335:1.

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Published

2024-01-24