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Hantoushzadeh, S., Behzadian, A., Hasheminejad, M. M., Hasheminejad, F., Birjandi, A. H., Akbari, M., & Ghaemi, M. (2024). Aspirin administration from early pregnancy versus initiation after 11 weeks of gestation for prevention of pre-eclampsia in high-risk pregnant women: Study protocol for randomized controlled trial. International Journal of Reproductive BioMedicine (IJRM), 22(1), 69–80. https://doi.org/10.18502/ijrm.v22i1.15244
https://doi.org/10.18502/ijrm.v22i1.15244
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authors
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Sedigheh Hantoushzadeh
Sedigheh Hantoushzadeh
Vali-E-Asr Reproductive Health Research Center, Family Health Research Institute, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
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Arezoo Behzadian
Arezoo Behzadian
Department of Perinatology, Vali-E-Asr Hospital, Imam Khomeini Hospital Complex, Tehran, Iran.
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Mohammad Mehdi Hasheminejad
Mohammad Mehdi Hasheminejad
Iran University of Medical Sciences, Tehran, Iran.
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Faezeh Hasheminejad
Faezeh Hasheminejad
Asklepios Psychiatry Lower Saxony GmbH, Asklepios Specialist Clinic, Gottingen, Germany.
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Alireza Helal Birjandi
Alireza Helal Birjandi
Hannover Medical School, Clinic for Urology, Hannover, Germany.
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Mojtaba Akbari
Mojtaba Akbari
Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medicine Sciences, Isfahan, Iran.
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Marjan Ghaemi
Marjan Ghaemi
Vali-E-Asr Hospital, Imam Khomeini Hospital Complex, Iran.
Published Date
- Feb 18, 2024
Aspirin administration from early pregnancy versus initiation after 11 weeks of gestation for prevention of pre-eclampsia in high-risk pregnant women: Study protocol for randomized controlled trial
Abstract
Background: Pre-eclampsia (PE) is a multiorgan disorder that affects 2–5% of all pregnant women. Present recommendations for when to start aspirin in high-risk women are after 11 wk of gestation.
Objective: We present a protocol to investigate the effectiveness of aspirin use from early pregnancy, which is a randomized controlled trial to assess whether prescribed low-dose aspirin from early pregnancy reduces the prevalence of early and late-onset PE. Additionally, to compare the effectiveness of aspirin administration before and after 11 wk in reducing the occurrence of PE?
Materials and Methods: All pregnancies at risk of PE, according to demographic and midwifery history, who are referred to the Maternal-Fetal Clinic of Tehran University hospital, Tehran, Iran were invited to take part in the trial. The outcomes of pregnancy and newborns will be gathered and analyzed. The first registration for the pilot study was in January 2023, and the participants were recognized as high-risk for PE. In addition, enrollment in the main study will begin as of October 2023. Key words: Pre-eclampsia, Aspirin, Color doppler ultrasonography, Pregnancy, First trimester, Pregnancy-associated plasma protein-A.
Key words: Pre-eclampsia, Aspirin, Color doppler ultrasonography, Pregnancy, First-trimester, Pregnancy-associated plasma protein-A.
References
[1] Poon LC, Shennan A, Hyett JA, Kapur A, Hadar E, Divakar H, et al. The International Federation of Gynecology and Obstetrics (FIGO) initiative on pre-eclampsia: A pragmatic guide for first-trimester screening and prevention. Int J Gynaecol Obstet 2019; 145 (Suppl.): 1–33.
[2] Brosens I, Pijnenborg R, Vercruysse L, Romero R. The “great obstetrical syndrome” are associated with disorders of deep placentation. Am J Obstet Gynecol 2010; 204: 193–201.
[3] Zuo Q, Zou Y, Huang Sh, Wang T, Xu Y, Zhang T, et al. Aspirin reduces sFlt-1-mediated apoptosis of trophoblast cells in preeclampsia. Mol Hum Reprod 2021; 27: gaaa089.
[4] Benigni A, Gregorini G, Frusca T, Chiabrando C, Ballerini S, Valcamonico A, et al. Effect of low-dose aspirin on fetal and maternal generation of thromboxane by platelets in women at risk for ppregnancy-induced hypertension. N Engl J Med 1989; 321: 357–362.
[5] Espinoza J, Romero R, Kim YM, Kusanovic JP, Hassan S, Erez O, et al. Normal and abnormal transformation of the spiral arteries during pregnancy. J Perinat Med 2006; 34: 447–458.
[6] Rolnik DL, Wright D, Poon LC, O’Gorman N, Syngelaki A, de Paco Matallana C, et al. Aspirin versus placebo in pregnancies at high risk for preterm preeclampsia. N Engl J Med 2017; 377: 613–622.
[7] Hoffman MK, Goudar SS, Kodkany BS, Metgud M, Somannavar M, Okitawutshu J, et al. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): A randomised, double-blind, placebo-controlled trial. Lancet 2020; 395: 285–293.
[8] Roberge S, Sibai B, McCaw-Binns A, Bujold E. Low-dose aspirin in early gestation for prevention of preeclampsia and small-for-gestational-age neonates: Meta-analysis of large randomized trials. Am J Perinatol 2016; 33: 781–785.
[9] Li C, Raikwar NS, Santillan MK, Santillan DA, Thomas CP. Aspirin inhibits expression of sFLT1 from human cytotrophoblasts induced by hypoxia, via cyclo-oxygenase 1. Placenta 2015; 36: 446–453.
[10] Panagodage Sh, Yong HEJ, Da Silva Costa F, Borg AJ, Kalionis B, Brennecke ShP, et al. Low-dose acetylsalicylic acid treatment modulates the production of cytokines and improves trophoblast function in an in vitro model of earlyonset preeclampsia. Am J Pathol 2016; 186: 3217–3224.
[11] Henderson JT, Whitlock EP, O’Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: A systematic evidence review for the U.S. preventive services task force. Ann Intern Med 2014; 160: 695–703.
[12] Ahrens KA, Silver RM, Mumford SL, Sjaarda LA, Perkins NJ, Wactawski-Wende J, et al. Complications and safety of preconception low-dose aspirin among women with prior pregnancy losses. Obstet Gynecol 2016; 127: 689–698.
[13] US Preventive Services Task Force, Davidson KW, Barry MJ, Mangione CM, Cabana M, Caughey AB, et al. Aspirin use to prevent preeclampsia and related morbidity and mortality: US preventive services task force recommendation statement. JAMA 2021; 326: 1186–1191.
[14] Roberts JM, King TL, Barton JR, Beck S, Bernstein IM, Buck TE, et al. Care plan for individuals at risk for preeclampsia: Shared approach to education, strategies for prevention, surveillance, and follow-up.3. Am J Obstet Gynecol 2023; 229: 193–213.
[15] Poon L, Maiz N, Valencia C, Plasencia W, Nicolaides K. First-trimester maternal serum pregnancy-associated plasma protein-A and pre-eclampsia. Ultrasound Obstet Gynecol 2009; 33: 23–33.
[16] Martin AM, Bindra R, Curcio P, Cicero S, Nicolaides KH. Screening for pre-eclampsia and fetal growth restriction by uterine artery Doppler at 11–14 weeks of gestation. Ultrasound Obstet Gynecol 2001; 18: 583–586.
[17] Harrington K, Carpenter R, Goldfrad C, Campbell S. Transvaginal doppler ultrasound of the uteroplacental circulation in the early prediction of pre-eclampsia and intrauterine growth retardation. Br J Obstet Gynaecol 1997; 104: 674–681.
[18] Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, et al. Hypertensive disorders of pregnancy: ISSHP classification, diagnosis, and management recommendations for international practice. Hypertension 2018; 72: 24–43.
[19] Cotechini T, Komisarenko M, Sperou A, Macdonald- Goodfellow Sh, Adams MA, Graham ChH. Inflammation in rat pregnancy inhibits spiral artery remodeling leading to fetal growth restriction and features of preeclampsia. J Exp Med 2014; 211: 165–179.
[20] Lyall F. Priming and remodelling of human placental bed spiral arteries during pregnancy- a review. Placenta 2005; 26: S31-S36.
[21] Roberge S, Bujold E, Nicolaides KH. Aspirin for the prevention of preterm and term preeclampsia: Systematic review and metaanalysis. Am J Obstet Gynecol 2018; 218: 287–293.
[22] Bujold E, Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, et al. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: A meta-analysis. Obstet Gynecol 2010; 116: 402–414.
[23] Vainio M, Kujansuu E, Koivisto A-M, Maenpaa J. Bilateral notching of uterine arteries at 12–14 weeks of gestation for prediction of hypertensive disorders of pregnancy. Acta Obstet Gynecol Scand 2005; 84: 1062–1067.
[24] Sahin S, Ozakpinar OB, Eroglu M, Tulunay A, Ciraci E, Uras F, et al. The impact of platelet functions and inflammatory status on the severity of preeclampsia. J Matern Fetal Neonatal Med 2015; 28: 643–648.
[2] Brosens I, Pijnenborg R, Vercruysse L, Romero R. The “great obstetrical syndrome” are associated with disorders of deep placentation. Am J Obstet Gynecol 2010; 204: 193–201.
[3] Zuo Q, Zou Y, Huang Sh, Wang T, Xu Y, Zhang T, et al. Aspirin reduces sFlt-1-mediated apoptosis of trophoblast cells in preeclampsia. Mol Hum Reprod 2021; 27: gaaa089.
[4] Benigni A, Gregorini G, Frusca T, Chiabrando C, Ballerini S, Valcamonico A, et al. Effect of low-dose aspirin on fetal and maternal generation of thromboxane by platelets in women at risk for ppregnancy-induced hypertension. N Engl J Med 1989; 321: 357–362.
[5] Espinoza J, Romero R, Kim YM, Kusanovic JP, Hassan S, Erez O, et al. Normal and abnormal transformation of the spiral arteries during pregnancy. J Perinat Med 2006; 34: 447–458.
[6] Rolnik DL, Wright D, Poon LC, O’Gorman N, Syngelaki A, de Paco Matallana C, et al. Aspirin versus placebo in pregnancies at high risk for preterm preeclampsia. N Engl J Med 2017; 377: 613–622.
[7] Hoffman MK, Goudar SS, Kodkany BS, Metgud M, Somannavar M, Okitawutshu J, et al. Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): A randomised, double-blind, placebo-controlled trial. Lancet 2020; 395: 285–293.
[8] Roberge S, Sibai B, McCaw-Binns A, Bujold E. Low-dose aspirin in early gestation for prevention of preeclampsia and small-for-gestational-age neonates: Meta-analysis of large randomized trials. Am J Perinatol 2016; 33: 781–785.
[9] Li C, Raikwar NS, Santillan MK, Santillan DA, Thomas CP. Aspirin inhibits expression of sFLT1 from human cytotrophoblasts induced by hypoxia, via cyclo-oxygenase 1. Placenta 2015; 36: 446–453.
[10] Panagodage Sh, Yong HEJ, Da Silva Costa F, Borg AJ, Kalionis B, Brennecke ShP, et al. Low-dose acetylsalicylic acid treatment modulates the production of cytokines and improves trophoblast function in an in vitro model of earlyonset preeclampsia. Am J Pathol 2016; 186: 3217–3224.
[11] Henderson JT, Whitlock EP, O’Connor E, Senger CA, Thompson JH, Rowland MG. Low-dose aspirin for prevention of morbidity and mortality from preeclampsia: A systematic evidence review for the U.S. preventive services task force. Ann Intern Med 2014; 160: 695–703.
[12] Ahrens KA, Silver RM, Mumford SL, Sjaarda LA, Perkins NJ, Wactawski-Wende J, et al. Complications and safety of preconception low-dose aspirin among women with prior pregnancy losses. Obstet Gynecol 2016; 127: 689–698.
[13] US Preventive Services Task Force, Davidson KW, Barry MJ, Mangione CM, Cabana M, Caughey AB, et al. Aspirin use to prevent preeclampsia and related morbidity and mortality: US preventive services task force recommendation statement. JAMA 2021; 326: 1186–1191.
[14] Roberts JM, King TL, Barton JR, Beck S, Bernstein IM, Buck TE, et al. Care plan for individuals at risk for preeclampsia: Shared approach to education, strategies for prevention, surveillance, and follow-up.3. Am J Obstet Gynecol 2023; 229: 193–213.
[15] Poon L, Maiz N, Valencia C, Plasencia W, Nicolaides K. First-trimester maternal serum pregnancy-associated plasma protein-A and pre-eclampsia. Ultrasound Obstet Gynecol 2009; 33: 23–33.
[16] Martin AM, Bindra R, Curcio P, Cicero S, Nicolaides KH. Screening for pre-eclampsia and fetal growth restriction by uterine artery Doppler at 11–14 weeks of gestation. Ultrasound Obstet Gynecol 2001; 18: 583–586.
[17] Harrington K, Carpenter R, Goldfrad C, Campbell S. Transvaginal doppler ultrasound of the uteroplacental circulation in the early prediction of pre-eclampsia and intrauterine growth retardation. Br J Obstet Gynaecol 1997; 104: 674–681.
[18] Brown MA, Magee LA, Kenny LC, Karumanchi SA, McCarthy FP, Saito S, et al. Hypertensive disorders of pregnancy: ISSHP classification, diagnosis, and management recommendations for international practice. Hypertension 2018; 72: 24–43.
[19] Cotechini T, Komisarenko M, Sperou A, Macdonald- Goodfellow Sh, Adams MA, Graham ChH. Inflammation in rat pregnancy inhibits spiral artery remodeling leading to fetal growth restriction and features of preeclampsia. J Exp Med 2014; 211: 165–179.
[20] Lyall F. Priming and remodelling of human placental bed spiral arteries during pregnancy- a review. Placenta 2005; 26: S31-S36.
[21] Roberge S, Bujold E, Nicolaides KH. Aspirin for the prevention of preterm and term preeclampsia: Systematic review and metaanalysis. Am J Obstet Gynecol 2018; 218: 287–293.
[22] Bujold E, Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, et al. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: A meta-analysis. Obstet Gynecol 2010; 116: 402–414.
[23] Vainio M, Kujansuu E, Koivisto A-M, Maenpaa J. Bilateral notching of uterine arteries at 12–14 weeks of gestation for prediction of hypertensive disorders of pregnancy. Acta Obstet Gynecol Scand 2005; 84: 1062–1067.
[24] Sahin S, Ozakpinar OB, Eroglu M, Tulunay A, Ciraci E, Uras F, et al. The impact of platelet functions and inflammatory status on the severity of preeclampsia. J Matern Fetal Neonatal Med 2015; 28: 643–648.