L A Magee1,2,3, P von Dadelszen2,3, J Singer3,4, T Lee4, E Rey5, S Ross6, E Asztalos7,8,9, K E Murphy8,9, J Menzies2, J Sanchez9, A Gafni10, A Gruslin11, M Helewa12, E Hutton13, G Koren7, S K Lee7, A G Logan14, J W Ganzevoort15, R Welch16, J G Thornton17, J-M Moutquin18. 1. Medicine, University of British Columbia, Vancouver, BC, Canada. 2. Obstetrics and Gynaecology, University of British Columbia, Vancouver, BC, Canada. 3. School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada. 4. Centre for Health Evaluation and Outcome Sciences (CHÉOS), Providence Health Care Research Institute, UBC, Vancouver, BC, Canada. 5. Medicine and Obstetrics and Gynaecology, University of Montreal, Montreal, QC, Canada. 6. Obstetrics and Gynaecology, University of Alberta, Edmonton, AB, Canada. 7. Paediatrics, University of Toronto, Toronto, ON, Canada. 8. Obstetrics and Gynaecology, University of Toronto, Toronto, ON, Canada. 9. The Centre for Mother, Infant and Child Research, Sunnybrook Research Institute, University of Toronto, Toronto, ON, Canada. 10. Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. 11. Obstetrics and Gynaecology, University of Ottawa, Ottawa, ON, Canada. 12. Obstetrics and Gynaecology, University of Manitoba, Winnipeg, MB, Canada. 13. Obstetrics and Gynaecology, McMaster University, Hamilton, ON, Canada. 14. Medicine, University of Toronto, Toronto, ON, Canada. 15. Obstetrics and Gynaecology, University of Amsterdam, Amsterdam, the Netherlands. 16. Obstetrics and Gynaecology, Derriford Hospital, Devon, UK. 17. Obstetrics and Gynaecology, University of Nottingham, Nottingham, UK. 18. Obstetrics and Gynaecology, Universite de Sherbrooke, Sherbrooke, QC, Canada.
Abstract
OBJECTIVE: To compare pregnancy outcomes, accounting for allocated group, between methyldopa-treated and labetalol-treated women in the CHIPS Trial (ISRCTN 71416914) of 'less tight' versus 'tight' control of pregnancy hypertension. DESIGN: Secondary analysis of CHIPS Trial cohort. SETTING: International randomised controlled trial (94 sites, 15 countries). POPULATION OR SAMPLE: Of 987 CHIPS recruits, 481/566 (85.0%) women treated with antihypertensive therapy at randomisation. Of 981 (99.4%) women followed to delivery, 656/745 (88.1%) treated postrandomisation. METHODS: Logistic regression to compare outcomes among women who took methyldopa or labetalol, adjusted for the influence of baseline factors. MAIN OUTCOME MEASURES: CHIPS primary (perinatal loss or high level neonatal care for >48 hours) and secondary (serious maternal complications) outcomes, birthweight <10th centile, severe maternal hypertension, pre-eclampsia and delivery at <34 or <37 weeks. RESULTS:Methyldopa and labetalol were used commonly at randomisation (243/987, 24.6% and 238/987, 24.6%, respectively) and post-randomisation (224/981, 22.8% and 433/981, 44.1%, respectively). Following adjusted analyses, methyldopa (versus labetalol) at randomisation was associated with fewer babies with birthweight <10th centile [adjusted odds ratio (aOR) 0.48; 95% CI 0.20-0.87]. Methyldopa (versus labetalol) postrandomisation was associated with fewer CHIPS primary outcomes (aOR 0.64; 95% CI 0.40-1.00), birthweight <10th centile (aOR 0.54; 95% CI 0.32-0.92), severe hypertension (aOR 0.51; 95% CI 0.31-0.83), pre-eclampsia (aOR 0.55; 95% CI 0.36-0.85), and delivery at <34 weeks (aOR 0.53; 95% CI 0.29-0.96) or <37 weeks (aOR 0.55; 95% CI 0.35-0.85). CONCLUSION: These nonrandomised comparisons are subject to residual confounding, but women treated with methyldopa (versus labetalol), particularly those with pre-existing hypertension, may have had better outcomes. TWEETABLE ABSTRACT: There was no evidence that women treated with methyldopa versus labetalol had worse outcomes.
RCT Entities:
OBJECTIVE: To compare pregnancy outcomes, accounting for allocated group, between methyldopa-treated and labetalol-treated women in the CHIPS Trial (ISRCTN 71416914) of 'less tight' versus 'tight' control of pregnancy hypertension. DESIGN: Secondary analysis of CHIPS Trial cohort. SETTING: International randomised controlled trial (94 sites, 15 countries). POPULATION OR SAMPLE: Of 987 CHIPS recruits, 481/566 (85.0%) women treated with antihypertensive therapy at randomisation. Of 981 (99.4%) women followed to delivery, 656/745 (88.1%) treated postrandomisation. METHODS: Logistic regression to compare outcomes among women who took methyldopa or labetalol, adjusted for the influence of baseline factors. MAIN OUTCOME MEASURES: CHIPS primary (perinatal loss or high level neonatal care for >48 hours) and secondary (serious maternal complications) outcomes, birthweight <10th centile, severe maternal hypertension, pre-eclampsia and delivery at <34 or <37 weeks. RESULTS:Methyldopa and labetalol were used commonly at randomisation (243/987, 24.6% and 238/987, 24.6%, respectively) and post-randomisation (224/981, 22.8% and 433/981, 44.1%, respectively). Following adjusted analyses, methyldopa (versus labetalol) at randomisation was associated with fewer babies with birthweight <10th centile [adjusted odds ratio (aOR) 0.48; 95% CI 0.20-0.87]. Methyldopa (versus labetalol) postrandomisation was associated with fewer CHIPS primary outcomes (aOR 0.64; 95% CI 0.40-1.00), birthweight <10th centile (aOR 0.54; 95% CI 0.32-0.92), severe hypertension (aOR 0.51; 95% CI 0.31-0.83), pre-eclampsia (aOR 0.55; 95% CI 0.36-0.85), and delivery at <34 weeks (aOR 0.53; 95% CI 0.29-0.96) or <37 weeks (aOR 0.55; 95% CI 0.35-0.85). CONCLUSION: These nonrandomised comparisons are subject to residual confounding, but women treated with methyldopa (versus labetalol), particularly those with pre-existing hypertension, may have had better outcomes. TWEETABLE ABSTRACT: There was no evidence that women treated with methyldopa versus labetalol had worse outcomes.
Authors: Sascha Dublin; Abisola Idu; Lyndsay A Avalos; T Craig Cheetham; Thomas R Easterling; Lu Chen; Victoria L Holt; Nerissa Nance; Zoe Bider-Canfield; Romain S Neugebauer; Kristi Reynolds; Sylvia E Badon; Susan M Shortreed Journal: PLoS One Date: 2022-05-16 Impact factor: 3.752
Authors: Laura A Magee; Peter von Dadelszen; Joel Singer; Terry Lee; Evelyne Rey; Susan Ross; Elizabeth Asztalos; Kellie E Murphy; Jennifer Menzies; Johanna Sanchez; Amiram Gafni; Andrée Gruslin; Michael Helewa; Eileen Hutton; Shoo K Lee; Alexander G Logan; Wessel Ganzevoort; Ross Welch; Jim G Thornton; Jean Marie Moutquin Journal: Acta Obstet Gynecol Scand Date: 2016-04-07 Impact factor: 3.636