Treatment for Mild Chronic Hypertension during Pregnancy
Alan T Tita, Jeff M Szychowski, Kim Boggess, Lorraine Dugoff, Baha Sibai, Kirsten Lawrence, Brenna L Hughes, Joseph Bell, Kjersti Aagaard, Rodney K Edwards, Kelly Gibson, David M Haas, Lauren Plante, Torri Metz, Brian Casey, Sean Esplin, Sherri Longo, Matthew Hoffman, George R Saade, Kara K Hoppe, Janelle Foroutan, Methodius Tuuli, Michelle Y Owens, Hyagriv N Simhan, Heather Frey, Todd Rosen, Anna Palatnik, Susan Baker, Phyllis August, Uma M Reddy, Wendy Kinzler, Emily Su, Iris Krishna, Nicki Nguyen, Mary E Norton, Daniel Skupski, Yasser Y El-Sayed, Dotum Ogunyemi, Zorina S Galis, Lorie Harper, Namasivayam Ambalavanan, Nancy L Geller, Suzanne Oparil, Gary R Cutter, William W Andrews, Chronic Hypertension and Pregnancy (CHAP) Trial Consortium, Carmen Beamon, Ronald Librizzi, Leonardo Pereira, Everett F Magann, Mounira Habli, Shauna Williams, Giancarlo Mari, Gabriella Pridjian, David S McKenna, Marc Parrish, Eugene Chang, Sarah Osmundson, JoAnne Quinones, Uma Perni, Ronald Wapner, Whitney Booker, Amy P Murtha, Ed Chien, Michael Varner, C Edward Wells, Joseph Biggio, Fatima Nagvi, George A Macones, Molly Stout, Ebony Carter, Heather Lipkind, Kristina Roloff, Donald J Dudley, Glenn Heller, Paula K Roberson, Seetha Shankaran, Robert Wachbroit, John C Hauth, Akila Subramaniam, Rachel LeDuke, Janatha Grant, Tawanda Hill, Amber Boyd, Lisa Dimperio, Glenda Corley-Topham, Michelle L Feese, Robin W Parks, Robin Steele, Hui-Chien Kuo, Yukiko N Orange, Christopher Parks, Karen Dorman, Kathia Pena, Janet Stock, Beth Norton, Samantha Murphy, Lucia Muzzarelli, Sean C Blackwell, Khalil M Chahine, Sarah Tounsi, Joseph Lucci 4th, Maria Hutchinson, Stephanie Lynch, Caroline Torres, Luiza Kalemi, Geeta K Swamy, Jennifer Ferrara, Danielle Lanpher, Amy O'Berry, Kristin Weaver, Thomas Parsons, Susan Hahn, Margaret Clement, Israel Zighelboim, Jorge Tolosa, Almaguer Juarez, Melissa Munoz Beilis, Jia Chen, Jorge Zaragoza Zapian, Tiffany Ostovar-Kermani, Zaida Bisbal, Elizabeth Standerfer, Christina Zornes, Kyra Woods, Alyson Brinkman, Jennifer Trent, LuAnn Polito, Caroline Rouse, Jennifer Wilson, Heather Dickerson, Shannon Barnes, Hannah Shockley, Brandy Firman, Cheryl Tocci, Amber Sowles, Kim Hill, Denise Lamb, Lisa Moseley, Catherine Meadows, Sandi Dellermann, Chris Servay, Cathryn Garvey, Kathleen Arias, Melissa Hendricks, Kelly Ruhstaller, Amy D Staples, Jennifer Chambers, Hassan Harirah, Chasey Omere, Corey Clifford, Gayle Olson, Luis Pacheco, Antonio Saad, Shannon Clark, Sangeeta Jain, Jennifer Sikes DeVolder, Maria Wilson-Jimenez, Lisa Thibodeaux, Heather Martin, Gabriela Andrade, Ashley Salazar, Dinesh Shah, Melissa Zernick, Jennifer Heintz, Kazumasa Hashimoto, Joseph Welter, Alison Sampson, Pam Mundt, Fatima Naqvi, Kristy Palomares, Imene Beche, Anne Bergman, Clara Perez, Molly Sklios, A Macones, Kaytelyn Slack, Emily Diveley, Kedra Wallace, Arun Jeyabalan, Melissa Bickus, Victoria Lopata, Jeanette Boyce, Catalin Buhimschi, Anna Bartholomew, Taryn Summerfield, Shama Khan, Caroline Herdeman, Nicolette Holliday, Catera Duhon, Casey Armistead, Ingrid Paul-Nelson, Line Malha, Rosemerie Marion, Tracy B Grossman, Kathy C Matthews, Amrin Kander, Lauren Perley, Abigail Wilpers, Kim Byrnes, Jocelyn Phipers, Sarah Schwartz, Betsy Burke, Martina Badell, Les'Shon Irby, Juan Gonzalez, Tiffany Lee, Natalie Oman, Rosalyn Chan-Akeley, Susan Ingenito, Deirdre J Lyell, Christine J Lee, Anna I Girsen, Imee A Datoc, Suzanne Cao, Karen Skaret, Ali Alhousseini, Ray Bahado-Singh, Tonyie Andrews Johnson, Jennylin Schott, Monica Rincon, Donna Eastham, Heather Moody, Crystal Daffner, Vivian Ghodsi Mulholland, Yanille Taveras, Annette Hickerson, Cecilia Gambala, Chi Dola, Eduardo Herrera, Emily Callegari, Samantha Wiegand, Kaye Snowe, John Moore, Julio F Mateus Nino, Jesslyn Payne, John C Smulian, Nikki Breslaw, Mary Joe Allen, Wendy Spencer, Alexa Argyres Goldberg, Robert J Ringer, Norbert E Archibeque, Jeffrey R Huminik, Theresa M Miles, Steve Tapia, Karsondra Lovato, Amy Schwartz, Lawton S Cooper, Christine Maric-Bilkan, Diane Reid, H Eser Tolunay, Paula Schum, Ray Ebert, George Black, Nina Hall, Judy Sint, Alan T Tita, Jeff M Szychowski, Kim Boggess, Lorraine Dugoff, Baha Sibai, Kirsten Lawrence, Brenna L Hughes, Joseph Bell, Kjersti Aagaard, Rodney K Edwards, Kelly Gibson, David M Haas, Lauren Plante, Torri Metz, Brian Casey, Sean Esplin, Sherri Longo, Matthew Hoffman, George R Saade, Kara K Hoppe, Janelle Foroutan, Methodius Tuuli, Michelle Y Owens, Hyagriv N Simhan, Heather Frey, Todd Rosen, Anna Palatnik, Susan Baker, Phyllis August, Uma M Reddy, Wendy Kinzler, Emily Su, Iris Krishna, Nicki Nguyen, Mary E Norton, Daniel Skupski, Yasser Y El-Sayed, Dotum Ogunyemi, Zorina S Galis, Lorie Harper, Namasivayam Ambalavanan, Nancy L Geller, Suzanne Oparil, Gary R Cutter, William W Andrews, Chronic Hypertension and Pregnancy (CHAP) Trial Consortium, Carmen Beamon, Ronald Librizzi, Leonardo Pereira, Everett F Magann, Mounira Habli, Shauna Williams, Giancarlo Mari, Gabriella Pridjian, David S McKenna, Marc Parrish, Eugene Chang, Sarah Osmundson, JoAnne Quinones, Uma Perni, Ronald Wapner, Whitney Booker, Amy P Murtha, Ed Chien, Michael Varner, C Edward Wells, Joseph Biggio, Fatima Nagvi, George A Macones, Molly Stout, Ebony Carter, Heather Lipkind, Kristina Roloff, Donald J Dudley, Glenn Heller, Paula K Roberson, Seetha Shankaran, Robert Wachbroit, John C Hauth, Akila Subramaniam, Rachel LeDuke, Janatha Grant, Tawanda Hill, Amber Boyd, Lisa Dimperio, Glenda Corley-Topham, Michelle L Feese, Robin W Parks, Robin Steele, Hui-Chien Kuo, Yukiko N Orange, Christopher Parks, Karen Dorman, Kathia Pena, Janet Stock, Beth Norton, Samantha Murphy, Lucia Muzzarelli, Sean C Blackwell, Khalil M Chahine, Sarah Tounsi, Joseph Lucci 4th, Maria Hutchinson, Stephanie Lynch, Caroline Torres, Luiza Kalemi, Geeta K Swamy, Jennifer Ferrara, Danielle Lanpher, Amy O'Berry, Kristin Weaver, Thomas Parsons, Susan Hahn, Margaret Clement, Israel Zighelboim, Jorge Tolosa, Almaguer Juarez, Melissa Munoz Beilis, Jia Chen, Jorge Zaragoza Zapian, Tiffany Ostovar-Kermani, Zaida Bisbal, Elizabeth Standerfer, Christina Zornes, Kyra Woods, Alyson Brinkman, Jennifer Trent, LuAnn Polito, Caroline Rouse, Jennifer Wilson, Heather Dickerson, Shannon Barnes, Hannah Shockley, Brandy Firman, Cheryl Tocci, Amber Sowles, Kim Hill, Denise Lamb, Lisa Moseley, Catherine Meadows, Sandi Dellermann, Chris Servay, Cathryn Garvey, Kathleen Arias, Melissa Hendricks, Kelly Ruhstaller, Amy D Staples, Jennifer Chambers, Hassan Harirah, Chasey Omere, Corey Clifford, Gayle Olson, Luis Pacheco, Antonio Saad, Shannon Clark, Sangeeta Jain, Jennifer Sikes DeVolder, Maria Wilson-Jimenez, Lisa Thibodeaux, Heather Martin, Gabriela Andrade, Ashley Salazar, Dinesh Shah, Melissa Zernick, Jennifer Heintz, Kazumasa Hashimoto, Joseph Welter, Alison Sampson, Pam Mundt, Fatima Naqvi, Kristy Palomares, Imene Beche, Anne Bergman, Clara Perez, Molly Sklios, A Macones, Kaytelyn Slack, Emily Diveley, Kedra Wallace, Arun Jeyabalan, Melissa Bickus, Victoria Lopata, Jeanette Boyce, Catalin Buhimschi, Anna Bartholomew, Taryn Summerfield, Shama Khan, Caroline Herdeman, Nicolette Holliday, Catera Duhon, Casey Armistead, Ingrid Paul-Nelson, Line Malha, Rosemerie Marion, Tracy B Grossman, Kathy C Matthews, Amrin Kander, Lauren Perley, Abigail Wilpers, Kim Byrnes, Jocelyn Phipers, Sarah Schwartz, Betsy Burke, Martina Badell, Les'Shon Irby, Juan Gonzalez, Tiffany Lee, Natalie Oman, Rosalyn Chan-Akeley, Susan Ingenito, Deirdre J Lyell, Christine J Lee, Anna I Girsen, Imee A Datoc, Suzanne Cao, Karen Skaret, Ali Alhousseini, Ray Bahado-Singh, Tonyie Andrews Johnson, Jennylin Schott, Monica Rincon, Donna Eastham, Heather Moody, Crystal Daffner, Vivian Ghodsi Mulholland, Yanille Taveras, Annette Hickerson, Cecilia Gambala, Chi Dola, Eduardo Herrera, Emily Callegari, Samantha Wiegand, Kaye Snowe, John Moore, Julio F Mateus Nino, Jesslyn Payne, John C Smulian, Nikki Breslaw, Mary Joe Allen, Wendy Spencer, Alexa Argyres Goldberg, Robert J Ringer, Norbert E Archibeque, Jeffrey R Huminik, Theresa M Miles, Steve Tapia, Karsondra Lovato, Amy Schwartz, Lawton S Cooper, Christine Maric-Bilkan, Diane Reid, H Eser Tolunay, Paula Schum, Ray Ebert, George Black, Nina Hall, Judy Sint
Abstract
Background: The benefits and safety of the treatment of mild chronic hypertension (blood pressure, <160/100 mm Hg) during pregnancy are uncertain. Data are needed on whether a strategy of targeting a blood pressure of less than 140/90 mm Hg reduces the incidence of adverse pregnancy outcomes without compromising fetal growth.
Methods: In this open-label, multicenter, randomized trial, we assigned pregnant women with mild chronic hypertension and singleton fetuses at a gestational age of less than 23 weeks to receive antihypertensive medications recommended for use in pregnancy (active-treatment group) or to receive no such treatment unless severe hypertension (systolic pressure, ≥160 mm Hg; or diastolic pressure, ≥105 mm Hg) developed (control group). The primary outcome was a composite of preeclampsia with severe features, medically indicated preterm birth at less than 35 weeks' gestation, placental abruption, or fetal or neonatal death. The safety outcome was small-for-gestational-age birth weight below the 10th percentile for gestational age. Secondary outcomes included composites of serious neonatal or maternal complications, preeclampsia, and preterm birth.
Results: A total of 2408 women were enrolled in the trial. The incidence of a primary-outcome event was lower in the active-treatment group than in the control group (30.2% vs. 37.0%), for an adjusted risk ratio of 0.82 (95% confidence interval [CI], 0.74 to 0.92; P<0.001). The percentage of small-for-gestational-age birth weights below the 10th percentile was 11.2% in the active-treatment group and 10.4% in the control group (adjusted risk ratio, 1.04; 95% CI, 0.82 to 1.31; P = 0.76). The incidence of serious maternal complications was 2.1% and 2.8%, respectively (risk ratio, 0.75; 95% CI, 0.45 to 1.26), and the incidence of severe neonatal complications was 2.0% and 2.6% (risk ratio, 0.77; 95% CI, 0.45 to 1.30). The incidence of any preeclampsia in the two groups was 24.4% and 31.1%, respectively (risk ratio, 0.79; 95% CI, 0.69 to 0.89), and the incidence of preterm birth was 27.5% and 31.4% (risk ratio, 0.87; 95% CI, 0.77 to 0.99).
Conclusions: In pregnant women with mild chronic hypertension, a strategy of targeting a blood pressure of less than 140/90 mm Hg was associated with better pregnancy outcomes than a strategy of reserving treatment only for severe hypertension, with no increase in the risk of small-for-gestational-age birth weight. (Funded by the National Heart, Lung, and Blood Institute; CHAP ClinicalTrials.gov number, NCT02299414.).
Copyright © 2022 Massachusetts Medical Society.
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Source: PubMed