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1. Maternal Side-Effects After Multiple Courses of Antenatal Corticosteroids (MACS): The Three- Month Follow-Up of Women in the Randomized Controlled Trial of MACS for Preterm Birth Study

Author

Kellie E. Murphy, Mary E. Hannah, Andrew R. Willan, Arne Ohlsson, Edmond N. Kelly, Stephen G. Matthews, Saroj Saigal, Elizabeth Asztalos, Sue Ross, Marie-France Delisle, Laura Tomat, Kofi Amankwah, Patricia Guselle, Amiram Gafni, Shoo K. Lee, B. Anthony Armson, null for the MACS Collaborative Group, MarieFrance Delisle, Sheila A. Hewson, Joanne Rovet, Renee Sananes, Isabelle Schmid, Leonardo Kwiatkowski, Susana Marisa Tortorella, Marta Susana Bertin, José Luis Castaldi, Carlos Deguer, Milton Klun, Cintia Besegato, Gustavo Izbizky, Maria Cristina Vaneri, Carlos Alberto Fustinana, Lucas Otano, Mario S.F. Palermo, Emerson Javier Murua, Dolores Montes Valera, Hector Sampietro, Antonio Monaco, Argentina Ricardo Savransky, Armando Dunaiewsky, Maria Natalia Basualdo, Elsa Andina, Ingrid Di Marco, Mabel Rivero, Maria Celeste Feu, Sergio Garcia, Jesus Daniel Aguirre, Elba Mirta Morales, Liana Elisa Ayala, Maria Teresa De Sagastizabal, Griselda Abreo, Alfredo Uranga, Raquel de Lourdes Martin, Carlos Arias, Raul Abalos Gorostiaga, Miguel Curioni, Jorge Alvarado, Carlos Fuchtner, Desiree Mostajo Flores, Dilma Maria Tonoli Tessari, Jose Mauro Madi, Dino Roberto Soares de Lorenzi, Maria do Carmo Mattana, Carla Brunstein, Alberto Trapani, Luiza Schmaltz, Goianice Ribero de Souza, Maria Elaine de Assis, Irene Angela Melo Melgaco, Renato Augusto Moreira de Sa, Rita Guerios Bornia, Nestor N Demianczuk, Elizabeth Penttinen, Kimberly Butt, Kathryn Hay, Vicki Sandwich, B Anthony Armson, Michael Vincer, Victoria Allen, Cora Fanning, Ramesh Kulkarni, Joanne Laplante, George D Carson, Suzanne Williams, Sandy Holfeld, Femi Olatunbosun, Shirley Dalton, April Henry, Janna Haughian, Jean-Marie Moutquin, Daniel Blouin, Suzanne Kocsis Bédard, Kellie Murphy, Edmond Kelly, Anne Jordan, Jodi Shapiro, Jon Barrett, Howard Cohen, Leigh Andrews, Holly Owen, Vesna Popovska, Shelley Soanes, Michael E Helewa, Doris Kenny-Lodewyks, Ricardo Gomez, Karla Silva, Jorge Figueroa Poblete, Pedro Ferrand, Cristian Belmar, Claudio Vera, Qi Feng Su, Wei Gu, Zhi Wei Liu, Martha Marrugo Flores, Carlos Malabet Santoro, Edgar Ivan Ortiz, Javier Torres, Adriana Rodriguez, Lone Hvidman, Anne Mouritzen, Jennifer Vikre-Jørgensen, Hartmut Hopp, Andreas Nonnenmacher, Ute Braig, Christoph Berg, Gabriele Bizjak, Ulrich Gembruch, Verena Schwarzer, U B Hoyme, Hans-Jorg Bittrich, Britta Oletzky, Joachim Schneider, Bettina Hollwitz, Katrin Oehler, Frank Dressler, A Kubilay Ertan, Juliane Hentschel, Annegret Mack, W. Schmidt, Renaldo Faber, Holger Stepan, Maritta Kuhnert, Susanne Stiller, Bettina Kuschel, K.T.M. Schneider, Andrea Zimmermann, Michael Krause, H Gröbe, Neslisah Terzioglu, Birgit Seelbach-Goebel, Andreas Falkert, Karin Mueller, Hana Voss, Tamas Major, Krasznai Zoärd, Tünde Bartha, Polonkai Bea, Judit Zsadänyi, Zohar Nachum, Marina Peniakov, Mordechai Hallak, Avraham Harlev, Linda Harel, Benny Chayen, Sima Siev, Ichel Samberg, Leslie Wolff, Oscar Sadan, Anat Elyassi, Carolina Baider, David Kohelet, Abraham Golan, David Mankuta, Benjamin Bar-Oz, Danielle Combs, Doron J.D. Rosen, Hagai Y. Kaneti, Tal Tzachi, Janice Zausmer, Maor Maman, Tamar Perri, Shani Taitelboum, Michal Simchen, Gilat Shalev, Michael Goldinfeld, Orit Levine, Mazen Y El-Zibdeh, Lama T Al-Faris, Hussein A Ayyash, Pedro Saona Ugarte, Krzysztof Preis, Iwona Domzalska-Popadiuk, Malgorzata Swiatkowska-Freund, Iwona Janczewska, Jan Wilczynski, Michael Krekora, Marcin Kesiak, Ewa Gulczynska, Mariola Ropacka, Mateusz Madejczyk, Joanna Rozycka, Grzegorz H Breborowicz, Marta Szymankiewicz, Nadezhda Borzova, Lubov V Posiseeva, Zulfiya Khodjaeva, Ekaterina Vikhlyaeva, Montse Palacio, Dolors Salvia, Francesc Botet, Marta Massanes, Marta Lopez, Irene Hösli, Wolfgang Holzgreve, Cora A. Voekt, Fadhil Belhia, Patrick Hohlfeld, Edmond Prince-dit-Clottu, Ernst Beinder, Ursula von Mandach, Jean-Claude Fauchere, Frans J.M.E. Roumen, Mijntje Pieters, Frans Smits, Ibrahim I Bolaji, Pauline Adiotomre, Hamed Al-Taher, Hayley Barnes, Rezan Abdul-Kadir, Claudia Chi, Vivienne Van Someren, Scott Dexter, Renee Samelson, Michael J Horgan, Cathryn Valentini, Setul Pardanani, Michael Bebbington, Cynthia Chazotte, Sarah Kilpatrick, Jessica L. Drahos, Luis Saldana, Beverly Mount, Barbara Warner, Kathy Wedig, Andrzej Lysikiewicz, Fadi Bsat, Jennie Fleming, Alison Lee, Despina Hoffman, Michael Bracken, Patricia Crowley, Allan Donner, Lelia Duley, and Jon Tyson

Subjects
Postpartum depression, medicine.medical_specialty, Pregnancy, Pediatrics, Respiratory distress, business.industry, Obstetrics, Obstetrics and Gynecology, medicine.disease, Placebo, law.invention, Randomized controlled trial, law, Edinburgh Postnatal Depression Scale, Medicine, medicine.symptom, business, Weight gain, Depression (differential diagnoses)
Abstract

Objective A single course of antenatal corticosteroids (ACS) is associated with a reduction in respiratory distress syndrome and neonatal death. Multiple Courses of Antenatal Corticosteroids Study (MACS), a study involving 1858 women, was a multicentre randomized placebo-controlled trial of multiple courses of ACS, given every 14 days until 33+6 weeks or birth, whichever came first. The primary outcome of the study, a composite of neonatal mortality and morbidity, was similar for the multiple ACS and placebo groups (12.9% vs. 12.5%), but infants exposed to multiple courses of ACS weighed less, were shorter, and had smaller head circumferences. Thus for women who remain at increased risk of preterm birth, multiple courses of ACS (every 14 days) are not recommended. Chronic use of corticosteroids is associated with numerous side effects including weight gain and depression The aim of this postpartum assessment was to ascertain if multiple courses of ACS were associated with maternal side effects. Methods Three months postpartum, women who participated in MACS were asked to complete a structured questionnaire that asked about maternal side effects of corticosteroid use during MACS and included the Edinburgh Postnatal Depression Scale Women were also asked to evaluate their study participation Results Of the 1858 women randomized, 1712 (92.1%) completed the postpartum questionnaire. There were no significant differences in the risk of maternal side effects between the two groups. Large numbers of women met the criteria for postpartum depression (14.1% in the ACS vs. 16.0% in the placebo group). Most women (94.1%) responded that they would participate in the trial again. Conclusion In pregnancy, corticosteroids are given to women for fetal lung maturation and for the treatment of various maternal diseases. In this international multicentre randomized controlled trial, multiple courses of ACS (every 14 days) were not associated with maternal side effects, and the majority of women responded that they would participate in such a study again.

Published
2011
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2. Association between gestational age at birth, antenatal corticosteroids, and outcomes at 5 years: multiple courses of antenatal corticosteroids for preterm birth study at 5 years of age (MACS-5)

Author

Saroj Saigal, Joanne Rovet, Anthony Armson, Renee Sananes, Patricia Guselle, Andrew R. Willan, Amiram Gafni, Elizabeth Asztalos, Arne Ohlsson, Shoo K. Lee, Edmond Kelly, Kofi Amankwah, Marie-France Delisle, Kellie E. Murphy, and Stephen G. Matthews

Subjects
Adult, Antenatal corticosteroids, medicine.medical_specialty, Pediatrics, Time Factors, Term Birth, Developmental Disabilities, Long-term neurodevelopmental outcomes, Reproductive medicine, Gestational Age, Infant, Premature, Diseases, Betamethasone, Dexamethasone, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, 030225 pediatrics, Infant Mortality, Obstetrics and Gynaecology, medicine, Humans, Young adult, 030219 obstetrics & reproductive medicine, Obstetrics, business.industry, Incidence (epidemiology), Gestational age at birth, Infant, Newborn, Infant, Obstetrics and Gynecology, Gestational age, Preterm birth, medicine.disease, Infant mortality, 3. Good health, Survival Rate, Perinatal Care, Premature birth, Child, Preschool, Sensation Disorders, Premature Birth, Gestation, business, Follow-Up Studies, Research Article
Abstract

Background The Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS) showed no benefit in the reduction of major neonatal mortality/morbidity or neurodevelopment at 2 and 5 years of age. Using the data from the randomized controlled trial and its follow-up, the aim of this study was to evaluate the association between gestational ages at birth in children exposed to single versus multiple courses of antenatal corticosteroid (ACS) therapy in utero and outcomes at 5 years of age. Method A total of 1719 children, with the breakdown into groupings of

Published
2014
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3. Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study

Author

Elizabeth V, Asztalos, Kellie E, Murphy, Andrew R, Willan, Stephen G, Matthews, Arne, Ohlsson, Saroj, Saigal, B Anthony, Armson, Edmond N, Kelly, Marie-France, Delisle, Amiram, Gafni, Shoo K, Lee, Renee, Sananes, Joanne, Rovet, Patricia, Guselle, Kofi, Amankwah, Mariam, Saleem, Johanna, Sanchez, Ibrahim, Bolaji, Kindergeneeskunde, and RS: GROW - School for Oncology and Reproduction

Subjects
Adult, Pediatrics, medicine.medical_specialty, Developmental Disabilities, Child Behavior Disorders, Infant, Premature, Diseases, Prenatal care, Betamethasone, Injections, Intramuscular, Cerebral palsy, law.invention, Cohort Studies, Randomized controlled trial, Pregnancy, Risk Factors, law, medicine, Humans, Glucocorticoids, Maternal-Fetal Exchange, business.industry, Infant, Newborn, Pregnancy Outcome, Abnormalities, Drug-Induced, Gestational age, Odds ratio, medicine.disease, Survival Rate, Treatment Outcome, Premature birth, Child, Preschool, Pediatrics, Perinatology and Child Health, Cohort, Premature Birth, Female, business, Follow-Up Studies, Cohort study
Abstract

Importance A single course of antenatal corticosteroid therapy is recommended for pregnant women at risk of preterm birth between 24 and 33 weeks’ gestational age. However, 50% of women remain pregnant 7 to 14 days later, leading to the question of whether additional courses should be given to women remaining at risk for preterm birth. The Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS) was an international randomized clinical trial that compared multiple courses of antenatal corticosteroids with a single course in women at risk of preterm birth. Objective To determine the effects of single vs multiple courses of antenatal corticosteroid therapy on death or neurodevelopmental disability (neuromotor, neurosensory, or neurocognitive/neurobehavioral function) at 5 years of age in children whose mothers participated in MACS. Our secondary aims were to determine the effect on height, weight, head circumference, blood pressure, intelligence, and specific cognitive (visual, spatial, and language) skills. Design, Setting, and Participants Cohort follow-up study of children seen between June 2006 and May 2012 at 55 centers. In total, 1724 women (2141 children) were eligible for the study, of whom 1728 children (80.7% of the 2141 eligible children) participated and 1719 children contributed to the primary outcome. Intervention Single and multiple courses of antenatal corticosteroid therapy. Main Outcomes and Measures The primary outcome was death or survival with a neurodevelopmental disability in 1 of the following domains: neuromotor (nonambulatory cerebral palsy), neurosensory (blindness, deafness, or need for visual/hearing aids), or neurocognitive/neurobehavioral function (abnormal attention, memory, or behavior). Results There was no significant difference between the groups in the risk of death or neurodevelopmental disability: 217 of 871 children (24.9%) in the multiple-courses group vs 210 of 848 children (24.8%) in the single-course group (odds ratio, 1.02 [95% CI, 0.81 to 1.29]; P = .84). Conclusions and Relevance Multiple courses, compared with a single course, of antenatal corticosteroid therapy did not increase or decrease the risk of death or disability at 5 years of age. Because of a lack of strong conclusive evidence of short-term or long-term benefits, it remains our opinion that multiple courses not be recommended in women with ongoing risk of preterm birth. Trial Registration clinicaltrials.gov Identifier:NCT00187382

Published
2013
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4. Maternal side-effects after multiple courses of antenatal corticosteroids (MACS): the three-month follow-up of women in the randomized controlled trial of MACS for preterm birth study

Author

Kellie E, Murphy, Mary E, Hannah, Andrew R, Willan, Arne, Ohlsson, Edmond N, Kelly, Stephen G, Matthews, Saroj, Saigal, Elizabeth, Asztalos, Sue, Ross, Marie-France, Delisle, Laura, Tomat, Kofi, Amankwah, Patricia, Guselle, Amiram, Gafni, Shoo K, Lee, B Anthony, Armson, and Jon, Tys

Subjects
Adult, Respiratory Distress Syndrome, Newborn, Infant, Newborn, Gestational Age, Puerperal Disorders, Depression, Postpartum, Placebos, Affect, Fetal Organ Maturity, Adrenal Cortex Hormones, Patient Satisfaction, Pregnancy, Birth Weight, Humans, Premature Birth, Female, Lung
Abstract

A single course of antenatal corticosteroids (ACS) is associated with a reduction in respiratory distress syndrome and neonatal death. Multiple Courses of Antenatal Corticosteroids Study (MACS), a study involving 1858 women, was a multicentre randomized placebo-controlled trial of multiple courses of ACS, given every 14 days until 33+6 weeks or birth, whichever came first. The primary outcome of the study, a composite of neonatal mortality and morbidity, was similar for the multiple ACS and placebo groups (12.9% vs. 12.5%), but infants exposed to multiple courses of ACS weighed less, were shorter, and had smaller head circumferences. Thus for women who remain at increased risk of preterm birth, multiple courses of ACS (every 14 days) are not recommended. Chronic use of corticosteroids is associated with numerous side effects including weight gain and depression. The aim of this postpartum assessment was to ascertain if multiple courses of ACS were associated with maternal side effects.Three months postpartum, women who participated in MACS were asked to complete a structured questionnaire that asked about maternal side effects of corticosteroid use during MACS and included the Edinburgh Postnatal Depression Scale. Women were also asked to evaluate their study participation.Of the 1858 women randomized, 1712 (92.1%) completed the postpartum questionnaire. There were no significant differences in the risk of maternal side effects between the two groups. Large numbers of women met the criteria for postpartum depression (14.1% in the ACS vs. 16.0% in the placebo group). Most women (94.1%) responded that they would participate in the trial again.In pregnancy, corticosteroids are given to women for fetal lung maturation and for the treatment of various maternal diseases. In this international multicentre randomized controlled trial, multiple courses of ACS (every 14 days) were not associated with maternal side effects, and the majority of women responded that they would participate in such a study again.

Published
2011

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