Randomized trial of inhaled beclomethasone dipropionate versus theophylline for moderate asthma during pregnancy☆
Section snippets
Methods
This study was designed and sponsored by the National Institute of Child Health and Human Development (NICHD) and the NHLBI. It was conducted at 13 centers of the Maternal-Fetal Medicine Units Network (MFMU) of the NICHD. This was a prospective, double-blind, double placebo-controlled randomized trial. Case finding was by questioning all women presenting for prenatal care about having physician-diagnosed asthma. Informed written consent was obtained for all participants, and the study was
Results
A total of 4975 women were screened for eligibility; 147 were excluded because they had been enrolled in an asthma study3., 7. either in the present or an earlier pregnancy (Figure 1), 199 were randomly assigned to receive oral theophylline, and 199 received inhaled beclomethasone. A total of 13 (3.3%) were lost to follow-up before primary outcome determination. Only 34 (8.5%) participants did not take any asthma medications during pregnancy before enrollment. Although self-reported smoking was
Comment
We found no significant differences in the proportion of women experiencing at least 1 asthma exacerbation. In the beclomethasone cohort, 18.0% had a primary outcome compared with 20.4% in the theophylline cohort; to detect this magnitude of difference with 80% power, a study would require approximately 8000 participants. The theophylline cohort had a significantly increased proportion of FEV1 less than 80% predicted, and a greater proportion discontinued study medications because of side
Participating institutions and staff members
National Heart Lung and Blood Institute: J. Kiley
National Institute of Child Health and Human Development Network of Maternal-Fetal Medicine Units: University of Pittsburgh Magee Women's Hospital—P. Heine, M. Cotroneo, E. Daugherty; University of Tennessee—B. Sibai, R. Ramsey; University of Alabama at Birmingham—W. Andrews, R. Copper, S. Tate, A. Northen; Wayne State University—Y. Sorokin, G. S. Norman, A. Millinder; University of Cincinnati—T. A. Siddiqi, N. Elder, V. Pemberton; Wake Forest
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Cited by (84)
Use of Asthma Medication During Gestation and Risk of Specific Congenital Anomalies
2023, Immunology and Allergy Clinics of North AmericaCitation Excerpt :Concerns raised about a potential association of congenital anomalies and moderate- to high-dose ICSs have been examined. A previous literature review32 summarizing the risk of congenital malformations with the use of ICSs in pregnancy found that in 15 separate studies29,33–46 comparing women with asthma using any ICS versus women with asthma not using ICS the adjusted relative risk ranged from 0.4 to 1.1. Bakhireva and colleagues35 were the only investigators to report a significantly increased risk of congenital anomalies associated with ICS use when they compared 438 pregnant women using ICSs during pregnancy with nonasthmatic control pregnant women (4.1% vs 0.3% presence of major anomalies, respectively, P = <0.05).
Impact of Maternal-Fetal Medicine Units Network's publications on American College of Obstetricians and Gynecologists guidelines
2022, American Journal of Obstetrics and Gynecology MFMManagement of asthma during pregnancy
2021, Revue des Maladies RespiratoiresLong-Acting β<inf>2</inf>-Agonists and Risk of Hypertensive Disorders of Pregnancy: A Cohort Study
2018, Journal of Allergy and Clinical Immunology: In PracticeRespiratory Disease in Pregnancy
2016, Obstetrics: Normal and Problem PregnanciesAntiasthmatic and cough medication
2015, Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment: Third Edition
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Supported by grants from the National Institute of Child Health and Human Development (HD21410, HD21414, HD21434, HD27869, HD27917, HD27905, HD27889, HD27860, HD27861, HD27915, HD27883, HD34122, HD34116, HD34208, HD34136, and HD36801) and the National Heart Lung and Blood Institute.
Presented at the Society of Maternal Fetal Medicine 2001 annual meeting, Reno, Nev.