National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

MFMU Network A Prospective Cohort Study of the Effects of
Asthma and Treatment Regimens on Perinatal Outcome

Related Publications & Presentations

Objective

To compare the frequency of very premature births among moderate and severeasthmatics with that of normal controls, to compare normal controls with bothmild asthmatics and moderate to severe asthmatics with respect to maternal morbidity and neonatal outcome and to investigate the effects of degree of asthma control and medications, with other demographic and social factors ondifferences in perinatal outcome.

Conclusion

Except for an increased incidence of a discharge diagnosis of neonatal sepsis, asthma and its contemporary management were not associated with adverse perinatal outcome.

Clinical Centers

Magee Womens, Tennessee, USC, Alabama, Wayne State, Cincinnati, Oklahoma,Bowman Gray, Chicago, Ohio State, South Carolina

Major Eligibility Criteria

• Gestational age < 26 weeks
• Singleton
• Not enrolled in Theophylline vs Beclomethasone Trial
• Informed consent

Groups

• Moderate/severe asthmatics
• Mild asthmatics
• Normal controls

Sample Size

• Goal = 2700 (900/group)

Scheduled Evaluations/Data Collection

• All groups at enrollment:
• Demographics, social, medical, pregnancy history, stress assessment
• Asthma groups at enrollment:
• FEV1, PEFR, FVC, symptoms, medications, asthma history, management behavior, emergency room visits/hospital admissions
• All groups at prenatal visits:
• FEV1, PEFR, FVC, symptoms. medications, emergency room visits/hospitaladmissions
• All groups at discharge postpartum:
• Pregnancy, labor and delivery data
• All groups at neonatal discharge:
• Neonatal outcome
• Asthma groups postpartum:
• Interview: asthma management behavior, symptoms, medications, emergencyroom visits/hospital admissions

Outcome Measures

• Primary:
• Delivery < 32 weeks
• Secondary:
• Small for gestational age (< 10th percentile)
• Low birth weight (<2500 gm)
• Perinatal morbidity and mortality
• Preterm delivery rate < 37 weeks
• Maternal asthma morbidity
• Pregnancy complications
• Effectiveness of antenatal diagnostic procedures

Timetable

• Recruitment: 10/94-08/98
• Data Collection: 10/94-04/99
• Closeout/Final Analysis: 04/99-12/99