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临床试验/NCT00000578
NCT00000578已完成3 期

NHLBI/NICHD Collaborative Studies of Asthma in Pregnancy

National Heart, Lung, and Blood Institute (NHLBI)0 个研究点开始时间: 1994年4月最近更新:
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试验速览

阶段
3 期
状态
已完成

研究概览

简要总结

To conduct a collaborative program of research on asthma and pregnancy consisting of two studies: the Asthma in Pregnancy Study (APS) was an observational study to evaluate relationships between asthma severity and treatment programs and perinatal outcome, and the Asthma Therapy in Pregnancy Trial (ATPT) was a randomized clinical trial of inhaled beclomethasone versus theophylline in the treatment of moderate asthma during pregnancy. Both studies were conducted in the Maternal-Fetal Medicine Unit (MFMU) Network, an ongoing group of participating obstetric centers supported by the National Institute of Child Health and Human Development. Studies were co-funded by the NHLBI.

详细描述

BACKGROUND:

Asthma is one of the most common illnesses that complicates pregnancy. Asthma complicates at least 4 percent of all pregnancies; however, because at least 10 percent of the population appears to have nonspecific airway hyper-responsiveness, the true prevalence may be much higher.

Asthma can produce serious maternal and fetal complications. A number of investigators have reported an increased incidence of pre-eclampsia, gestational hypertension, hyperemesis gravidarum, vaginal hemorrhage, toxemia, and induced and complicated labor. Fetal complications include increased risk of perinatal mortality, prematurity, low birth weight, and neonatal hypoxia. In contrast, several studies have failed to confirm some or all of these previous observations. Patients with severe asthma may have the greatest risk for complications during pregnancy, in addition to the risk of maternal morbidity from the asthma. For example, it has been shown that reduced pulmonary function in asthmatic women is associated with an increased likelihood of intrauterine growth retardation. On the other hand, studies in which asthma was successfully controlled have resulted in pregnancy outcomes similar to the general population.

The mechanisms by which asthma may have adverse perinatal effects are not well known. Poor control of asthma leading to chronic or episodic fetal hypoxia is thought to be important. Medications used in asthma treatment may also play a role, although the limited data suggests minimal or no effects. In addition, it is possible that extrapulmonary autonomic nervous system abnormalities, such as uterine muscle hyperreactivity, could contribute to pre-term delivery or gestational hypertension independent of asthma control or therapy.

Unfortunately, previous studies have been limited by relatively small numbers. Few studies have controlled for factors known to affect infant birth weight, such as maternal race, height, weight, parity, nutrition, and cigarette smoking. Particularly, race may be an important contributing factor in assessing the relationship between asthma and pregnancy outcomes, since Blacks of both sexes are twice as likely to be hospitalized from asthma and three times as likely to die from asthma as whites.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

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