Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000578
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-10-27
Brief Title:
NHLBINICHD Collaborative Studies of Asthma in Pregnancy
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Under the auspices of the National Asthma Education Program NAEP a Working Group on Asthma and Pregnancy developed a statement regarding the treatment of asthma during pregnancy In its deliberations the Working Group noted the paucity of data on the relative contributions of biological social and environmental factors on asthma in pregnant women as well as the lack of data on the efficacy and safety of commonly used asthma therapies in pregnancy
DESIGN NARRATIVE
The Asthma in Pregnancy Study evaluated the relationship between maternal asthma severity and control The primary objective was to determine the frequency of preterm delivery 32 weeks among moderate and severe asthmatics compared to non-asthmatic controls The incidence of small-for-gestational-age infants in women with mild and moderate asthma was a secondary outcome Other independent variables included type of medications used race socioeconomic status height weight parity nutrition smoking other substance abuse and prenatal care Secondary outcomes included birth weight and prematurity maternal pre-eclampsia gestational hypertension and asthma morbidity The study began February 11995 and patient recruitment continued for 46 months or less
The Asthma Therapy in Pregnancy Trial was a randomized double-blind controlled clinical trial which began recruitment in November 1996 with enrollment lasting 44 months Patients were randomized to receive either active oral theophylline and a placebo beclomethasone inhaler or an active beclomethasone inhaler and placebo oral theophylline Albuterol was used for relief of symptoms The primary outcome measure was incidence of Emergency Department visits or hospitalizations during pregnancy Secondary outcome measures included birth weight incidence of small-for-gestational-age infants gestational hypertension pre-eclampsia lung function daily peak flow and quality of life Patients were seen monthly for measurements of fetal growth morbidity and lung function Extensive interviews were conducted with each patient at the first prenatal visit in the third trimester and shortly before birth
The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System QVR
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
Under the auspices of the National Asthma Education Program NAEP a Working Group on Asthma and Pregnancy developed a statement regarding the treatment of asthma during pregnancy In its deliberations the Working Group noted the paucity of data on the relative contributions of biological social and environmental factors on asthma in pregnant women as well as the lack of data on the efficacy and safety of commonly used asthma therapies in pregnancy
DESIGN NARRATIVE
The Asthma in Pregnancy Study evaluated the relationship between maternal asthma severity and control The primary objective was to determine the frequency of preterm delivery 32 weeks among moderate and severe asthmatics compared to non-asthmatic controls The incidence of small-for-gestational-age infants in women with mild and moderate asthma was a secondary outcome Other independent variables included type of medications used race socioeconomic status height weight parity nutrition smoking other substance abuse and prenatal care Secondary outcomes included birth weight and prematurity maternal pre-eclampsia gestational hypertension and asthma morbidity The study began February 11995 and patient recruitment continued for 46 months or less
The Asthma Therapy in Pregnancy Trial was a randomized double-blind controlled clinical trial which began recruitment in November 1996 with enrollment lasting 44 months Patients were randomized to receive either active oral theophylline and a placebo beclomethasone inhaler or an active beclomethasone inhaler and placebo oral theophylline Albuterol was used for relief of symptoms The primary outcome measure was incidence of Emergency Department visits or hospitalizations during pregnancy Secondary outcome measures included birth weight incidence of small-for-gestational-age infants gestational hypertension pre-eclampsia lung function daily peak flow and quality of life Patients were seen monthly for measurements of fetal growth morbidity and lung function Extensive interviews were conducted with each patient at the first prenatal visit in the third trimester and shortly before birth
The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System QVR
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: