Lung DiseasesNCT00005448
Adverse Events With Magnesium Sulfate
An observational study of Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
To investigate in pregnant women the adverse pulmonary effects of magnesium sulfate (MgSO4), a commonly used drug for tocolysis or arrest of labor. Read more about this study
- Who is it for?
- Ages Up to 100 years, women only
- Conditions the study is for
- Lung Diseases
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1996to Jun 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
To investigate in pregnant women the adverse pulmonary effects of magnesium sulfate (MgSO4), a commonly used drug for tocolysis or arrest of labor.
Read the detailed description
BACKGROUND:
Preterm labor is a major public health concern in the United States. The delay of labor, particularly for idiopathic preterm labor, is important because it allows further fetal development and the opportunity to administer steroids which improve fetal lung maturity. It is now common for MgSO4 to be administered to delay labor. The most dangerous adverse event with MgSO4 treatment is the development of pulmonary edema which may lead to maternal adult respiratory distress syndrome and death with associated fetal morbidity and mortality. The estimates of the frequency of this complication vary from 0 to 8 percent. Therefore, improved understanding of the pulmonary toxicity of this therapeutic agent is clinically important.
DESIGN NARRATIVE:
There were three phases in the study. The first, a retrospective cohort study, examined the incidence rate of pulmonary edema when MgSO4 was administered as a tocolytic agent. The second, a case-control study nested within the cohort, examined the relationship between the patient and other clinical factors and the incidence of pulmonary edema in patients treated with MgSO4. The third phase used the results of the case-control study to develop and validate a predictive index to define a group of patients at increased risk of developing pulmonary edema associated with MgSO4.
Patients were identified using ICD-9-CM codes for preterm labor and delivery. The medical record was reviewed to determine exposure to MgSO4 as a tocolytic agent, excluding patients who received MgSO4 for other indications. Cases were defined as probable when patients met the clinical definition for pulmonary edema, including chest X-ray findings. The medical charts of both cases and a random sample of non cases were then reviewed in detail and the data from these groups were compared. The primary analysis of these case-control data included unadjusted analysis and multivariable explanatory models to provide insight into the risk factors for pulmonary edema associated with MgSO4. The data from the case-control study were used to develop a clinical predictive index. The predictive rule was then validated in a separate patient population.
- Conditions
- Lung Diseases
- Medical subject headings
- Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1996
- Primary completionJun 2002 (estimated)
- Study completionJun 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- George Macones, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005448
- Sponsor's protocol ID
- 4377
- Other IDs
- R01HL056814
- Status last verified
- Aug 2016
- First submitted
- 25 May 2000
- Last updated
- 8 Sep 2016
- Results posted
- No
Publications
Macones GA, Segel SY, Stamilio DM, Morgan MA. Prediction of delivery among women with early preterm labor by means of clinical characteristics alone. Am J Obstet Gynecol. 1999 Dec;181(6):1414-8. doi: 10.1016/s0002-9378(99)70385-6.
PubMed 10601922Macones GA, Segel SY, Stamilio DM, Morgan MA. Predicting delivery within 48 hours in women treated with parenteral tocolysis. Obstet Gynecol. 1999 Mar;93(3):432-6. doi: 10.1016/s0029-7844(98)00412-8.
PubMed 10074994
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Events With Magnesium Sulfate
- ClinicalTrials.gov ID
- NCT00005448
- Acronym / sponsor ID
- 4377
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1996
- Primary completion
- Jun 2002 (estimated)
- Study completion
- Jun 2002 (estimated)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate in pregnant women the adverse pulmonary effects of magnesium sulfate (MgSO4), a commonly used drug for tocolysis or arrest of labor.
Detailed description
BACKGROUND:
Preterm labor is a major public health concern in the United States. The delay of labor, particularly for idiopathic preterm labor, is important because it allows further fetal development and the opportunity to administer steroids which improve fetal lung maturity. It is now common for MgSO4 to be administered to delay labor. The most dangerous adverse event with MgSO4 treatment is the development of pulmonary edema which may lead to maternal adult respiratory distress syndrome and death with associated fetal morbidity and mortality. The estimates of the frequency of this complication vary from 0 to 8 percent. Therefore, improved understanding of the pulmonary toxicity of this therapeutic agent is clinically important.
DESIGN NARRATIVE:
There were three phases in the study. The first, a retrospective cohort study, examined the incidence rate of pulmonary edema when MgSO4 was administered as a tocolytic agent. The second, a case-control study nested within the cohort, examined the relationship between the patient and other clinical factors and the incidence of pulmonary edema in patients treated with MgSO4. The third phase used the results of the case-control study to develop and validate a predictive index to define a group of patients at increased risk of developing pulmonary edema associated with MgSO4.
Patients were identified using ICD-9-CM codes for preterm labor and delivery. The medical record was reviewed to determine exposure to MgSO4 as a tocolytic agent, excluding patients who received MgSO4 for other indications. Cases were defined as probable when patients met the clinical definition for pulmonary edema, including chest X-ray findings. The medical charts of both cases and a random sample of non cases were then reviewed in detail and the data from these groups were compared. The primary analysis of these case-control data included unadjusted analysis and multivariable explanatory models to provide insight into the risk factors for pulmonary edema associated with MgSO4. The data from the case-control study were used to develop a clinical predictive index. The predictive rule was then validated in a separate patient population.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Background: PubMed 10601922Macones GA, Segel SY, Stamilio DM, Morgan MA. Prediction of delivery among women with early preterm labor by means of clinical characteristics alone. Am J Obstet Gynecol. 1999 Dec;181(6):1414-8. doi: 10.1016/s0002-9378(99)70385-6.
- Background: PubMed 10074994Macones GA, Segel SY, Stamilio DM, Morgan MA. Predicting delivery within 48 hours in women treated with parenteral tocolysis. Obstet Gynecol. 1999 Mar;93(3):432-6. doi: 10.1016/s0029-7844(98)00412-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Macones
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005448, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.