Pre-eclampsiaNCT00004399
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
A study testing magnesium sulfate and nimodipine in people with Pre-eclampsia, run by FDA Office of Orphan Products Development.
Trial summary
OBJECTIVES: I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pre-eclampsia
- What is being tested?
- magnesium sulfate and nimodipine
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 1995to Aug 2000
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following criteria:
- Blood pressure greater than 160/110 mmHg OR Mean arterial pressure of 126 mmHg
- Proteinuria greater than 5 g/24 hr
- Epigastric pain OR Right upper quadrant pain AST/ALT greater than 70 U/L
- Severe headache and/or scotomata
- Thrombocytopenia as evidenced by: Platelet count less than 100,000/mm3 Disseminated intravascular coagulation Microangiopathic hemolytic anemia Oliguria (less than 400 mL/day or 30 mL/hr)
- Pulmonary edema
--Prior/Concurrent Therapy--
- No prior/concurrent magnesium sulfate or dihydropyridine agents
- No other concurrent antiseizure medications
--Patient Characteristics--
- Age: Not specified
- Performance status: Not specified
- Hematopoietic: See Disease Characteristics
- Hepatic: See Disease Characteristics
- Renal: No severe renal failure See Disease Characteristics
- Cardiovascular: No history of angina or myocardial infarction No cardiac dysfunction No history or sign of congestive cardiac failure No arrhythmia with ventricular rate less than 60 bpm See Disease Characteristics
- Pulmonary: See Disease Characteristics
--Other:--
- No severe mental or physical disorder that may affect therapy
- Not allergic to drugs with chemical structure similar to nimodipine or magnesium sulfate
- No evidence of fetal distress or fetal anomalies
About this study
OBJECTIVES:
- Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, international, multicenter study. Patients are randomized to receive either nimodipine or magnesium sulfate.
Arm I: Patients receive nimodipine by mouth every 4 hours. Treatment is continued until 24 hours post-partum.
Arm II: Patients receive a loading dose of magnesium sulfate IV for 20 minutes, followed by continuous infusion of magnesium sulfate. Treatment is continued until 24 hours post-partum.
- Conditions
- Pre-eclampsia
- Being tested
- magnesium sulfate, nimodipine
- Keywords
- cardiovascular and respiratory diseases, hypertensive disorder, pre-eclampsia, rare disease
- Medical subject headings
- Pre-Eclampsia, Respiratory Tract Diseases, Hypertension, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium sulfateDrug
nimodipineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startSep 1995
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-eclampsiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
- Collaborators
- University of Utah
- Investigators
- Michael Anthony Belfort, Study chair, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004399
- Sponsor's protocol ID
- 199/13249
- Other IDs
- UU-FDR001061, BCM-FDR001061
- Status last verified
- Jan 2001
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia
- ClinicalTrials.gov ID
- NCT00004399
- Acronym / sponsor ID
- 199/13249
- Conditions
- Pre-eclampsia
- Keywords
- cardiovascular and respiratory diseases, hypertensive disorder, pre-eclampsia, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Collaborators
- University of Utah
- Study start
- Sep 1995
- Study completion
- Aug 2000
- First posted
- 19 Oct 1999 (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.
OBJECTIVES:
- Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.
Detailed description
PROTOCOL OUTLINE: This is a randomized, international, multicenter study. Patients are randomized to receive either nimodipine or magnesium sulfate.
Arm I: Patients receive nimodipine by mouth every 4 hours. Treatment is continued until 24 hours post-partum.
Arm II: Patients receive a loading dose of magnesium sulfate IV for 20 minutes, followed by continuous infusion of magnesium sulfate. Treatment is continued until 24 hours post-partum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium sulfate | Drug | – |
| nimodipine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
Michael Anthony Belfort study chair
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing magnesium sulfate and nimodipine in people with Pre-eclampsia, run by FDA Office of Orphan Products Development.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 25 Mar 2015.