Severe Pre-eclampsiaNCT03661775
Serum Magnesium Level Administration in Severe Pre-eclampsia Obese Pregnancy
A study testing Magnesium sulfate administration in people with Severe Pre-eclampsia and Magnesium Level, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Severe Pre-eclampsia, Magnesium Level
- What is being tested?
- Magnesium sulfate administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 30 Sep 2018to 31 May 2019
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnancy women who have MBI ≥ 31kg/m2
- Pregnancy women who were diagnosed severe pre-eclampsia at gestational age 24 weeks more.
- Pregnancy women who were diagnosed eclampsia at gestational age 24 weeks more.
Who cannot join
- Pregnancy women who were chronic kidney disease or have serum creatinine more than 1.1 mg/dl
- Pregnancy women who have contraindication to use magnesium sulfate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Magnesium Level Between Administered Rate of 2 g/hr Versus 2.5 g/hr in Severe Pre-eclampsia Obese Pregnancy, Multicentered Randomized Study
Comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese
Read the detailed description
Magnesium sulfate is, generally, applied in order to alleviate or to avoid seizures. It can be administered according to many medical approaches. Nevertheless, at Rajavithi Hospital, the recommended administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour (Zudpan regimen). The therapeutic index of magnesium is in the range of 4.8-8.4 mg/dL. After that, the level of magnesium sulfate will be evaluated every 4 or 6 hours.
At Rajavithi Hospital, there are a lot of patients having pre-eclampsia symptom and many patients, who were received magnesium sulfate in the treatment, having the level of magnesium sulfate lower than the therapuetic level and needed to increase the maintenance dose to 2.5 grams/hour. Therefore, this work aims to studying the amount of magnesium sulfate administered to pregnant woman with pre-eclampsia symptom who possess high body mass index (BMI), especially for BMI greater than or equal to 30 kg/m2.
- Conditions
- Severe Pre-eclampsia, Magnesium Level
- Being tested
- Magnesium sulfate administration
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate administrationDrug
controlled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour Experimental group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour
| Study group | Role | What they receive |
|---|---|---|
| controlled group | Experimental | controlled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour Receives: Drug: Magnesium sulfate administration |
| Experimental group | Experimental | group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour Receives: Drug: Magnesium sulfate administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic level
Serum magnesium level
Measured: 4 hours after infusion magnesium sulfate
Secondary outcomes (1)
Outcome of pregnancy
maternal and fetal outcome
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start30 Sep 2018
- Primary completion30 Dec 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe 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
- Intervention model
- Factorial
- Model description
- Factorial 2-by-2 open labeled randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661775
- Sponsor's protocol ID
- RJMAG001
- Status last verified
- Sep 2018
- First submitted
- 14 May 2018
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.
PubMed 37815037
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Magnesium Level Between Administered Rate of 2 g/hr Versus 2.5 g/hr in Severe Pre-eclampsia Obese Pregnancy, Multicentered Randomized Study
- ClinicalTrials.gov ID
- NCT03661775
- Acronym / sponsor ID
- RJMAG001
- Conditions
- Severe Pre-eclampsia, Magnesium Level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- 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.
Comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese
Detailed description
Magnesium sulfate is, generally, applied in order to alleviate or to avoid seizures. It can be administered according to many medical approaches. Nevertheless, at Rajavithi Hospital, the recommended administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour (Zudpan regimen). The therapeutic index of magnesium is in the range of 4.8-8.4 mg/dL. After that, the level of magnesium sulfate will be evaluated every 4 or 6 hours.
At Rajavithi Hospital, there are a lot of patients having pre-eclampsia symptom and many patients, who were received magnesium sulfate in the treatment, having the level of magnesium sulfate lower than the therapuetic level and needed to increase the maintenance dose to 2.5 grams/hour. Therefore, this work aims to studying the amount of magnesium sulfate administered to pregnant woman with pre-eclampsia symptom who possess high body mass index (BMI), especially for BMI greater than or equal to 30 kg/m2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Factorial 2-by-2 open labeled randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| controlled group | Experimental | Drug: Magnesium sulfate administrationcontrolled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour |
| Experimental group | Experimental | Drug: Magnesium sulfate administrationgroup : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnancy women who have MBI ≥ 31kg/m2
- Pregnancy women who were diagnosed severe pre-eclampsia at gestational age 24 weeks more.
- Pregnancy women who were diagnosed eclampsia at gestational age 24 weeks more.
Key exclusion criteria (2 listed)
- Pregnancy women who were chronic kidney disease or have serum creatinine more than 1.1 mg/dl
- Pregnancy women who have contraindication to use magnesium sulfate
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 administrationcontrolled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour Experimental group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour | Drug | Experimental group, controlled group |
Primary outcome
therapeutic level
Time frame: 4 hours after infusion magnesium sulfate
Serum magnesium level
1 secondary outcome
Outcome of pregnancy
Time frame: 24 hours after delivery
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 12 Oct 2020.
- Derived from this study: PubMed 37815037Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate administration in people with Severe Pre-eclampsia and Magnesium Level, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 12 Oct 2020. 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 Thailand. 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 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.
What does the primary outcome measure?
therapeutic level (time frame: 4 hours after infusion magnesium sulfate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03661775, which also lists 1 linked publication.
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 12 Oct 2020; AzTrials last refreshed its copy on 1 Nov 2026.