Pre-EclampsiaNCT03112551
Safety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan
A study testing Adminstration of magnesium Sulphate for treatment of eclampsia in people with Pre-Eclampsia, run by Gadarif University at 1 site in Sudan.
Trial summary
the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short duration of drug exposure is suitable for low resource setting where there is little tools or busy staff for monitoring drug toxicity. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Adminstration of magnesium Sulphate for treatment of eclampsia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSudan
- Study dates
- 1 Dec 2018to 30 Jun 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
- clinical diagnosis of eclampsia
- must accept to participate in the study
Who cannot join
- epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Twelve Hours Duration of Magnesium Sulphate in the Treatment of Eclampsia in Low Resource Setting in Sudan
the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short duration of drug exposure is suitable for low resource setting where there is little tools or busy staff for monitoring drug toxicity.
Read the detailed description
The idea of using 12 hours duration of magnesium sulphate for treating eclampsia may be effective and attractive, especially in settings with limited resources and where there is no availability of tools to monitor the serum level of magnesium sulphate. This is because the most common reported maternal adverse effects of magnesium sulphate are minor and may be confused with other symptom of eclampsia of even labor.The administration of Magnesium sulphate for 24 hours in the absence of monitoring of the serum magnesium sulphate might be life threatening in a resource- challenged situation , thus the current study is planned to be conducted to investigate the efficacy and safety of shorter duration (12 hours) of magnesium sulphate therapy in preventing development of convulsions in cases of eclampsia.
- Conditions
- Pre-Eclampsia
- Being tested
- Adminstration of magnesium Sulphate for treatment of eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adminstration of magnesium Sulphate for treatment of eclampsiaDrug
A total of 100 eclamptic patients are suspected to be approached alternately and subcategorized into two groups - one group will be treated with 24 hours maintenance dose of magnesium sulphate (Group-1; n=50), and the other with 12 hours maintenance dose of magnesium sulphate (Group-2; n=50).
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | group one will be treated with 24 hours maintenance dose of magnesium sulphate Receives: Drug: Adminstration of magnesium Sulphate for treatment of eclampsia |
| group 2 | Experimental | group 2 will be treated with 12 hours maintenance dose of magnesium sulphate Receives: Drug: Adminstration of magnesium Sulphate for treatment of eclampsia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who will receive magnesium sulfate and develop drug toxicity
the adverse effect of magnesium sulphate either minor signs:flushing, increased warmth and sweating, nausea, vomiting, headaches, muscle weakness and blurred vision or major effects such as absent tendon reflexes and oliguria.
Measured: 12 - 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Dec 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
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 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadarif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdelAziem AbdAllah Ali, Gadarif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112551
- Sponsor's protocol ID
- GadarifU
- Status last verified
- Nov 2017
- First submitted
- 28 Mar 2017
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Twelve Hours Duration of Magnesium Sulphate in the Treatment of Eclampsia in Low Resource Setting in Sudan
- ClinicalTrials.gov ID
- NCT03112551
- Acronym / sponsor ID
- GadarifU
- Conditions
- Pre-Eclampsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gadarif UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 13 Apr 2017 (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.
the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short duration of drug exposure is suitable for low resource setting where there is little tools or busy staff for monitoring drug toxicity.
Detailed description
The idea of using 12 hours duration of magnesium sulphate for treating eclampsia may be effective and attractive, especially in settings with limited resources and where there is no availability of tools to monitor the serum level of magnesium sulphate. This is because the most common reported maternal adverse effects of magnesium sulphate are minor and may be confused with other symptom of eclampsia of even labor.The administration of Magnesium sulphate for 24 hours in the absence of monitoring of the serum magnesium sulphate might be life threatening in a resource- challenged situation , thus the current study is planned to be conducted to investigate the efficacy and safety of shorter duration (12 hours) of magnesium sulphate therapy in preventing development of convulsions in cases of eclampsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: Adminstration of magnesium Sulphate for treatment of eclampsiagroup one will be treated with 24 hours maintenance dose of magnesium sulphate |
| group 2 | Experimental | Drug: Adminstration of magnesium Sulphate for treatment of eclampsiagroup 2 will be treated with 12 hours maintenance dose of magnesium sulphate |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of eclampsia
- must accept to participate in the study
Key exclusion criteria (1 listed)
- epilepsy
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 |
|---|---|---|
| Adminstration of magnesium Sulphate for treatment of eclampsiaA total of 100 eclamptic patients are suspected to be approached alternately and subcategorized into two groups - one group will be treated with 24 hours maintenance dose of magnesium sulphate (Group-1; n=50), and the other with 12 hours maintenance dose of magnesium sulphate (Group-2; n=50). | Drug | group 1, group 2 |
Primary outcome
Number of patients who will receive magnesium sulfate and develop drug toxicity
Time frame: 12 - 24 hours
the adverse effect of magnesium sulphate either minor signs:flushing, increased warmth and sweating, nausea, vomiting, headaches, muscle weakness and blurred vision or major effects such as absent tendon reflexes and oliguria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- 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.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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 Adminstration of magnesium Sulphate for treatment of eclampsia in people with Pre-Eclampsia, run by Gadarif University at 1 site in Sudan.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. 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 Sudan. 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?
Results are not available in the source record.
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?
Number of patients who will receive magnesium sulfate and develop drug toxicity (time frame: 12 - 24 hours). 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 NCT03112551, 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 22 Mar 2018.