Maternal Care PatternsMgso4NCT04576364
12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients
A study testing Magnesium sulfate for 12 hour and Magnesium sulfate for 24 hour in people with Maternal Care Patterns, run by Assiut University at 2 sites in Egypt.
Trial summary
To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with pre-eclampsia with severe features , to ensure maximum efficacy of anticonvulsant action that can be achieved with least exposure to Mgso4 side effects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Maternal Care Patterns
- What is being tested?
- Magnesium sulfate for 12 hour and Magnesium sulfate for 24 hour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2020to 30 Nov 2022
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have pre-eclampsia with severe features as defined by American College of Obstetricians and Gynecologists guidelines 2019(defined in methodology)
- Singleton pregnancy.
- who accept to participate the study.
Who cannot join
- Patients with eclampsia
- Epilepsy
- Central Nervous System disorder
- Chronic kidney disease
- Seizures due to metabolic disturbances, space occupying lesions or intra cerebral infections
- Cardiac patients
- Hypersensitivity to Mgso4
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assuit University women Health hospital
Asyut, Assuit, 71511
Mai mahoud
Asyut, 71511
About this study
Official title: 12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients :A Randomized Controlled Trial
To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with pre-eclampsia with severe features , to ensure maximum efficacy of anticonvulsant action that can be achieved with least exposure to Mgso4 side effects.
Read the detailed description
Hypertensive disorders of pregnancy constitute one of the leading causes of maternal and perinatal mortality worldwide. It has been estimated that preeclampsia complicates 2-8% of pregnancies globally.
Preeclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term. Although often accompanied by new-onset proteinuria, hypertension and other signs or symptoms of preeclampsia may present in some women in the absence of proteinuria. Recently preeclampsia is divided into preeclampsia with severe features, preeclampsia without severe, features. One of serious complication of preeclampsia is occurrence of eclampsia. Eclampsia refers to the occurrence of new-onset, generalized, tonic-clonic seizures or coma in a woman with preeclampsia. Eclampsia can be prevented with magnesium sulphate, which decreases the risk of seizures by 50%, paralleled by a reduction in maternal mortality. It is considered as the gold standard of management of eclampsia Although magnesium sulphate administration is recommended for all women with severe preeclampsia, consensus has not yet to be reached on the ideal duration of prophylactic postpartum anticonvulsant therapy. The use of magnesium sulphate has been recommended for 24 hours following delivery, the period of greatest risk for the occurrence of eclampsia. There are other regimen 12-hour, 6-hour Use of magnesium sulphate therapy is not without complications, consequently longer duration therapy possesses the risk of magnesium toxicity such as respiratory depression, renal and neuromuscular dysfunction. Risks of these complications require regular supervision; hence it is particularly important to assess the minimum effective duration of treatment
- Conditions
- Maternal Care Patterns
- Being tested
- Magnesium sulfate for 12 hour, Magnesium sulfate for 24 hour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate for 12 hourDrug
drug used to prevent convulsions in patients having preeclampsia with severe features
Magnesium sulfate for 24 hourDrug
drug used to prevent convulsions in patients having preeclampsia with severe features
| Study group | Role | What they receive |
|---|---|---|
| 12-hour postpartum Mgso4 | Active comparator | Patients having preeclampsia with severe features will receive 12-hour postpartum Mgso4 Receives: Drug: Magnesium sulfate for 12 hour |
| 24-hour postpartum Mgso4 | Active comparator | Patients having preeclampsia with severe features will receive 24-hour postpartum Mgso4 Receives: Drug: Magnesium sulfate for 24 hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need to prolong treatment
Compare efficacy of 12-hour vs 24 hour postpartum Mgso4 in the term of Percentage of patients who will Need to prolong treatment in each group.
Measured: up to 12 hour
Secondary outcomes (1)
Percentage of prevention of eclampsia
Number of patients who develop eclampsia in each group.
Measured: up to 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start1 Nov 2020
- Primary completion20 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Care PatternsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Mahmoud Mohamed, Assiut University
- Investigators
- ِAhmed Fayek, Proffessor, Study director, Assiut Universitysherif Badran, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576364
- Sponsor's protocol ID
- Postpartum Mgso4
- Acronym
- Mgso4
- Status last verified
- Aug 2023
- First submitted
- 28 Sep 2020
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients :A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04576364
- Acronym / sponsor ID
- Mgso4 / Postpartum Mgso4
- Conditions
- Maternal Care Patterns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Oct 2020 (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.
To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with pre-eclampsia with severe features , to ensure maximum efficacy of anticonvulsant action that can be achieved with least exposure to Mgso4 side effects.
Detailed description
Hypertensive disorders of pregnancy constitute one of the leading causes of maternal and perinatal mortality worldwide. It has been estimated that preeclampsia complicates 2-8% of pregnancies globally.
Preeclampsia is a disorder of pregnancy associated with new-onset hypertension, which occurs most often after 20 weeks of gestation and frequently near term. Although often accompanied by new-onset proteinuria, hypertension and other signs or symptoms of preeclampsia may present in some women in the absence of proteinuria. Recently preeclampsia is divided into preeclampsia with severe features, preeclampsia without severe, features. One of serious complication of preeclampsia is occurrence of eclampsia. Eclampsia refers to the occurrence of new-onset, generalized, tonic-clonic seizures or coma in a woman with preeclampsia. Eclampsia can be prevented with magnesium sulphate, which decreases the risk of seizures by 50%, paralleled by a reduction in maternal mortality. It is considered as the gold standard of management of eclampsia Although magnesium sulphate administration is recommended for all women with severe preeclampsia, consensus has not yet to be reached on the ideal duration of prophylactic postpartum anticonvulsant therapy. The use of magnesium sulphate has been recommended for 24 hours following delivery, the period of greatest risk for the occurrence of eclampsia. There are other regimen 12-hour, 6-hour Use of magnesium sulphate therapy is not without complications, consequently longer duration therapy possesses the risk of magnesium toxicity such as respiratory depression, renal and neuromuscular dysfunction. Risks of these complications require regular supervision; hence it is particularly important to assess the minimum effective duration of treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12-hour postpartum Mgso4 | Active comparator | Drug: Magnesium sulfate for 12 hourPatients having preeclampsia with severe features will receive 12-hour postpartum Mgso4 |
| 24-hour postpartum Mgso4 | Active comparator | Drug: Magnesium sulfate for 24 hourPatients having preeclampsia with severe features will receive 24-hour postpartum Mgso4 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients who have pre-eclampsia with severe features as defined by American College of Obstetricians and Gynecologists guidelines 2019(defined in methodology)
- Singleton pregnancy.
- who accept to participate the study.
Key exclusion criteria (7 listed)
- Patients with eclampsia
- Epilepsy
- Central Nervous System disorder
- Chronic kidney disease
- Seizures due to metabolic disturbances, space occupying lesions or intra cerebral infections
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 for 12 hourdrug used to prevent convulsions in patients having preeclampsia with severe features | Drug | 12-hour postpartum Mgso4 |
| Magnesium sulfate for 24 hourdrug used to prevent convulsions in patients having preeclampsia with severe features | Drug | 24-hour postpartum Mgso4 |
Primary outcome
Need to prolong treatment
Time frame: up to 12 hour
Compare efficacy of 12-hour vs 24 hour postpartum Mgso4 in the term of Percentage of patients who will Need to prolong treatment in each group.
1 secondary outcome
Percentage of prevention of eclampsia
Time frame: up to 24 hour
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 1 Sep 2023.
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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.
ِAhmed Fayek, Proffessor study director
Assiut University
sherif Badran, Lecturer study director
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate for 12 hour and Magnesium sulfate for 24 hour in people with Maternal Care Patterns, run by Assiut University at 2 sites in Egypt.
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 7 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Need to prolong treatment (time frame: up to 12 hour). It is what the study was designed to measure, not a finding.
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 1 Sep 2023.