Preeclampsia (PE)NCT06791668
Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia
An observational study of Preeclampsia (PE), run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
The goal of this observational study is to learn about the effects of the different drug regimens of magnesium sulphate in treatment of (severe pre-eclampsia). This condition affects some pregnant women and raises their blood pressure. It may also cause seizures (fits). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia (PE)
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Hospital records will be reviewed for pregnant women presented to Ain Shams University Maternity Hospital (ASUMH) diagnosed as a case of preeclampsia with criteria of severity: Preeclampsia with severe hypertension that does not respond to treatment or is associated with ongoing or recurring severe headaches, visual scotomata, nausea or vomiting, epigastric pain, oliguria, and severe hypertension, as well as progressive deterioration in laboratory blood tests such as rising creatinine or liver transaminases or falling platelet count, or failure of fetal growth or abnormal doppler findings.
Who may be able to join
- All hospital records of patients diagnosed as preeclampsia with severe features planned to receive magnesium sulphate.
Who cannot join
- Records with missing data about the regimen of magnesium sulphate used
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sherif Ashoush, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo
Sherif Ashoush, MD, 20201222660266, sherifashoush@med.asu.edu.eg
Ahmed Sakr
About this study
Official title: Comparison of Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia in Ain Shams University Maternity Hospital (Retrospective Cohort)
The goal of this observational study is to learn about the effects of the different drug regimens of magnesium sulphate in treatment of (severe pre-eclampsia). This condition affects some pregnant women and raises their blood pressure. It may also cause seizures (fits). The medication (magnesium sulphate) helps to prevent seizures. The main question this study aims to answer is:
What are the different regimens of magnesium sulphate that are used to prevent seizures in pregnant women with severe pre-eclampsia?
Participants already have taken the magnesium sulphate as part of their regular medical care for severe pre-eclampsia. Researchers will look into the records of the participants in the past 5 years to collect the data.
Read the detailed description
This will be a retrospective study describing the different regimens of MgSO4 used in patients diagnosed with SPE in Ain Shams University Maternity Hospital (ASUMH), and the occurrence of eclamptic fits and any other complications with each of them.
Methodology:
- Protocol approval will be sought from ethical committee and hospital administration.
- Screening of all hospital records over the past 5 years to identify eligible records.
- Eligible records will be reviewed to extract the following data: Age, Parity, Gestational age, BMI, Prior medical disorders, previous surgeries - including cesarean section (CS). Data upon admission: (Blood pressure, albuminuria) Available labs (CBC, AST, ALT, serum creatinine, PTT, INR) Timing (since admission) and route of delivery. Regimen of MgSO4 used (loading and maintenance doses, the route, and total time of therapy - antepartum and postpartum); any changes in dosage, and the reason for change. Any DOCUMENTED patient-reported MgSO4 side effects (nausea, vomiting, muscle weakness, palpitations, hypotension dizziness). Any DOCUMENTED signs of magnesium toxicity (clinical: defined as a presence of respiratory depression with less than 16 respirations per minute or loss of deep tendon reflexes necessitating cessation of MgSO4 or administration of calcium gluconate and / or biochemical: serum magnesium level >8.4mg/dl) Occurrence of eclamptic fits despite MgSO4 therapy, and timing, duration, how it was managed. Maternal admission to intensive care unit (ICU). Other complications (pulmonary edema, postpartum hemorrhage) Neonatal ICU (NICU) admission. All files with SPE will be examined. The number of files excluded from analysis will be noted as well as a table for the different causes of exclusion . Files showing serum magnesium level will be also analyzed in more detailed tables together with the reasons behind checking the serum level.
- Data will be recorded in a case report form (appendix 1)
- Statistical analysis will be done accordingly.
Ethical Consideration:
- The study design will be approved by the Local Ethics committee, Faculty of Medicine, Ain Shams University.
- Confidentiality will be respected in all levels of the study.
- Conditions
- Preeclampsia (PE)
- Keywords
- eclampsia, magnesium sulphate, intensive care unit, pulmonary edema
- Medical subject headings
- Pre-Eclampsia, Eclampsia, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with severe preeclampsia | Preeclampsia with severe hypertension that does not respond to treatment or is associated with ongoing or recurring severe headaches, visual scotomata, nausea or vomiting, epigastric pain, oliguria, and severe hypertension, as well as progressive deterioration in laboratory blood tests such as rising creatinine or liver transaminases or falling platelet count, or failure of fetal growth or abnormal doppler findings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of eclamptic fits
Development of generalized tonic clonic convulsions in pregnant women with preeclampsia
Measured: within 24 hours before or after delivery
Secondary outcomes (3)
ICU admission
admission to the intensive care unit
Measured: within 48 hours before or after delivery
magnesium sulphate toxicity
clinical: defined as a presence of respiratory depression with less than 16 respirations per minute or loss of deep tendon reflexes necessitating cessation of MgSO4 or administration of calcium gluconate and / or biochemical: serum magnesium level >8.4mg/dl
Measured: within 48 hours before or after delivery
primary postpartum hemorrhage
occurrence of complications as primary postpartum hemorrhage (the loss of 500 ml or more of blood from the genital tract within 24 hours of the birth of a baby)
Measured: within 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 posted24 Jan 2025
- Study start3 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Hassan Mostafa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791668
- Sponsor's protocol ID
- FMASU MS 619/2024
- Status last verified
- Jan 2025
- First submitted
- 19 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the dataset generated and analyzed in this study after publication of the results.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia in Ain Shams University Maternity Hospital (Retrospective Cohort)
- ClinicalTrials.gov ID
- NCT06791668
- Acronym / sponsor ID
- FMASU MS 619/2024
- Conditions
- Preeclampsia (PE)
- Keywords
- eclampsia, magnesium sulphate, intensive care unit, pulmonary edema
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 24 Jan 2025 (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 goal of this observational study is to learn about the effects of the different drug regimens of magnesium sulphate in treatment of (severe pre-eclampsia). This condition affects some pregnant women and raises their blood pressure. It may also cause seizures (fits). The medication (magnesium sulphate) helps to prevent seizures. The main question this study aims to answer is:
What are the different regimens of magnesium sulphate that are used to prevent seizures in pregnant women with severe pre-eclampsia?
Participants already have taken the magnesium sulphate as part of their regular medical care for severe pre-eclampsia. Researchers will look into the records of the participants in the past 5 years to collect the data.
Detailed description
This will be a retrospective study describing the different regimens of MgSO4 used in patients diagnosed with SPE in Ain Shams University Maternity Hospital (ASUMH), and the occurrence of eclamptic fits and any other complications with each of them.
Methodology:
- Protocol approval will be sought from ethical committee and hospital administration.
- Screening of all hospital records over the past 5 years to identify eligible records.
- Eligible records will be reviewed to extract the following data: Age, Parity, Gestational age, BMI, Prior medical disorders, previous surgeries - including cesarean section (CS). Data upon admission: (Blood pressure, albuminuria) Available labs (CBC, AST, ALT, serum creatinine, PTT, INR) Timing (since admission) and route of delivery. Regimen of MgSO4 used (loading and maintenance doses, the route, and total time of therapy - antepartum and postpartum); any changes in dosage, and the reason for change. Any DOCUMENTED patient-reported MgSO4 side effects (nausea, vomiting, muscle weakness, palpitations, hypotension dizziness). Any DOCUMENTED signs of magnesium toxicity (clinical: defined as a presence of respiratory depression with less than 16 respirations per minute or loss of deep tendon reflexes necessitating cessation of MgSO4 or administration of calcium gluconate and / or biochemical: serum magnesium level >8.4mg/dl) Occurrence of eclamptic fits despite MgSO4 therapy, and timing, duration, how it was managed. Maternal admission to intensive care unit (ICU). Other complications (pulmonary edema, postpartum hemorrhage) Neonatal ICU (NICU) admission. All files with SPE will be examined. The number of files excluded from analysis will be noted as well as a table for the different causes of exclusion . Files showing serum magnesium level will be also analyzed in more detailed tables together with the reasons behind checking the serum level.
- Data will be recorded in a case report form (appendix 1)
- Statistical analysis will be done accordingly.
Ethical Consideration:
- The study design will be approved by the Local Ethics committee, Faculty of Medicine, Ain Shams University.
- Confidentiality will be respected in all levels of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women with severe preeclampsia | – | –Preeclampsia with severe hypertension that does not respond to treatment or is associated with ongoing or recurring severe headaches, visual scotomata, nausea or vomiting, epigastric pain, oliguria, and severe hypertension, as well as progressive deterioration in laboratory blood tests such as rising creatinine or liver transaminases or falling platelet count, or failure of fetal growth or abnormal doppler findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital records will be reviewed for pregnant women presented to Ain Shams University Maternity Hospital (ASUMH) diagnosed as a case of preeclampsia with criteria of severity: Preeclampsia with severe hypertension that does not respond to treatment or is associated with ongoing or recurring severe headaches, visual scotomata, nausea or vomiting, epigastric pain, oliguria, and severe hypertension, as well as progressive deterioration in laboratory blood tests such as rising creatinine or liver transaminases or falling platelet count, or failure of fetal growth or abnormal doppler findings.
Key inclusion criteria (1 listed)
- All hospital records of patients diagnosed as preeclampsia with severe features planned to receive magnesium sulphate.
Key exclusion criteria (1 listed)
- Records with missing data about the regimen of magnesium sulphate used
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
Occurrence of eclamptic fits
Time frame: within 24 hours before or after delivery
Development of generalized tonic clonic convulsions in pregnant women with preeclampsia
3 secondary outcomes
ICU admission
Time frame: within 48 hours before or after delivery
magnesium sulphate toxicity
Time frame: within 48 hours before or after delivery
primary postpartum hemorrhage
Time frame: within 24 hours after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Yes. We plan to share the dataset generated and analyzed in this study after publication of the results.
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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.
Sherif Ashoush, MD contact
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 Preeclampsia (PE), run by Ain Shams Maternity Hospital at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rania HM Ahmed, MD (20201200522444, raneyah@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of eclamptic fits (time frame: within 24 hours before or after delivery). 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 24 Jan 2025.