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NCT Number: NCT06791668

Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

Location status: Recruiting

Location contact

Ahmed Sakr

SUB_INVESTIGATOR

Sherif Ashoush, MD

CONTACT

[email protected]

20201222660266

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All hospital records of patients diagnosed as preeclampsia with severe features planned to receive magnesium sulphate.

Exclusion criteria

  • Records with missing data about the regimen of magnesium sulphate used

Treatment and study plan

Primary outcomes

  1. Occurrence of eclamptic fits

    Time frame: within 24 hours before or after delivery

    Development of generalized tonic clonic convulsions in pregnant women with preeclampsia

Secondary outcomes

  1. ICU admission

    Time frame: within 48 hours before or after delivery

    admission to the intensive care unit

  2. magnesium sulphate toxicity

    Time frame: within 48 hours before or after delivery

    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

  3. primary postpartum hemorrhage

    Time frame: within 24 hours after delivery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Rania HM Ahmed, MD

CONTACT

[email protected]

20201200522444

Sherif Ashoush, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Ain Shams Maternity Hospital

Other

Registry information

Official study title

Comparison of Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia in Ain Shams University Maternity Hospital (Retrospective Cohort)

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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