Different Regimens of Magnesium Sulphate in Patients With Severe Preeclampsia

NCT06791668 | Recruiting DMC

• 1 other identifier: FMASU MS 619/2024
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Preeclampsia (PE)

Keywords

eclampsia; magnesium sulphate; intensive care unit; pulmonary edema

Outcome Measures

Primary Outcomes (1)

• Occurrence of eclamptic fits

  Development of generalized tonic clonic convulsions in pregnant women with preeclampsia

  within 24 hours before or after delivery

Secondary Outcomes (3)

• ICU admission

  within 48 hours before or after delivery

• magnesium sulphate toxicity

  within 48 hours before or after delivery

• primary postpartum hemorrhage

  within 24 hours after delivery

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia; Pulmonary Edema

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Rania HM Ahmed, MD

CONTACT

20201200522444; raneyah@med.asu.edu.eg

Sherif Ashoush, MD

CONTACT

sherifashoush@med.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: January 24, 2025
• Study Start: December 3, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: start date: after publication of the study results end date: for 10years

Locations

EG (1)