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Completed

NCT Number: NCT04576364

12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assuit University women Health hospital, Asyut, Assuit, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Magnesium sulfate for 12 hour

Drug

drug used to prevent convulsions in patients having preeclampsia with severe features

Magnesium sulfate for 24 hour

Drug

drug used to prevent convulsions in patients having preeclampsia with severe features

Primary outcomes

  1. 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.

Secondary outcomes

  1. Percentage of prevention of eclampsia

    Time frame: up to 24 hour

    Number of patients who develop eclampsia in each group.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

12-hour Versus 24-hour Postpartum Magnesium Sulphate for Preeclamptic Patients :A Randomized Controlled Trial

Acronym: Mgso4

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2020
Registry last updated
Sep 1, 2023

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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