NCT03164304

Brief Summary

Preeclampsia is commonly viewed as one of the hypertensive pregnancy disorders, which cover a spectrum of clinical presentations from chronic hypertension ( hypertension occurring prior to 20 weeks of gestation) and gestational hypertension (hypertension occurring after 20 weeks of gestation) To more severe forms, including preeclampsia, eclampsia (its convulsive form), and HELLP syndrome (hemolysis, elevated liver enzyme S, and low platelets)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2.7 years

First QC Date

May 17, 2017

Last Update Submit

April 22, 2020

Conditions

Severe Preeclampsia

Outcome Measures

Primary Outcomes (3)

  • The rate of convulsions in each group.

    the number of participants who have convulsion

    24 hour

  • The percentage of women reaching the Mg therapeutic level of 4,8 mg/dl

    Follow up by Serum Magnesium level

    24 hour

  • The rate of adverse events in each group

    the number of participants who have adverse events

    24 hour

Study Arms (2)

One gram magnesium sulfate

ACTIVE COMPARATOR

Pregnant women with a diagnosis of severe pre-eclampsia will receive 1 g of mgso4 to prevent and control of convulsions

Drug: Magnesium Sulfate

Two grams magnesium sulfate

EXPERIMENTAL

Pregnant women with a diagnosis of severe pre-eclampsia will receive 2 g of mgso4 to prevent and control of convulsions

Drug: Magnesium Sulfate

Interventions

Magnesium SulfateDRUG

intravenous

One gram magnesium sulfateTwo grams magnesium sulfate

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women admitted to Women health hospital with a diagnosis of severe pre-eclampsia

You may not qualify if:

  • Women with Non-proteinuric hypertension, 2- severe renal impairment 3- Myasthenia gravis 4- High amount of magnesium in blood 5- Low or high amount of calcium in blood 6- Myocardial damage, diabetic coma, heart block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University, woman health hospital

Asyut, Egypt

Location

Related Publications (4)

  • Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D; Magpie Trial Collaboration Group. Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial. Lancet. 2002 Jun 1;359(9321):1877-90. doi: 10.1016/s0140-6736(02)08778-0.

    PMID: 12057549BACKGROUND

  • Zakiyah N, Postma MJ, Baker PN, van Asselt AD; IMPROvED Consortium. Pre-eclampsia Diagnosis and Treatment Options: A Review of Published Economic Assessments. Pharmacoeconomics. 2015 Oct;33(10):1069-82. doi: 10.1007/s40273-015-0291-x.

    PMID: 26048352BACKGROUND

  • Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013 Nov;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88. No abstract available.

    PMID: 24150027BACKGROUND

  • Diaz V, Long Q, Oladapo OT. Alternative magnesium sulphate regimens for women with pre-eclampsia and eclampsia. Cochrane Database Syst Rev. 2023 Oct 10;10(10):CD007388. doi: 10.1002/14651858.CD007388.pub3.

    PMID: 37815037DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 23, 2017

Study Start

May 30, 2017

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

EG(1)