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Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia

NCT ID: NCT01408979

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-02-29

Brief Summary

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Magnesium sulfate is the ideal drug for seizures prophilaxis in preeclampsia. The ideal duration of this treatment after delivery is still to be established. The hypothesis is that in stable patients a shorter course of treatment is possible without prejudice to the mother.

Detailed Description

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Magnesium sulfate (MgSO4) is certainly the ideal drug for prevention and control of eclamptic seizures. However, there is no consensus on the appropriate duration of prophylaxis with this anticonvulsant postpartum.The objective of the present study is to compare effectiveness of 12 hours of magnesium sulfate versus 24 hours (standard treatment) in stable patients with preeclampsia.

Conditions

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Severe Preeclampsia

Keywords

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Severe preeclampsia magnesium sulfate anticonvulsivant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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12 hours of magnesium sulfate

Patients in this group will have magnesium sulfate administered for 12 hours after delivery

Group Type EXPERIMENTAL

Magnesium sulfate 12 hours

Intervention Type DRUG

Magnesium sulfate, 1g/h, (10% solution), for 12 hours

24 hours of magnesium sulfate

Patients in this group will have magnesium sulfate administered for 24 hours after delivery

Group Type ACTIVE_COMPARATOR

Magnesium sulfate 24 hours

Intervention Type DRUG

Magnesium sulfate, 1g/h, (10% solution), for 24 hours

Interventions

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Magnesium sulfate 12 hours

Magnesium sulfate, 1g/h, (10% solution), for 12 hours

Intervention Type DRUG

Magnesium sulfate 24 hours

Magnesium sulfate, 1g/h, (10% solution), for 24 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pre-eclampsia;
* Puerperium.

Exclusion Criteria

* Associated maternal diseases;
* Use of illicit drugs or other medications that might interfere with maternal hemodynamics;
* Contraindications to the use of magnesium sulfate: drug hypersensitivity, oliguria with urine output below 25ml/h; anuria (absent urine output), myasthenia gravis.
Minimum Eligible Age

11 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role lead

Responsible Party

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Leila Katz

Obstetrical ICU obstetrical coordinator; MD , PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melania M Amorim, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

IMIP

Locations

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IMIP

Recife, Pernambuco, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 37815037 (View on PubMed)

Maia SB, Katz L, Neto CN, Caiado BV, Azevedo AP, Amorim MM. Abbreviated (12-hour) versus traditional (24-hour) postpartum magnesium sulfate therapy in severe pre-eclampsia. Int J Gynaecol Obstet. 2014 Sep;126(3):260-4. doi: 10.1016/j.ijgo.2014.03.024. Epub 2014 May 10.

Reference Type DERIVED
PMID: 24890747 (View on PubMed)

Other Identifiers

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MgSO4

Identifier Type: -

Identifier Source: org_study_id