## Protocol Section
### Identification Module
**NCT ID:** NCT01408979

**Acronym:** MgSO4

**Brief Title:** Effectiveness Study of Short Course of Magnesium Sulfate for Severe Preeclamsia

**Official Title:** Postpartum Prophylaxis With Short Course Magnesium Sulfate in Severe Preeclampsia: a Randomized Clinical Trial

#### Organization Study ID Info
**ID:** MgSO4
#### Organization
**Class:** OTHER
**Full Name:** Instituto Materno Infantil Prof. Fernando Figueira
### Status Module
#### Completion Date
**Date:** 2012-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-08-22

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-08-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Start Date
**Date:** 2011-08

**Status Verified Date:** 2012-04

#### Study First Post Date
**Date:** 2011-08-03
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-02
**Study First Submit QC Date:** 2011-08-02
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Instituto Materno Infantil Prof. Fernando Figueira

#### Responsible Party

**Investigator Affiliation:** Instituto Materno Infantil Prof. Fernando Figueira

**Investigator Full Name:** Leila Katz

**Investigator Title:** Obstetrical ICU obstetrical coordinator; MD , PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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:** 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 Module

**Conditions:**

- Severe Preeclampsia

**Keywords:**

- Severe preeclampsia

- magnesium sulfate

- anticonvulsivant

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Magnesium sulfate 12 hours

**Label:** 12 hours of magnesium sulfate

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Magnesium sulfate 24 hours

**Label:** 24 hours of magnesium sulfate

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 12 hours of magnesium sulfate

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

**Name:** Magnesium sulfate 12 hours

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 24 hours of magnesium sulfate

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

**Name:** Magnesium sulfate 24 hours

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Defined as the need to continue therapy for another 12 hours, this will occur when after the first 12 hours of magnesium sulfate therapy the patient has severe hypertension, unsatisfactory diureses or has signs or symptoms of iminent eclampsia.

**Measure:** Need to continue therapy for another 12 hours.

**Time Frame:** 24 hours

#### Secondary Outcomes

**Description:** Patients satisfaction with the duration of therapy

**Measure:** Satisfaction

**Time Frame:** 24 hours

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 50 Years

**Minimum Age:** 11 Years

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Recife

**Country:** Brazil

**Facility:** IMIP

**State:** Pernambuco

**Zip:** 50.000

#### Overall Officials

**Official 1:**

**Affiliation:** IMIP

**Name:** Melania M Amorim, MD; PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 24890747

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000046110

- Term: Hypertension, Pregnancy-Induced

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14106

- Name: Pre-Eclampsia

- Relevance: HIGH

- As Found: Preeclampsia

- ID: M7633

- Name: Eclampsia

- Relevance: LOW

- As Found: Unknown

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M25635

- Name: Hypertension, Pregnancy-Induced

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: T2019

- Name: Eclampsia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011225

- Term: Pre-Eclampsia

### Intervention Browse Module - Ancestors

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000000927

- Term: Anticonvulsants

- ID: D000002121

- Term: Calcium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000077264

- Term: Calcium-Regulating Hormones and Agents

- ID: D000015149

- Term: Tocolytic Agents

- ID: D000012102

- Term: Reproductive Control Agents

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: Analg

- Name: Analgesics

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M11270

- Name: Magnesium Sulfate

- Relevance: HIGH

- As Found: Optimal

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4246

- Name: Anticonvulsants

- Relevance: LOW

- As Found: Unknown

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5384

- Name: Calcium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M17869

- Name: Tocolytic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008278

- Term: Magnesium Sulfate

### Misc Info Module

- Version Holder: 2024-05-24
