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Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia (MAG-PIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307201
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

Brief Summary:
There is no evidence that patients receiving magnesium sulfate before birth are required to maintain the drug for 24 hours. Therefore the investigators will have a randomized clinical study in patients with severe preeclampsia who have been treated with impregnation of magnesium sulphate and at least eight hours have received the drug before birth. If the patient agrees and signs the consent is randomized to: 1-receive sulfate for 24 hours postpartum as usual or, 2- not receiving the postpartum magnesium sulfate or other anticonvulsant drugs. This study can be conducted in 12 maternity latin america.

Condition or disease Intervention/treatment Phase
Post Partum Severe Preeclampsia Drug: Magnesium Sulfate Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia Receiving Treatment for More Than 8 Hours Before Delivery. A Randomized Multicenter Clinical Trial .
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: Postpartum Magnesium sulfate
The patient will receive magnesium sulfate as usual for 24 hours postpartum
Drug: Magnesium Sulfate
The patient will receive magnesium sulfate for 24 hours postpartum
Other Name: No postpartum treatment

No Intervention: No postpartum treatment
The patient did not receive postpartum magnesium sulfate or other anticonvulsant during 24 hours postpartum



Primary Outcome Measures :
  1. Eclampsia [ Time Frame: 24 hours postpartum ]
    Convulsion after delivery in any group (with magnesium sulfate or without magnesium sulfate), during 24 hours postpartum.


Secondary Outcome Measures :
  1. Postpartum hemorrhage [ Time Frame: 24 hours postpartum ]
    Blood loss > 500 post vaginal delivery or > 800 cc post cesarean section, during 24 hours postpartum

  2. Maternal respiratory distress [ Time Frame: 24 hours postpartum ]
    clinical respiratory distress,during 24 hours postpartum

  3. Grams of magnesium sulfate before delivery [ Time Frame: 8 to 72 hours with magnesium sulfate before delivery ]
    Hours and grams of magnesium sulfate before delivery

  4. Severe hypertension postpartum [ Time Frame: 72 hours postdelivery ]
    Diastolic Blood pressure > 110 mmHg and/or systolic blood pressure > 160 mmHg



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Ages Eligible for Study:   14 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Severe preeclampsia or severe preeclampsia aggregated to chronic hypertension with > 24 weeks of gestation treated with 4-6 grams of magnesium sulfate for impregnation with a minimum of 8 hours continuous of magnesium sulfate before delivery
  • The study begins to terminate pregnancy

Exclusion Criteria:

  • HELLP syndrome
  • Eclampsia
  • Renal insufficiency
  • Diabetes mellitus
  • Disease of collagen
  • Heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307201


Locations
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Dominican Republic
Hospital Materno Infantil san Lorezo de las Minas
Santo Domingo, Dominican Republic
Hospital Universitario Maternidad Nuestra señoa de Alta Gracia
Santo Domingo, Dominican Republic
Ecuador
Hospital Teodoro Maldonado De Guayaquil
Guayaquil, Ecuador
El Salvador
Hospital Primero de Mayo
San Salvador, El Salvador
Panama
Hospital Jose Domingo De Obaldia
Chiriqui, Panama, 507
Complejo Hospitalario Caja de Seguro Social
Panamá, Panama, 507
Hospital Santo Tomás
Panamá, Panama, 507
Peru
Hospital Regional de Cojamarca, Perú,
Cajamarca, Peru
Instituto Materno perinatal, Maternidad de Lima
Lima, Peru
Sponsors and Collaborators
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Investigators
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Principal Investigator: Paulino Vigil De Gracia Complejo Hospitalario Dr. Arnulfo Arias Madrid
Study Chair: Jack Ludmir, MD School of medicine, Pennsylvania Hospital. University de Pennsylvania. Philadelphia

Publications of Results:
Other Publications:
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Responsible Party: Paulino Vigil-De Gracia, MEDICAL DOCTOR, GYNECOLOGY AND OBSTETRIC, Complejo Hospitalario Dr. Arnulfo Arias Madrid
ClinicalTrials.gov Identifier: NCT02307201     History of Changes
Other Study ID Numbers: complejoh
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents