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Trial record 5 of 8 for:    severe preeclampsia AND eclampsia | Panama

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

Tracking Information
First Submitted Date  ICMJE November 24, 2014
First Posted Date  ICMJE December 4, 2014
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE December 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2015)
Eclampsia [ Time Frame: 24 hours postpartum ]
Convulsion after delivery in any group (with magnesium sulfate or without magnesium sulfate), during 24 hours postpartum.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
Eclampsia [ Time Frame: 24 hours postpartum ]
Convulsion after delivery in any group (with magnesium sulfate or without magnesium sulfate), during 72 hours postpartum.
Change History Complete list of historical versions of study NCT02307201 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2015)
  • Postpartum hemorrhage [ Time Frame: 24 hours postpartum ]
    Blood loss > 500 post vaginal delivery or > 800 cc post cesarean section, during 24 hours postpartum
  • Maternal respiratory distress [ Time Frame: 24 hours postpartum ]
    clinical respiratory distress,during 24 hours postpartum
  • 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
  • Severe hypertension postpartum [ Time Frame: 72 hours postdelivery ]
    Diastolic Blood pressure > 110 mmHg and/or systolic blood pressure > 160 mmHg
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2014)
  • Postpartum hemorrhage [ Time Frame: 24 hours postpartum ]
    Blood loss > 500 post vaginal delivery or > 800 cc post cesarean section, during 72 hours postpartum
  • Maternal respiratory distress [ Time Frame: 24 hours postpartum ]
    clinical respiratory distress,during 24 hours postpartum
  • 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
  • Severe hypertension postpartum [ Time Frame: 72 hours postdelivery ]
    Diastolic Blood pressure > 110 mmHg and/or systolic blood pressure > 160 mmHg
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia
Official Title  ICMJE Magnesium Sulfate During the Postpartum in Women With Severe Preeclampsia Receiving Treatment for More Than 8 Hours Before Delivery. A Randomized Multicenter Clinical Trial .
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.
Detailed Description

The final treatment known for pre-eclampsia and eclampsia is the termination of pregnancy. However to prevent eclampsia in patients with severe pre-eclampsia has been demonstrated the effectiveness of magnesium sulfate. There are multiple studies that prove the effectiveness of magnesium sulfate to prevent eclampsia in patients with severe disorder of blood pressure during pregnancy. These studies used the drug before birth and continue after birth. Therefore the investigators can not conclude whether the administration just before pregnancy is sufficient to prevent seizure. If the cure or definitive treatment of pre-eclampsia is the interruption, did not seem necessary to justify the administration of drugs anti-eclampsia after birth. Obvious post delivery management with magnesium sulfate arises from the large number of postpartum eclampsia reported in many studies. It is unknown whether administration of magnesium sulfate for a minimum period before delivery, requires even keep the drug post partum.

In addition to magnesium sulfate postpartum, is necessary to maintain urinary catheter to monitoring the removal of magnesium sulfate; is usual to maintain the patient at all or almost all rest by monitoring sulfate and diuresis , this prevents a proper relationship mother and babe and even prevents breastfeeding during that period and is also known increased risk of secondary thromboembolism due to prolonged rest in the postpartum / caesarean section.Thus, maintain magnesium sulfate for 24 hours carries a higher cost, greater vigilance and some risks, without known real effect.

A randomized clinical study conducted by Belfort and colleagues and published in January 2003, where magnesium sulphate compared to nimodipine to prevent eclampsia in women with severe pre-eclampsia, showed interesting outcome. Such research analyzed 819 randomized patients in the nimodipine group and 831 in the magnesium sulfate group. Magnesium sulphate was better than Nimodipine in preventing eclampsia. Interestingly, the greater effectiveness of sulfate appears to prevent all eclampsia postpartum (9 vs 0) and obviously was used before the termination of pregnancy, however no difference compared with nimodipine in eclampsia before birth (12 vs 7).

There are two possible reasons for the non-appearance of postpartum eclampsia: 1- maintain postpartum magnesium sulfate, 2- dose 12-13 grams before birth disruption are sufficient to prevent eclampsia.

The MAGPIE study randomized 1335 postpartum patients (unused sulphate before delivery) using magnesium sulfate postpartum / cesarean (696 women) or placebo postpartum / cesarean (639 women), and found no significant difference in the amount of eclampsia . Thus, the use of magnesium sulfate for first time in the postpartum is not better to use a placebo. If the investigators combine the findings of eclampsia postpartum Belfort study and MAGPIE study is logical to think that the success of the Belfort study in the postpartum is not for the use of magnesium sulfate post delivery and not only due to the termination of pregnancy because there are postpartum eclampsia in the nimodipine group.

If the investigators consider unjustified use of magnesium sulfate postpartum, when maintained at least 8 hours before delivery, the investigators decided to make a non-inferiority randomized study.The investigators assume that using or not using magnesium sulfate during the postpartum prevents similar amount of postpartum eclampsia, if during pregnancy was used (impregnation and at least 8 hours before birth).

For all these reasons the investigators propose the following: A randomized trial is necessary where all those patients who received magnesium sulfate for at least 8 hours before birth (involves impregnation and maintenance 8 hours) will be randomized to two groups of study: 1- Continue magnesium sulfate for 24 hours and 2-not use magnesium sulfate or other anticonvulsant drug post delivery.

This study is planned in 12 maternity latin america

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Post Partum Severe Preeclampsia
Intervention  ICMJE Drug: Magnesium Sulfate
The patient will receive magnesium sulfate for 24 hours postpartum
Other Name: No postpartum treatment
Study Arms  ICMJE
  • Experimental: Postpartum Magnesium sulfate
    The patient will receive magnesium sulfate as usual for 24 hours postpartum
    Intervention: Drug: Magnesium Sulfate
  • No Intervention: No postpartum treatment
    The patient did not receive postpartum magnesium sulfate or other anticonvulsant during 24 hours postpartum
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 24, 2015)
1114
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2014)
1240
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama,   Dominican Republic,   Ecuador,   El Salvador,   Peru
Removed Location Countries Guatemala,   Honduras,   Mexico,   Paraguay,   Uruguay
 
Administrative Information
NCT Number  ICMJE NCT02307201
Other Study ID Numbers  ICMJE complejoh
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid
Study Sponsor  ICMJE Complejo Hospitalario Dr. Arnulfo Arias Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Complejo Hospitalario Dr. Arnulfo Arias Madrid
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP