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Trial record 8 of 9 for:    severe preeclampsia AND eclampsia | Panama

Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term (MEXPRE-Latin)

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: NCT01164852
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

Tracking Information
First Submitted Date  ICMJE July 15, 2010
First Posted Date  ICMJE July 19, 2010
Last Update Posted Date August 14, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
Perinatal death [ Time Frame: After begining the randomization until 4 weeks after delivery. ]
Number of perinatal in each group (interventionist or expectant management)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2010)
Perinatal complications and maternal complications [ Time Frame: Maternal and perinatal complication after begining the randomization until 4 weeks after delivery. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term
Official Title  ICMJE Expectant Management of Severe Preeclampsia at 28 to 33 Week`s Gestation:a Randomized Controlled Trial
Brief Summary

How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.

The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.

Detailed Description Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Preeclampsia
Intervention  ICMJE Procedure: Delivery
Termination of pregnancy (delivery)after completed corticosteroids
Other Names:
  • Severe preeclampsia
  • expectant management of severe preeclampsia
Study Arms  ICMJE
  • No Intervention: Expectant management
    Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.
  • Active Comparator: Interventionist management
    Interventionist management: in which blood pressure is stabilized, corticosteroids are given for acceleration of fetal maturity and delivery is planned within 48-72 hours.
    Intervention: Procedure: Delivery
Publications * Not Provided

*   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: August 13, 2012)
264
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2010)
280
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation

Exclusion Criteria:

  • Uncontrollable blood pressure or persistent severe hypertension (160/110 mmHg)
  • Persistent symptoms of preeclampsia
  • Maternal complications (HELLP syndrome, acute renal insufficiency, cerebral edema, eclampsia, pulmonary edema)
  • Fetal death, restriction of fetal grown
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama,   Ecuador,   Guatemala,   Mexico,   Peru,   Venezuela
Removed Location Countries Colombia,   El Salvador
 
Administrative Information
NCT Number  ICMJE NCT01164852
Other Study ID Numbers  ICMJE ComplejoH 01
Has Data Monitoring Committee No
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, MD Complejo Hospitalario
Study Chair: Jack Ludmir, MD Pennsylvania Hospital
PRS Account Complejo Hospitalario Dr. Arnulfo Arias Madrid
Verification Date August 2012

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