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

Primary Purpose

Preeclampsia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Delivery
Sponsored by
Complejo Hospitalario Dr. Arnulfo Arias Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preeclampsia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital Terodoro Maldonado, del IESS
  • Hospital Carlos Andrade Marin
  • Hospital de Gineco-Obstetricia del seguro social
  • Hospital de Ginecologia del Instituto Materno Infantil
  • Complejo Hospitalario Caja de Seguro Social
  • Hospital Santo Tomás
  • Hospital Nacional Madre Niño, Lima Perú
  • Hospital Nuestra Señora de Chiquinquira

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Expectant management

Interventionist management

Arm Description

Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.

Interventionist management: in which blood pressure is stabilized, corticosteroids are given for acceleration of fetal maturity and delivery is planned within 48-72 hours.

Outcomes

Primary Outcome Measures

Perinatal death
Number of perinatal in each group (interventionist or expectant management)

Secondary Outcome Measures

Perinatal complications and maternal complications

Full Information

First Posted
July 15, 2010
Last Updated
August 13, 2012
Sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01164852
Brief Title
Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term
Acronym
MEXPRE-Latin
Official Title
Expectant Management of Severe Preeclampsia at 28 to 33 Week's Gestation:a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expectant management
Arm Type
No Intervention
Arm Description
Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.
Arm Title
Interventionist management
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Delivery
Other Intervention Name(s)
Severe preeclampsia, expectant management of severe preeclampsia
Intervention Description
Termination of pregnancy (delivery)after completed corticosteroids
Primary Outcome Measure Information:
Title
Perinatal death
Description
Number of perinatal in each group (interventionist or expectant management)
Time Frame
After begining the randomization until 4 weeks after delivery.
Secondary Outcome Measure Information:
Title
Perinatal complications and maternal complications
Time Frame
Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulino Vigil-De Gracia, MD
Organizational Affiliation
Complejo Hospitalario
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jack Ludmir, MD
Organizational Affiliation
Pennsylvania Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Terodoro Maldonado, del IESS
City
Gauyas
Country
Ecuador
Facility Name
Hospital Carlos Andrade Marin
City
Quito
Country
Ecuador
Facility Name
Hospital de Gineco-Obstetricia del seguro social
City
Ciudad Guatemala
Country
Guatemala
Facility Name
Hospital de Ginecologia del Instituto Materno Infantil
City
Toluca
Country
Mexico
Facility Name
Complejo Hospitalario Caja de Seguro Social
City
Panamá
Country
Panama
Facility Name
Hospital Santo Tomás
City
Panamá
Country
Panama
Facility Name
Hospital Nacional Madre Niño, Lima Perú
City
Lima
Country
Peru
Facility Name
Hospital Nuestra Señora de Chiquinquira
City
Maracaibo
Country
Venezuela

12. IPD Sharing Statement

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Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

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