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

This study has been completed.
Information provided by (Responsible Party):
Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid Identifier:
First received: July 15, 2010
Last updated: August 13, 2012
Last verified: August 2012

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.

Condition Intervention
Procedure: Delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Expectant Management of Severe Preeclampsia at 28 to 33 Week`s Gestation:a Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Complejo Hospitalario Dr. Arnulfo Arias Madrid:

Primary Outcome Measures:
  • Perinatal death [ Time Frame: After begining the randomization until 4 weeks after delivery. ]
    Number of perinatal in each group (interventionist or expectant management)

Secondary Outcome Measures:
  • Perinatal complications and maternal complications [ Time Frame: Maternal and perinatal complication after begining the randomization until 4 weeks after delivery. ]

Enrollment: 264
Study Start Date: August 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Delivery
Termination of pregnancy (delivery)after completed corticosteroids
Other Names:
  • Severe preeclampsia
  • expectant management of severe preeclampsia

Detailed Description:
Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01164852

Hospital Terodoro Maldonado, del IESS
Gauyas, Ecuador
Hospital Carlos Andrade Marin
Quito, Ecuador
Hospital de Gineco-Obstetricia del seguro social
Ciudad Guatemala, Guatemala
Hospital de Ginecologia del Instituto Materno Infantil
Toluca, Mexico
Complejo Hospitalario Caja de Seguro Social
Panamá, Panama
Hospital Santo Tomás
Panamá, Panama
Hospital Nacional Madre Niño, Lima Perú
Lima, Peru
Hospital Nuestra Señora de Chiquinquira
Maracaibo, Venezuela
Sponsors and Collaborators
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Principal Investigator: Paulino Vigil-De Gracia, MD Complejo Hospitalario
Study Chair: Jack Ludmir, MD Pennsylvania Hospital
  More Information

Responsible Party: Paulino Vigil-De Gracia, Paulino Emilio Vigil De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid Identifier: NCT01164852     History of Changes
Other Study ID Numbers: ComplejoH 01
Study First Received: July 15, 2010
Last Updated: August 13, 2012

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications processed this record on May 25, 2017