Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term (MEXPRE-Latin)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
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|
- Perinatal death [ Time Frame: After begining the randomization until 4 weeks after delivery. ] [ Designated as safety issue: Yes ]Number of perinatal in each group (interventionist or expectant management)
- Perinatal complications and maternal complications [ Time Frame: Maternal and perinatal complication after begining the randomization until 4 weeks after delivery. ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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.
Termination of pregnancy (delivery)after completed corticosteroids
Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164852
|Hospital Terodoro Maldonado, del IESS|
|Hospital Carlos Andrade Marin|
|Hospital de Gineco-Obstetricia del seguro social|
|Ciudad Guatemala, Guatemala|
|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|
|Principal Investigator:||Paulino Vigil-De Gracia, MD||Complejo Hospitalario|
|Study Chair:||Jack Ludmir, MD||Pennsylvania Hospital|