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
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 or disease||Intervention/treatment||Phase|
|Preeclampsia||Procedure: Delivery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Expectant Management of Severe Preeclampsia at 28 to 33 Week`s Gestation:a Randomized Controlled Trial|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
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
- Perinatal death [ Time Frame: After begining the randomization until 4 weeks after delivery. ]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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|