Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expectant management | No Intervention | Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. | |
| Interventionist management | Active Comparator | Interventionist management: in which blood pressure is stabilized, corticosteroids are given for acceleration of fetal maturity and delivery is planned within 48-72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delivery | Procedure | Termination of pregnancy (delivery)after completed corticosteroids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perinatal death | Number of perinatal in each group (interventionist or expectant management) | After begining the randomization until 4 weeks after delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| Perinatal complications and maternal complications | Maternal and perinatal complication after begining the randomization until 4 weeks after delivery. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paulino Vigil-De Gracia, MD | Complejo Hospitalario | Principal Investigator |
| Jack Ludmir, MD | Pennsylvania Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Terodoro Maldonado, del IESS | Gauyas | Ecuador | ||||
| Hospital Carlos Andrade Marin |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D036801 | Parturition |
| ID | Term |
|---|---|
| D011247 | Pregnancy |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quito |
| Ecuador |
| Hospital de Gineco-Obstetricia del seguro social | Guatemala City | Guatemala |
| Hospital de Ginecologia del Instituto Materno Infantil | Toluca | Mexico |
| Complejo Hospitalario Caja de Seguro Social | Panama City | Provincia de Panamá | Panama |
| Hospital Santo Tomás | Panama City | Panama |
| Hospital Nacional Madre Niño, Lima Perú | Lima | Peru |
| Hospital Nuestra Señora de Chiquinquira | Maracaibo | Maracaibo | Venezuela |