Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term (MEXPRE-Latin)
This study has been completed.
Sponsor:
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Information provided by (Responsible Party):
Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid
ClinicalTrials.gov Identifier:
NCT01164852
First received: July 15, 2010
Last updated: August 13, 2012
Last verified: August 2012
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Purpose
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 |
|---|---|
|
Preeclampsia |
Procedure: Delivery |
| Study Type: | Interventional |
| 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 |
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. ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: Yes ]
| 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:
|
Detailed Description:
Severa Preeclampsia between 28 and 33 weeks of gestation Women and fetus with stable condition All women receive complete dosis of steroids
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164852
Locations
| Ecuador | |
| Hospital Terodoro Maldonado, del IESS | |
| Gauyas, Ecuador | |
| Hospital Carlos Andrade Marin | |
| Quito, Ecuador | |
| Guatemala | |
| Hospital de Gineco-Obstetricia del seguro social | |
| Ciudad Guatemala, Guatemala | |
| Mexico | |
| Hospital de Ginecologia del Instituto Materno Infantil | |
| Toluca, Mexico | |
| Panama | |
| Hospital Santo Tomás | |
| Panamá, Panama | |
| Complejo Hospitalario Caja de Seguro Social | |
| Panamá, Panama | |
| Peru | |
| Hospital Nacional Madre Niño, Lima Perú | |
| Lima, Peru | |
| Venezuela | |
| Hospital Nuestra Señora de Chiquinquira | |
| Maracaibo, Venezuela | |
Sponsors and Collaborators
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Investigators
| Principal Investigator: | Paulino Vigil-De Gracia, MD | Complejo Hospitalario |
| Study Chair: | Jack Ludmir, MD | Pennsylvania Hospital |
More Information
No publications provided
| Responsible Party: | Paulino Vigil-De Gracia, Paulino Emilio Vigil De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid |
| ClinicalTrials.gov Identifier: | NCT01164852 History of Changes |
| Other Study ID Numbers: | ComplejoH 01 |
| Study First Received: | July 15, 2010 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Panama: Ministry of Health |
Additional relevant MeSH terms:
|
Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications |
ClinicalTrials.gov processed this record on May 19, 2013