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Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

NCT ID: NCT01164852

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Preeclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Expectant management

Expectant management: refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Delivery

Intervention Type PROCEDURE

Termination of pregnancy (delivery)after completed corticosteroids

Interventions

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Delivery

Termination of pregnancy (delivery)after completed corticosteroids

Intervention Type PROCEDURE

Other Intervention Names

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Severe preeclampsia expectant management of severe preeclampsia

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Complejo Hospitalario Dr. Arnulfo Arias Madrid

OTHER

Sponsor Role lead

Responsible Party

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Paulino Vigil-De Gracia

Paulino Emilio Vigil De Gracia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulino Vigil-De Gracia, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario

Jack Ludmir, MD

Role: STUDY_CHAIR

Pennsylvania Hospital

Locations

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Hospital Terodoro Maldonado, del IESS

Gauyas, , Ecuador

Site Status

Hospital Carlos Andrade Marin

Quito, , Ecuador

Site Status

Hospital de Gineco-Obstetricia del seguro social

Guatemala City, , Guatemala

Site Status

Hospital de Ginecologia del Instituto Materno Infantil

Toluca, , Mexico

Site Status

Complejo Hospitalario Caja de Seguro Social

Panama City, Provincia de Panamá, Panama

Site Status

Hospital Santo Tomás

Panama City, , Panama

Site Status

Hospital Nacional Madre Niño, Lima Perú

Lima, , Peru

Site Status

Hospital Nuestra Señora de Chiquinquira

Maracaibo, Maracaibo, Venezuela

Site Status

Countries

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Colombia El Salvador Ecuador Guatemala Mexico Panama Peru Venezuela

Other Identifiers

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ComplejoH 01

Identifier Type: -

Identifier Source: org_study_id