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Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

NCT01164852 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2012-08-14

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Delivery

Termination of pregnancy (delivery)after completed corticosteroids

Sponsors & Collaborators

  • Complejo Hospitalario Dr. Arnulfo Arias Madrid

    lead OTHER

Principal Investigators

  • Paulino Vigil-De Gracia, MD · Complejo Hospitalario

  • Jack Ludmir, MD · Pennsylvania Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Ecuador
  • Guatemala
  • Mexico
  • Panama
  • Peru
  • Venezuela

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01164852 on ClinicalTrials.gov