NCT01164852

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

July 15, 2010

Last Update Submit

August 13, 2012

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

  • Perinatal death

    Number of perinatal in each group (interventionist or expectant management)

    After begining the randomization until 4 weeks after delivery.

Secondary Outcomes (1)

  • Perinatal complications and maternal complications

    Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.

Study Arms (2)

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.

Procedure: Delivery

Interventions

DeliveryPROCEDURE

Termination of pregnancy (delivery)after completed corticosteroids

Also known as: Severe preeclampsia, expectant management of severe preeclampsia
Interventionist management

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnancy with severe preeclampsia and 28 to 33 weeks of gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital Terodoro Maldonado, del IESS

Gauyas, Ecuador

Location

Hospital Carlos Andrade Marin

Quito, Ecuador

Location

Hospital de Gineco-Obstetricia del seguro social

Guatemala City, Guatemala

Location

Hospital de Ginecologia del Instituto Materno Infantil

Toluca, Mexico

Location

Complejo Hospitalario Caja de Seguro Social

Panama City, Provincia de Panamá, Panama

Location

Hospital Santo Tomás

Panama City, Panama

Location

Hospital Nacional Madre Niño, Lima Perú

Lima, Peru

Location

Hospital Nuestra Señora de Chiquinquira

Maracaibo, Maracaibo, Venezuela

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Parturition

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Paulino Vigil-De Gracia, MD

    Complejo Hospitalario

    PRINCIPAL INVESTIGATOR

  • Jack Ludmir, MD

    Pennsylvania Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Paulino Emilio Vigil De Gracia

Study Record Dates

First Submitted

July 15, 2010

First Posted

July 19, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

GU(1)ME(1)PA(2)PE(1)VE(1)EC(2)