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CompletedNCT01164852MEXPRE-LatinUpdated Aug 14, 2012

Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

An interventional study of Delivery in Preeclampsia, sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid. Completed at 8 sites in 6 countries. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-14.

Sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
264
Allocation
Randomized
Sex
Female
01

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.

Read the detailed description

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

02

Conditions studied

  • Preeclampsia

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03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's enrollment of 264 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Complejo Hospitalario Dr. Arnulfo Arias Madrid is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
264 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureDelivery

    Termination of pregnancy (delivery)after completed corticosteroids

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

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What researchers measure

Primary outcomes

  1. Perinatal death

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

    Time frame: After begining the randomization until 4 weeks after delivery.

Secondary outcomes

  1. Perinatal complications and maternal complications

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

07

Study locations

8 sites
  • Hospital Terodoro Maldonado, del IESS
    Gauyas, Ecuador
  • Hospital Carlos Andrade Marin
    Quito, Ecuador
  • Hospital de Gineco-Obstetricia del seguro social
    Ciudad Guatemala, Guatemala
  • Hospital de Ginecologia del Instituto Materno Infantil
    Toluca, Mexico
  • Complejo Hospitalario Caja de Seguro Social
    Panamá, Panama
  • Hospital Santo Tomás
    Panamá, Panama
  • Hospital Nacional Madre Niño, Lima Perú
    Lima, Peru
  • Hospital Nuestra Señora de Chiquinquira
    Maracaibo, Venezuela
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01164852
Lead sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Responsible party
Paulino Vigil-De Gracia (Paulino Emilio Vigil De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid) — Principal investigator
First posted
Jul 19, 2010
Start date
Aug 2010
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Aug 14, 2012

Study contacts

Paulino Vigil-De Gracia, MD
principal investigator · Complejo Hospitalario
Jack Ludmir, MD
study chair · Pennsylvania Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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