Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term (MEXPRE-Latin)

Expectant Management of Severe Preeclampsia at 28 to 33 Week's Gestation:a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Procedure: Delivery

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Severe preeclampsia; expectant management of severe preeclampsia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perinatal death	Number of perinatal in each group (interventionist or expectant management)	After begining the randomization until 4 weeks after delivery.

Secondary Outcome Measures

Outcome Measure	Time Frame
Perinatal complications and maternal complications	Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.

Collaborators and Investigators

• Sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Investigators: Principal Investigator: Paulino Vigil-De Gracia, MD, Complejo Hospitalario; Study Chair: Jack Ludmir, MD, Pennsylvania Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 15, 2010
• First Submitted That Met QC Criteria: July 16, 2010
• First Posted (Estimate): July 19, 2010

Study Record Updates

• Last Update Posted (Estimate): August 14, 2012
• Last Update Submitted That Met QC Criteria: August 13, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: ComplejoH 01