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

Complejo Hospitalario Dr. Arnulfo Arias Madrid

Status: Completed

Conditions: Preeclampsia

Treatments: Procedure: Delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT01164852

ComplejoH 01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 264 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

264 participants in 2 patient groups

Expectant management

No Intervention group

Description:

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

Interventionist management

Active Comparator group

Description:

Interventionist management: in which blood pressure is stabilized, corticosteroids are given for acceleration of fetal maturity and delivery is planned within 48-72 hours.

Treatment:

Procedure: Delivery