Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01164852

Acronym

MEXPRE-Latin

Enrollment

264

Registered

2010-07-19

Start date

2010-08-31

Completion date

2012-08-31

Last updated

2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

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.

Detailed description

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

Interventions

PROCEDUREDelivery

Termination of pregnancy (delivery)after completed corticosteroids

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Ecuador, Guatemala, Mexico, Panama, Peru, Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026