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OpenTrials
Completed

NCT Number: NCT01164852

Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Terodoro Maldonado, del IESS, Gauyas, Ecuador

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delivery

Procedure

Termination of pregnancy (delivery)after completed corticosteroids

Other names: Severe preeclampsia, expectant management of severe preeclampsia

Primary outcomes

  1. Perinatal death

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

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

Secondary outcomes

  1. Perinatal complications and maternal complications

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

Sponsors and collaborators

Lead sponsor

Complejo Hospitalario Dr. Arnulfo Arias Madrid

Other

Registry information

Official study title

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

Acronym: MEXPRE-Latin

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2010
Registry last updated
Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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