Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

Preeclampsia Clinical Trial

— MEXPRE-Latin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164852
• Other study ID #: ComplejoH 01
• Status: Completed
• Phase: N/A
• First received: July 15, 2010
• Last updated: August 13, 2012
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Procedure:
• Delivery
Termination of pregnancy (delivery)after completed corticosteroids

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Complejo Hospitalario Dr. Arnulfo Arias Madrid

Countries where clinical trial is conducted

Ecuador,  Guatemala,  Mexico,  Panama,  Peru,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal death	Number of perinatal in each group (interventionist or expectant management)	After begining the randomization until 4 weeks after delivery.	Yes
Secondary	Perinatal complications and maternal complications		Maternal and perinatal complication after begining the randomization until 4 weeks after delivery.	Yes