Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome

Phase 4

Terminated

• Conditions: HELLP Syndrome
• Interventions: Drug: dexamethasone; Drug: Placebo

• Registration Number: NCT00711841
• Lead Sponsor: Instituto Materno Infantil Prof. Fernando Figueira

Brief Summary

Corticotherapy accelerates maternal postpartum recovery in women with class I HELLP syndrome. The benefit of faster and better recovery would be observed in fewer complications, less utilization of blood products and shorter hospital stay.

Detailed Description

Patients with Class I HELLP Syndrome will be recruited for use os dexamethasone or placebo in the puerperium. Effects such as clinical course (blood pressure and diureses), laboratorial behaviour and complications will be compared. Duration of hospitalization will also be accessed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-09
• Study Start: 2011-07
• Status Verified: 2019-06
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

• Postpartum women with Class I HELLP syndrome

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Exclusion Criteria

• Chronic users of corticosteroids
• Patients with chronic conditions affecting the laboratory parameters involved in the HELLP syndrome
• Women who had received antenatal corticosteroids to treat HELLP syndrome were excluded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline solution	Placebo	Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
saline solution	dexamethasone	Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
Dexamethasone	dexamethasone	Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours

Primary Outcome Measures

Name	Time	Method
severe maternal morbidity	postpartum	42 days after delivery

Secondary Outcome Measures

Name	Time	Method
hospital stay duration	postpartum

Trial Locations

Locations (1)

Instituto Materno Infantil Prof. Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil