Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HELLP Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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saline solution

Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours

Group Type PLACEBO_COMPARATOR

dexamethasone

Intervention Type DRUG

Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours

Placebo

Intervention Type DRUG

Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours

Dexamethasone

Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours

Interventions

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dexamethasone

Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours

Intervention Type DRUG

Placebo

Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours

Intervention Type DRUG

dexamethasone

dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postpartum women with Class I HELLP syndrome

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

Minimum Eligible Age

13 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No