Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome (COHELLP)

Instituto Materno Infantil Prof. Fernando Figueira

Status and phase: Terminated; Phase 4

Conditions: HELLP Syndrome

Treatments: Drug: Placebo; Drug: dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00711841

IMIFernando Figueira

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: Female

Ages: 13 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

saline solution

Placebo Comparator group

Description:

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

Treatment:

Drug: dexamethasone

Drug: Placebo

Drug: dexamethasone

Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: dexamethasone

Drug: dexamethasone