Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome

HELLP Syndrome Clinical Trial

— COHELLP  

Official title:

Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00711841
• Other study ID #: IMIFernando Figueira
• Status: Terminated
• Phase: Phase 4
• Start date: July 2011
• Est. completion date: June 2019

Study information

• Verified date: June 2019
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• HELLP Syndrome
• Syndrome

Intervention

Drug:
• dexamethasone
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
• Placebo
Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
• dexamethasone
dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours

Locations

Country	Name	City	State
Brazil	Instituto Materno Infantil Prof. Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severe maternal morbidity	42 days after delivery	postpartum
Secondary	hospital stay duration		postpartum