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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00711841
Other study ID # IMIFernando Figueira
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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