Overview

This trial is active, not recruiting.

Condition hellp syndrome
Treatments dexamethasone, placebo
Phase phase 4
Sponsor Instituto Materno Infantil Prof. Fernando Figueira
Start date July 2011
End date December 2016
Trial size 400 participants
Trial identifier NCT00711841, IMIFernando Figueira

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
dexamethasone
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
placebo
Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
(Active Comparator)
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
dexamethasone
dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours

Primary Outcomes

Measure
severe maternal morbidity
time frame: postpartum

Secondary Outcomes

Measure
hospital stay duration
time frame: postpartum

Eligibility Criteria

Female participants from 13 years up to 49 years old.

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

Additional Information

Official title Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial
Principal investigator Leila Katz, pHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Instituto Materno Infantil Prof. Fernando Figueira.