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Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00711841
Acronym
COHELLP
Enrollment
400
Registered
2008-07-09
Start date
2011-07-31
Completion date
2019-06-30
Last updated
2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HELLP Syndrome

Keywords

HELLP syndrome, dexamethasone, postpartum period, class I HELLP syndrome

Brief 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.

Detailed 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.

Interventions

DRUGdexamethasone

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

DRUGPlacebo

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

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
13 Years to 49 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
severe maternal morbiditypostpartum42 days after delivery

Secondary

MeasureTime frame
hospital stay durationpostpartum

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026