Efficacy of Postpartum Dexamethasone for Women With Class I HELLP Syndrome - Full Text View

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

This study is not yet open for participant recruitment.

Verified by Instituto Materno Infantil Prof. Fernando Figueira, August 2009

First Received: July 7, 2008 Last Updated: August 25, 2009 History of Changes

Sponsored by:	Instituto Materno Infantil Prof. Fernando Figueira
Information provided by:	Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:	NCT00711841

Purpose

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.

Condition	Intervention	Phase
HELLP Syndrome	Drug: dexamethasone Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:

severe maternal morbidity [ Time Frame: postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

hospital stay duration [ Time Frame: postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	December 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
saline solution: Placebo Comparator Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours	Drug: dexamethasone Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours Drug: Placebo Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
Dexamethasone: Active Comparator Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours	Drug: dexamethasone dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours

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.

Eligibility

Ages Eligible for Study:	13 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711841

Contacts

Contact: Leila Katz, pHD	55 81 21224739 ext 4739	katzleila@yahoo.com.br
Contact: Melania M Amorim, pHD	55 83 88221514	melamorim@uol.com

Locations

Brazil, Pernambuco
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, Brazil, 50.070-550

Sponsors and Collaborators

Instituto Materno Infantil Prof. Fernando Figueira

Investigators

Principal Investigator:

Leila Katz, pHD

IMIP

More Information

No publications provided

Responsible Party:	IMIFernando Figueira ( Leila Katz )
Study ID Numbers:	IMIFernando Figueira
Study First Received:	July 7, 2008
Last Updated:	August 25, 2009
ClinicalTrials.gov Identifier:	NCT00711841 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:

HELLP syndrome
dexamethasone
postpartum period
class I HELLP syndrome

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Pregnancy Complications
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics

Glucocorticoids
Hormones
HELLP Syndrome
Hypertension, Pregnancy-Induced
Peripheral Nervous System Agents
Dexamethasone acetate
Hypertension

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Disease
Pregnancy Complications
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones

Glucocorticoids
Pharmacologic Actions
HELLP Syndrome
Hypertension, Pregnancy-Induced
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Syndrome
Peripheral Nervous System Agents
Central Nervous System Agents
Dexamethasone acetate

ClinicalTrials.gov processed this record on September 11, 2009