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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00711841
First received: July 7, 2008
Last updated: March 1, 2017
Last verified: March 2017
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • severe maternal morbidity [ Time Frame: postpartum ]
    42 days after delivery


Secondary Outcome Measures:
  • hospital stay duration [ Time Frame: postpartum ]

Estimated Enrollment: 400
Study Start Date: July 2011
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: saline solution
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
Active Comparator: Dexamethasone
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   (Child, Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leila Katz, Obstetrical ICU obstetrical coordinator; MD , PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT00711841     History of Changes
Other Study ID Numbers: IMIFernando Figueira
Study First Received: July 7, 2008
Last Updated: March 1, 2017

Keywords provided by Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira:
HELLP syndrome
dexamethasone
postpartum period
class I HELLP syndrome

Additional relevant MeSH terms:
Syndrome
HELLP Syndrome
Disease
Pathologic Processes
Hypertension, Pregnancy-Induced
Pregnancy Complications
Pharmaceutical Solutions
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 22, 2017