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

Primary Purpose

HELLP Syndrome

Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
dexamethasone
Placebo
dexamethasone
Sponsored by
Instituto Materno Infantil Prof. Fernando Figueira
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HELLP Syndrome focused on measuring HELLP syndrome, dexamethasone, postpartum period, class I HELLP syndrome

Eligibility Criteria

13 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto Materno Infantil Prof. Fernando Figueira

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

saline solution

Dexamethasone

Arm Description

Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours

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

Outcomes

Primary Outcome Measures

severe maternal morbidity
42 days after delivery

Secondary Outcome Measures

hospital stay duration

Full Information

First Posted
July 7, 2008
Last Updated
June 4, 2019
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
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1. Study Identification

Unique Protocol Identification Number
NCT00711841
Brief Title
Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome
Acronym
COHELLP
Official Title
Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
The speed of recruitment was slower than anticipated.
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HELLP Syndrome
Keywords
HELLP syndrome, dexamethasone, postpartum period, class I HELLP syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
saline solution
Arm Type
Placebo Comparator
Arm Description
Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Description
dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours
Primary Outcome Measure Information:
Title
severe maternal morbidity
Description
42 days after delivery
Time Frame
postpartum
Secondary Outcome Measure Information:
Title
hospital stay duration
Time Frame
postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Katz, pHD
Organizational Affiliation
IMIP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Materno Infantil Prof. Fernando Figueira
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50.070-550
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23697398
Citation
Katz L, Amorim M, Souza JP, Haddad SM, Cecatti JG; COHELLP Study Group. COHELLP: collaborative randomized controlled trial on corticosteroids in HELLP syndrome. Reprod Health. 2013 May 22;10:28. doi: 10.1186/1742-4755-10-28.
Results Reference
derived

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Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome

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