Study Stopped
The speed of recruitment was slower than anticipated.
Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome
COHELLP
Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2008
CompletedFirst Posted
Study publicly available on registry
July 9, 2008
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedJune 6, 2019
June 1, 2019
7.9 years
July 7, 2008
June 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
severe maternal morbidity
42 days after delivery
postpartum
Secondary Outcomes (1)
hospital stay duration
postpartum
Study Arms (2)
saline solution
PLACEBO COMPARATORPlacebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
Dexamethasone
ACTIVE COMPARATORDexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Interventions
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Eligibility Criteria
You may qualify if:
- Postpartum women with Class I HELLP syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, 50.070-550, Brazil
Related Publications (1)
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.
PMID: 23697398DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leila Katz, pHD
IMIP
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Obstetrical ICU obstetrical coordinator; MD , PhD
Study Record Dates
First Submitted
July 7, 2008
First Posted
July 9, 2008
Study Start
July 1, 2011
Primary Completion
June 1, 2019
Study Completion
June 1, 2019
Last Updated
June 6, 2019
Record last verified: 2019-06