| July 7, 2008 |
| August 25, 2009 |
| December 2009 |
| January 2011 (final data collection date for primary outcome measure) |
| severe maternal morbidity [ Time Frame: postpartum ] [ Designated as safety issue: No ] |
- hospital stay [ Time Frame: postpartum behaviour ] [ Designated as safety issue: Yes ]
- platelet count [ Time Frame: postpartum behaviour ] [ Designated as safety issue: Yes ]
|
| Complete list of historical versions of study NCT00711841 on ClinicalTrials.gov Archive Site |
| hospital stay duration [ Time Frame: postpartum ] [ Designated as safety issue: No ] |
| complications [ Time Frame: postpartum ] [ Designated as safety issue: Yes ] |
| |
| Efficacy 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 |
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. |
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. |
| Phase IV |
| Interventional |
| Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| HELLP Syndrome |
- 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
- Drug: dexamethasone
dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours
|
- saline solution: Placebo Comparator
Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours
Interventions:
- Drug: dexamethasone
- Drug: Placebo
- Dexamethasone: Active Comparator
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Intervention: Drug: dexamethasone
|
| |
| |
| Not yet recruiting |
| 150 |
| March 2011 |
| January 2011 (final data collection date for primary outcome measure) |
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
|
| Female |
| 13 Years to 49 Years |
| No |
|
|
| Brazil |
| |
| NCT00711841 |
| Leila Katz, IMIFernando Figueira |
| IMIFernando Figueira |
| Instituto Materno Infantil Prof. Fernando Figueira |
|
| Principal Investigator: |
Leila Katz, pHD |
IMIP |
|
|
| Instituto Materno Infantil Prof. Fernando Figueira |
| August 2009 |
