Effectivity of Postpartum Dexamethasone for Women With Cl... | NCT00711841

Studies
Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome

NCT00711841

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Status

Terminated

Last Update Posted

Jun 6, 2019Actual

Enrollment

400Estimated

Phase

Phase 4

Conditions

HELLP Syndrome

Interventions

dexamethasone
Placebo
dexamethasone

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The speed of recruitment was slower than anticipated.

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jun 2019Actual

Completion Date

Jun 2019Actual

First Submitted Date

Jul 7, 2008

First Submission Date that Met QC Criteria

Jul 7, 2008

First Posted Date

Jul 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2019

Last Update Posted Date

Jun 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leila Katz, Obstetrical ICU obstetrical coordinator; MD , PhD, Instituto Materno Infantil Prof. Fernando FigueiraPrincipal Investigator

Lead Sponsor

Instituto Materno Infantil Prof. Fernando FigueiraOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
saline solution	Placebo Comparator	Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours	Drug: dexamethasone Drug: Placebo
Dexamethasone	Active Comparator	Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours	Drug: dexamethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dexamethasone	Drug	Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours	saline solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
severe maternal morbidity	42 days after delivery	postpartum

Secondary Outcomes

Measure	Description	Time Frame
hospital stay duration		postpartum

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

49 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leila Katz, pHD	IMIP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Materno Infantil Prof. Fernando Figueira		Recife	Pernambuco	50.070-550	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23697398	Derived	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.

ID	Term
D046110	Hypertension, Pregnancy-Induced
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids