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

June 4, 2019 updated by: Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50.070-550
        • Instituto Materno Infantil Prof. Fernando Figueira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: dexamethasone
dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours
ACTIVE_COMPARATOR: Dexamethasone
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
hospital stay duration
Time Frame: postpartum
postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Investigators

  • Principal Investigator: Leila Katz, pHD, IMIP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (ESTIMATE)

July 9, 2008

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMIFernando Figueira

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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