HELLP SyndromePhase 4COHELLPNCT00711841
Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome
A Phase 4 study testing dexamethasone in people with HELLP Syndrome, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 49 years, women only
- Conditions the study is for
- HELLP Syndrome
- What is being tested?
- dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Postpartum women with Class I HELLP syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, 50.070-550
About this study
Official title: 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.
Read the 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.
- Conditions
- HELLP Syndrome
- Being tested
- dexamethasone, Placebo
- Keywords
- HELLP syndrome, dexamethasone, postpartum period, class I HELLP syndrome
- Medical subject headings
- HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasoneDrug
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
PlaceboDrug
Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
dexamethasoneDrug
dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| saline solution | Placebo comparator | Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours Receives: Drug: dexamethasone; Drug: Placebo |
| Dexamethasone | Active comparator | Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours Receives: Drug: dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
severe maternal morbidity
42 days after delivery
Measured: postpartum
Secondary outcomes (1)
hospital stay duration
Measured: postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2011
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: The speed of recruitment was slower than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HELLP SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Leila Katz, pHD, Principal investigator, IMIP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711841
- Sponsor's protocol ID
- IMIFernando Figueira
- Acronym
- COHELLP
- Status last verified
- Jun 2019
- First submitted
- 7 Jul 2008
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23697398
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00711841
- Acronym / sponsor ID
- COHELLP / IMIFernando Figueira
- Conditions
- HELLP Syndrome
- Keywords
- HELLP syndrome, dexamethasone, postpartum period, class I HELLP syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The speed of recruitment was slower than anticipated.
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline solution | Placebo comparator | Drug: dexamethasone, Drug: PlaceboPlacebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours |
| Dexamethasone | Active comparator | Drug: dexamethasoneDexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours |
Who may qualify
- Ages
- 13 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Postpartum women with Class I HELLP syndrome
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasoneDexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours | Drug | saline solution |
| PlaceboSaline solution, 2 mL, intravenous, every 12 hours, for 48 hours | Drug | saline solution |
| dexamethasonedexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours | Drug | Dexamethasone |
Primary outcome
severe maternal morbidity
Time frame: postpartum
42 days after delivery
1 secondary outcome
hospital stay duration
Time frame: postpartum
Results and safety
The study was stopped early (reason given: The speed of recruitment was slower than anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 23697398Katz 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.
Related trials for HELLP Syndrome
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
RecruitingObservational study
PROTECT-Africa: Biomarker Validation for Preeclampsia Triage
Hypertension, Pregnancy-Induced, HELLP Syndrome
Not yet recruitingPhase 4
Vitamin D Supplementation Among Pregnant Women in Uganda for the Prevention of Hypertensive Disorders in Pregnancy, and Other Adverse Maternal and Foetal Outcomes
Preeclampsia, Eclampsia
Not yet recruitingObservational study
Study of Prognostic Values of Platelet Indices and Inflammatory Markers in Patients With HELLP Syndrome.
HELLP Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leila Katz, pHD principal investigator
IMIP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone in people with HELLP Syndrome, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The speed of recruitment was slower than anticipated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severe maternal morbidity (time frame: postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.