Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00711841
Other study ID # IMIFernando Figueira
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date July 2011
Est. completion date June 2019

Study information

Verified date June 2019
Source Instituto Materno Infantil Prof. Fernando Figueira
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 400
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender Female
Age group 13 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
dexamethasone
Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours
Placebo
Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
dexamethasone
dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours

Locations

Country Name City State
Brazil Instituto Materno Infantil Prof. Fernando Figueira Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary severe maternal morbidity 42 days after delivery postpartum
Secondary hospital stay duration postpartum
See also
  Status Clinical Trial Phase
Recruiting NCT03605511 - TTP and aHUS in Complicated Pregnancies
Completed NCT02911701 - Effect of Acetaminophen on Postpartum Blood Pressure Control in Preeclampsia With Severe Features Phase 4
Recruiting NCT02247297 - Pancreatic Stone Protein (PSP) in Pregnant Women
Terminated NCT04725812 - Complement Regulation to Undo Systemic Harm in Preeclampsia Phase 2
Recruiting NCT02020174 - The Preeclampsia Registry
Recruiting NCT06377878 - The Preeclampsia Registry
Recruiting NCT02920593 - A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy Phase 4
Recruiting NCT01138839 - Dexamethasone Efficacy in HELLP I Syndrome Phase 3
Recruiting NCT05500989 - PlacEntal Acute Atherosis RefLecting Subclinical Atherosclerosis
Completed NCT04216706 - Early Vascular Adjustments to Prevent Preeclampsia
Recruiting NCT03834285 - Liver Disease in Pregnancy
Completed NCT00000534 - Calcium for Pre-Eclampsia Prevention (CPEP) Phase 3
Recruiting NCT02807324 - Women Specific Cardiac Recovery After Preeclampsia
Completed NCT01736826 - Free DNA and Nucleosome Concentrations in Pathological Pregnancies
Completed NCT00097110 - RCT of Antioxidant Therapy to Prevent Preeclampsia in Brazil Phase 3
Completed NCT03715647 - Correlation of Survival in Puerperae by Electrical Impedance Tomography
Completed NCT03455387 - Evaluation of the Serum Markers sFLt1 and PlGF for the Prediction of the Complications of the Placental Vascular Pathologies in the 3rd Quarter of the Pregnancy.
Completed NCT03246542 - Promising Bimarker Prediction of Outcome of HELLP Syndrome. N/A
Completed NCT03232359 - Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome N/A
Not yet recruiting NCT06452498 - Preeclampsia Intervention Netherlands Phase 3