Impact of Antenatal Steroids on Coagulation.

March 9, 2024 updated by: Sara Ahmed Mohamed Aly Ahmed Nasr, Assiut University

Antenatal Steroids Before Elective Caesarean Section : Impact on Coagulation, Fibrinolytic System, and Other Haematological Parameters.

Aim of the research :

1- Detection of the presence or absence of any effect of antenatal corticosteroid administration on coagulopathy, fibrinolysis, and other haematological markers.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Corticosteroid administration before anticipated preterm birth is one of the most important antenatal therapies available to improve newborn outcomes. A single course of corticosteroids is recommended for pregnant women between 28 weeks and 40 weeks of gestation who are at risk of preterm delivery within 7 days, including for those with ruptured membranes and multiple gestations (1). The administration of antenatal corticosteroids to women who, at risk of imminent preterm birth, is strongly associated with decreased neonatal morbidity and mortality (2). Neonates whose mothers received antenatal corticosteroids have significantly lower severity, frequency, or both, of respiratory distress syndrome, intracranial haemorrhage, necrotizing enterocolitis, and death, compared with neonates whose mothers did not receive antenatal corticosteroids, Betamethasone and dexamethasone are the most widely studied corticosteroids, and they generally have been preferred for antenatal treatment to accelerate foetal organ maturation (3). Both cross the placenta in their active form and have nearly identical biologic activity. Both lack mineralocorticoid activity and have relatively weak immunosuppressive activity with short-term use (4).

Increased levels of haemostatic factors, including factor VII, factor VIII, factor XI, fibrinogen, soluble CD40 ligand, and von Willebrand Factor VWF have been associated with venous and arterial thrombotic events. Similarly, impaired thrombolysis, reflected by an increase in Plasminogen activator inhibitor-1 PAI-1 levels, has been associated with adverse cardiovascular events. Although there are no previous in vivo studies in humans demonstrating that glucocorticoids directly affect haemostasis, there is in vitro and epidemiologic evidence of this phenomenon (5). In cultured human and animal cell lines, glucocorticoids increase production of von Willebrand Factor (VWF), endothelin, and PAI-1. Two studies have demonstrated dexamethasone-mediated increases in PAI-1 in cultured human adipose tissue. In patients with Cushing syndrome, elevated levels of VWF, PAI-1, thrombin-antithrombin and plasmin-antiplasmin complexes and factor VIII may resolve after curative surgical treatment. Similarly, altered levels of haemostatic factors have been reported in patients receiving exogenous glucocorticoids. The potential impact of glucocorticoids on thrombosis is clinically relevant (6). Therefore, we sought to determine the effects of antenatal glucocorticoid administration on haemostatic factors in pregnant females.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Child
  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with gestational age between 28-40 weeks ( third trimester ) who will be offered antenatal steroids ( test subjects ) versus gestational-age matched controls who will not be on steroids ( controls ).

Description

Inclusion Criteria:

  • Pregnant women with gestational age between 28-40 weeks ( third trimester ) who will be offered antenatal steroids versus gestational-age matched controls who will not be on steroids.

Exclusion Criteria:

  • Pregnant women with gestational age < 28 weeks (First trimester & Second trimester).
  • Women in labour.
  • Pregnant women receiving blood transfusions or on any drugs that might counteract the effect of Antenatal corticosteroids, or any drug that may have an effect on coagulation or fibrinolysis.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antenatal corticosteroids impact on Coagulopathy
Time Frame: Baseline
Detection of the presence or absence of any effect of antenatal corticosteroid administration on coagulopathy, fibrinolysis, and other haematological markers.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow up for cases on corticosteroid therapy
Time Frame: Day 4
Determine a good, feasible marker to use for follow up on cases under corticosteroid therapy.
Day 4

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 9, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 9, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Antenatal steroids & clotting

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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