Corticosteroids Adverse ReactionNCT06312852
Impact of Antenatal Steroids on Coagulation.
An observational study of Corticosteroids Adverse Reaction, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Corticosteroids Adverse Reaction
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to May 2025
- Phase
- Observational
- 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 15 to 45 years
- Women only
- Child, Adult
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 ).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Corticosteroids Adverse Reaction
- Keywords
- steroid, antenatal, coagulation, fibrinolytic system, haematological parameters, hematological parameters, corticosteroid, hematological, haematological, elective, caesarean, cesarean, Fibrinolysis, Hemostasis, Plasminogen
- Medical subject headings
- Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal corticosteroids impact on Coagulopathy
Detection of the presence or absence of any effect of antenatal corticosteroid administration on coagulopathy, fibrinolysis, and other haematological markers.
Measured: Baseline
Secondary outcomes (1)
Follow up for cases on corticosteroid therapy
Determine a good, feasible marker to use for follow up on cases under corticosteroid therapy.
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Corticosteroids Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed Mohamed Aly Ahmed Nasr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312852
- Sponsor's protocol ID
- Antenatal steroids & clotting
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Obstetric Care Consensus No. 4: Periviable Birth. Obstet Gynecol. 2016 Jun;127(6):e157-e169. doi: 10.1097/AOG.0000000000001483.
PubMed 27214190Carlo WA, McDonald SA, Fanaroff AA, Vohr BR, Stoll BJ, Ehrenkranz RA, Andrews WW, Wallace D, Das A, Bell EF, Walsh MC, Laptook AR, Shankaran S, Poindexter BB, Hale EC, Newman NS, Davis AS, Schibler K, Kennedy KA, Sanchez PJ, Van Meurs KP, Goldberg RN, Watterberg KL, Faix RG, Frantz ID 3rd, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association of antenatal corticosteroids with mortality and neurodevelopmental outcomes among infants born at 22 to 25 weeks' gestation. JAMA. 2011 Dec 7;306(21):2348-58. doi: 10.1001/jama.2011.1752.
PubMed 22147379Chawla S, Bapat R, Pappas A, Bara R, Zidan M, Natarajan G. Neurodevelopmental outcome of extremely premature infants exposed to incomplete, no or complete antenatal steroids. J Matern Fetal Neonatal Med. 2013 Oct;26(15):1542-7. doi: 10.3109/14767058.2013.791273. Epub 2013 May 7.
PubMed 23565886American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 172: Premature Rupture of Membranes. Obstet Gynecol. 2016 Oct;128(4):e165-77. doi: 10.1097/AOG.0000000000001712.
PubMed 27661655American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711.
PubMed 27661654Kamstrup P, Rastoder E, Hellmann PH, Sivapalan P, Larsen EL, Vestbo J, Ulrik CS, Goetze JP, Knop FK, Jensen JUS. Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men-A Randomised Placebo-Controlled Trial. Biomedicines. 2023 Jul 21;11(7):2052. doi: 10.3390/biomedicines11072052.
PubMed 37509691
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal Steroids Before Elective Caesarean Section : Impact on Coagulation, Fibrinolytic System, and Other Haematological Parameters.
- ClinicalTrials.gov ID
- NCT06312852
- Acronym / sponsor ID
- Antenatal steroids & clotting
- Conditions
- Corticosteroids Adverse Reaction
- Keywords
- steroid, antenatal, coagulation, fibrinolytic system, haematological parameters, hematological parameters, corticosteroid, hematological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
- 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 ).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Follow up for cases on corticosteroid therapy
Time frame: Day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 27214190Obstetric Care Consensus No. 4: Periviable Birth. Obstet Gynecol. 2016 Jun;127(6):e157-e169. doi: 10.1097/AOG.0000000000001483.
- Background: PubMed 22147379Carlo WA, McDonald SA, Fanaroff AA, Vohr BR, Stoll BJ, Ehrenkranz RA, Andrews WW, Wallace D, Das A, Bell EF, Walsh MC, Laptook AR, Shankaran S, Poindexter BB, Hale EC, Newman NS, Davis AS, Schibler K, Kennedy KA, Sanchez PJ, Van Meurs KP, Goldberg RN, Watterberg KL, Faix RG, Frantz ID 3rd, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Association of antenatal corticosteroids with mortality and neurodevelopmental outcomes among infants born at 22 to 25 weeks' gestation. JAMA. 2011 Dec 7;306(21):2348-58. doi: 10.1001/jama.2011.1752.
- Background: PubMed 23565886Chawla S, Bapat R, Pappas A, Bara R, Zidan M, Natarajan G. Neurodevelopmental outcome of extremely premature infants exposed to incomplete, no or complete antenatal steroids. J Matern Fetal Neonatal Med. 2013 Oct;26(15):1542-7. doi: 10.3109/14767058.2013.791273. Epub 2013 May 7.
- Background: PubMed 27661655American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 172: Premature Rupture of Membranes. Obstet Gynecol. 2016 Oct;128(4):e165-77. doi: 10.1097/AOG.0000000000001712.
- Background: PubMed 27661654American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711.
- Background: PubMed 37509691Kamstrup P, Rastoder E, Hellmann PH, Sivapalan P, Larsen EL, Vestbo J, Ulrik CS, Goetze JP, Knop FK, Jensen JUS. Effect of 10-Day Treatment with 50 mg Prednisolone Once-Daily on Haemostasis in Healthy Men-A Randomised Placebo-Controlled Trial. Biomedicines. 2023 Jul 21;11(7):2052. doi: 10.3390/biomedicines11072052.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Corticosteroids Adverse Reaction, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Ahmed Nasr, MBBCh (+201116210831, saranasr_97@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antenatal corticosteroids impact on Coagulopathy (time frame: Baseline). 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 NCT06312852, which also lists 6 linked publications.
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 15 Mar 2024.