NCT06312852|Unknown
Impact of Antenatal Steroids on Coagulation.
Antenatal Steroids Before Elective Caesarean Section : Impact on Coagulation, Fibrinolytic System, and Other Haematological Parameters.
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Antenatal Steroids Before Elective Caesarean Section : Impact on Coagulation, Fibrinolytic System, and Other Haematological Parameters.
Sponsor study identifier
observational
45
0 countries
N/A
Study Start
April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 5, 2024
Actual (reported)March 15, 2024
Actual (reported)April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Baseline
Follow up for cases on corticosteroid therapy
Day 4
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 ).
Obstetric Care Consensus No. 4: Periviable Birth. Obstet Gynecol. 2016 Jun;127(6):e157-e169. doi: 10.1097/AOG.0000000000001483.
Carlo 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.
First Submitted
March 5, 2024
First Posted
March 15, 2024
Study Start
April 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
Chawla 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.
American 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.
American 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.
Kamstrup 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.
April 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 15, 2024
Record last verified: 2024-03
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