NCT06312852

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 5, 2024

Last Update Submit

March 9, 2024

Conditions

Corticosteroids Adverse Reaction

Keywords

steroidantenatalcoagulationfibrinolytic systemhaematological parametershematological parameterscorticosteroidhematologicalhaematologicalelectivecaesareancesareanFibrinolysisHemostasisPlasminogen

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Follow up for cases on corticosteroid therapy

    Day 4

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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 ).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Obstetric Care Consensus No. 4: Periviable Birth. Obstet Gynecol. 2016 Jun;127(6):e157-e169. doi: 10.1097/AOG.0000000000001483.

    PMID: 27214190BACKGROUND

  • 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.

    PMID: 22147379BACKGROUND

  • 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.

    PMID: 23565886BACKGROUND

  • 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.

    PMID: 27661655BACKGROUND

  • 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.

    PMID: 27661654BACKGROUND

  • 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.

    PMID: 37509691BACKGROUND

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Sara Ahmed Nasr, MBBCh

CONTACT

+201116210831saranasr_97@yahoo.com

Eman Nasr Eldin, Prof

CONTACT

+20100267890emannasr2000@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Clinical pathology department, Faculty of Medicine, Assiut University, Egypt

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 15, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03