Effect of Antenatal Steroid on Pulmonary Artery Blood Flow
NCT ID: NCT02978976
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
126 participants
INTERVENTIONAL
2017-01-31
2018-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients included in the study will be 20-38 years of age, have an indication for elective caesarean section. Patients will be excluded if they are hypertensive, diabetic or have any disorder that may be aggravated by administration of steroids, women with systemic infection including tuberculosis or sepsis, any fetal congenital anomalies (affecting the fetal heart, lungs, and circulation), history of rupture membranes, or suspected chorioamnionitis, intrauterine growth retardation (IUGR), and intrauterine fetal demise (IUFD).
Patients will be randomized on 37 weeks and 6 days gestation by the nurse attending the clinic using a computer generated randomization table, and a closed envelope system will be used. Patients will be equally divided into two groups. Patients in group (A) will receive two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA) intramuscularly (IM) 24 hours apart, while group (B) patients will receive a saline placebo injection in the same regimen.
Ultrasound examination will be done where all patients will lie down in a semi-recumbent position, and the ultrasound will be performed by an expert ultrasonographer, with expert training in fetal echocardiography. The ultrasound specialist will be blinded to which study arm the patients belongs. The abdominal probe of the ultrasound machine (voluson730; kretz,Zipf,Austria) will be placed so that the fetal chest will be in a transverse section, giving us the four chamber view of the fetal heart. The color Doppler will then be switched on, and the fetal pulmonary artery will be identified. The measurements will be taken from the middle segment of the pulmonary artery just after the first bifurcation of the pulmonary branch (just after crossing the aortic arch). We will obtain our measurements from either the right or left pulmonary arteries, whichever is easier according to fetal position, as there is no difference between the values obtained from either according to the work done by Rasanen et al.
The pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug (betamethasone / placebo), 24 hours after the last dose, and on the day of elective Cs. Caesarean section will be performed 7 days after the last dose of betamethasone, and a senior neonatologist will attend the birth, document Apgar score, and any neonatal respiratory distress.
A sample size was calculated where the difference in the mean pulsatility index (PI) before and after administration of antenatal steroids for the middle segment of the fetal pulmonary artery was 0.42 in a previous study by Bartha et al, and the standard deviation was set as 0.79. The Type I error probability was set at 0.05, and the power at 80%. This gave us 57 patients in each arm, and allowing for dropout rate of 10%, 63 patients will be recruited in each arm of the study, as the ratio between both study and control was 1:1. PS Power and Sample size Calculations software, Versionv2.1.30 for MS Windows, was used to calculate sample size Dupont and Vanderbilt, USA).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
betamethasone
will receive two doses of 12mg betamethasone, then the pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug (betamethasone), 24 hours after the last dose, and on the day of elective Cs.
Betamethasone
will receive two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA) intramuscularly (IM) 24 hours apart.
Saline
will receive saline injection placebo, then the pulsatility index (PI), resistance index (RI), systolic/diastolic ratio (SD), and the acceleration-time/ejection-time ratio (At/Et) will be determined in all cases after recruitment, just before the administration of the drug ( placebo), 24 hours after the last dose, and on the day of elective Cs.
saline
saline placebo injection in the same regimen.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Betamethasone
will receive two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA) intramuscularly (IM) 24 hours apart.
saline
saline placebo injection in the same regimen.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 37weeks +6days
Exclusion Criteria
* diabetic
* any disorder that may be aggravated by administration of steroids
* women with systemic infection including tuberculosis or sepsis
* any fetal congenital anomalies (affecting the fetal heart, lungs, and circulation)
* history of rupture membranes, or suspected chorioamnionitis
* intrauterine growth retardation (IUGR)
* intrauterine fetal demise (IUFD).
28 Years
38 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kasr El Aini Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ahmed M.Kamel
Lecturer of Obstetrtics & gynecology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed Kamel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lecturer Of obstetrics and gynecology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
11562
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ahmed M KameL, M.D
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Bartha JL, Largo-Heinrich M, Machado MJ, Gonzalez-Bugatto F, Hervias-Vivancos B. Effects of antenatal betamethasone on human fetal branch pulmonary artery flow velocity waveforms. Fetal Diagn Ther. 2008;23(1):46-53. doi: 10.1159/000109226. Epub 2007 Oct 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A22102016
Identifier Type: -
Identifier Source: org_study_id