ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Antenatal Steroid on Pulmonary Artery Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02978976
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed M.Kamel, Kasr El Aini Hospital

Brief Summary:
The aim of this study is to determine the effect of administering antenatal steroids in term fetuses on the blood flow in the fetal pulmonary artery, and to correlate these findings with clinical data obtained after birth documenting respiratory disorders.

Condition or disease Intervention/treatment Phase
Neonatal Respiratory Distress Drug: Betamethasone Drug: saline Phase 4

Detailed Description:

After internal review board approval, 126 consecutive patients attending the antenatal care clinic of Kasr Alainy Hospital, part of Cairo university hospitals will be recruited in this study. All patients will sign informed consent.

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Maternal Antenatal Steroid Administration on the Blood Flow Through the Pulmonary Artery in the Term Fetus; a Randomized Control Double Blinded Study
Actual Study Start Date : January 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018


Arm Intervention/treatment
Experimental: 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.
Drug: Betamethasone
will receive two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA) intramuscularly (IM) 24 hours apart.
Other Name: Dipropfos

Placebo Comparator: 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.
Drug: saline
saline placebo injection in the same regimen.
Other Name: NaCl 0.9




Primary Outcome Measures :
  1. changes in the mean doppler parameters between the study groups before and after the drug administration ( compare means of doppler reading between both groups using t-test) [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Presense of respiratory disorders in neonate (yes/no) [ Time Frame: 8 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   28 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • indication for elective caesarean section.
  • 37weeks +6days

Exclusion Criteria:

  • hypertensive
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978976


Contacts
Contact: Ahmed M Kamel, M.D. 00201120022332 dr.ahmed.m.kamel@gmail.com
Contact: Emad Salah, M.D. emadsalah148@gmail.com

Locations
Egypt
11562 Recruiting
Cairo, Egypt, 11562
Contact: Ahmed M KameL, M.D    01120022332    dr.ahmed.m.kamel@gmail.com   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
Principal Investigator: Ahmed Kamel, M.D. Lecturer Of obstetrics and gynecology

Publications:
Responsible Party: Ahmed M.Kamel, Lecturer of Obstetrtics & gynecology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02978976     History of Changes
Other Study ID Numbers: A22102016
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: yes

Keywords provided by Ahmed M.Kamel, Kasr El Aini Hospital:
RDS
Doppler on fetal pulmonary artery

Additional relevant MeSH terms:
Infant, Premature, Diseases
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Newborn, Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents