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临床试验/NCT02978976
NCT02978976Unknown4 期

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

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
126
试验地点
1
主要终点
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)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
28 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • hypertensive
  • 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).

研究组 & 干预措施

betamethasone

Experimental

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.

干预措施: Betamethasone (Drug)

Saline

Placebo Comparator

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.

干预措施: saline (Drug)

结局指标

主要结局

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)

时间窗: 1 week

次要结局

  • Presense of respiratory disorders in neonate (yes/no)(8 days)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed M.Kamel

Lecturer of Obstetrtics & gynecology

Kasr El Aini Hospital

研究点 (1)

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