]>
IRCT20230801059003N1 IRCT 2023-08-16 Tehran University of Medical Sciences Efficacy of melatonin in fetal pulmonary artery doppler index and a role of this parameters in prevention of neonatal respiratory distress syndrome in preterm neonates with maternal abnormal implantation placenta Efficacy of melatonin in fetal pulmonary artery doppler index and a role of this parameters in prevention of neonatal respiratory distress syndrome in preterm neonates with maternal abnormal implantation placenta 2023-09-21 anticipated 64 Complete https://irct.ir/trial/71797 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked randomization method will be used for randomly assigning the intervention and control groups. The number of blocks will be four and will be in the form of code a and b. 3 Condition 1: Preterm neonates. Condition 2: Infant respiratory distress. Intervention 1: Intervention group: 19 to 45-year-old singleton pregnant women without fetal anomalies with a gestational age of 32-34 weeks with placental disorders (ecreta, increta, percreta, previa) without any other underlying disease will be included in the study. Melatonin tablets of 10 mg (2 tablets of 5 mg) are given daily before going to bed for a period of 2 weeks. The sample number is 64 people, of which 32 people are in this group (melatonin consumption group). Doppler examination of the pulmonary artery by measuring AT/ET in ultrasound is done before the start of melatonin treatment once and again the day before delivery, and the baby is evaluated after birth, and the results of the Doppler indices are compared with the condition of the baby in two groups. Intervention 2: Control group: Control group: 19-45-year-old singleton pregnant women without fetal anomalies with a gestational age of 32-34 weeks with placental disorders (ecreta, increta, precreta, previa) without any other underlying disease will be included in the study. This group will not be treated with melatonin tablets, and there are 32 people in this group (group without melatonin). Pulmonary artery doppler examination by measuring ET (ejection time) AT (acceleration time) AT/ET is performed in ultrasound once a day before delivery and the baby is evaluated after birth and the results of pulmonary artery doppler indices are compared with the condition of the baby after birth. will be. No - There is not a plan to make this available Justification or reason for not sharing IPD is Intellectual Property/Confidentiality Issues/Ethical Concerns
public Bahar Farshidfar
Keshavarz Blvd., corner of Qods
Tehran Iran (Islamic Republic of) 1416633591 0098218895586 farshidfarbahar@gmail.com Tehran University of Medical Sciences scientific Bahar Farshidfar
Keshavarz Blvd., corner of Qods
Tehran Iran (Islamic Republic of) 1416633591 0098218895586 farshidfarbahar@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Singleton pregnant women with gestational age of 32-34 weeks with placental disorders (acreta, increta, percreta, previa) 19 years 45 years Female Fetal anomaly Mother's underlying disease O60.3 P22.8 Preterm delivery by: caesarean section, without spontaneous labour Other respiratory distress of newborn Prevention N/A Intervention group: 19 to 45-year-old singleton pregnant women without fetal anomalies with a gestational age of 32-34 weeks with placental disorders (ecreta, increta, percreta, previa) without any other underlying disease will be included in the study. Melatonin tablets of 10 mg (2 tablets of 5 mg) are given daily before going to bed for a period of 2 weeks. The sample number is 64 people, of which 32 people are in this group (melatonin consumption group). Doppler examination of the pulmonary artery by measuring AT/ET in ultrasound is done before the start of melatonin treatment once and again the day before delivery, and the baby is evaluated after birth, and the results of the Doppler indices are compared with the condition of the baby in two groups. Control group: Control group: 19-45-year-old singleton pregnant women without fetal anomalies with a gestational age of 32-34 weeks with placental disorders (ecreta, increta, precreta, previa) without any other underlying disease will be included in the study. This group will not be treated with melatonin tablets, and there are 32 people in this group (group without melatonin). Pulmonary artery doppler examination by measuring ET (ejection time) AT (acceleration time) AT/ET is performed in ultrasound once a day before delivery and the baby is evaluated after birth and the results of pulmonary artery doppler indices are compared with the condition of the baby after birth. will be Pulmonary artery Doppler of the fetus. Timepoint: 2 weeks. Method of measurement: Philips ultrasound. Apgar minutes 1 and 5. Timepoint: Day 1, birthday, minutes 1 and 5. Method of measurement: clinical. The degree of respiratory distress of the infant. Timepoint: day 1 birthday. Method of measurement: clinical. Middle cerebral artery Doppler. Timepoint: 2 weeks. Method of measurement: Philips ultrasound. Doppler of the umbilical artery. Timepoint: 2 weeks. Method of measurement: Philips ultrasound. Uterine artery doppler. Timepoint: 2 weeks. Method of measurement: Philips ultrasound. Neonatal resuscitation. Timepoint: First day after birth. Method of measurement: clinical. Tehran University of Medical Sciences Approved 2023-07-19 Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences Tehran University of Medical Sciences Headquarters, Qods Corner, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)