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IRCT20231015059721N1 IRCT 2023-10-22 Clinical Research Development Unit of Imam Khomeini Medical Education Center (RA) Changes of betamethasone on non-stress test (NST) and Doppler ultrasound parameters in fetuses with growth restriction The cheanges of betamethasone on non-stress test (NST) and Doppler ultrasound parameters in fetuses with Intra uterine growth retardation in pregnant women referred to Imam Khomeini Hospital in Sari 2023-10-22 anticipated 50 Complete https://irct.ir/trial/73184 observational Randomization: N/A, Blinding: Triple blinded, Placebo: Not used, Assignment: Other, Purpose: Diagnostic, Blinding description: All people including researchers, participants, outcome assessors and analysts will be blinded in this study.Only the clinical caregiver will be aware of the study process due to the protection of the patients (the clinical caregiver is the nurse, midwife or doctor of the patients who are not part of the research team, but are aware of the study process). 1 In fetuses with growth restriction in pregnant women referred to Imam Khomeini Hospital in Sari. Intervention group: Betamethasone receiving group. Yes - There is a plan to make this available What will be shared: Data collection is done at Imam Khomeini (RA) Hospital in Sari. After data collection, it will be provided to the Research Center and Research Development Unit of Mazandaran University of Medical Sciences as research documentation. When: At least three months after the start of sampling To whom: Mazandaran University of Medical Sciences, Research Center of Mazandaran University of Medical Sciences, Research Development Unit of Mazandaran University of Medical Sciences and Iran Clinical Trial Center Conditions: To inquire about the accuracy of the sampling process, only to the centers covered by the Ethics Committee of Mazandaran University and the Clinical Trial Center of Iran. Where to obtain: Scientific responsible person of the project, Mazandaran University of Medical Sciences, Research Center of Mazandaran University of Medical Sciences, Research Development Unit of Mazandaran University of Medical Sciences How to obtain: Correspondence with Mazandaran University of Medical Sciences, Research Center of Mazandaran University of Medical Sciences, Research Development Unit of Mazandaran University of Medical Sciences Comments:
public Zahra Rahmani
Mazandaran, Sari, Razi St., Imam Khomeini Educational and Medical Center (RA) Sari
sari Iran (Islamic Republic of) ۳۳۹۷۱-۴۸۱۵۷ +98 11 3304 4000 refah@mazums.ac.ir Mazandaran University of Medical Sciences scientific Zahra Rahmani
Mazandaran, Sari, Razi St., Imam Khomeini Educational and Medical Center (RA) Sari
sari Iran (Islamic Republic of) ۳۳۹۷۱-۴۸۱۵۷ +98 11 3304 4000 refah@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) 1- Singleton pregnancy 2- Gestational age of 28 to 32 weeks and threat of preterm delivery 3- Fetal growth restriction confirmed by ultrasound based on fetal growth percentage 14 years 55 years Female 1- Arrhythmia or fetal heart problems 2- Congenital anomaly of the fetus 3- Symptoms of active infection of the mother 4- Premature rupture of the amniotic sac (PPROM) 5-Pregnant women receiving benzodiazepines and narcotics 6- Women who give birth during the study 7- Mother's underlying diseases (hypertension, diabetes Z35.2 Z35.2 Treatment - Drugs Intervention group: Betamethasone receiving group Determination of Doppler ultrasound parameters of the umbilical artery and MCA, determination of the basic fetal heart rate and beat-to-beat variability of the fetal heart rate and the increase or decrease of the fetal heart rate. Timepoint: First, a non-stress test of NST for 20 minutes and Doppler of the umbilical MCA artery were performed for the patient, then 2 doses of betamethasone ampoule (12 mg) were injected into the patient at an interval of 24 hours. After 12 hours (day 1), 24 hours (day 2) and 36 hours (day 2), NST is performed again for 20 minutes. Time range of Doppler ultrasound (24 to 36 hours) after receiving two doses of betamethasone. Method of measurement: Demographic and clinical characteristics questionnaire, non-stress test before and 12, 24 and 36 hours after the injection of two doses of betamethasone and doppler ultrasound 24 to 36 hours after the injection of the first dose of betamethasone. Clinical Research Development Unit of Imam Khomeini Medical Education Center (RA) Approved 2022-09-27 Mazandaran University of Medical Sciences Research Center Sari, Ayatollah Taleghani, Moalem Street, Moalem Square sari Mazandaran Iran (Islamic Republic of)