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IRCT20170515033976N3 IRCT 2026-03-14 Shiraz University of Medical Sciences The Efficacy of Melatonin in Intrauterine Growth Restriction The Efficacy of Melatonin in Intrauterine Growth Restriction, A Double blind Randomized Clinical Trial 2026-04-04 anticipated 66 Recruiting https://irct.ir/trial/89093 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 46 blocks; Hiding method: Use similar bottles, Blinding description: The tablets of both groups are in packets with the same shape, color, size, and other characteristics, and the patients are randomly assigned to one of the placebo or Melatonin groups, and intake continues at the same dose until the end of pregnancy. In group A, patients are prescribed Melatonin tablets manufactured by Abidi Pharmaceutical Company and for group B three placebo tablets (placebo tablets will be manufactured by the Faculty of Pharmacy, Shiraz University of Medical Sciences). 3 Intrauterine Growth Restriction (IUGR) / Fetal Growth Restriction (FGR). Intervention 1: Intervention group: Oral prolonged-release melatonin tablets, 10 mg, three times daily, from enrolment until delivery. Manufacturer: Abidi Pharmaceutical Company, Iran. Intervention 2: Control group: Oral placebo tablets identical in appearance (shape, color, size), three times daily, from enrolment until delivery. Manufacturer: Faculty of Pharmacy, Shiraz University of Medical Sciences, Iran. Yes - There is a plan to make this available What will be shared: Information and research data Ethic form: Complete the ٍEthic form by the patient When: IPD: 2025, Ethic form: 2026 To whom: IPD: Researcher & Patient Ethic form: Patient Conditions: IPD: Ethic form: Awareness of test results Where to obtain: IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences How to obtain: IPD: Vice chancellery Ethic form: Vice chancellery Comments:
public Elham Gorjipour
Maternal- Fetal Medicine (Perinatology)research center; Hafez Hospital; Chamran Ave.,Shiraz
Shiraz Iran (Islamic Republic of) 7194634786 +98 71 3647 9830 e.gorjipour۲۰۰۰@gmail.com Shiraz University of Medical Sciences scientific Azam Faraji
Maternal- Fetal Medicine (Perinatology) research center; Hafez Hospital; Chamran Ave., Shiraz
Shiraz Iran (Islamic Republic of) 34786-71946 +98 71 3647 9830 farajiaz@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Singleton pregnancy 28 weeks and over of gestation Intrauterine Growth Restriction 18 years 50 years Female Current use of melatonin Pregnancies requiring immediate delivery A history of systemic diseases A history of smoking Contraindications to melatonin use P05 Disorders of newborn related to slow fetal growth and fetal malnutrition Treatment - Drugs Placebo Intervention group: Oral prolonged-release melatonin tablets, 10 mg, three times daily, from enrolment until delivery. Manufacturer: Abidi Pharmaceutical Company, Iran. Control group: Oral placebo tablets identical in appearance (shape, color, size), three times daily, from enrolment until delivery. Manufacturer: Faculty of Pharmacy, Shiraz University of Medical Sciences, Iran. Estimated fetal weight. Timepoint: weekly. Method of measurement: Sonography. Fetal Doppler. Timepoint: weekly. Method of measurement: Sonography. Birth weight. Timepoint: After birth. Method of measurement: Scale. Umbilical cord blood gases. Timepoint: After birh. Method of measurement: Analyzer. Shiraz University of Medical Sciences Approved 2026-02-02 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz Shiraz Fars Iran (Islamic Republic of)