Protocol summary
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Study aim
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The Efficacy of Melatonin in Intrauterine Growth Restriction
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Design
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Double-blind, parallel-group, randomized placebo-controlled trial. Sample size: 66 (33 per group). Block randomization (block size 6), concealed allocation, participants and outcome assessors blinded.
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Settings and conduct
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Namazi and Hafez Hospitals, Shiraz, Iran. Pregnant women with severe FGR enrolled and followed weekly until delivery. Identical packaging of melatonin and placebo ensures blinding.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: singleton pregnancy; gestational age ≥28 weeks; severe FGR (AC <3rd centile or <10th centile with abnormal Doppler); maternal age ≥18 years; written informed consent.
Exclusion criteria: current melatonin use; need for immediate delivery; systemic diseases; smoking; melatonin contraindications; maternal/fetal infection; fetal chromosomal/structural anomalies; non-placental FGR
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Intervention groups
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Prior to the initiation of the study intervention, both the experimental and control groups will be homogenized for key baseline characteristics, including age, BMI, Health-Related Quality of Life (SF-۳۶). The sleep disorder (PSQI) and ۳۶-item quality of life (SF-۳۶) questionnaires will be completed before the start of the intervention and then at monthly intervals until delivery.
Intervention: will receive oral tablet melatonin prolonged release ۱۰ mg, three times daily, until delivery
Control: will receive placebo (placebo tablet will be manufactured by the faculty of pharmacy, shiraz university of medical sciences), three times daily, until delivery
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Main outcome variables
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Quality of sleep questionnaire, Estimated fetal weight; Doppler indices (uterine, umbilical, MCA, ductus venosus); birth weight; Apgar scores at 1 and 5 min; NICU admission; umbilical cord blood gases
General information
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Reason for update
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With greetings, Change the start date of the patient's from 04/04/2026
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170515033976N3
Registration date:
2026-03-14, 1404/12/23
Registration timing:
prospective
Last update:
2026-03-30, 1405/01/10
Update count:
1
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Registration date
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2026-03-14, 1404/12/23
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Registrant information
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Recruitment status
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recruiting
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Funding source
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Expected recruitment start date
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2026-04-04, 1405/01/15
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Expected recruitment end date
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2026-09-06, 1405/06/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Efficacy of Melatonin in Intrauterine Growth Restriction, A Double blind Randomized Clinical Trial
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Public title
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The Efficacy of Melatonin in Intrauterine Growth Restriction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Singleton pregnancy
28 weeks and over of gestation
Intrauterine Growth Restriction
Exclusion criteria:
Current use of melatonin
Pregnancies requiring immediate delivery
A history of systemic diseases
A history of smoking
Contraindications to melatonin use
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: use block; Random unit: Individual; Randomization tool: Statistical software Minitab; Sequence Building: Using randomized 46 blocks; Hiding method: Use similar bottles
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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).
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2026-02-02, 1404/11/13
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Ethics committee reference number
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IR.SUMS.MED.REC.1404.596
Health conditions studied
1
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Description of health condition studied
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Intrauterine Growth Restriction (IUGR) / Fetal Growth Restriction (FGR)
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ICD-10 code
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P05
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ICD-10 code description
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Disorders of newborn related to slow fetal growth and fetal malnutrition
Primary outcomes
1
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Description
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Estimated fetal weight
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Timepoint
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weekly
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Method of measurement
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Sonography
2
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Description
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Fetal Doppler
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Timepoint
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weekly
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Method of measurement
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Sonography
3
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Description
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Birth weight
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Timepoint
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After birth
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Method of measurement
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Scale
Secondary outcomes
1
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Description
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Umbilical cord blood gases
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Timepoint
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After birh
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Method of measurement
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Analyzer
Intervention groups
1
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Description
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Intervention group: Oral prolonged-release melatonin tablets, 10 mg, three times daily, from enrolment until delivery. Manufacturer: Abidi Pharmaceutical Company, Iran.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Information and research data Ethic form: Complete the ٍEthic form by the patient
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When the data will become available and for how long
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IPD: 2025, Ethic form: 2026
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To whom data/document is available
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IPD: Researcher & Patient Ethic form: Patient
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Under which criteria data/document could be used
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IPD: Ethic form: Awareness of test results
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From where data/document is obtainable
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IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
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What processes are involved for a request to access data/document
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IPD: Vice chancellery Ethic form: Vice chancellery
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Comments
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