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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033976N3
Registration date:2026-03-14, 1404/12/23
Registration timing:registered_while_recruiting
Last update:2026-03-14, 1404/12/23
Update count:1
Registration date
2026-03-14, 1404/12/23
Registrant information
Name
Azam Faraji
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 2365
Email address
farajiaz@sums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-03-06, 1404/12/15
Expected recruitment end date
2026-09-06, 1405/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Melatonin in Intrauterine Growth Restriction, A Double blind Randomized Clinical Trial
Public title
The Efficacy of Melatonin in Intrauterine Growth Restriction
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
Disorders of newborn related to slow fetal growth and fetal malnutrition
Primary outcomes
1
Description
Estimated fetal weight
Timepoint
weekly
Method of measurement
Sonography
2
Description
Fetal Doppler
Timepoint
weekly
Method of measurement
Sonography
3
Description
Birth weight
Timepoint
After birth
Method of measurement
Scale
Secondary outcomes
1
Description
Umbilical cord blood gases
Timepoint
After birh
Method of measurement
Analyzer
Intervention groups
1
Description
Intervention group: Oral prolonged-release melatonin tablets, 10 mg, three times daily, from enrolment until delivery. Manufacturer: Abidi Pharmaceutical Company, Iran.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Haspial affiliated to Shiraz university of medical sciences
Full name of responsible person
Azam Faraji
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7184837786
Phone
+98 71 3647 9830
Email
farajiaz@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3235 7282
Email
mohammadi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Gorjipour
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology)research center; Hafez Hospital; Chamran Ave.,Shiraz
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3647 9830
Email
e.gorjipour۲۰۰۰@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Azam Faraji
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology) research center; Hafez Hospital; Chamran Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3647 9830
Email
farajiaz@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
AZam Faraji
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology) research center; Hafez Hospital; Chamran Ave., Shiraz
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3647 9830
Email
farajiaz@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2025, Ethic form: 2026
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document