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
Investigating the effect of melatonin on fetal pulmonary artery doppler indices and prevention of fetal distress syndrome in pregnancy with placental implantation disorders
Design
64 of these people are randomly divided into two groups treated with melatonin for two weeks with a daily dose of 10 mg and the group without treatment (control) melatonin. Study phase 2-3; The basis of the formula for determining the sample size based on multiple regression was equal to 29 in each group to compensate for missing items.
3 people were added in each group and a total of 32 people were selected in each group. Blocked randomization method will be used for the random allocation of intervention and control groups. The number of blocks will be four and will be named as codes a and b. How to select eligible women will be available in the method.
Settings and conduct
All pregnant women aged 19 to 45 with singletons referred to Imam Khomeini Hospital in Tehran in 2023 without fetal anomalies with a gestational age of 32-34 weeks with placental disorders without any other underlying disease are included in the study. These people are randomly divided into two groups treated with melatonin and the group without melatonin treatment. Melatonin tablets 10 mg daily before going to bed for a period of 2 weeks for each patient who is in the melatonin group. The sample is 64 people, 32 people are in the group with melatonin and 32 people are in the group without melatonin.
Participants/Inclusion and exclusion criteria
All pregnant women aged 19 to 45 with singletons without fetal anomalies with a gestational age of 32-34 weeks with placental disorders without any other underlying disease.
Intervention groups
Groups treated with melatonin for two weeks at a dose of 10 mg daily and the group without melatonin treatment.
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
Public title
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
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Singleton pregnant women with gestational age of 32-34 weeks with placental disorders (acreta, increta, percreta, previa)
Exclusion criteria:
Fetal anomaly
Mother's underlying disease
Age
From 19 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences Headquarters, Qods Corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.164
Health conditions studied
1
Description of health condition studied
Preterm neonates
ICD-10 code
O60.3
ICD-10 code description
Preterm delivery by: caesarean section, without spontaneous labour
2
Description of health condition studied
Infant respiratory distress
ICD-10 code
P22.8
ICD-10 code description
Other respiratory distress of newborn
Primary outcomes
1
Description
Pulmonary artery Doppler of the fetus
Timepoint
2 weeks
Method of measurement
Philips ultrasound
2
Description
Apgar minutes 1 and 5
Timepoint
Day 1, birthday, minutes 1 and 5
Method of measurement
clinical
3
Description
The degree of respiratory distress of the infant
Timepoint
day 1 birthday
Method of measurement
clinical
4
Description
Middle cerebral artery Doppler
Timepoint
2 weeks
Method of measurement
Philips ultrasound
5
Description
Doppler of the umbilical artery
Timepoint
2 weeks
Method of measurement
Philips ultrasound
6
Description
Uterine artery doppler
Timepoint
2 weeks
Method of measurement
Philips ultrasound
7
Description
Neonatal resuscitation
Timepoint
First day after birth
Method of measurement
clinical
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Full name of responsible person
Bahar Farshidfar
Street address
Keshavarz Blvd., Qods Corner, Tehran University of Medical Sciences Headquarters
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
farshidfarbahar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
الهه محمدی
Street address
Keshavarz Blvd., Naderi St., Hojat Dost St., No. 57
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
+98 21 8895 5846
Email
hperc@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Bahar Farshidfar
Position
Obstetrics and Gynecology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Blvd., corner of Qods
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
0098218895586
Email
farshidfarbahar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahar Farshidfar
Position
Obstetrics and Gynecology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Blvd., corner of Qods
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
0098218895586
Email
farshidfarbahar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bahar Farshidfar
Position
Obstetrics and Gynecology Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Keshavarz Blvd., corner of Qods
City
Tehran
Province
Tehran
Postal code
1416633591
Phone
0098218895586
Email
farshidfarbahar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD