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Comparison effects of lactation induction protocol in non-pregnant mothers waiting for the birth of a baby from surrogacy according to the treatment duration

Protocol summary

Study aim
Main objective: determination of the effect of lactation induction according to the time of treatment in non-pregnant mothers. Subtopics: determination of any side effects in mothers undergoing lactation induction.
Design
There is no randomization method in this study, and in fact, mothers are divided into the three mentioned groups based on how much time is left until the birth of their child. Clinical trial phase: 3 sample size we intend to collect 30 mothers with the age of less than 40 years who chose the surrogacy method for childbearing.
Settings and conduct
Place of study: Imam Khomeini Hospital Complex. In this pilot study, we plan to implement lactation induction in a systematic way, on mothers who have a child with surrogacy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-pregnant, non-lactating and non-menopausal mothers who replace the child through the womb. Exclusion criteria: Unwillingness to continue the intervention in each phase of the study. Occurrence of unmanageable and intolerable drug side effects by the patient Identification of any anomaly in the baby before or after birth
Intervention groups
Depending on how long the protocol is implemented on them and how much time is left until the birth of the baby, mothers are divided into three groups: 6 to 4 months before birth, 4 to two months, and two months and less. In the first stage, mothers receive drospirenone, ethinyl estradiol tablets daily along with domperidone tablets for one week. In the second stage, 6 weeks before the birth of the child, OCP is stopped, domperidone continues and vaginal bleeding occurs, and milking begins with an electric breast pump.
Main outcome variables
Primary outcome: milk production determined by the volume of milk produced in millimeters during the prenatal intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240522061869N1
Registration date: 2024-07-20, 1403/04/30
Registration timing: prospective

Last update: 2024-07-20, 1403/04/30
Update count: 0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Parvaneh sadeghimoghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4614 5618
Email address
md_sadeghimoghadam@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of lactation induction protocol in non-pregnant mothers waiting for the birth of a baby from surrogacy according to the treatment duration
Public title
Comparison effects of lactation induction protocol in non-pregnant mothers waiting for the birth of a baby from surrogacy according to the treatment duration
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Non-pregnant, non-breastfeeding, and non-menopause mothers under 40 years of age who have children through surrogacy. no history of breast surgery or other breast problems in the mother or their first-degree family. Lack of drug interactions with the patient's medications. No underlying diseases such as hypertension, diabetes, thrombophilia, previous thromboembolic events, migraine with aura, liver disease, and rheumatological diseases. Absence of heart problems such as QT Prolongation. Body Mass Index (BMI below 30). No alcohol and tobacco use Willingness to participate in the study and follow-ups
Exclusion criteria:
fetal congenital anomaly
Age
To 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
There is no randomization in this study and mothers are divided into three groups based on how long they have left until the birth of their child (first group 6 months to birth, second group 4 months to birth and third group 2 months to birth).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Imam Khomeini Hospital Complex - Tehran University of Medical Sciences (Research Ethics Committee)
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.054

Health conditions studied

1

Description of health condition studied
lactation induction in non-pregnant mothers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Duration and amount of milk production in three study groups
Timepoint
Monthly for up to 6 months
Method of measurement
Mother's report

Secondary outcomes

1

Description
Full or partial feeding of the baby with breast milk
Timepoint
Monthly for up to 6 months
Method of measurement
mother's report

2

Description
complications
Timepoint
Monthly for up to 6 months
Method of measurement
mother's report

3

Description
The satisfaction of being a parent
Timepoint
Monthly for up to 6 months
Method of measurement
Parenting satisfaction questionnaire

Intervention groups

1

Description
Intervention group:Mothers who are included in this study are first subjected to cardiac counseling and a complete history and ECG are taken from them to ensure the absence of heart diseases. Depending on how long the protocol is implemented on them and what There is time left until the birth of the baby. Mothers are divided into three groups: 6 to 4 months before birth, 4 to two months, and two months and less. In two groups, 6 to 4 months and 4 to 2 months until the birth of the baby (protocol is implemented at most 6 months before the birth of the child), in the first stage of mothers, drospirenone ethinyl estradiol 3 and 0.02 tablets (OCP) which is equivalent to They take Roja Maid tablet daily regardless of the menstrual cycle along with 10 mg domperidone tablet 4 times a day for one week. After that, the patient continues to receive Roja tablets on a daily basis, but the dose of domperidone is gradually increased up to 20 mg 4 times a day (10 mg of domperidone is added every other day). In the group of mothers who have two They have a month until the birth of the child. In the initial stage, the protocol starts with 20 mg of domperidone 4 times a day along with Roquin (drospirenone ethinyl estradiol 0.03) tablets. If the breast size increases by at least one cup, they enter the next phase. In the second stage, 6 weeks before the birth of the child, OCP is stopped, domperidone continues and vaginal bleeding occurs. If there is no bleeding, preferably, a pregnancy test is performed and milking begins with an electric breast pump. The mother should breastfeed every three hours and once during the night (between 1:00 am and 5:00 am) for 5 to 7 minutes in two stages (5 to 7 minutes of milking, then massage and shaking, followed by another 5 to 7 minutes of milking) with Do low or medium milking. (Written instructions are given to all patients). The use of Domperidone tablets with the previous dose will continue until the end of the mother's breastfeeding period and the child starts eating (or until the mother is satisfied with her breastfeeding). During the study, mothers are advised to drink enough fluids. Before the birth of the baby, the mother's milk is pumped, measured and recorded in the chart presented to the mother. After the birth of the baby, we measure the amount of milk produced with the criteria of the child's growth and the frequency of urination. The follow-up of the patients during the study will continue once a month before the birth of the child and then monthly for up to 6 months. The visit of the newborn will be weekly in the first month of life and then monthly for up to 6 months, and the results will be measured in each visit. It is recommended to take domperidone and use a breast pump until the baby is fully fed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Pavaneh Sadeghimoghadam
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 2357
Email
md_sadeghimoghadam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Research and Technology Vice-Chancellor, Tehran University of Medical Sciences, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۱۴۱۵۳
Phone
+98 21 8163 3685
Email
akbarisari@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
Pavaneh Sadeghimoghadam
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
pediatrics
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 2357
Email
md_sadeghimoghadam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pavaneh Sadeghimoghadam
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 2357
Email
md_sadeghimoghadam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pavaneh Sadeghimoghadam
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
pediatrics
Street address
Imam Khomeini Hospital Complex, End of Keshavarz Blvd., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 2357
Email
md_sadeghimoghadam@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Title and more details about the data/document
In the form of an article and upon request from the responsible author, the non-identifiable information of the study subjects will be made available.
When the data will become available and for how long
one year
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Conducting research and meta-analysis
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document
Request from the correspnding author via email
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