Objectives: To determine the effect of metoclopramide administration to mother on newborn’s bilirubin and mother’s prolactin.
Design: A randomized controlled trial with two parallel arms.
Conduct: This study will be conducted on 112 mothers who hospitalized in the postpartum wards of Taleghani and Alzahra hospitals. Eligible women who have willingness to participate in the study will be assigned into two groups of intervention (receiving metoclopramide) and control (receiving placebo) through stratified block randomization (based on the type of delivery) with a block sizes of four and six, and the allocation ratio of 1: 1.
Participants: Hospitalized women in the postpartum wards of Taleghani and Alzahra hospitals.
Interventions: metoclopramide and placebo tablets, both with dosages of 10 mg three times daily after breakfast, lunch and dinner will be consumed by participants. The intervention will be from 2 to 10 hours after birth and will be continued until the fifth day.
The main outcome variables include the neonatal total bilirubin that will be assessed by Bilicheck (TCB) on the first and sixth day of study. Also, serum level of prolactin will be assessed in the next day after starting of the intervention and sixth day.
Secondary outcome variables include volume of milk will be assessed two hours after the last breastfeeding in the first and sixth day. As well as satisfaction checklist of breastfeeding status will be completed by questioning of mothers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101710324N34
Registration date:2017-02-20, 1395/12/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-20, 1395/12/02
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of metoclopramide administration to mother on newborn’s bilirubin and mother’s prolactine: a randomized controlled clinical trial
Public title
The effect of metoclopramide administration to mother on newborn’s bilirubin and mother’s prolactine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Healthy full-term pregnancy; Mothers with singleton pregnancy; Being Lactating, and having tendency and motivation to breast-feeding; Living in Tabriz; Willingness to continue in the study; -Having at least literacy of reading and writing.
Exclusion criteria: Newborns with birth defects; Newborns that need to neonatal intensive cares; Neonatal jaundice in first day after birth; Neonatal metabolic disease; Taking of hormonal drugs by mothers such as estrogen; Taking of medications that affect the serum prolactin like halopridol, reserpine, mytel- dopa, opiates and cimetidine; Maternal depression; History of previous depression; Inverted nipple; Having absolute or relative contraindication for breast-feeding in the mother including diseases such as untreated TB, infection with HIV, CMV, herpes simplex virus and hepatitis and taking of radioactive drugs and illegal drugs during the breastfeeding period, such as methotrexate, lithium, cyclophosphamide, hydroxyurea, phencyclidine, phenidone, opiate substances and metronidazole; History of chronic disease in the mother
Age
From 15 years old to 49 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, participants, assessor and data analyzer will be blinded from type of intervention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Univercity of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East azerbaijan
City
Tabriz
Postal code
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.TBZMED.REC.1395.1020
Health conditions studied
1
Description of health condition studied
prevention of neonatal jaundice and increasing the volum of breast milk
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Newborn’s bilirubin
Timepoint
Before intervention and sixth day after the intervention
Method of measurement
TCB
2
Description
Mother’s prolactin serum level
Timepoint
Next day after starting of the intervention and sixth day.
Method of measurement
Prolactin ELISA Kit
Secondary outcomes
1
Description
Volume of breast milk
Timepoint
Two hours after the last breastfeeding in the first and sixth day of intervention
Method of measurement
Syringe
2
Description
Satisfaction from breastfeeding status
Timepoint
After the end of intervention
Method of measurement
Satisfaction checklist
Intervention groups
1
Description
The intervention group will receive Metoclopramide tablet, 10 mg three times per day for five days
Category
Treatment - Drugs
2
Description
The control group will receive 10 mg placebo tablet three times per day for five days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr. Mojgan Mirghafourvand
Street address
Taleghani hospital, Rah ahan street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Osouli Tabrizi
Position
MSc Student of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati street
City
Tabriz
Postal code
00984166156156
Phone
00
Fax
Email
shirin.osouli@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
Associate professor
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
5138947977
Phone
+98 41347967700
Fax
Email
mirghafourvandm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shirin Osouli Tabrizi
Position
Msc Student of Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Postal code
Phone
Fax
Email
Shirin.osouli@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)