The effect of the implementation of the World Health Organization recommendations on maternal and newborn care for a positive postnatal experience: a randomized controlled clinical trial.
The effect of the World Health Organization's clinical guideline on maternal and newborn care
Design
The clinical trial with control group, parallel, a blind strain, randomized, on 272 mothers who have given birth, random block method will be used for randomization.
Settings and conduct
This study is a single-blind randomized controlled trial (the outcome assessor will be unaware of intervention) that will be implemented in the delivery and postnatal wards of Taleghani Hospital in Tabriz. Mothers will be allocated randomly into intervention and control groups. The intervention group will receive cares based on clinical guideline and the control group will receive routine cares. Two and six weeks after delivery, the outcomes will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Delivered women, Mothers with full-term, singleton births.
Exclusion criteria: Mothers with newborns hospitalized in the NICU; Depression score of 13 or higher based on the postpartum depression questionnaire
Intervention groups
In the intervention group, the care of mother and baby in delivery and post-delivery department is based on WHO guideline and includes the assessment and control of mother and baby, pain control in mother and the necessary training provided by the researcher. The educational recommendations will be provided in the form of face-to-face training and through the virtual network, so a training session (10-15 min) on guideline recommendations was held. Also, the content of the trainings will be sent to mothers and fathers as simple text and a short educational video, and the researcher will answer all the problems up to six weeks and provide solutions based on the recommendations of WHO. Mothers in the control group will receive routine postpartum care.
Main outcome variables
Maternal functioning, specific postpartum anxiety, postpartum depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N76
Registration date:2023-01-27, 1401/11/07
Registration timing:registered_while_recruiting
Last update:2023-01-27, 1401/11/07
Update count:0
Registration date
2023-01-27, 1401/11/07
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
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-05-30, 1402/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the implementation of the World Health Organization recommendations on maternal and newborn care for a positive postnatal experience: a randomized controlled clinical trial.
Public title
The effect of implementation of the recommendations of the World Health Organization postpartum clinical guideline
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Postpartum women in the maternity and postpartum department of Taleghani educational-therapeutic center
Mothers with term newborn
Single birth
At least secondary school education and higher
Exclusion criteria:
Mothers with newborns hospitalized in NICU
The occurrence of unpleasant events during the last three months, including the death of loved ones, divorce and ...
Obtaining a score of 13 and above based on the postpartum depression questionnaire
The existence of chronic diseases in the mother, including cardiovascular diseases, chronic high blood pressure, Diabetes Mellitus and etc.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to the intervention group (recipient of care based on World Health Organization clinical guidelines) and control (routine care) using blocked randomization with randomly varying block sizes of 4 and 6 stratifying by parity and type of delivery with an allocation ratio of 1:1. The allocation sequence will be generated using a computer program (the randomizer) within each stratum by a person not involved in the research. In order to conceal the allocation, the type of care provided will be written on a piece of paper and sealed inside the sequentially numbered, opaque envelopes. After the enrolment of each participant (after receiving informed consent and collecting baseline data ), the envelopes will be opened sequentially after writing the name of the participant on it and the allocated group of the participant will be identified.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention, it is not possible to blind the researcher and the participant. In order to blind the outcome assessor, the
questionnaires will be completed by the research assistant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2022-10-24, 1401/08/02
Ethics committee reference number
IR.TBZMED.REC.1401.661
Health conditions studied
1
Description of health condition studied
Postpartum care
ICD-10 code
Z39
ICD-10 code description
Postpartum care and examination
Primary outcomes
1
Description
Maternal Functioning
Timepoint
After completing the intervention in the sixth week after delivery
Method of measurement
Barkin Maternal Performance Questionnaire
2
Description
Postpartum depression
Timepoint
Before intervention and after completing the intervention in the sixth week after delivery
Method of measurement
Edinburgh postpartum depression questionnaire
3
Description
Postpartum Specific Anxiety
Timepoint
After completing the intervention in the sixth week after delivery
Method of measurement
Postpartum Specific Anxiety Scale
Secondary outcomes
1
Description
Infant Care Behavior
Timepoint
Two weeks after the start of the intervention and after the end of the intervention in the sixth week after delivery
Method of measurement
Infant Care Behavior Questionnaire
2
Description
Mother's health problems
Timepoint
Two weeks after the start of the intervention and after the end of the intervention in the sixth week after delivery
Method of measurement
Checklist of maternal health problems
3
Description
Domestic Violence
Timepoint
After the end of the intervention in the sixth week after delivery
Method of measurement
Violence questionnaire
Intervention groups
1
Description
For the intervention group, maternal and newborn cares will be provided by the researcher based on the recommendations of the WHO clinical guideline in the delivery and postnatal wards that includes the assessment of danger signs, mother's pain relief, nutritional and health recommendations, and all postpartum education regarding the mother and baby care (breastfeeding, vaccination, newborn jaundice, emotional issues of mother, baby and family, etc.). Educational recommendations will be provided in the form of face-to-face training (in the postnatal ward) and through the accessible virtual network, so that in the training room for mothers in the postnatal ward, a training session (10-15 minutes) was held based on the recommendations of the clinical guide. Also, the content of the recommendations in the form of simple text and a short educational video will be sent for mothers and fathers regarding the danger signs, nutritional recommendations, personal health, mental and physical problems of mothers, breastfeeding counseling, and the researcher will answer all the issues from birth to six weeks and will provide counseling based on the recommendations of clinical guideline for mothers and fathers.
Category
Behavior
2
Description
Mothers in the control group will receive standard care and routine postpartum education.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani educational and therapeutic center
Full name of responsible person
Leila Abdoli Najmi
Street address
Taleghani Hospital, Railway street
City
Tabriz
Province
East Azarbaijan
Postal code
5197615413
Phone
+98 41 3442 4421
Fax
+98 41 3442 4882
Email
taleghanihospital.tabriz@gmail.com
Web page address
https://taleghanihosp.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Reaserch department, third floor, central construction number 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5921
Fax
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Leila Abdoli Najmi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3475 1708
Email
leilanajmi97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mojgan Mirghafourvand
Position
Professor of Tabriz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3475 1708
Email
mirghafourvand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mojgan Mirghafourvand
Position
Professor of Tabriz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
0098347501708
Email
mirghafourvand@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
Confidentiality of participants' information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available