Effectiveness of comprehensive home care program for high-risk pregnancies on maternal and fetal outcomes
Design
A clinical trial with a control group, with parallel groups, without blinding for caregivers and participants, randomized on 190 high-risk pregnant woman. Randomization with sealed envelope software.
Settings and conduct
After designing the intervention and obtaining permission from the ethics committee and registering it in the IRCT,This part of the research is carried out in Shushtar and Ahvaz cities.
Participants/Inclusion and exclusion criteria
1. Having a high-risk pregnancy
2. Obtaining a score (4-6 or moderate risk) based on the modified Copeland high-risk pregnancy scoring scale.
3. Pregnancy age below 28 weeks
4. Receiving perinatal care for high-risk pregnancies based on national guidelines regularly ( control group)
5. Receiving combined care: Perinatal care for high-risk pregnancies based on national guidelines and receiving a comprehensive home care plan for high-risk pregnancies compiled based on the conditions and needs of high-risk pregnant women ( intervention group) ; Exclusion criteria
1.Drug abuse
2. Deterioration of the patient's condition (intervention group)
3. Taking certain medicine due to a physical or psychological problem
Intervention groups
Intervention is a comprehensive home care program. The comprehensive home care program was finalized by the research team based on the results of the previous steps. We will conduct a clinical trial study with the aim of determining the effectiveness of this program on maternal and fetal outcomes in high-risk pregnant women receiving a comprehensive home care program. The intervention group will receive combined care and the control group will receive perinatal care for high-risk pregnancies according to national guidelines.
Main outcome variables
Birth weight, Apgar, postpartum bleeding and type of delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221221056885N1
Registration date:2024-06-23, 1403/04/03
Registration timing:registered_while_recruiting
Last update:2024-06-23, 1403/04/03
Update count:0
Registration date
2024-06-23, 1403/04/03
Registrant information
Name
Masoumeh Sayahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
sayahi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of comprehensive home care program for high-risk pregnancies on maternal and fetal outcomes
Public title
Effectiveness of comprehensive home care program for high-risk pregnancies
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having a high-risk pregnancy including: history of previous caesarean section, history of abortion and premature birth, pre-eclampsia symptoms (pre-eclampsia history) and blood pressure, abnormal BMI, gestational diabetes and Before pregnancy, anemia, age above 35 and fifth pregnancy and above.
Getting a score (4-6) based on Copeland's revised high-risk pregnancy scoring scale
Pregnancy age below 28 weeks
Receiving perinatal care for high-risk pregnancies based on national guidelines regularly (for the control group)
combined care: Perinatal care for high-risk pregnancies based on national guidelines and comprehensive home care plan for high-risk pregnancies (for the intervention group)
Ability to speak and understand Persian language
Informed consent to participate in research
Suitable home conditions for women with high-risk pregnancies to provide care
Exclusion criteria:
Drug abuse
Deterioration of the client's condition and the need to receive hospital care in the group receiving care at home
Taking certain medicine due to a physical or psychological problem
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
Permutational block randomization method with blocks of four will be used.
Sealed envelope software will be used to determine the sequence, and based on the sample size, which is 190 people, 48 blocks of 4 are needed.
Also, to coceal the allocation, we will use sealed white envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences and Health Services
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
shahroud
Province
Semnan
Postal code
3614773955
Approval date
2022-10-12, 1401/07/20
Ethics committee reference number
IR.SHMU.REC.1401.152
Health conditions studied
1
Description of health condition studied
Prenatal care for pregnant women with a history of previous cesarean section, history of miscarriage and premature birth, preeclampsia symptoms (preeclampsia history) and blood pressure, abnormal BMI, gestational and pre-pregnancy diabetes, anemia, age under 18 and over 35 and fifth pregnancy and higher at home
ICD-10 code
Z35.7
ICD-10 code description
Supervision of high-risk pregnancy due to social problems
Primary outcomes
1
Description
Primary maternal outcomes: percentage of mothers with postpartum hemorrhage and percentage of cesarean delivery and primary fetal-neonatal outcomes: average weight of newborns and percentage of Apgar score higher than 7
Timepoint
Primary maternal outcomes: the percentage of mothers with postpartum hemorrhage and the percentage of cesarean section after delivery ; Early fetal-neonatal outcomes, which include the average birth weight and the percentage of Apgar score above 7 at birth.
Method of measurement
By studying the delivery record of high-risk pregnant women in the hospital
Secondary outcomes
1
Description
Prenatal Distress
Timepoint
At the beginning of the study and week 37-40 and after delivery
Method of measurement
PrenatalDistress Questionnaire (PDQ)
2
Description
Self-care during pregnancy
Timepoint
At the beginning of the study and week 37-40 and after delivery
Method of measurement
Self-care questionnaire during pregnancy
Intervention groups
1
Description
Intervention group: Teaching self-care according to the type of high-risk pregnancy, performing routine pregnancy care and care according to the type of high-risk pregnancy and teaching the wife and other family members (emphasis on the importance of their companionship and participation in supporting high-risk pregnant women, teaching them the danger signs of pregnancy and the necessity Immediate attention and referral in case of occurrence, training on the role of parents and how to communicate with the child, etc.) will be done by the person providing the service.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Ahvaz
Full name of responsible person
Masoumeh Sayahi
Street address
Ahvaz Faculty of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
7616913555
Phone
+98 916 318 2369
Email
m.saiahi430@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Health centers in Shoushtar
Full name of responsible person
Masoumeh Sayahi
Street address
Shoushtar Faculty of Medical Sciences, Shahid Rajaei Street, Pasdaran Square, Shuoshtar, Iran.
City
Shoushtar
Province
Khouzestan
Postal code
7616913555
Phone
+98 916 318 2369
Email
m.saiahi430@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Behzad Garmabi
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
+98 23 3239 1609
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Masoumeh Sayahi
Position
PhD student in reproductive health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
+98 23 3239 1609
Email
m.saiahi430@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masoumeh Sayahi
Position
PhD student in reproductive health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 916 318 2369
Email
m.saiahi430@ gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Masoumeh Sayahi
Position
PhD student in reproductive health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 916 318 2369
Email
m.saiahi430@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available