The effect of prenatal supportive care of midwives in pregnant women with chronic diseases
Design
A clinical trial with a control group, with parallel design, without blinding, will be performed on 204 pregnant women (102 people in each group For randomization, 4 random blocks with a 1: 1 allocation ratio will be used. After listing all possible modes of 4 blocks and assigning a number to each of them using a computer random number table, with a 1: 1 allocation ratio, individuals will be divided into two groups receiving routine care and supportive care. To hide the allocation, the type of intervention will be written on paper and numbered in a series of matte envelopes.
Settings and conduct
This study will be performed in the pregnancy clinic in Imam Khomeini Hospital in Ahvaz. Participants will be eligible for pregnant women with chronic illness. Pregnant women will be randomly divided into intervention and control groups, the intervention group will receive supportive care and the control group will receive routine pregnancy care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with one or more chronic diseases؛ between 16-20 weeks of pregnancy؛ single pregnancy؛ able to understand Persian speech and writing؛ resident of Ahvaz, having a mobile phone؛ consent to participate in the study.
Exclusion criteria: self-report history of substance abuse؛ self-report of mental disorder and use of psychiatric drugs؛ unwillingness to continue participating in the study.
Intervention groups
Intervention group, supportive care and pregnancy control control group will receive the routine.
Main outcome variables
The length of hospital stay (mean and standard deviation) is measured from the time of admission to the study until 2 weeks after delivery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220203053927N1
Registration date:2022-02-10, 1400/11/21
Registration timing:prospective
Last update:2022-02-10, 1400/11/21
Update count:0
Registration date
2022-02-10, 1400/11/21
Registrant information
Name
solmaz mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3321 9122
Email address
mohammadi-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-26, 1400/12/07
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of prenatal supportive care of midwives in pregnant women with chronic diseases: Randomized Controlled Trial
Public title
The effect of prenatal supportive care of midwives in pregnant women with chronic diseases
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1.Pregnant women with one or more chronic diseases that are diagnosed more than 6 months before pregnancy, with continued recurrence and need for medical treatment
2.Be between 16-20 weeks pregnant at the time of enrollment in the study
3.Single pregnancy
4.Be able to understand Persian speech and writing
5.To live in Ahvaz
6.Having a cell phone
7.Satisfaction to participate in the study
Exclusion criteria:
1.Self-report history of substance abuse
2.Self-report of mental disorder and use of psychiatric drugs
3.Reluctance to continue participating in the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
204
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women will randomly assign into two groups of routine (individual) prenatal care or group prenatal care using block randomization with a block size of 4 and an allocation ratio of 1:1. Thus, after listing all possible situations of 4 blocks and assigning a number to each of them using a computer random number table with a 1: 1 ratio, participants will be allocated into two groups, namely routine prenatal care and supportive care care. For allocation concealment, each woman will receive a code and all codes will be kept in an opaque envelope until the time of intervention. Sequencing of allocation and preparation of envelopes will be done by a person that will not involve sampling and data collection. The researcher and the participant will not aware of the groups and the intervention that they received until the commencement of intervention
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
Shahroud University of Medical Sciences
Street address
Shahroud ,7th of Tir Square - Shahroud University of Medical Sciences and Health Services
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.SHMU.REC.1399.123
Health conditions studied
1
Description of health condition studied
prenatal supportive care
ICD-10 code
O36.7
ICD-10 code description
Maternal care for viable fetus in abdominal pregnancy
Primary outcomes
1
Description
The length of hospital stay (mean and standard deviation) is measured from the time of admission to the study until 2 weeks after delivery.
Timepoint
Evaluation of this outcome will be done 2 weeks after delivery.
Method of measurement
medical records
Secondary outcomes
1
Description
World Health Organization 5-item Welfare Index
Timepoint
The evaluation will be performed at the beginning of the study (baseline), at 33-37 weeks of gestation and 6 weeks after delivery
Method of measurement
World Health Organization 5-item Welfare Scale World Health Organization 5-item Welfare Scale Questionnaire
2
Description
Pregnancy and postpartum depression
Timepoint
The evaluation will be performed at the beginning of the study (baseline), at 33-37 weeks of gestation and 6 weeks after delivery
Method of measurement
Edinburgh Postpartum Depression Scale
3
Description
Pregnancy worries
Timepoint
The evaluation will be done at the beginning of the study (baseline) and at 33-37 weeks of pregnancy
Method of measurement
Cambridge Pregnancy Anxiety Scale Questionnaire
4
Description
Health-related quality of life
Timepoint
The evaluation will be performed at the beginning of the study (baseline), at 33-37 weeks of gestation and 6 weeks after delivery
Method of measurement
Health-related quality of life questionnaire
5
Description
Quality prenatal care from the perspective of service recipients
Timepoint
Evaluation 6 weeks after delivery
Method of measurement
Quality of Prenatal Care Questionnaire
6
Description
Satisfaction with childbirth
Timepoint
Evaluation 2 weeks after delivery
Method of measurement
Maki Maternity Satisfaction Scale
7
Description
Economic consequences of health (use of health services)
Timepoint
Evaluation 6 weeks after delivery
Method of measurement
Researcher-made questionnaire
8
Description
Prenatal health behaviors
Timepoint
The evaluation will be done at the beginning of the study (baseline) and at 33-37 weeks of pregnancy
Method of measurement
Prenatal health behaviors scale
9
Description
Consequences of pregnancy and childbirth
Timepoint
Evaluation 6 weeks after delivery
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
InterIntervention group: Supportive prenatal care in the intervention group consists of 3 components: (1) active and passive telephone counseling before and after delivery, (2) coordination of care and case management, (3) continuous care buyDedicated midwife during pregnancy, during labor and delivery.Individuals in the prenatal care intervention group will receive the researcher in the specialized clinic of the selected hospital in weeks 30-24, 34-31, 37-35, 38, 39, 40.The researcher works in consultation with a perinatologist.At each visit, while examining the individual needs and desires of each woman, counseling and training appropriate to the gestational age will be provided individually and face to face.During the intervention period, the researcher will have one phone call per week with the participants and in each post-greeting call, she will examine three main areas: physical-mental health status and pregnancy health, evaluation-based recommendations, and discussion about Any other additional issues that are important to the mother.In this intervention, each participant can contact the midwife whenever they need to be consulted.Care coordination will be done by the researcher during the intervention period.The researcher identifies the specific needs and wants of each woman and discusses the optimal care of the woman with the obstetrician who is responsible for her medical care.The intervention group will be supported by the researcher as a companion midwife (Dola) from the beginning of the mother's hospitalization (beginning of the active phase of labor in the expansion of the cervix 3-4 cm) until the first 2 hours after delivery.The researcher will provide supportive measures for the mother during labor, classified into psychological, emotional, educational, and physical categories.The researcher will also be able to follow up and respond to maternal problems by phone and, if necessary, in person after the first 2 hours of labor.
Category
N/A
2
Description
Control group: The control group will receive routine care at the prenatal care clinic of the selected hospital by the resident on duty and under the supervision of a perinatologist. Routine pregnancy care based on national protocol includes 8 visits (in weeks 6-10, 20-16, 30-24, 34-31, 37-35, 38, 39, 40) which Based on the severity of the chronic disease and the risks associated with pregnancy, the treating physician will set up an individual care plan for each person's visit and care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Pregnancy care clinic is an Imam Khomeini Hospital in Ahvaz (referral level 3 Hospital)
Full name of responsible person
Solmaz Mohammadi
Street address
Ahvaz - Azadegan St. - Imam Khomeini Medical Center of Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Fax
Email
sl.mohammadi89@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hamid Vahedi
Street address
Shahroud,Haft Tir Square, University of Medical Sciences, School of Medicine
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5009
Email
vahedi@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
Zahra Motaghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Haftam Tir Square - Shahroud University of Medical Sciences and Health Services
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5009
Email
Zahra.motagy63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Solmaz Mohammadi
Position
PhD Student in Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Golestan Alley, Dey Bin Bahman and Esfand St.No.116
City
Ahvaz
Province
Khouzestan
Postal code
6135935697
Phone
+98 61 3321 9122
Email
sl.mohammadi89@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Solmaz Mohammadi
Position
PhD student in Reproductive Health
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Golestan alley, Dee street between Bahman and Esfand, NO.116
City
Ahvaz
Province
Khouzestan
Postal code
6135935697
Phone
+98 61 3321 9122
Email
sl.mohammadi89@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
The data can be published after the completion of the dissertation
When the data will become available and for how long
One year after completing the dissertation
To whom data/document is available
Shahroud and Ahvaz University of Medical Sciences, Hospital Officials, Researchers
Under which criteria data/document could be used
Data analysis through publication in scientific research journals in
They will be available to others
From where data/document is obtainable
solmaz mohammadi, E mail: sl.mohammadi89@yahoo.com
What processes are involved for a request to access data/document
The information will be available through the publication
of the article. But if more information is needed, the
request should be sent via email