1. Home
  2. Approved trials
  3. » فارسی

Implementation and evaluation of the effectiveness of the continuous midwifery care model in socially vulnerable women: a randomized controlled clinical trial

Protocol summary

Study aim
Implementation and Evaluation of the Effectiveness of the Continuous Midwifery Care Model in Pregnant Women with Social Vulnerability
Design
A randomized, controlled clinical trial with parallel groups on 92 pregnant women with vulnerable conditions (violence or poverty or unwanted pregnancy). A stratified random block design (primiparous and multiparous) with block sizes of 4 and 6 and an allocation ratio of 1:1 will be used for randomization.
Settings and conduct
This study is a randomized controlled trial that will be conducted in health centers and Shohada Hospital in Bonab. Women will be randomly assigned to intervention and control groups. The intervention group will receive the continuous midwifery care model and the control group will receive routine care.
Participants/Inclusion and exclusion criteria
Eligible pregnant women are 12–14 weeks gestation, literate (≥5th grade), have smartphone access, plan to deliver in Bonab, and meet criteria like vulnerability, prior vaginal birth or nulliparity, and ability to attend health center sessions.
Intervention groups
The intervention group will receive continuous midwifery care alongside routine maternity services, spanning antenatal, intrapartum, and postpartum phases. Antenatal care includes six sessions from 12 to 38 weeks gestation, covering education, counseling, and clinical assessments. Intrapartum and postpartum phases provide labor support and Giving birth and two postnatal sessions up to six weeks after delivery.
Main outcome variables
Pregnancy experience, childbirth experience, and depression during pregnancy and postpartum

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120718010324N84
Registration date: 2025-08-23, 1404/06/01
Registration timing: prospective

Last update: 2025-08-23, 1404/06/01
Update count: 0
Registration date
2025-08-23, 1404/06/01
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
2025-09-11, 1404/06/20
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementation and evaluation of the effectiveness of the continuous midwifery care model in socially vulnerable women: a randomized controlled clinical trial
Public title
Investigating the impact of continuous midwifery care on socially vulnerable women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with vulnerable conditions (violence or poverty or unplanned pregnancy). Gestational age 12-14 weeks Possibility of participants attending (depending on location) in antenatal and postnatal group sessions at health centers. Nulliparous women or with a history of vaginal delivery Possibility of access to a smartphone Literacy (at least fifth grade education) Willingness to give birth in Bonab city
Exclusion criteria:
Multiple pregnancy History of cesarean delivery Major fetal anomalies Medical comorbidities History of high-risk pregnancy (stillbirth, recurrent miscarriage, preeclampsia, etc.)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
A study will be conducted on 92 pregnant women identified as vulnerable (experiencing violence, living in poverty, or having an unplanned pregnancy), with 46 participants in each group, beginning from gestational weeks 12 to 14. Eligible participants will be selected for inclusion in the present study. Sampling will be performed using a simple random method based on a random number table. Comprehensive information regarding the research, its objectives, and implementation procedures will be provided to the women. Those who express willingness to participate will complete the following questionnaires: the World Health Organization's Domestic Violence Questionnaire, the Socio-Economic Status (SES) assessment, and forms collecting individual, social, and obstetric information. Subsequently, participants who, based on the aforementioned questionnaires, have experienced physical or sexual violence, fall within the poor or poorest categories according to the wealth index, or report an unplanned pregnancy, will be asked to provide written informed consent. These individuals will then be randomly assigned to the study groups. For the allocation of participants into intervention and control groups, a simple block randomization method will be employed, using block sizes of 4 and 6 and an allocation ratio of 1:1. Stratification will be based on parity status (primiparous vs. multiparous). To ensure allocation concealment, the type of intervention will be written on paper and placed inside opaque, consecutively numbered envelopes. These envelopes will be opened in the order of participants’ entry into the study, thereby determining their group assignment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of this study, blinding of participants or the intervention provider is not feasible. However, the outcome assessor and data analyst will remain blinded. Outcome evaluation will be conducted by a research assistant. Regarding data analysis, participants will be coded in such a way that the analyst will not have access to information indicating group allocation. This approach ensures that data analysis and interpretation remain unbiased.
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
2025-07-30, 1404/05/08
Ethics committee reference number
IR.TBZMED.REC.1404.345

Health conditions studied

1

Description of health condition studied
Maternal care and high-risk pregnancies
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mean score of pregnancy experience
Timepoint
At 34–36 weeks of gestation
Method of measurement
Pregnancy Experience Scale (PES)

2

Description
Mean score of childbirth experience
Timepoint
At 4–6 weeks postpartum
Method of measurement
Childbirth experience questionnaire version 2.0 (CEQ2.0):

3

Description
Depression scores at both time points, while controlling for baseline levels
Timepoint
At 34-36 weeks of pregnancy and 4-6 weeks after delivery
Method of measurement
Edinburgh postnatal depression scale (EPDS)

Secondary outcomes

1

Description
Frequency of type of delivery (cesarean section and vaginal delivery)
Timepoint
After birth
Method of measurement
Maternal and neonatal outcome checklist

2

Description
Average length of labor stages (active, second, and third phases)
Timepoint
In labour
Method of measurement
Maternal and neonatal outcome checklist

3

Description
Average length of hospitalization until delivery
Timepoint
From hospitalization to delivery
Method of measurement
Maternal and neonatal outcome checklist

4

Description
Average score of satisfaction with care
Timepoint
After completing the intervention in 36-39 weeks of pregnancy
Method of measurement
Visual Analogue Scale

5

Description
Average lactation performance score
Timepoint
At 4-6 weeks postpartum
Method of measurement
Breastfeeding performance questionnaire

6

Description
Average score of fear of childbirth
Timepoint
After birth
Method of measurement
(W-DEQ= The Wijma Delivery Experience Questionnaire version B)

7

Description
Average specific anxiety score
Timepoint
At 4-6 weeks postpartum
Method of measurement
Postpartum specific anxiety scale

8

Description
Frequency of desire to have more children
Timepoint
At 4-6 weeks postpartum
Method of measurement
Maternal and neonatal outcome checklist

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive continuous midwifery care from the 14th week of pregnancy until 6 weeks after delivery by a permanent midwife (researcher). In addition to routine prenatal and postpartum services, this care will include continuous and individualized care in three stages: antenatal (pregnancy), labor, and postpartum. In the prenatal stage, obstetric care will include continuous visits, group education, assessment of the mother's clinical condition, and continuous response to women's physical and psychological needs. For this purpose, six group sessions will be held during pregnancy at intervals of (14-16 weeks, 18-20 weeks, 22-24 weeks, 26-30 weeks, 32-34 weeks, and 36-38 weeks) in health centers in Bonab city. In the postpartum phase, two counseling and education sessions will be held in the health centers of Bonab city within 3 to 5 days and 4 to 6 weeks after delivery. Each group session will be held for 2 hours with the presence of 2 to 10 women and will be facilitated by a researcher (midwifery doctoral student). The content of each session will be based on the educational curriculum of the World Health Organization (WHO), the International Confederation of Midwives (ICM), the national guide to providing midwifery and childbirth services, and the content of the Midwifery continuous care model. The opinions of experts (perinatologists, reproductive health specialists, and midwives) will be used to confirm the content of the sessions. The duration of training in each session will be 60 minutes on predetermined topics focused on the patient's needs and related to the content, and 30 minutes will be allocated to measuring vital signs, listening to the fetal heartbeat, checking the height of the uterus and the weight of the pregnant mother, and the remaining 30 minutes of each session will be allocated to group discussion on possible questions and problems of the mothers. Also, a group will be formed on the social network that the mothers have the most convenient and most access to (such as ETA or WhatsApp, etc.), and the meeting materials will be uploaded there in a completely simple and understandable language, as well as additional materials, and the group members will also have the opportunity to ask questions and answer questions, and the research midwife will be available to the mothers at any time. The control group will receive standard care according to national guidelines. Participants in the intervention group will be encouraged not to visit the hospital before the onset of real pain (even before the start of the active phase of labor, if possible) to minimize unnecessary intervention, and participants will also be emphasized to inform the researcher when they visit and are hospitalized for delivery. For participants in the intervention group, the researcher will be present at their bedside in the labor ward and will support and encourage them throughout all stages of labor (this support includes providing a calm and stress-free environment, psychological and emotional support, and the active presence of the midwife to guide the mother by teaching breathing and relaxation techniques, encouraging the mother to focus on her abilities, reducing anxiety and boosting self-confidence, and helping to do appropriate exercises such as waist movements, kicking mud, and climbing stairs). The mother will be delivered by the researcher's midwife. She will also accompany the mothers in starting breastfeeding for the first 2 hours after delivery to support this stage. If mothers are hospitalized prematurely, the researcher will meet with the mothers in person at least once a day to check on their condition. Participants in both groups will be followed up for up to 6 weeks postpartum, and the final two counseling and education sessions will be held 3-5 days and 4-6 weeks postpartum.
Category
Treatment - Other

2

Description
Control group: The control group will receive standard care according to national guidelines.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in Bonab city
Full name of responsible person
Fatemeh Ahadi- yulghunlu
Street address
Health Center, Esteghlal Ave, 1st Street, Bonab City
City
Bonab
Province
East Azarbaijan
Postal code
5551746469
Phone
+98 41 3776 9050
Email
info@bonab.tbzmed.ac.ir

2

Recruitment center
Name of recruitment center
Bonab shohada hospital
Full name of responsible person
Fatemeh Ahadi- yulghunlu
Street address
Bonab City, Bonab Malekan Road, next to the Seminary
City
Bonab
Province
East Azarbaijan
Postal code
5557113379
Phone
+98 41 3774 4530
Email
bonabshohadahosp@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khosrow Adibkia
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
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
Fatemeh Ahadi- yulghunlu
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Chaharborj, Imam Ave, Shahid Shokrani Alley, next to the clinic
City
Chaharborj
Province
West Azarbaijan
Postal code
5977183808
Phone
+98 914 496 5317
Email
fatemehahadi8@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
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
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
Fax
Email
mirghafourvand@gmail.com
Web page address

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
No - There is not 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
Loading...