Protocol summary

Study aim
To determine the effect of implementing the continuous care model by midwifery students during pregnancy, childbirth, and postpartum on childbirth experience, fear of childbirth, and postpartum depression
Design
A randomized clinical controlled trial with two parallel arms, with no blinding, on 92 participants. The allocation sequence will be generated through individual stratified (based on 1st or 2nd-3rd birth order) block randomization with randomly varied block sizes of four and six, and an allocation ratio of 1:1 using a computer program. The central method will be used for the allocation concealment.
Settings and conduct
The continuous care will be at least two in-person visits and a required number of virtual consultations during pregnancy, attending labor and delivery, an in-person visit after delivery, and at least three postpartum virtual consultations provided by Tabriz sixth/seventh-semester midwifery students
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age 26 to 29 weeks; single pregnancy; maximum history of two births; no underlying disease; no pregnancy complications; no high-risk pregnancy; a minimum of secondary education; willingness to give birth in one of Tabriz Government Hospitals. Exclusion criteria: history of cesarean section; willingness to elective cesarean section; lack of access to smartphones and the internet; major known abnormalities in the fetus; occurrence of stressful events in the last three months; simultaneous participation in another trial
Intervention groups
The intervention group will receive continuous care provided by midwifery students from pregnancy to six weeks after delivery, in addition to routine care. The control group will receive only routine care during pregnancy, birth, and postpartum.
Main outcome variables
Scores of fear of childbirth; childbirth experienceو and postpartum depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100414003706N41
Registration date: 2022-04-30, 1401/02/10
Registration timing: prospective

Last update: 2022-04-30, 1401/02/10
Update count: 0
Registration date
2022-04-30, 1401/02/10
Registrant information
Name
Sakineh Mohammad-Alizadeh-Charandabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 2699
Email address
alizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-25, 1401/04/04
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of implementing the continuous care model by midwifery students during pregnancy, childbirth, and postpartum on childbirth experience, fear of childbirth, and postpartum depression
Public title
Effect of continuous care model from pregnancy to postpartum by midwifery students
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 26 to 29 weeks based on LMP or under 12- week ultrasonography Single pregnancy Maximum history of two birth No known underlying disease before pregnancy No history of high-risk pregnancy Have a minimum of secondary education Willingness to give birth in hospitals affiliated with Tabriz University of Medical Sciences or Tabriz Social Security Hospital
Exclusion criteria:
History of cesarean section Willingness to elective cesarean section No access to smartphones and the internet Known major abnormalities in the fetus Occurrence of any stressful events (such as divorce, death of first-degree family members, and diagnosis of an incurable disease for a family member) in the last three months Simultaneous participation in another trial
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Participating pregnant women will be randomized into two groups, receiving continuous care by midwifery students or control. The allocation sequence will be generated by a person not involved in the recruitment and data collection through stratified (based on 1st or 2nd-3rd birth order) block randomization with randomly varied block sizes of four and six, and an allocation ratio of 1:1 using a computer program. Central allocation (phone) will be used for the allocation concealment. Simple randomization will be used to determine the sequence of assigning the participating women to midwifery students. Two pregnant women will be assigned to each student (as primary caregivers) and each student will support another student who provides care for two other women.
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
Ethics committee of Tabriz University of Medical Sciences
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-04-19, 1400/01/30
Ethics committee reference number
IR.TBZMED.REC.1401.094

Health conditions studied

1

Description of health condition studied
Fear of childbirth
ICD-10 code
F40.232
ICD-10 code description
Fear of other medical care

2

Description of health condition studied
Postpartum depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes

3

Description of health condition studied
Childbirth experience
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Childbirth experience score
Timepoint
40 to 50 days after delivery
Method of measurement
Childbirth Experiences Questionnaire vsersion 2.0 (CEQ2.0)

2

Description
Postpartum depression score
Timepoint
50-40 days after delivery
Method of measurement
Edinburgh Postnatal Depression Scale (EPDS)

3

Description
Fear of childbirth score
Timepoint
Baseline (before randomization), 35-36 weeks of pregnancy, 50-40 days after delivery
Method of measurement
The Wijma delivery expectancy/experience questionnaire (W-DEQ-A and B)

Secondary outcomes

1

Description
Fear of childbirth score (during pregnancy)
Timepoint
Baseline (before randomization), 35-36 weeks of pregnancy
Method of measurement
The Wijma delivery expectancy/experience questionnaire (W-DEQ-A)

2

Description
Pregnancy depression score
Timepoint
Baseline (before randomization), 35-36 weeks of pregnancy
Method of measurement
Edinburgh Postnatal Depression Scale (EPDS)

3

Description
Childbirth satisfaction score
Timepoint
12 to 24 hours after delivery
Method of measurement
Maternal satisfaction in normal and caesarean birth (SMMS-normal birth and SMMS- caesarean birth)

4

Description
Score for receiving support and control
Timepoint
12 to 24 hours after delivery
Method of measurement
Support and Control in Birth (SCIB)

5

Description
Score of experiences of maternity care
Timepoint
40-50 days after delivery
Method of measurement
Women’s experiences of maternity care (EMC)

6

Description
Breastfeeding self-efficacy score
Timepoint
40-50 days after delivery
Method of measurement
Breastfeeding Self-efficacy Scale (BSES)

7

Description
Type of delivery
Timepoint
After delivery
Method of measurement
Checklist (vaginal/cesarean)

8

Description
Duration of hospitalization until delivery
Timepoint
12-24 hours after delivery
Method of measurement
Mother's hospital record

9

Description
Infant's fifth-minute APGAR
Timepoint
12-24 hours after delivery
Method of measurement
Infant's hospital record

10

Description
Change in hematocrit between before and after delivery
Timepoint
At the time of admission of the mother in the hospital and 12-24 hours after delivery
Method of measurement
Measurement of blood hematocrit at laboratory of the hospital

Intervention groups

1

Description
Intervention group: Continuous care will include the following:1. Receive at least twice face-to-face care (between 26-29 weeks and between 35-36 weeks of pregnancy), ۲. Telephone or video consultations (at least four consultations with intervals of 7-10 days between two face-to-face care sessions and then weekly until delivery), 3. Attending a woman's bedside and providing care during labor and delivery up to 2 hours after delivery, 4. Face-to-face visit 24-12 hours after delivery in the hospital, 5. Giving at least three telephone or video consultations (3-5 days, 7-10 days and 20-30 days) after delivery, 6. Giving students' mobile numbers to women to answer possible non-emergency questions (from 8 am to 11 pm) and emergency questions and delivery information (24 hours a day, 7 days a week), 7. Additional face-to-face or online care will also be provided by the students during pregnancy or after delivery.
Category
Prevention

2

Description
Control group: Control group: will receive their usual pregnancy, childbirth, and postpartum care in health centers and hospitals. This group of mothers will also receive free online counseling from six weeks (end of follow-up on the impact of the intervention) to six months after delivery by the Ph.D. student in midwifery who owns the dissertation.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Selected health centers in Tabriz
Full name of responsible person
Ahmad Mardi
Street address
Nesfeh-rah, Tabriz City Health Center
City
Tabriz
Province
East Azarbaijan
Postal code
5183875357
Phone
+98 41 3444 2510
Email
Tabrizphc@tbzmed.ac.ir
Web page address
https://tabriz-phc.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
No. 2, Central building of the university, Golgasht street, Azadi Ave., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.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
Elham Jafari
Position
P.hD student in midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tabriz- South Shariati St. School of Nursing & Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3475 3906
Email
elhamdjafari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sakineh Mohammad-Alizadeh-Charandabi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing & Midwifery, South Shariati
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 2699
Fax
+98 41 3479 6969
Email
alizades@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elham Jafari
Position
P.hD student in midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery, South Shariati Street. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
0098 4234753906
Email
elhamdjafari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All deidentified IPD can be shared.
When the data will become available and for how long
Starting soon after the publication of the study results.
To whom data/document is available
Data will be available for researchers working in academic institutions, as well as to the chief editor and reviewers of the submitted manuscript.
Under which criteria data/document could be used
The data will be available to researchers upon request and submission of the proposal to perform a meta-analysis using IPD. Also, in exceptional cases, data will be made available to the chief editor of the journals for checking.
From where data/document is obtainable
Refer to the email addresses (alizades@tbzmed.ac.ir)
What processes are involved for a request to access data/document
The requests should be sent by email and data will be available within two weeks.
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