Protocol summary
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Study aim
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1. Compare mean childbirth preparedness between groups at 4 weeks (adjusted for baseline).
2. Compare mean fear of childbirth at 4 weeks and 24h postpartum (adjusted for confounders).
1. Compare mean childbirth experience at 24h postpartum (adjusted for confounders).
2. Compare mean childbirth self-efficacy at 24h postpartum (adjusted for baseline).
3. Compare mean postpartum depression literacy at 4 weeks (adjusted for baseline).
4. Compare frequency of delivery type between groups.
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Design
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This randomized clinical trial with parallel groups and no blinding will be conducted on 70 pregnant women. Participants will be allocated to intervention and control groups in a 1:1 ratio using block randomization (blocks of 4 and 6) generated in RAS software by an independent person. The allocation will be concealed in sequentially numbered opaque envelopes, which will be opened in order of participants’ enrollment.
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Settings and conduct
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A randomized parallel trial on pregnant women (24–32 weeks) will be conducted in Tabriz health centers (2025). Participants are allocated by block randomization to intervention (personalized web app) or control (routine care). Data are collected before, after intervention, and postpartum. No blinding is applied.
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Participants/Inclusion and exclusion criteria
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Inclusion: 24–32 weeks, singleton, literate, smartphone, app use ability, non-medical education.
Exclusion: Pregnancy complications/diseases, multiples, cesarean indications, prior cesarean or classes, high-risk pregnancy.
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Intervention groups
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Intervention group:personalized web application will be used four weeks, supplemented with researcher-led online support. To ensure thorough content engagement, each section of the app includes questions.Control group Participants will receive only routine standard care
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Main outcome variables
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childbirth preparation
fear of childbirth
General information
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Reason for update
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We registered [the study] in the IRCT, but we were supposed to start sampling in January 2025. However, due to the delay in the web development process, the probable date for the third phase of the study and the RCT is now projected for February 2027.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171007036615N16
Registration date:
2025-11-18, 1404/08/27
Registration timing:
prospective
Last update:
2026-10-14, 1405/07/22
Update count:
1
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Registration date
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2025-11-18, 1404/08/27
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Registrant information
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Recruitment status
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Not yet recruiting
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Funding source
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Expected recruitment start date
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2027-01-11, 1405/10/21
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Expected recruitment end date
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2027-06-20, 1406/03/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Design, development and evaluation of an educational web application based on woman-centered care for childbirth preparation in pregnant women
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Public title
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Design and evaluation of an educational web application based on woman-centered care for childbirth preparation
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Gestational age of 24 to 32 weeks
Singleton pregnancy
Literacy (ability to read and write)
Ability to use a mobile application
Not having a medical field education
Possession of a smartphone
Exclusion criteria:
Development of any pregnancy complications, such as preeclampsia.
Bleeding and intrauterine fetal death.
Multiple pregnancy
Presence of chronic diseases or conditions that are induced or exacerbated by pregnancy, such as hypertension, cardiovascular diseases, diabetes, preeclampsia, etc.
Indications for cesarean section, such as placenta previa, non-cephalic presentations, abnormal fetal heart rate patterns, etc.
History of cesarean section or uterine surgery/scarring.
Previous participation in physiological childbirth classes.
Abnormal pregnancy conditions, such as polyhydramnios, oligohydramnios, or intrauterine growth restriction (IUGR).
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Age
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From 15 years old to 49 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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One-half of the health centers will be selected, considering diverse geographical locations and socioeconomic levels. In total, five centers will be selected from different areas of Karaj (taking into account diversity in terms of socioeconomic status). A list of pregnant mothers is available in the 'Sib' Health Information System at the health centers. The researcher will attend the selected centers, prepare a list of potentially eligible individuals, and then contact them by phone. After assessing the inclusion and exclusion criteria, those who qualify will be given a brief explanation of the study's purpose. If they are willing to participate, they will be invited to an in-person session at a health center near their residence.
Participants will be allocated to either the intervention or control group with a 1:1 ratio using block randomization, stratified by the number of previous births. A person not involved in the sampling will perform the allocation using RAS software with block sizes of 4 and 6.
The allocation details will be written on paper and placed in sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. The envelopes will be opened in the order of the participants' entry into the study. The mother's name will be written on the selected envelope, and she will be informed of her assigned group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-09-08, 1404/06/17
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Ethics committee reference number
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IR.TBZMED.REC.1404.435
Health conditions studied
1
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Description of health condition studied
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childbirth preparation
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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fear of childbirth
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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childbirth preparation score
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Timepoint
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Before the intervention and 4 weeks after the intervention
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Method of measurement
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Childbirth Readiness Scale(CRS)
2
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Description
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fear of childbirth score
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Timepoint
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Before the intervention and 4 weeks after the intervention and 24 hours after delivery
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Method of measurement
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Wijma delivery expectancy/experience questionnaire
Secondary outcomes
1
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Description
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childbirth experience score
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Timepoint
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24hours after delivery
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Method of measurement
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Childbirth Experiences (CEQ-2.0) 2.0 Questionnaire version
2
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Description
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Child Birth Self Efficacy score
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Timepoint
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Before the intervention and 24 hours after delivery
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Method of measurement
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Child Birth Self Efficacy questionnaire
3
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Description
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Postpartum depression literacy score
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Timepoint
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Before the intervention and 4 weeks after the intervent
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Method of measurement
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Postpartum depression literacy Scale (PoDLiS)
4
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Description
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Frequency of mode of delivery
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Timepoint
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24 hours after delivery
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Method of measurement
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Frequency of mode of delivery check list
Intervention groups
1
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Description
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Intervention group: The designed web application will be installed on the smartphones of participants in the intervention group. Its content will be personalized so that, at the beginning, users must enter information such as gestational age and their symptoms. Based on these settings, each user will access the section of the app that contains information relevant to their pregnancy condition. The researcher will train participants in the intervention group on how to use the app so they can fully utilize its content over four weeks. The researcher will also provide online support and guidance during this period. Throughout the intervention, the researcher (student) will maintain contact with participants via phone calls and text messages to remind them to use the relevant content at each stage, and will share their contact information for any questions. To ensure thorough engagement with the app content, a limited set of relevant questions will be designed to be answered before and after each section.
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Category
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Prevention
2
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Description
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Control group: They will receive routine care according to the national guidelines.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No further information is available.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available