Study setting {9}
Pregnant women will be chosen from private hospitals located in Tehran.
Eligibility criteria {10}
Inclusion criteria: The criteria for entering women are being literate, being in gestational age 24 to 32 weeks, being able to speak Persian, having no complications in the current pregnancy, having no indications for CS, and having enough time to participate in the interventions.
Exclusion criteria: We exclude women, who show complications during the study, have preterm
labour, and are reluctant to continue to participate in this study.
Who will take informed consent? {26a}
Written informed consent will be obtained from all the participants by the principal investigator or subinvestigators prior to enrollment.
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Not applicable. No biological specimens will be collected for research purposes; hence, no additional consent will be sought from the participants.
Interventions
Explanation for the choice of comparators {6b}
Not applicable
Intervention description {11a}
The content of interventions will be designed based on a qualitative evidence synthesis and a quantitative systematic review and meta- analysis in Iran (55). Also we will design the interventions tailored to the participants needs.
1. Motivational interviewing
In this intervention group, pregnant women will be trained face-to-face based on the MI. During three 45-60 minutes sessions, MI techniques will be provided to the participants. MI is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence. It is most centrally defined not by technique but by its spirit as a facilitative style for interpersonal relationship. MI is a relatively simple, transparent and supportive talk therapy based on the principles of cognitive–behavior therapy. In this group, we will help women to explore and resolve ambivalence about mode of delivery and builds their intrinsic motivation.
We will not force women to choose a specific mode of delivery. We will ask open–ended questions (for example “Tell me what you think about CS?" or “What do encourage you to choose this type of delivery (CS or NVD)?”). Open-ended questions can help us to understand how they are thinking about type of delivery. Affirming is one of the fundamental MI skills. We will use it to support engagement, encourage the women to further explore change processes and build confidence. We will find an opinion the client is making or a strength she will notice and reflect it back to her (for example” So how did you manage to control your fear after attending our training sessions? (". We will use reflective listening. It is a simple method to reduce resistance in MI and the last step of this technique is to summarize what the pregnant women have said.
2. Information, motivation and behavioral skill model through face-to-face approach
During three 45-60 minutes sessions, the model’s strategies will be provided to the participants. Participants will receive information and behavioral skills related to the choice of mode of delivery as well as internal and external motivational factors related to the choice of delivery. The strategy include: 1) Information: the intervention will begin with information on prevalence of CS and CS-related complications in women; and outcome of unnecessary CS; 2) Motivation: the interventionist will perform this technique to motivate pregnant women; providing personal feedback, asking open ended questions, affirming desirable behavior, reflective listening, working at the women’s pace and negotiating goals that will be realistic and attainable; 3) Behavioral skills: women will be given behavioural skills training on how to control the obstacle of NVD. To build skills for choosing the mode of delivery, training will be given on how reduce these barriers.
3. Information, motivation and behavioral skill model through Mobile App
The mobile application (M-health) has been designed based on IMB model. The software will be installed on mobile phones of participants in the group; and its operation will be taught individually. Women will work with the application in presence of the research team, and any existing problems will be resolved. The strategies foreseen for adherence improvement include reminders set at defined intervals in the form of pop-up messages. In order to monitor adherence, the data collected on the server will be used. In addition to the application, a server will be designed in which the users’ activities will be collected. Items such as the duration of application usage, the sections used by the user (in addition to registering their time and duration), etc. will be registered. Every time the user’s mobile is connected to the Internet, the data will be uploaded and saved on to the server. These data can be used as a proxy of adherence to the intervention.
Control group: without any intervention
Criteria for discontinuing or modifying allocated interventions {11b}
The intervention will be discontinued based on participant’s request, or if woman undergo birth.
Strategies to improve adherence to interventions {11c}
Not applicable.
Relevant concomitant care permitted or prohibited during the trial {11d}
Usual prenatal care in all study groups
Provisions for post-trial care {30}
Not applicable
Outcomes {12}
- Determining and comparing the effects of face-to-face MI, face-to-face IMB model, and using a mobile application on intention of performing CS in women in the target and control groups before and after the interventions.
- Determining and comparing the effect of face-to-face MI, face-to-face IMB model, and using mobile application on women's self-efficacy in target and control groups before and after the interventions.
- Determining and comparing the effects of face-to-face MI, face-to-face IMB model, and using a mobile application on mode of delivery in the target and control groups before and after the interventions.
- Determining the usability of mobile application by pregnant women.
Participant timeline {13}
The recruitment of participants for this study started in December 2019 and is still ongoing. The recruitment is expected to be completed in April 2020. The data analysis, writing of scientific manuscripts, and submissions to peer-reviewed scientific journals will occur from 2020-2021.
Sample size {14}
The sample size is 120 pregnant women (30 in each group) with a power of 80% to detect a minimum difference
Recruitment {15}
We will be present in the research setting during the intervention period to recruit all eligible women. The study will be available to all pregnant women interested in participating and speaking Persian. Individuals who fulfil the inclusion criteria will receive a description of the study, indicating the follow-up schedule and assurance of confidentiality; and they will be directed to complete a consent form. Included participants will be randomized to three interventions and one control group.
Assignment Of Interventions: Allocation
Sequence generation {16a}
The participants will be randomly assigned to four groups after the initial assessment and upon completing the baseline data form. We will recruit the participants based on registration order of women with clinic, and no other factor will contribute to participants’ order on the list. Each participant on the list will be assigned a consecutive research identification number according to the order by which they will be registered with the clinic. The first participant on the list will be randomly assigned to the MI intervention group, and the next two participants will be assigned to the IMB and IMB app-based interventions, respectively. The forth participant will be assigned to the control group.
Concealment mechanism {16b}
Randomization will be performed by a person who will not be engaged in the study and will be blinded to the identity of the participants.
Implementation {16c}
There will be four arms. The above-mentioned interventions will be implemented among three intervention groups. The control group will only receive usual care.
Assignment of interventions: Blinding
Not applicable. It is not possible to mask this study because of the nature of the study. To avoid bias in the outcome assessment, research assistants concerned with data collection and/or preparation will be blind to the allocation of the participants.
Who will be blinded {17a}
As the RCT is an educational intervention study, blinding of participants and researchers is not possible. To minimize bias, we will be used randomization.
Procedure for unblinding if needed {17b}
Not applicable
Data Collection And Management
Plans for assessment and collection of outcomes {18a}
The primary outcomes of the intervention will be measured by questionnaire.
Questionnaire: The questionnaire contains the women’s demographic information, self-efficacy in CS, and intention (56, 57). The questionnaire include items on age, income, educational level (pregnant women and their spouses), employment status (pregnant women and their spouses), number of births, number of pregnancies, current gestational age, number of live children, history of infertility, history of illness, occupation, date of birth, participating in birth classes, preferred mode of delivery. The questionnaire also consist of 17 items about self-efficacy and two items about intention. The Cronbach’s coefficient alpha will be calculated to test the reliability; and exploratory factor analysis will be conducted to examine construct validity of the questionnaire.
Plans to promote participant retention and complete follow-up {18b}
We will follow the participants until time of delivery. The pregnant women will be participated in this study after ensuring that they have study criteria. They will complete informed consent forms. In the first visit, the baseline measurement will be completed by the researcher. During the second visit, the application will be installed on cell phones of the IMB app-based group and its operation will be taught to them.
Data management {19}
In order to ensure that the data is correctly entered, a double entry of data will be performed by two different individuals.
Confidentiality {27}
Only researchers will have access to the personal data in the trial. These data will not be published, and they will be discarded after the publication of results.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Not applicable. Researchers confirm that there are no laboratory and storage of biological specimens for genetic or molecular analysis in this study.
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Data will be analyzed using the Chi-squared test and logistic regression modelling to examine the factors affecting their choice on mode of delivery in order to examine the simultaneous effect of variables on the chances of choosing CS. The significance level of the tests will be considered as less than 0.05.
Interim analyses {21b}
Not applicable.
Methods for additional analyses (e.g. subgroup analyses) {20b}
Not applicable.
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
Not applicable
Plans to give access to the full protocol, participant level-data and statistical code {31c}
Information from the full protocol will be published in a peer-reviewed journal. The relevant data analyzed during the development of this study protocol are available upon request from the corresponding author.
Oversight and monitoring
A team from Tehran University of Medical Sciences and a peer reviewer (audit) from ISNF will regularly monitor the study implementation and datasets and make recommendations on necessary protocol modifications or termination of all or part of the study.
Composition of the coordinating centre and trial steering committee {5d}
N/A
Composition of the data monitoring committee, its role and reporting structure {21a}
Data monitoring will be coordinated by ISNF. The auditors will follow a monitoring plan to verify that the clinical trial is conducted and that data are generated, documented, and reported in compliance with the protocol and the applicable regulatory requirements.
Adverse event reporting and harms {22}
Due to the nature of the intervention, there are no adverse event and no harms in this study. Based on our knowledge, the study will not have any negative consequences.
Frequency and plans for auditing trial conduct {23}
Every six months, we will send a report to the auditor.
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Not applicable.
Dissemination plans {31a}
We will share the results of this study with key stakeholders via presenting in related seminars and publishing in peer-reviewed journals. We will also provide and share monographs with related departments in the Ministry of Health, Iran.