Effect of “motivational interviewing” and “information, motivation, and behavioral skills” counseling interventions on choosing the mode of delivery in pregnant women: a study protocol for a randomized controlled trial

Cesarean section (CS) is an important surgical procedure, when normal vaginal delivery (NVD) imposes a risk to mother and/or baby [1]. The World Health Organization (WHO) states that a rate of CS between 10 and 15% of all births is ideal; however, the rate is steadily growing in recent years [2]. The average worldwide rate of CS is 18.6%, ranging from 6.0 to 27.2% in the least and more developed countries, respectively. Countries with the highest CS rates are Brazil (55.6%) and Dominican Republic (56.4%) in Latin America and the Caribbean. Iran and Turkey (47.9% and 47.5%, respectively) have the highest rates in Asia [3]. In Iran, the rate is even higher in private hospitals (72–89%) [4‐7].

CS can save the lives of mothers and infants in emergency situations. However, current rates suggest that the CS is now used for women with normal and non-complicated pregnancies and births, when it is not medically necessary [8]. Unnecessary CSs could create complications with no benefits to both mother and baby [3, 9‐12]. According to an observational study conducted by the WHO in nine Asian countries, women who undergo an unplanned CS before or during labor or who have an assisted (operative) vaginal delivery are more likely to experience morbidity than those who have spontaneous vaginal delivery [13]. As with any surgery, CS is associated with short- and long-term risks that may be minor or severe [14]. CS can be associated with significant short-term risks such as asphyxia, if the uterus is hypoperfused due to anesthesia, scalpel lacerations, and neonatal respiratory morbidities [9]. Other short-term risks of CS include increased risk of infection and lower likelihood of breastfeeding [10, 11, 15]. Moreover, urinary catheterization is associated with post-CS bacteriuria and has been reported to be as high as 11% [16]. Increasing rates of CS are associated with increased maternal and perinatal morbidities [17].

In 2014, Iran’s “health sector evolution policy” was launched to improve public health. One important objective of this policy was to decrease the rate of unnecessary CSs [18]. Several strategies have been conducted such as freeing NVDs in all public hospitals, developing mother-friendly hospitals, developing standard protocols of birth and preparation classes for women, improving privacy and infrastructure of labor, promoting standards in birth facilities, promoting water birth, and determining financial incentives to doctors to encourage them to do NVDs in public hospitals [19]. There was a reduction in CS rate after implementing the policy; however, the rate is still significantly higher than the rate recommended by the WHO [19].

Several studies have been conducted on reasons behind the high rate of CS in Iran [20‐23]. Studies have shown that the main reason is the willingness of women to undergo CS due to fear of pain during labor and childbirth [21, 24, 25], concerns about genital modifications after vaginal delivery [26‐28], belief that CS is safer for the baby [29‐31], and the convenience for women and their families [18]. Studies show that women can play a major role in the decision-making process about their birth [32‐36].

In recent years, different interventions intended to reduce the CS rate in Iran [37‐40]. Although these interventions have been effective in the short term, they have not been effective in the long term. To further reduce the rate of CS, it is necessary not only to address the health system, health facility, and health professional factors, but also to change women’s choice behaviors [19]. The WHO has provided recommendations on non-clinical interventions to reduce unnecessary CSs. The recommendations are grouped according to the target of intervention: (a) interventions targeted at women, (b) interventions targeted at healthcare professionals, and (c) interventions targeted at health organizations, facilities, or systems [41].

Regarding non-clinical interventions on reducing unnecessary CS targeted at women, the WHO has recommended implementing psycho-education interventions for women [8, 42]. A Cochrane review conducted by Chen et al. on non-clinical interventions for reducing unnecessary CS reported that psycho-education interventions were effective in reducing unnecessary CSs [43]. The educational interventions included psycho-education on fear of childbirth [44], intensive group therapy (cognitive-behavioral therapy and childbirth psycho-therapy) [45], psycho-education by telephone [46], role-play education versus standard education using lectures [47], and nurse-led applied relaxation training program [44].

Several psycho-educational models and methods/strategies have been introduced to change behaviors effectively. Motivational interviewing (MI) is a patient-centered counseling approach to motivate individuals to change their behaviors [48], and it is specifically designed to enhance motivation to change among patients not ready to change [49]. It highlights the importance of motivation in personal behavior change. Research on MI has demonstrated positive effects of helping patients clarify goals, explore obstacles to treatment, and make commitments to change [49]. MI is a relatively new cognitive-behavioral technique that aims to help patients identify and change behaviors that may be placing them at risk of developing health problems or may be preventing optimal management of a chronic condition.

In the Information-Motivation-Behavioral skills (IMB) model, preventive behavioral skills represent a final common pathway for predicting complex preventive behaviors [50]. The IMB model is a generalizable and simple model to guide thinking about complex health behaviors. The IMB constructs, and how they pertain to patient adherence, are outlined below: (1) Information is the basic knowledge about a medical condition that might include how the disease develops, its expected course, and effective strategies for its management; (2) Motivation encompasses personal attitudes towards the adherence behavior, the perceived social support for such behavior, and the patients’ subjective norms or perceptions of how others with this medical condition might behave; and (3) Behavioral skills include ensuring that the patient has specific behavioral tools or strategies necessary to perform the adherence behavior such as enlisting social support and other self-regulation strategies.

In recent years, mobile applications play an important role in delivering educational content. People carry their mobile phones with themselves wherever they go, so educational interventions can be delivered at any time to anyone with extra support upon request wherever and whenever it is needed. This opportunity provides simple and non-expensive interventions to various ranges of individuals. Motivational messages, monitoring, and behavior change tools can be modified for delivery via mobile phones [51]. The effectiveness of this type of intervention is affirmed in several studies such as smoking cessation [52], adherence to prescribed medication [53], and blood pressure management [54]. This paper explains our study protocol aiming at comparing the effect of MI and IMB, and IMB based on mobile application (IMB-App) on choosing the mode of delivery in pregnant women.

This is the protocol of our study that aims at comparing the effect of IM, IMB, and IMB-App counseling interventions on choosing the mode of delivery in pregnant women.

This study is a randomized controlled, parallel-design trial.

Pregnant women will be chosen from private hospitals located in Tehran. We have chosen private hospitals, because they support elective CS by providing high-quality facilities for women. Only in private hospitals, women are able to choose CS as a mode of delivery (maternal request) [18].

Written informed consent will be obtained from all the participants by the principal investigator or sub-investigators prior to enrollment.

This is not applicable. No biological specimens will be collected for research purposes; hence, no additional consent will be sought from the participants.

This is not applicable.

The intervention will be discontinued based on the participant’s request, or if a woman undergoes birth.

This is not applicable.

Usual prenatal care will be provided in all study groups.

This is not applicable.

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 to 2021.

The sample size is 120 pregnant women (30 in each group) with a power of 80% to detect a minimum difference.

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 fulfill 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 randomly allocated in three intervention groups and one control group.

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 the registration order of women with the 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 interventions, respectively. The fourth participant will be assigned to the control group.

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.

There will be four arms. The abovementioned interventions will be implemented among the three intervention groups. The control group will only receive usual care.

As the RCT is an educational intervention study, blinding of participants and researchers is not possible. To minimize selection bias, we will use randomization.

This is not applicable.

The primary outcome of the intervention (mode of delivery) will be measured using a checklist after the childbirth.

The secondary outcomes will be measured by a questionnaire 1 month after the interventions.

We will follow the participants until the time of delivery. The pregnant women will be participated in this study after ensuring that they have met the 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 group and its operation will be taught to them.

To ensure that the data is correctly entered, a double entry of data will be performed by two different individuals. Pregnant women who refer to the hospital will be registered, by chronological order of selection, and they will be allocated randomly in each group. All data obtained from women will be entered to SPSS software. A code will be defined to identify missing data. After screening the data and preparing the data for statistical analysis, first using descriptive statistics such as frequency tables, means and standard deviation, and bar chart and histogram, the distribution of variables will be checked. The obtained data will be kept strictly confidential and will be stored with secured and restricted access; also, the signed consent will be kept locked. Follow-up data are received using the same questionnaires as used at baseline.

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.

This is not applicable. Researchers confirm that there are no laboratory and storage of biological specimens for genetic or molecular analysis in this study.

Data will be analyzed using descriptive statistics (mean, frequency, and standard deviation); inferential statistics including independent t test, paired t test, chi-squared, and one-way ANOVA tests; and logistic regression modeling to examine the factors affecting the women’s choice on the mode of delivery 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.

This is not applicable.

This is not applicable.

This is not applicable.

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.

This is not applicable.

Data monitoring will be coordinated by INSF. 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.

Due to the nature of the intervention, there is no adverse event and no harm in this study. Based on our knowledge, the study will not have any negative consequences.

Every 6 months, we will send a report to the auditor.

This is not applicable.

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.

We understand that women may be inclined to respond in certain ways because they come to receive certain services. However, we will ensure that their responses will not affect the service they will receive and ensure confidentiality. The self-report nature of the questionnaire and necessity of owning a smartphone are another limitation.

Diverse interventions will allow the researchers to obtain different perspectives from the outcome. We have designed evidence-based non-clinical interventions to reduce unnecessary CSs targeted at women. Causes of increasing CS rates are various and different between and within countries. Before implementing any intervention on the issue, we should recognize the reasons behind this increase, as well as locally relevant determinants of CS, and the views and cultural norms of women and healthcare providers. Our study is supported by evidence-based (qualitative synthesis and meta-analysis in Iran) (unpublished paper) information. We will also use a mobile app, a technology that is ubiquitous and has no limitations. Another strength is the simple and non-expensive nature of the interventions.