This multi-method research will be conducted in two phases: the first phase involves intervention design and the application of the Delphi technique, while the second phase encompasses the implementation and evaluation of a part of the intervention program.
In the initial phase, which focuses on program design, the planning framework of Talbot and Verinder (23) will serve as the foundation. The process will commence with a needs analysis utilizing a literature review to identify factors pertinent to vaginal birth after cesarean. To prioritize these factors, a cross-sectional study will be conducted involving pregnant mothers with a history of cesarean section, alongside gynecologists, midwives, and healthcare managers at the levels of vice president of treatment and vice president of health. Following the analysis of results and determination of priorities, program objectives will be established based on feasibility. Subsequently, the program will undergo validation using the Delphi method by reproductive health specialists, obstetrics and gynecology experts, midwives, and healthcare managers at the levels of vice president of treatment and vice president of health, and considering a panel of experts.
In the second phase, a part of the designed program will be conducted in the form of an interventional study in order to evaluate the impact of the intervention.
First phase: program design and Delphi technique
During this phase, following the Talbot and Verinder model, the researcher aims to uncover the needs, challenges, and solutions for enhancing vaginal birth after cesarean among pregnant women with a history of one cesarean section. The objective is to develop an intervention program with their active involvement.
The first step of the first phase: review study
The researcher will conduct a narrative study utilizing a Boolean search strategy to identify and categorize factors associated with VBAC.
This study will involve searching Iranian databases such as SID, MagIran, IranMedex, and Google Scholar using Persian keywords, specifically “vaginal birth after cesarean section,” “repeat cesarean section,” “trial of labor after cesarean delivery,” and “multi-method study.” Due to the limitations of Iranian databases in recognizing the terms “and” and “or,” each keyword will be searched independently. Additionally, English keywords such as “vaginal birth after cesareans,” “vaginal births after cesarean,” “trial of labor after cesarean,” “repeated cesarean section,” and “multi-method study” will be searched using “AND” and “OR” operators in Embase, Scopus, PubMed, Medscape, Cochrane Library, and Web of Science without any time restrictions. This search will encompass a review of various quantitative and qualitative studies, including reports from cross-sectional, longitudinal, clinical, and qualitative clinical trial studies.
The Second Step of the First Phase: Cross-Sectional Study
Statistical population:
The study’s statistical population comprises all gynecologists, midwives, health managers at the levels of vice president of treatment and vice president of health, and all pregnant mothers seeking prenatal care at the comprehensive health centers in Isfahan City.
Samples:
In the quantitative phase, the sample will consist of 75 pregnant mothers with a history of one cesarean section and 75 gynecologists, midwives, and health managers at the levels of vice president of treatment and vice president of health of Isfahan University of Medical Sciences.
Research setting:
This research will be conducted at Isfahan comprehensive health centers, private practices, and hospitals.
Sampling method:
In collaboration with the Vice-Chancellor of Health and Medical Sciences at Isfahan University of Medical Sciences, a list of hospitals, comprehensive health centers under Isfahan Health Centers 1 and 2, and private practices in Isfahan City will be compiled. Following the random selection of districts, a specific number of comprehensive health centers, hospitals, and private practices covered by Isfahan Health Centers 1 and 2 will be chosen based on the volume of clients visiting these facilities using a quota sampling approach. The samples will be selected based on the inclusion criteria using an available sampling method.
Sample size:
In order to prioritize factors associated with VBAC from the perspectives of expectant mothers and healthcare professionals (gynecologists, midwives, and managers at the levels of vice president of treatment and vice president of health), assuming an equal percentage (75%) based on relevant studies (21) in the two groups with a 5% error level and 80% power, the sample size for each group, comprising mothers and health staff (gynecologists, midwives, and managers at the levels of vice president of treatment and vice president of health), will be set at 75 participants each.
$$\:n=\frac{\left[{p}_{1}\left(1-{p}_{1}\right)+{p}_{2}\left(1-{p}_{2}\right)\right]\times\:{\left({z}_{1-\frac{\propto\:}{2}}+{z}_{1-\beta\:}\right)}^{2}}{{\left({p}_{2}-{p}_{1}\right)}^{2}}$$
Inclusion criteria for mothers:
Inclusion criteria for gynecologists, midwives, and health managers:
Exclusion criterion:
Data collection tool:
To assess the attitudes of pregnant women, the Childbirth Attitude Questionnaire (24) will be utilized. This questionnaire consists of 20 questions measuring attitude, scored on a five-point Likert scale ranging from 4 to 0 (“I completely agree,” “I agree,” “I have no opinion,” “I disagree,” and “I completely disagree”). For negative questions, the scoring is reversed from 4 to 0. Participants will be categorized into three groups based on their attitude scores: positive, neutral, and negative. The scoring ranges are as follows: 0 to 33.33% for the negative attitude group, 33.34 to 66.66% for the neutral attitude group, and 67.67 to 100% for the positive attitude group
To identify factors influencing the choice of delivery method as perceived by managers at the levels of vice president of treatment, midwives, and gynecologists, the Mode of Delivery Questionnaire will be employed. The validity and reliability of this questionnaire were confirmed by Valiani et al. (25). It comprises 13 questions for gynecologists, 20 questions for midwives, and 18 questions for managers.
Validity and reliability of the Mode of Delivery Questionnaire:
The Mode of Delivery Questionnaire in Iran was validated and psychometrically evaluated by Khalsi et al. (24). The validity of this questionnaire was confirmed using the content validity method, and its reliability was established with a Cronbach’s alpha of 0.85.
Content validity was employed to validate the researcher-developed questionnaire on factors affecting the mode of delivery as perceived by managers, midwives, and gynecologists. The reliability of this questionnaire was confirmed through a retest method (26).
Implementation method in the cross-sectional study:
Following the identification of factors influencing VBAC through a literature review, the researcher will undertake a cross-sectional study to prioritize these factors related to VBAC. These factors will be assessed from the perspectives of mothers, gynecologists, midwives, and managers at the levels of vice president of treatment and vice president of health in Isfahan City. The study will include a sample of 75 pregnant mothers with a history of one cesarean section and 75 gynecologists, midwives, and health managers at the levels of vice president of treatment and vice president of health of Isfahan University of Medical Sciences. For sampling, in collaboration with the Medical and Health Vice-Chancellor of Isfahan University of Medical Sciences, a list of hospitals, comprehensive health centers under Health Centers 1 and 2 in Isfahan city, and private practices will be compiled. Subsequently, quota sampling will be performed randomly. From all districts in Isfahan city, a random selection will be made to ensure that the samples chosen are representative of the population under study in Isfahan city. Subsequently, within these selected districts and accounting for the number of clients visiting these centers and the required sample size for the study, specific comprehensive health centers covered by Isfahan Health Centers 1 and 2, hospitals, and private practices will be randomly chosen. Sampling will be conducted using convenience sampling while considering the inclusion criteria. The researcher will then visit the comprehensive health centers and distribute the Childbirth Attitude Questionnaire to all eligible pregnant mothers. Additionally, the researcher will approach the offices of gynecologists, midwives, and health managers at Isfahan University of Medical Sciences, selected through convenience sampling, to assess their attitudes towards VBAC.
The data analysis method in the cross-sectional study:
The data will be analyzed using SPSS 20 software. Descriptive statistics, including measures of central tendency, dispersion, standard deviation, and frequency, will be employed. Analytical statistics such as the chi-square test, one-way analysis of variance, and Pearson correlation coefficient will also be utilized. To prioritize the influencing factors in the cross-sectional study, logistic regression will be conducted. This analysis will showcase the importance of factors based on the weight of the regression coefficients or the odds ratio.
The third step of the first phase: Delphi technique
Upon developing the initial version of the intervention, the researcher will validate it using the Delphi technique. Sampling at this stage will be purposeful, involving gynecologists (faculty members), policymakers, managers, and maternal healthcare providers. The Delphi technique typically recommends 10–15 participants for homogeneous groups (27). In this case, the Delphi technique will encompass all medical groups providing services, including gynecologists, reproductive health specialists, midwives, managers at the levels of vice president of treatment and vice president of health, policymakers at Isfahan University of Medical Sciences, and maternal health experts at the levels of vice president of treatment and health in Isfahan province. The Delphi technique will consist of four rounds. Following the selection of participants for the Delphi technique, in the first round, they will receive official invitations to participate. Participants will be provided with a printed or electronic version, along with open-ended questions. After 2–4 weeks, their feedback and suggestions will be collected. In the second round, the analysis results, expert opinions, and their levels of agreement will be shared with the participants after compilation. Moving to the third round, the experts’ average scores will be calculated to identify areas of the intervention that require modification. Parts with scores exceeding a certain threshold, agreed upon by the experts, will be revised. In the fourth round, experts will be asked to review the revised intervention and indicate their level of agreement regarding the changes made in different sections of the intervention.
The fourth step of the first phase: the panel of experts
Following the design and development of the draft intervention for implementing VBAC and its validation through the Delphi technique, a panel of experts will be convened to finalize the intervention. This panel will consist of ten experts, including specialists in reproductive health, gynecology, and obstetrics, as well as managers at the levels of vice president of treatment and vice president of health. Additional experts may be included as needed based on the intervention draft. These experts will be invited to a meeting where the draft intervention will be provided to them in written form. The panel will be managed by tutors and advisors. Initially, the solutions derived from the review and cross-sectional studies, along with their prioritization, will be presented. Experts will then be asked to share their opinions on the designed intervention program. The researcher will document the topics discussed during the meeting and record the opinions expressed, subject to collective approval, for use in modifying the intervention program. Subsequently, necessary adjustments will be made to the draft, leading to the preparation of the final version of the intervention
Second phase: Implementation and evaluation of a part of the intervention program
Statistical population:
The statistical population comprises all pregnant mothers attending hospitals, medical centers, and private practices in Isfahan City.
Samples:
The sample will consist of individuals from the statistical population who meet the specified inclusion criteria.
Research setting:
The research will be conducted in all medical centers, hospitals, and private practices where gynecologists are supportive of performing VBAC.
Sampling:
The sampling method will involve computer randomization using Excel software.
Sample size:
Taking into account the maximum variance in the intervention and control groups at a 5% error level and 80% test power, and following a relevant study (28), the sample size in each group is initially estimated to be 25. However, considering the potential attrition associated with the intervention, this number will be doubled to 50 cases in each group.
$$\:n=\frac{\left({s}_{1}^{2}+{s}_{2}^{2}\right)\times\:{\left({z}_{1-\frac{\propto\:}{2}}+{z}_{1-\beta\:}\right)}^{2}}{{\left({\mu\:}_{2}-{\mu\:}_{1}\right)}^{2}}$$
Inclusion criteria for pregnant mothers:
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Iranian nationality
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Resident of Isfahan city
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Scoring 7 or higher according to the Flamm and Geiger scoring system (29)
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Absence of known mental disorders based on medical records
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Age under 40 years
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Mother’s vital signs within normal range
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No history of intrauterine fetal demise (IUFD)
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Absence of previous cesarean section for reasons such as prolonged labor, breech presentation, or fetal distress
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Singleton pregnancy
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No history of placenta praevia
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Absence of pelvic stenosis
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History of transverse cesarean section
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Normal body mass index (19.8–24 kg/m2)
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Not currently pregnant through assisted reproductive methods
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Minimum 18-month interval between current pregnancy and previous cesarean birth (30)
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Absence of conditions or complications that would impede natural delivery, as determined by the gynecologist
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Willingness to participate in the study
Exclusion criteria for pregnant mothers:
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Lack of willingness to continue cooperation at every stage of the research
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Occurrence of any sudden pregnancy complication that, according to the gynecologist, impedes natural childbirth
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Emergency cesarean section
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Irregular participation in the intervention program (missing more than three consecutive sessions)
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Absence of a non-stress test (NST) at 28 weeks and beyond
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Presence of placental adhesion and abnormal placental function as indicated by Doppler ultrasound
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Absence of spontaneous onset of labor pains
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Breech presentation
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Estimated fetal weight exceeding 3.5 kg
Research variables
In this study, the designed interventions are regarded as the independent variable, while the outcomes of VBAC are considered the dependent variable.
Data collection tool and its validity and reliability:
To assess mothers’ satisfaction with the mode of delivery, the Birth Satisfaction Scale (BSS) (31) will be employed. This scale comprises ten dimensions, encompassing the mother’s perception of healthcare personnel (4 items), midwifery and nursing care during labor (2 items), sense of peace and comfort (4 items), involvement in decision-making and access to information (8 items), visiting the newborn (3 items), postpartum care (6 items), hospital room environment (3 items), hospital facilities (3 items), respect for privacy (3 items), and fulfillment of expectations (5 items). Similarly, the Satisfaction with Cesarean Section Questionnaire comprises ten dimensions, covering the mother’s perception of healthcare personnel (5 items), preparation for cesarean section (2 items), sense of peace and comfort (3 items), involvement in decision-making and access to information (8 items), visiting the newborn (3 items), postpartum care (6 items), hospital room environment (3 items), hospital facilities (3 items), respect for privacy (4 items), and fulfillment of expectations (5 items). Pakari et al. validated and established the reliability of this questionnaire, reporting its face validity, content validity (content validity index and content validity ratio), construct validity (confirmatory factor analysis), criterion validity, and reliability. Concerning internal consistency, Cronbach’s alpha values for both questionnaires indicated high internal consistency (0.89 for natural delivery and 0.84 for cesarean delivery). In terms of stability, they demonstrated a significantly high correlation (r = 0.99, p = 0.000 for natural delivery; r = 0.98, p = 0.000 for cesarean delivery) (32).
To evaluate birth outcomes in the intervention and control groups, researcher-developed birth outcomes checklists will be utilized, with content validity being assessed for reliability. Consequently, alongside literature reviews, the researcher will distribute the checklist to faculty members of nursing and midwifery departments and experts in university fields to align it with the study’s objectives and variables. Following the study, review, and assessment of the intervention by these experts, incorporating their feedback, necessary adjustments will be implemented to enhance the content validity.
Intervention implementation:
Following the approval from the Ethical Committee of Isfahan University of Medical Sciences, the researcher will commence the intervention program tailored for mothers and gynecologists. This program will encompass birth preparation classes and acupressure. The target population consists of pregnant mothers attending healthcare centers, private practices, and hospitals who have undergone one cesarean section. The researcher will gather detailed medical and obstetric histories from these mothers at the medical facilities. After assessing the inclusion criteria, and explaining the study’s objectives and methodology, the participants will be invited to partake in the research and provide written informed consent. Subsequently, eligible pregnant women will be assigned to the intervention and control groups through computer randomization utilizing Excel software. In addition to standard pregnancy care, the intervention group will engage in birth preparation classes and acupressure sessions. This group will be introduced to the center’s midwives for eight 90-minute sessions starting from the 20th week of pregnancy. The childbirth preparation classes consist of both group and individual sessions focusing on pregnancy care, childbirth readiness, nutrition, relaxation techniques, and breathing exercises. These sessions will involve instruction, guidance, and practical exercises. Upon reaching the 37th week, following examinations and re-evaluations by the gynecologist to ensure the mother is fit for a natural delivery, acupressure sessions will commence at the BL32 and GB30 points of the mothers (33). Participants in the intervention groups will be instructed to visit the nearest medical center where the researcher can administer acupressure 0.5 to 1 hour after breakfast. The researcher will perform acupressure twice for 2 minutes each with a 20-minute interval. The researcher will instruct the spouse or mother’s companion on how to apply pressure to the points. By comparing the pressure applied by the companion to that applied by the mother, the researcher will assess if the pressure levels match. Subsequently, the spouse or mother’s companion will be taught to apply pressure to these points five times at a one-hour interval. This daily pressure application will continue until the onset of labor pains and until the gynecologist determines the appropriate timing based on the mother’s condition. Throughout pregnancy and delivery, mothers in the intervention group will receive supervision from the research team (comprising gynecologists and midwives) to facilitate a natural physiological delivery. VBAC delivery will take place in well-equipped maternity hospitals in Isfahan city, with the presence of gynecologists, the research team, and accompanying midwives. On the other hand, the control group will solely receive standard pregnancy care.
Data analysis:
The data will undergo analysis through descriptive statistics (mean, standard deviation, etc.) and descriptive and analytical tests employing suitable comparative methods, correlation coefficients, and data modeling based on the nature of the results, including potential confounding factors. All analyses will be conducted at a 5% error level utilizing SPSS version 20 software.