This was a pretest and post-test quasi-experimental study that used a non-equivalent control group to recruit primigravid women who were staying in hospital maternity waiting homes to await labor and give birth at the rural Mitundu and Kabudula community hospitals in Lilongwe, Malawi (Fig. 2). The baseline data were collected during the pretest study; post-test data were collected 2 weeks after the pretest, and the follow-up assessment was conducted between 24 and 48 h after childbirth. The quasi-experimental design was opted for instead of a randomized control trial to sidestep the increased risk of contamination in the control group. To achieve this, one health facility (Mitundu) was assigned as an intervention site, whereas the other facility acted as a control.
Mitundu Community Hospital is situated in the outskirts of Lilongwe, Malawi’s capital, 38 km south of the city. It serves a population of about 127,000, with 6310 women giving birth per year, 2040 of which are primigravid women. Similarly, Kabudula community hospital is in the outskirts of Lilongwe, 57 km west of the city. It serves a population of about 43,014, including 4492 pregnant women, approximately 1800 of whom are primigravid women giving birth at the facility per year. These facilities were chosen because they offer a similar level of public health services in a rural population setting in Malawi, and they have maternity waiting homes. The maternity waiting homes are residential facilities located near the health facilities where pregnant women can wait for labour to give birth at a hospital . Since we aimed to evaluate the efficacy of C-ICP during late pregnancy, we felt maternity waiting homes to be ideal settings in which to obtain our sample. In these facilities, pregnant women are admitted when they are between 35 and 40 weeks of gestation after attending required antenatal care visits . Ideally, pregnant women would come to the maternity waiting homes during their last trimester , and they are always accompanied by a birth companion .
To be recruited into the study, primigravid women needed to meet the following criteria: a) being a primigravid woman in late pregnancy with a singleton pregnancy, b) staying at the maternity waiting home while waiting for childbirth at a health facility, c) having a birth companion, and d) having the ability to communicate verbally in either Chichewa (the local language) or English. To be included in the study, the birth companion had to meet the following criteria: a) being a female birth companion accompanying the primigravid woman to the health facility for childbirth, b) staying at the hospital with the primigravid woman she has accompanied, and c) having the ability to communicate verbally in either Chichewa or English.
To guide the sample size calculation, we used the primary variable of childbirth fear. We reviewed previous experimental studies that used childbirth attitude scale. To our knowledge, no study was done in Africa that measured childbirth fear using childbirth attitude scale. However, in Iran, Nevaee and Abedian  study in an urban health care setting reported moderately large effect size (Cohen’s d = 0.58) while Khorsandi et al.  study at a specialized urban hospital setting reported very large effect size (Cohen’s d = 0.99). Furthermore, a study conducted in a rural community setting in India by Swaroopa & Deepthi  reported very large effect size (Cohen’s d = 1.25). In the current study, we expected large effect size (Cohen’s d = 0.80) on the reduction of childbirth fear mean score between the two study groups. We, therefore, used G*Power version 3.0.10  with a priori power analysis for independent t-test on the following parameters: effect size of 0.8; alpha (α error prob) of 0.05; power (1- β err prob) of 0.95; and allocation ratio (N1/N2) of 1. The required sample size of 35 participants in each study group was reached (Fig. 2).
Implementation of the C-ICP intervention strategy
The C-ICP intervention package was designed to educate and support the primigravid women and their birth companions in late pregnancy through structured childbirth education. The C-ICP package was adapted from the BP/CR matrix  and the Integrated Maternal and Neonatal Health Practice guide . The C-ICP intervention builds on BP/CR elements, such as, birth companionship, danger signs and signs of labor, principles of woman-friendly care strategies effective for minimizing labor pains, and bearing down during childbirth, that may increase primigravid women’s confidence in giving birth .
Before implementation, the intervention’s applicability was enhanced through the rigorous consultative process with leading professional nurses and midwives at the selected health facilities to improve the reliability and acceptability of the package. Then, four research assistants (one registered nurse and three nurse technicians) at the intervention site and three (one registered nurse and two nurse technicians) at the control site were hired and trained to implement the C-ICP package in line with this study. The intervention was implemented using two educational sessions delivered to groups with a maximum of six pairs of participants each, one session per week for 2 weeks, upon their recruitment.
The C-ICP sessions were conducted at the antenatal clinic in the late afternoon hours after the clinic was closed. Each C-ICP session took approximately 1 h and 20 min and was delivered in Chichewa by at least two research assistants. Appropriate demonstrations and role-play of practical tasks were carried out during the sessions (Table 1). Each dyad was encouraged to interact to prepare for childbirth, and if they needed more support on childbirth preparation, they could seek help from facilitators or any care provider. Additionally, the arrangement was made with the hospital authorities to allow birth companions in the intervention group to accompany primigravid woman during the latent phase of labor at the waiting bay in the labor ward.
Measures and data collection
Trained research assistants conducted face-to-face interviews using an integrated questionnaire to collect data. The questionnaire consisted of five parts. The first part was used to collect the participant’s demographic characteristics including age, marital status, tribe, level of education, employment status of the woman and her partner, monthly income, and gestation age. The other four parts comprised of; the Childbirth Attitudes Questionnaire, the Childbirth Self-Efficacy Inventory (CBSEI), the Birth Companion Support Questionnaire (BCSQ) and Checklist for pregnancy outcomes (see an Additional file 1).
The CAQ was adopted to assess childbirth fear . This tool was utilized for pretest and post-test measures in the present study. It was initially developed in 1981 by Areskog, Kjessler, and Uddenberg . The version of the tool used in the study was a 16-item scale with a four-point Likert scale, having a total score range of 16 to 64 . The higher scores represent high fear reported, with internal consistency reliability estimated at 0.83.
Childbirth self-efficacy was measured using the CBSEI part II , based on Bandura’s self-efficacy theory, which is used to measure a pregnant woman’s ability to cope with labor and childbirth . The short version was developed  with 32 items, each of the two subscales containing 16 items on a Likert scale of 1 to 10. The Arabic translation of the CBSEI has demonstrated a high level of internal consistency, achieving 0.86 for the total outcome expectancy subscale and 0.90 for the total self-efficacy expectancy subscale . This tool was previously piloted in a neighboring country, Tanzania, where a highly reliable internal consistency with a Cronbach’s alpha of 0.80 was indicated, suggesting that the questions were well understood by pregnant women in the Tanzanian culture . Therefore, this result has demonstrated that the CBSEI tool can be used in a different cultural setting from the one in which it was originally developed. Although the tool has not been validated in Malawi, it was chosen because it had previously proven to be useful when applied either in the late third trimester or before the impending birth.
Birth companion support was measured using the BCSQ . The tool was developed to measure women’s perceptions of emotional and tangible aspects of functional support provided by the support person during labor and birth . In the present study, this tool was used at the pretest assessment and the follow-up assessment between 24 and 48 h after the participant had given birth. The BCSQ was modified from the Labor Support Questionnaire  by Dunne et al. . The BCSQ contains 13 items designed to measure emotional and tangible support with a four-point Likert ordinal response of 0 (not at all), 1 (a little), 2 (most of the time), and 3 (all the time). It has a reported Cronbach’s alpha of 0.80 .
The CAQ, CBSEI, and BCSQ were originally written in English, and we adapted and translated them into Chichewa by a bilingual translator (forward translation) with the authors’ permission to use the tools. The rigorous consultative process enhanced the applicability for professional nurses and midwives delivering care in the targeted rural community hospitals. The translated versions were then checked and discussed for wording and clarity by four midwives providing care to women at the antenatal clinic and labor ward. The researcher who has a midwifery background facilitated the process to ensure that the translated instrument versions retained core elements that the instruments were supposed to measure. Finally, the Chichewa versions were translated back into English by an independent bilingual translator (back-translation). The original and back-translated questionnaires were discussed separately and compared for clarity and inconsistencies by nurses and midwives at Mitundu and Kabudula community hospitals before reaching a consensus on the final version. To our knowledge, no study in Malawi has validated these tools. However, a pilot study was conducted to assess the applicability and clarity of the translated Chichewa versions, and modifications were made accordingly. The participants in the pilot study were15 primigravid women staying at a health center facility while waiting to give birth in Lilongwe, Malawi. We noted that primigravid women were more conversant with the Likert scale when they were asked to consider it from the perspective of their familiar practices at the maize mill, where a calibrated stick is used to determine the price on the of maize they want to process. This understanding helped the participants to give appropriate responses. The CAQ and CBSEI tools were also used in our survey on childbirth fear (being considered for publication), with good responses from the participants indicating a Cronbach’s alpha of 0.86 for the CAQ and 0.83 for the CBSEI, whereas the pilot study indicated that the BCSQ’s Cronbach’s alpha was 0.76.
A checklist review was conducted to collect data on the selected pregnancy outcomes. The researcher reviewed delivery notes using the checklist between 24 to 48 h after childbirth to capture the information on pregnancy outcomes, including gestation age, observed danger signs, problems experienced, duration of the first, second, and third stages of labor, type of delivery, perineal trauma, Apgar score, and the time when exclusive breastfeeding was initiated.
This study was approved by the Institutional Review Board of the Xiangya School of Nursing, Central South University, and The National Committee on Research in the Social Sciences and Humanities in Malawi (REF.NO.NCST/RTT/2/6). Participants, including birth companions in the intervention arm, received oral information about the study’s risks and benefits, that their participation was voluntary, that they could withdraw at any point without any reprisal, and that their names would remain confidential. Written informed consent was obtained from each participant and her birth companion. Oral consent from legal guardians was also obtained for those pregnant women under 18 years old.
The Statistical Package for the Social Sciences (SPSS) version 25 (IBM corp., Armonk, NY, USA) was used for data analysis. An independent t-test was used for continuous variables to compare the baseline data and posttest measures between the study groups. Mann–Whitney U tests were used to compare the two groups’ demographic characteristics and selected pregnancy outcomes in follow-up assessments due to a lack of normality, and χ2 tests were used for categorical variables. Simple linear regression was used to determine if the C-ICP intervention was significantly more efficacious at decreasing childbirth fear while increasing self-efficacy and maternal support than routine care. A statistical significance level was set at p < .05. The beta coefficients were reported adjusted at a 95% confidence interval .