Materials and methods

Study design and setting

This randomized controlled trial (RCT) was conducted at a tertiary care teaching institute in South India from October 2023 to January 2024 after obtaining ethical approval from the Institutional Ethics Committee (IEC No. JIP/CON/IEC/M.Sc./2022/OBG/1) and was prospectively registered with the Clinical Trials Registry of India (CTRI/2023/09/057815).

Study population and sample

This study included primiparous mothers aged 18-35 years who attended regular antenatal check-ups and planned to deliver at the same institution. Mothers whose babies were admitted to the neonatal intensive care unit (NICU) were excluded from the study. The sample size was calculated by considering the proportion of good breastfeeding practices in the control group as 50%, based on the reference article [6], and assuming that the proportion of good breastfeeding practices would be 25% higher in the intervention group. Using a 5% level of significance, 80% power, and accounting for a 10% attrition rate, a total of 130 mothers were enrolled in the study, with 65 participants allocated to each group.

Randomization and intervention

After obtaining informed consent, these mothers were enrolled in the study at 32 weeks of gestation and randomized into either the intervention or control group. A computer-generated randomization sequence was used, and allocation concealment was achieved through the serially numbered, opaque, sealed envelope (SNOSE) technique. After obtaining baseline data, a group counseling technique was used for the intervention group, wherein groups of five mothers were counseled for 30 minutes during antenatal visits. The lactation counseling on breastfeeding was repeated three times at different intervals, i.e., at 32 weeks, 34 weeks, and 36 weeks of gestation, while the control group received only routine care. Mothers in the intervention group were counseled regarding the meaning of exclusive breastfeeding, the timing of breastfeeding initiation, type and composition of breast milk, the importance of breastfeeding, breastfeeding techniques including positioning, frequency and adequacy of breastfeeding, newborn feeding behavior, and the prevention and management of breast engorgement.

Data collection and assessment

For outcome assessment, the mothers were assessed on the second postnatal day after delivery using a structured, faculty-validated, pretested checklist to evaluate breastfeeding practices. The checklist consisted of 17 questions with two response options. A correct answer was scored as 1, and an incorrect answer was scored as 0. The maximum possible score was 17, and the minimum score was 0. The level of breastfeeding practices was interpreted as good practice (13-17), fair practice (8-12), and poor practice (0-7). Newborn feeding behavior was assessed using the Infant Breastfeeding Assessment Tool (IBFAT) [7], a standardized tool. On the third postnatal day, the occurrence of breast engorgement was assessed through a telephone conversation to determine whether breast engorgement was present.

The content validity of the tool was assessed using the item-level content validity index (I-CVI/Avg) for the structured breastfeeding practices checklist. The obtained validity score was 0.97, indicating that the tool was valid, as an I-CVI/Avg value ranging from 0.9 to 1 is considered acceptable. The validity of the tool was determined based on its relevance, sufficiency, and appropriateness. The Cronbach’s alpha method was used to evaluate the reliability of the tool, and the obtained reliability coefficient was 0.759.

Statistical analysis

The data were tabulated and summarized in Microsoft Excel sheets and analyzed and interpreted using descriptive and inferential statistics. A p-value of <0.05 was considered statistically significant.

Figure 1 illustrates the flow of participants through the RCT. A total of 130 primigravida mothers attending the antenatal outpatient department (OPD) were assessed for eligibility and subsequently randomized into two equal groups (n = 65 each). The experimental group received antenatal lactation counseling, while the control group received routine antenatal care. During the follow-up period, nine participants from the experimental group and 16 participants from the control group were lost to follow-up. Consequently, 56 participants in the control group and 49 participants in the experimental group were included in the final analysis. The flowchart demonstrates the process of enrolment, randomization, allocation, follow-up, and analysis of study participants, ensuring transparency in participant progression throughout the study.

Figure 1: CONSORT flow diagram depicting the flow of participantsCONSORT: Consolidated Standards of Reporting Trials; OPD: outpatient department