Study design and setting
This study was a nonrandomized controlled study and was carried out from May 2020 to January 2021 in a tertiary hospital in Chengdu city, Sichuan Province, China. This hospital is one of the largest women and children’s hospitals in Sichuan Province and has two labour wards with identical health facilities and similar human resources in different hospital areas. These two wards had not implemented EENC or received any EENC coaching before this study, and they were assigned randomly to be the intervention group and control group. Each pregnant woman chose the labour ward in which she preferred to give birth at her antenatal visit in the hospital, and her selection depended entirely on her preferences. However, we began participant recruitment when the woman was awaiting delivery in the maternity ward; thus, the participants were not assigned to each group randomly.
The current study was a part of a larger trial. Because of the limitations to the length of an article, this paper focuses only on breastfeeding and maternal outcomes.
Participants in this study comprised women and their newborn infants. Pregnant women were recruited from the maternity ward when they were admitted to hospitals for await delivery and with no signs of labour. Pregnant women who met the following inclusion criteria were considered eligible and were invited by the researchers to participate in this study: (1) aged over 18 years, (2) gestational age between 37 and 42 weeks, (3) singleton pregnancy, (4) vaginal delivery, (5) no severe pregnancy complications and/or underlying disease, and (6) no medical indications against breastfeeding. If the woman was transferred from vaginal delivery to caesarean section or the newborn infant had an abnormal birthweight (< 2500 g or > 4000 g), deformities or needed to be transferred to the neonatal intensive care unit (NICU) immediately after birth, the mother and infant were excluded from the study. Written informed consent was obtained from all participants. Ethical approval was received from the hospital ethics review board.
Participants in the intervention group received the EENC interventions after birth from midwives in the intervention group, while participants in the control group received routine birth care from midwives in the control group. These interventions delivered in the delivery room. The midwives in the intervention group received 5-month training sessions from national and provincial facilitators, following the guidelines formulated by the WHO . After 5-month training sessions, a pilot study on 18 mother-newborn pairs was conducted in October 2020 to ensure that every midwife could implement the EENC correctly. The formal interventions were performed from November 2020 to January 2021.
EENC interventions include (1) drying the newborn infant immediately and thoroughly within five seconds after birth, (2) immediate skin-to-skin contact within the first minute and lasting for at least 90 min, (3) exclusive breastfeeding, (4) appropriately timed clamping and cutting of the cord, and (5) other routine care – eye care, vitamin K, immunizations, weighing and examinations . The duration of implementing EENC was between 90 to 120 min.
The sequence of routine birth care in this hospital was (1) drying of the newborn infant, (2) placement of the newborn infant on a heated table to keep warm for 20 min, during which the umbilical cord is clamped and the weight and length are measured, (3) vaccination, (4) skin-to-skin contact between the mother and newborn infant, and (5) exclusive breastfeeding after the third stage of labour. The duration of implementing routine birth care was between 90 to 120 min.
For both groups, the same postnatal care and education were delivered to mothers by midwives, including the contents of breastfeeding, diet, physical activity, safety, urine output, and stool output.
This study aimed to explore the effect of implementing EENC on breastfeeding and maternal outcomes. We hypothesized that implementing EENC could improve the breastfeeding outcomes and help mothers recover from delivery, especially for the incidence of early breastfeeding initiation.
Measures and data collection
Variables collected at baseline for women included age, educational level, height, weight, gestational age, previous obstetric history, anxiety, and nipple pattern. Variables for newborn infants included sex, length, and birthweight. Among these variables, the anxiety of women was assessed by the Chinese version of the strait form of the State-Trait Anxiety Inventory (STAI-S), which was developed by Spielberger in 1970 and was introduced to China in 1988 . The STAI-S has 20 self-report items and items are scored on a four-point Likert scale of 1 (not at all) to 4 (severe), with the scores summated to derive a total score ranging from 20 to 40 points. The Cronbach’s α of the Chinese version of STAI-S was 0.91. Higher STAI-S scores indicate severer anxiety. In addition, the nipple pattern was classified into three types, namely, normal, flat, and inverted patterns, and assessed by two female data collectors.
The primary outcome of the current study was the incidence of early breastfeeding initiation. If the first breastfeeding was initiated successfully within the first hour after birth, the early breastfeeding initiation was considered and would be recorded by the data collectors.
The second outcome of this study consisted of some breastfeeding-related outcomes and maternal outcomes; namely, the time of rooting reflex occurrence, the initiation time and duration of first breastfeeding, the number of successful first breastfeeding, the time when formula milk is first served, the total amount of formula milk given before discharge, the number of breastfeeding within the first day after birth, the feeding pattern before discharge, the duration of the third stage of labour, the postpartum blood loss within 2 h after birth, and the pain and anxiety of the woman after birth. Data on the duration of the third stage of labour and the postpartum blood loss within 2 h after birth were retrieved from hospital case record files. The woman’s pain was evaluated by means of the Visual Analogue Scale (VAS)  at 30 min, 60 min, and 120 min after birth. Anxiety was evaluated by the state form of the State-Trait Anxiety Inventory (STAI-S)  at 120 min after birth. Other variables were recorded by data collectors. Additionally, the 4-item Infant Breast Feeding Assessment Tool (IBFAT)  was used to assess the success of the first breastfeeding by data collectors. The total score of IBFAT ranges from 0 to 12, with 10–12 being the scores for vigorous and effective breastfeeding. The Breastfeeding Self-efficacy Scale Short Form (BSES-SF)  was used to assess the confidence of women to breastfeed before discharge from the hospital, with a higher BSES-SE score indicating stronger breastfeeding self-efficacy.
The data collectors were all women with medical educational background. Before the study, data collectors received the methods for collecting data by researchers. They were permitted to enter the ward to collect data by both the participants and the ethnic committee of hospitals.
PASS version 15.0 was used to calculate the sample size. We estimated the sample size based on the primary outcome of this study, which is the incidence of early breastfeeding initiation. The results of the pilot study showed that the incidence of early breastfeeding initiation were 77.8% and 44.4% in the intervention group and the control group, respectively. Hence, a sample size of 100 participants would be required (α = 0.05, β = 0.1) . Considering that the drop-out rate was 10%, the minimum sample size needed was 110 participants, with 55 participants in each group. To reduce sampling error , we include all pregnant women who met the inclusion criteria in the study during the recruitment phase.
The current study was a single-blinded trial. It was impossible to blind the midwives and data collectors in the delivery rooms because midwives were responsible for implementing EENC or routine birth care and data collectors were responsible for assessing and recording. Hence, only participants were blinded.
SPSS version 25.0 was used to analyse the data. The smallest unit that is being analyzed to assess intervention effects was the group. The mean ± standard deviation (SD) and median (interquartile range, IQR) were used to describe continuous data, and t test and Mann–Whitney U test were used to identify the differences. The number (n) and percentage (%) were used to describe categorical data, and the chi-square test and Fisher’s exact test were used to identify differences.