2.6.3 Flow of Participants during Data Collection
Pregnant women admitted in labor at Jinja, Lira, and Hoima Regional Referral Hospitals were first sensitized and educated about the study. They were then assessed, with those having diabetes mellitus or who were unscreened being screened for the condition. Women not meeting the inclusion criteria or without diabetes continued with their normal routine care. Those who met the inclusion criteria provided informed consent and were included in the study. Participants were monitored for neonatal outcomes: those with adverse outcomes received appropriate management, while those without adverse outcomes followed the standard postnatal care routine. Follow-up for all participants continued until discharge or up to seven days, whichever came first.
2.7 Study variables: The study examined various independent variables affecting adverse neonatal outcomes, including maternal age, occupation, monthly income, residence, number of antenatal care (ANC) visits, gestational age at delivery, history of previous neonatal adverse outcomes, treatment status, and whether the mother engaged in exercise.
Physical assessments involved measuring weight with a digital scale (model PS-103, up to 180 kg) and height with a stadiometer (200 cm, wall-mounted) to calculate Body Mass Index (BMI). BMI was categorized as normal (18.5–24.9), overweight (25-29.9), or obese (≥ 30) per WHO standards. Gestational weight gain was determined by subtracting the initial visit weight from the current weight.
Glycemic levels were measured using finger prick blood samples for mothers and heel prick blood samples for neonates, with both procedures involving cleaning the site with 70% alcohol antiseptic. A random blood glucose level > 200 mg/dL plus symptoms like polydipsia, polyuria, and unexplained weight loss indicated overt diabetes mellitus, while levels between 140 mg/dL and 200 mg/dL indicated gestational diabetes mellitus. Neonates with blood glucose levels below 40 mg/dL were considered hypoglycemic.
Gestational age was assessed postnatally using the New Ballard Scoring system for mothers unsure of their last menstrual period, evaluating neurological and physical maturity. Birth weight was assessed using INTERGROWTH-21st standards, with growth charts specific to boys and girls corresponding to gestational age.
Adverse early neonatal outcomes were defined as any of the following conditions: a low Apgar score (less than 7 at 5 minutes) (25), early neonatal death (death within seven days of birth) (26), hypoglycemia (blood glucose levels less than 40 mg/dL) (27), macrosomia (birth weight at or above the 90th percentile or greater than 4,000 g) (1), neonatal respiratory distress (symptoms including tachypnea, nasal flaring, grunting, and chest wall retractions) (28), and NICU admission due to these complications (12).
2.8 Data quality control: To ensure the integrity and reliability of this study, rigorous quality control measures were implemented throughout the research process. Research assistants received comprehensive training on the study protocol, data collection tools, informed consent procedures, and patient interaction. Regular refresher meetings were conducted to maintain high standards of accuracy and consistency in data collection. Data collection tools, including structured, pre-tested questionnaires and checklists, were used to ensure uniformity and precision. Daily reviews of collected data were performed to identify and rectify any inconsistencies promptly. Pre-testing of data collection instruments was carried out at Kampala International University Teaching Hospital, and necessary adjustments were made based on the findings. Physical assessments, including anthropometric measurements and glycemic level evaluations, were conducted using calibrated equipment to ensure accuracy. Gestational age was assessed using the New Ballard Scoring system, and birth weights were measured according to INTERGROWTH-21st standards. These measures ensured that the data collected was accurate, reliable, and reflective of the study population, thereby enhancing the validity of the study's findings.
2.9 Data analysis: Results were expressed as percentages, showing the proportion of neonates with early adverse outcomes among those born to women with diabetes mellitus and presented graphically. The numerator was neonates with adverse outcomes, and the denominator was the total number of neonates born to diabetic mothers.
Factors associated with adverse neonatal outcomes were analyzed using bivariate and multivariate logistic regression, reported as Odds Ratios (OR). A binary variable for adverse outcomes served as the dependent variable, with socio-demographic, obstetric, gynecologic factors, and treatment as independent variables. Bivariate analysis compared independent variables with the dependent variable using Chi-square tests and logistic regression, reporting unadjusted ORs with 95% confidence intervals (CI). Variables with p-value < 0.2 proceeded to multivariate analysis to control for confounding. Multivariate analysis checked assumptions like multicollinearity and normality, reporting adjusted ORs (aOR) with 95% CIs. Variables were deemed significant if p-value < 0.05.
2.10 Ethical considerations: The study was approved by the Research and Ethics Committee of KIU (KIU REC Reference Number: KIU-2022-140), the administration of KIU teaching sites, and the department of obstetrics and gynecology. Participants' autonomy was ensured through informed consent, explained in both English and local languages, with no coercion involved, allowing participants to withdraw at any time without affecting their care. The study posed minimal risk, primarily slight pain from blood sample collection, mitigated by aseptic techniques to prevent infections. Participants received close monitoring and appropriate management, with study findings expected to guide policy formulation, benefiting the broader community and healthcare system. Data collected was anonymized using codes, and interviews were conducted privately to maintain confidentiality. A consecutive sampling method was used, adhering strictly to eligibility criteria without bias regarding tribe, race, or religion. Participants were not paid or compensated for their participation. The study procedures were respectful of local beliefs, traditions, and culture.