Effect of a Nurse-Led, Technology-Enabled Antenatal Care Programme (e-MACC) on Quality of Life and Maternal-Fetal Outcomes among Primigravid Women: A Randomized Controlled Trial with Mixed-Effects and Multivariable Analysis

Abstract

Background: Pregnancy imposes profound physical, psychological, social and environmental demands on first-time mothers, and a substantial proportion of primigravid women report a measurable decline in health-related quality of life (QoL) across gestation. Nurse-led, technology-enabled antenatal programmes have been proposed as a scalable way to sustain engagement with antenatal advice between clinic visits, but rigorously designed trials that track QoL longitudinally alongside maternal and fetal outcomes remain scarce, particularly from India.
Objective: To evaluate the effect of a nurse-led, smartphone-delivered antenatal care programme (e-MACC) on the trajectory of quality of life and on maternal and fetal outcomes among primigravid women, and to identify independent predictors of postpartum quality of life.
Methods: A two-arm, parallel-group randomized controlled trial was conducted at Salem Polyclinic Hospital, Salem, Tamil Nadu, India (CTRI/2022/12/048086). One hundred sixty primigravid women at 12 weeks’ gestation were randomized 1:1 to the e-MACC mobile application plus routine antenatal care (n = 80) or routine antenatal care alone (n = 80). Quality of life was assessed with the WHOQOL-BREF at baseline, second trimester, third trimester and one month postpartum. Maternal outcomes (labour pain, duration of labour, mode of delivery, oxytocin augmentation) and fetal outcomes (Apgar score, birth weight, birth injury) were recorded with a structured observation checklist. Data were re-analysed using mixed-design (group × time) analysis of variance, analysis of covariance, multivariable linear and logistic regression, and Pearson/Spearman correlation, with Hedges’ g effect sizes and 95% confidence intervals throughout (Python 3.12; pandas, SciPy, statsmodels, pingouin).
Results: The two arms were comparable at baseline on education, occupation, income, source of information, antenatal visit frequency, marital duration and baseline clinical parameters (all p > 0.13), although the intervention group was on average younger (23.3 ± 2.6 vs 25.6 ± 4.2 years, p < 0.001), which was retained as a covariate in adjusted models. Overall quality of life rose steadily in the intervention arm (baseline 43.9 ± 3.6 to postpartum 68.5 ± 15.3) while remaining flat in the control arm (43.8 ± 4.3 to 44.2 ± 4.5). A mixed-design ANOVA showed a large group × time interaction (F = 145.4, p < 0.001, partial η² = 0.48), consistent across all four WHOQOL-BREF domains (partial η² 0.30–0.38). After adjusting for baseline score, the intervention effect on postpartum overall QoL remained large (ANCOVA F = 197.4, p < 0.001, partial η² = 0.56; Hedges’ g = 2.15, 95% CI 1.76–2.53). A multivariable model explained 60% of the variance in postpartum QoL (R² = 0.60), with group assignment (β = 23.9, p < 0.001) and 5–6 antenatal visits (β = 5.3, p = 0.002) as independent predictors. The intervention group reported less labour pain (3.5 ± 0.8 vs 4.6 ± 0.8 on a 0–10 scale, g = 1.27), shorter labour (8.0 ± 0.8 vs 9.2 ± 0.9 hours, g = 1.41) and higher one-minute Apgar scores (9.0 ± 0.8 vs 8.6 ± 1.0, g = 0.51), all p ≤ 0.001. Birth weight, mode of delivery, oxytocin augmentation and birth injury did not differ significantly between arms. The magnitude of QoL gain correlated with less labour pain (r = −0.53), shorter labour (r = −0.47) and higher Apgar scores (r = 0.29; all p < 0.001).
Conclusion: A nurse-led, app-based antenatal care programme was associated with a substantially better quality-of-life trajectory across pregnancy and the early postpartum period, with parallel improvements in labour pain, labour duration and neonatal condition at birth, but no measurable effect on birth weight or mode of delivery. These findings support the integration of structured, nurse-supervised mobile health support into routine antenatal care for first-time mothers, while underlining the need for multicentre trials with stratified randomization to confirm generalisability.