An mHealth-based social support program to improve antenatal care engagement and facility-based births in Uganda: A type I hybrid effectiveness-implementation clinical trial

BackgroundUgandan women and their children suffer from high maternal and perinatal mortality, often due to low antenatal care (ANC) and skilled birth usage. We partnered with community members, women and the Ugandan Ministry of Health to formatively develop an intervention (Support-Moms app) to improve health education, engage social support networks, and augment access to ANC and delivery by a formal health care provider (HCP) for pregnant women in rural Uganda. MethodsWe conducted a type 1 hybrid effectiveness-implementation trial to test the effectiveness of the Support-Moms intervention. We enrolled 824 pregnant women (<20 weeks gestation) living in Southwestern Uganda and randomized them (1:1) to standard of care or Support-Moms intervention. The primary effectiveness outcome was completion of a HCP-led skilled birth (discharge card) and was analyzed as intention-to-treat. Secondary outcomes included number of ANC visits, institution-based delivery, social support, quality-of-life, mode of infant delivery, pre-term birth, birth weight, obstetric complications and deaths (maternal, fetal, newborn). ResultsA total of 1,216 women were screened, and 824 pregnant women enrolled (mean age [~]28 years; gestation at enrolment [~]13 weeks). Complete outcomes were available for 818 (99%). The Support-Moms intervention increased HCP-led skilled births compared to standard of care (93% vs 84%; OR 2.51, 95% CI 1.57-4.03, p<0.001). Women in the intervention group were more likely to achieve [&ge;]4 ANC visits (84.1% vs 75.1%; OR 1.76, 95% CI 1.24-2.50, p=0.001) and less likely experience postpartum hemorrhage (9.1% vs 22.7%, OR 0.34, 95% CI 0.22-0.52, p<0.001) or for their neonates to require resuscitation (9.8% vs 13.7%, OR 0.69, 95% CI 0.45-0.99, p=0.001). Initiation of breastfeeding within an hour was higher (97.1% vs 71.7%, OR 1.76, 95% CI 1.15-3.44, p=0.001) and postnatal depression decreased (20.1% vs 27.1%, OR 0.68, 95% CI 0.49-0.94, p=0.019). More intervention participants reported adequate support, were birth-prepared and had a birth companion. There were no maternal deaths or differences in term births, birthweight, mode of delivery, perinatal mortality or other obstetric complications. ConclusionsIn rural Uganda, the Support-Moms mHealth-based, social-support intervention significantly increased HCP-led skilled births compared with routine care, while also improving ANC attendance, early breastfeeding initiation, birth preparedness, perceived social support and higher presence of companion at birth. Less women experienced PPH, neonatal resuscitation, and postnatal depression. Further evaluation should focus on the cost effectiveness and sustainability of this program. Trial registrationClinicaltrials.gov NCT05940831