Digital Prenatal Education to Reduce Fear of Childbirth in Term Pregnancy (FEARLESS-BIRTH)

Background. Fear of childbirth affects approximately 14% of pregnant women worldwide and has been associated with higher rates of maternal request caesarean section, greater use of epidural analgesia, prolonged second stage of labour, poorer postpartum mental health and difficulties with breastfeeding initiation. Structured antenatal education reduces fear of childbirth, but attendance at face-to-face programmes is limited by scheduling conflicts, occupational demands and geographical distance. Digital health interventions may overcome these barriers, yet evidence on stand-alone web-based antenatal education targeting term pregnancies, assessed with validated instruments and compared against usual care in a randomised design, remains scarce, particularly in the Spanish health care context.

Design. Single-centre, two-arm, parallel-group randomised controlled trial with 1:1 allocation. The protocol was developed in accordance with the SPIRIT statement, and the intervention is described following the TIDieR checklist.

Setting. Antenatal care services within the catchment area of the Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI), a tertiary public hospital of the Canary Islands Health Service in Gran Canaria, Spain. Recruitment takes place at both primary care midwifery clinics and hospital obstetric outpatient clinics.

Participants and procedures. Women are approached prospectively at any point during pregnancy and provide initial informed consent. Definitive eligibility is reassessed at 37+0 weeks of gestation, when consent is ratified, the baseline questionnaire is completed and randomisation takes place. This two-stage consent procedure protects participant autonomy and ensures that allocation occurs only among women who still meet low-risk criteria at term.

Randomisation and blinding. The allocation sequence is computer-generated centrally using simple randomisation (Epidat 4.2) and concealed in sequentially numbered, opaque, sealed envelopes opened in strict numerical order. Blinding of participants is not feasible given the nature of the intervention. Third-party blinding is applied: the clinicians attending labour are unaware of group allocation, so that intrapartum care is identical for all participants. Statistical analysis is performed by an external analyst working with a pseudonymised database in which the allocation variable is coded.

Intervention. Participants allocated to the experimental arm receive personal credentials for an interactive antenatal education website, activated at 37 weeks and accessible until hospital admission for birth. Content is delivered asynchronously through multimedia modules covering fear of childbirth, physiology of labour, pain management options, obstetric interventions, emotional coping strategies, guidance for the birth companion, immediate newborn care, and a virtual tour of the labour ward facilities. Materials are evidence-based and adapted to local clinical protocols. Server metrics automatically record logins, session duration and modules accessed, allowing objective assessment of adherence and intervention fidelity. Participants allocated to the control arm receive standard antenatal care only, including the option of attending conventional face-to-face antenatal classes, and are not given access to the platform.

Assessments. Fear of childbirth is measured with the Spanish version of the Wijma Delivery Expectancy/Experience Questionnaire: the expectancy version (W-DEQ-A-Sp, 31 items, range 0-155) at baseline (37 weeks, T0) and the experience version (W-DEQ-B-Sp, 33 items, range 0-165) during the first 15 days postpartum (T1). Obstetric and neonatal outcomes are extracted retrospectively from the electronic health record after birth.

Sample size. Assuming a population standard deviation of 15 points, a minimum clinically relevant difference of 9 points on the W-DEQ, alpha of 0.05 (two-sided), power of 80% and 1:1 allocation, 44 participants per arm are required. Given the interval between early recruitment and activation of the intervention at term, and the documented attrition in previous trials in this population and setting, a 50% loss to follow-up is anticipated. The final target is therefore 88 participants per arm, 176 in total.

Statistical analysis. Analyses are conducted in SPSS with a significance level of p < 0.05 and 95% confidence intervals. Normality is assessed using Kolmogorov-Smirnov or Shapiro-Wilk tests. Between-group comparisons use independent-samples t tests or Mann-Whitney U tests; within-group changes use paired t tests or Wilcoxon signed-rank tests; categorical variables use chi-square or Fisher's exact tests. The primary analysis follows the intention-to-treat principle with multiple imputation for missing postpartum data. A per-protocol sensitivity analysis includes only participants in the experimental arm meeting a minimum threshold of platform adherence, in order to explore a possible dose-response relationship.

Ethics. The protocol received a favourable opinion from the CEI/CEIm of Las Palmas (reference 2026-249-1). The intervention is classified as minimal risk. Data are processed in accordance with Regulation (EU) 2016/679 and Spanish Organic Law 3/2018, using pseudonymisation with a separately stored linkage document.