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

Impact of a Digital Prenatal Education Intervention on Fear of Childbirth in Term Pregnant Women: A Randomized Controlled Trial

Many pregnant women feel afraid of giving birth. This fear is common and can affect how a woman experiences labour, the type of birth she has, and how she feels afterwards.

Antenatal education helps women prepare for birth, but not everyone can attend the classes offered at health centres. Work schedules, family duties or travel distance often get in the way.

This study looks at whether an online education programme can help. The programme is a website that women can use at home, at any time, from a phone, tablet or computer. It explains how labour works, what pain relief and other options are available, how to prepare a birth plan, and how to manage difficult feelings. It also includes videos filmed in the hospital where the women will give birth, so the place feels familiar before they arrive.

Women taking part will be pregnant with one baby, will have a pregnancy considered low risk, and will be at least 37 weeks pregnant when they start. Half of the women will be given access to the website, chosen at random, like tossing a coin. The other half will receive the usual antenatal care offered by their midwife and doctor. All women continue with their normal pregnancy care.

Women will answer a questionnaire about their feelings towards birth when they join the study, and a second questionnaire in the first two weeks after their baby is born. The researchers will compare the answers of the two groups to see whether the website made a difference. Information about the birth will also be collected from the medical records.

The study will take place in Gran Canaria, Spain, and will include 176 women. It is run by midwives as part of a specialist training programme and has no commercial funding.

Study Overview

• Status: Not yet recruiting
• Conditions: Fear of Childbirth; Tocophobia; Pregnancy Related Anxiety
• Intervention / Treatment: Behavioral: Web-based prenatal education platform

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabela Jiménez López RM; Phone Number: +34 928 444 500; Email: sabelajimenezlopez@gmail.com
• Study Contact Backup: Name: Sergio Mies Padilla RN, PhD; Phone Number: 71363 +34928444000; Email: smiepad@gobiernodecanarias.org

Study Locations

• Spain
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35000
      • Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria
      • Contact: Sabela Jiménez López, RM; Phone Number: 71363 +34928444000; Email: sabelajimenezlopez@gmail.com
      • Contact: Sergio Mies Padilla, RN, PhD; Email: smiepad@gobiernodecanarias.org
      • Sub-Investigator: Lucía Sanzo López, RM
      • Sub-Investigator: Marlene Fernández Padrón, RM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged 18 years or older
• Nulliparous or multiparous
• Singleton pregnancy
• Pregnancy classified as low obstetric risk according to current local protocols
• Antenatal care provided at primary or specialised care centres within the catchment area of the Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI)
• Access to an internet-connected electronic device (smartphone, tablet or computer) allowing use of the web-based educational platform
• Able to understand, read and write in Spanish
• Written informed consent
• Gestational age between 37+0 and 42+0 weeks at the time of definitive eligibility confirmation, baseline questionnaire completion and randomisation

Exclusion Criteria:

• Estimated date of delivery, calculated by first-trimester ultrasound, later than 31 January 2027
• Risk of preterm birth or medical indication for early termination of pregnancy at the time of recruitment
• Elective caesarean section scheduled at the time of recruitment
• Known major structural fetal anomaly requiring specialised obstetric or neonatal management
• Previous or current diagnosis of an anxiety disorder, depression or other relevant psychopathology that, in the judgement of the recruiting clinician, could interfere with study participation
• Concurrent participation in another structured intervention study specifically targeting fear of childbirth
• Planned relocation outside the CHUIMI catchment area before the estimated date of delivery, precluding postpartum data collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web-based prenatal education; Participants receive personal credentials for an interactive web-based prenatal education platform, activated at 37+0 weeks of gestation and accessible until hospital admission for birth, in addition to standard antenatal care.	Behavioral: Web-based prenatal education platform; Asynchronous, self-paced digital education programme delivered through a password-protected website accessible from any internet-connected device. Content is organised in 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. Materials are evidence-based and adapted to local clinical protocols. Access is activated at 37+0 weeks and remains available until admission for birth. Server metrics record logins, session duration and modules accessed.
No Intervention: Usual care; Participants receive standard antenatal care according to the protocols of the Canary Islands Health Service for low-risk pregnancy, including scheduled midwifery and obstetric visits and the option of attending conventional face-to-face antenatal classes. No access to the study platform is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of childbirth (Wijma Delivery Expectancy/Experience Questionnaire, version B)	Fear of childbirth related to the birth experience, measured with the Spanish version of the Wijma Delivery Expectancy/Experience Questionnaire, experience version (W-DEQ-B-Sp). The instrument is self-administered and comprises 33 items rated on a 6-point Likert scale (0 = not at all to 5 = extremely). Total scores range from 0 to 165, with higher scores indicating greater fear of childbirth. Items 2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27 and 31 are reverse-scored. Cronbach's alpha in the Spanish validation study was 0.93. Scores are compared between arms, adjusted for baseline W-DEQ-A-Sp score.	Between day 1 and day 15 postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline fear of childbirth (W-DEQ-A-Sp)	Antenatal fear of childbirth measured with the Spanish expectancy version of the Wijma questionnaire (W-DEQ-A-Sp), 31 items rated 0-5, total score range 0-155, higher scores indicating greater fear. Cronbach's alpha 0.91. Collected prior to randomisation to characterise baseline levels and to confirm comparability between arms.	At 37+0 to 42+0 weeks of gestation, immediately before randomisation
Onset of labour	Categorised as spontaneous or induced, extracted from the electronic health record.	At birth, assessed through study completion (up to approximately 5 weeks after randomisation)
Use of synthetic oxytocin during labour	Intravenous administration of exogenous oxytocin to induce or augment uterine contractions (yes/no), extracted from the electronic health record.	At birth, assessed through study completion (up to approximately 5 weeks after randomisation)
Use of epidural analgesia	Effective administration of neuraxial analgesia during labour (yes/no), extracted from the electronic health record.	At birth, assessed through study completion (up to approximately 5 weeks after randomisation)
Duration of labour	Time in hours from admission to the labour ward in active phase to delivery of the placenta, extracted from the electronic health record.	At birth, assessed through study completion (up to approximately 5 weeks after randomisation)
Mode of birth	Categorised as spontaneous vaginal birth, instrumental vaginal birth or caesarean section, extracted from the electronic health record.	At birth, assessed through study completion (up to approximately 5 weeks after randomisation)
Apgar score	Neonatal vitality and physiological adaptation scored from 0 to 10 at 1 and 5 minutes of life, extracted from the electronic health record.	At 1 and 5 minutes after birth
Gestational age at birth	Duration of pregnancy in completed weeks and days at the time of birth, calculated preferentially from first-trimester dating ultrasound.	At birth, assessed through study completion (up to approximately 5 weeks after randomisation)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the intervention (experimental arm only)	Level of exposure to the intervention, recorded automatically by the platform server: total number of logins, session duration and number of modules completed per participant.	From randomisation at 37+0 weeks until hospital admission for birth (up to approximately 5 weeks)
Attendance at face-to-face antenatal education	Attendance at the conventional antenatal education programme delivered by primary care midwives, recorded as yes/no and, where applicable, as the number of sessions attended. Collected by self-report at T1 and verified against the primary care electronic health record.	Between day 1 and day 15 postpartum
Sources of childbirth information consulted	Self-reported use of digital and non-digital sources of information about labour and birth during the third trimester, collected in both arms to assess potential contamination of the control group.	At 37+0 to 42+0 weeks of gestation and between day 1 and day 15 postpartum

Collaborators and Investigators

• Sponsor: Sergio Mies Padilla
• Investigators: Principal Investigator: Sabela Jiménez López RM, Complejo Hospitalario Universitario Materno Infantil de Canarias

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: July 30, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; digital health; fear of childbirth; midwifery; antenatal education; term pregnancy; web-based intervention; prenatal education; tocophobia
• Other Study ID Numbers: 2026-249-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No