Digital Prenatal Education to Reduce Fear of Childbirth in Term Pregnancy

NCT07743502 | Not Yet Recruiting

• 1 other identifier: 2026-249-1
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fear of Childbirth; Tocophobia; Pregnancy Related Anxiety

Keywords

fear of childbirth; tocophobia; antenatal education; prenatal education; digital health; web-based intervention; midwifery; term pregnancy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Baseline fear of childbirth (W-DEQ-A-Sp)

  At 37+0 to 42+0 weeks of gestation, immediately before randomisation

• Onset of labour

  At birth, assessed through study completion (up to approximately 5 weeks after randomisation)

• Use of synthetic oxytocin during labour

  At birth, assessed through study completion (up to approximately 5 weeks after randomisation)

• Use of epidural analgesia

  At birth, assessed through study completion (up to approximately 5 weeks after randomisation)

• Duration of labour

  At birth, assessed through study completion (up to approximately 5 weeks after randomisation)

Other Outcomes (3)

• Adherence to the intervention (experimental arm only)

  From randomisation at 37+0 weeks until hospital admission for birth (up to approximately 5 weeks)

• Attendance at face-to-face antenatal education

  Between day 1 and day 15 postpartum

• Sources of childbirth information consulted

  At 37+0 to 42+0 weeks of gestation and between day 1 and day 15 postpartum

Study Arms (2)

Web-based prenatal education

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Web-based prenatal education platform BEHAVIORAL

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.

Web-based prenatal education

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sergio Mies Padilla: lead

Study Sites (1)

Complejo Hospitalario Universitario Insular Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, LAS Palmas, 35000, Spain

Location

Study Officials

• Sabela Jiménez López RM

  Complejo Hospitalario Universitario Materno Infantil de Canarias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabela Jiménez López RM

CONTACT

+34 928 444 500; sabelajimenezlopez@gmail.com

Sergio Mies Padilla RN, PhD

CONTACT

+34928444000; smiepad@gobiernodecanarias.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Blinding of participants is not feasible given the nature of the intervention. Clinicians attending labour and birth are unaware of group allocation, ensuring that intrapartum care is identical across arms. In addition, statistical analysis is performed by an independent external analyst who receives a pseudonymised dataset in which the allocation variable is coded, and who remains blinded to group identity until all hypothesis testing is complete. The primary outcome is self-reported by participants, who are not blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Biomedical Research

Model Details: Two-arm parallel-group design. Participants are recruited prospectively at any gestational age and randomised at 37+0 weeks, once definitive eligibility is confirmed. Both arms continue to receive standard antenatal care throughout the study; the experimental arm additionally receives access to a web-based antenatal education platform from randomisation until hospital admission for birth. There is no crossover between arms.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)