Digital Prenatal Education to Reduce Fear of Childbirth in Term Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSergio Mies Padilla
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 years or older
Nulliparous or multiparous
Singleton pregnancy
Pregnancy classified as low obstetric risk according to current local protocols
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Web-based prenatal education platform
BehavioralAsynchronous, 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.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: Web-based prenatal educationExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
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.
Time frame
Between day 1 and day 15 postpartumSecondary outcomes
1
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.
Time frame
At 37+0 to 42+0 weeks of gestation, immediately before randomisation2
Onset of labour
Categorised as spontaneous or induced, extracted from the electronic health record.
Time frame
At birth, assessed through study completion (up to approximately 5 weeks after randomisation)3
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.
Time frame
At birth, assessed through study completion (up to approximately 5 weeks after randomisation)4
Use of epidural analgesia
Effective administration of neuraxial analgesia during labour (yes/no), extracted from the electronic health record.
Time frame
At birth, assessed through study completion (up to approximately 5 weeks after randomisation)Other outcomes
1
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.
Time frame
From randomisation at 37+0 weeks until hospital admission for birth (up to approximately 5 weeks)2
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.
Time frame
Between day 1 and day 15 postpartum3
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.
Time frame
At 37+0 to 42+0 weeks of gestation and between day 1 and day 15 postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sergio Mies Padilla
Lead sponsor
Servicio Canario de Salud
Sponsor institution
Source ClinicalTrials.gov
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