Impact of a Digital Prenatal Education Intervention on Fear of Childbirth in Term Pregnant Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Fear of childbirth (Wijma Delivery Expectancy/Experience Questionnaire, version B)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Fear of childbirth (Wijma Delivery Expectancy/Experience Questionnaire, version B)
时间窗: Between day 1 and day 15 postpartum
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.
次要结局
- 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))
- Mode of birth(At birth, assessed through study completion (up to approximately 5 weeks after randomisation))
- Apgar score(At 1 and 5 minutes after birth)
- Gestational age at birth(At birth, assessed through study completion (up to approximately 5 weeks after randomisation))
研究者
Sergio Mies Padilla
Doctor of Biomedical Research
Servicio Canario de Salud