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Fear of Childbirth: Improving accurate identification in maternity services

Evaluating the properties of the Fear of Childbirth Questionnaire and feasibility of routine implementation for maternity services (FOCUS 2)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62032021
Enrollment
500
Registered
2023-05-01
Start date
2023-05-02
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproductive health and childbirth Pregnancy and Childbirth

Interventions

Study Design This project consists of two stages, involving quantitative and qualitative research methods. Stage One will evaluate the properties of the Fear of Childbirth Questionnaire (FCQ) and exp

Sponsors

University of the West of England
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 110 Years

Inclusion criteria

Inclusion criteria: Stage 1: 1. Participant is willing and able to give informed consent for participation in the study 2. Female, aged 18 years or above 3. Currently up to 16 weeks pregnant. This timeframe has been selected to examine the properties of the FCQ if completed early in pregnancy and is aligned with the proposed use of the FCQ between booking and 16-week midwife appointments (Stage 2). This timeframe was also supported by our service user panel, who felt that early identification of fears would provide the best opportunity for women to access further support 4. Good understanding of the English language. Due to the inclusion of clinical diagnostic interviews, it is required that participants are able to understand the English language Stage 2: 1. Participant is willing and able to give informed consent for participation in the study 2. Female, aged 18 years or above 3. Pregnant 4. Booked by a midwife trained in administering the FCQ at Liverpool Women's Hospital 5. Good understanding of the English language Community midwives at LWH (n = 40), selected as advised by our LWH co-investigator (GH)

Exclusion criteria

Exclusion criteria: Stage 1: 1. More than 16 weeks pregnant 2. Women who do not have a good understanding of the English language Stage 2: Women who do not have a good understanding of the English language

Design outcomes

Primary

MeasureTime frame
Fear of childbirth measured using the Fear of Childbirth Questionnaire (FCQ) when the woman is up to 16 weeks pregnant. The Structured Clinical Interview for DSM-5-RV will be used 2 weeks later to further assess fear of childbirth. Scores on the FCQ and responses to the SCID-5-RV clinical interviews will be compared. Sensitivity and specificity will be calculated for a range of possible cut-off values.

Secondary

MeasureTime frame
1. Fear of childbirth measured by the Fear of Birth Scale up to 16 weeks gestation. 2. State and trait anxiety measured by the State-Trait Anxiety Inventory up to 16 weeks gestation. 3. Generalised anxiety measured by the General Anxiety Disorder 7 up to 16 weeks gestation. 4. Depressive symptoms measured by the Patient Health Questionnaire 9 up to 16 weeks gestation.

Countries

England, United Kingdom

Contacts

Public ContactKayleigh;Rebecca Sheen;Hunter

;

kayleigh.sheen@uwe.ac.uk;Rebecca.hunter@liverpool.ac.uk+44 (0)117 965 6261;None available

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026