Comparing second-line tests in labour to assess fetal well-being

Fetal Scalp Stimulation (FSS) versus Fetal Blood Sampling (FBS) to assess fetal well-being in labour - a multi-centre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13295826

Enrollment

3000

Registered

2018-07-27

Start date

2019-02-01

Completion date

Unknown

Last updated

2020-04-27

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

Conditions

Fetal well-being in labour Pregnancy and Childbirth

Interventions

Allocation of eligible women who consent to participate in the trial will be concealed using a fully automated centralised web-based system provided by the Nottingham Randomised Trials Collaboration.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with a singleton pregnancy 2. Cephalic presentation 3. Gestational age greater than 36 weeks 4. Abnormal CTG that requires further assessment by fetal blood sampling

Exclusion criteria

Exclusion criteria: 1. Women with a contraindication to FBS 2. Limited understanding of English 3. Under 18 years of age 4. Eligibility will also be at the discretion of the responsible obstetrician in cases where there is urgency due to suspected fetal compromise (“fetal distress”)

Design outcomes

Primary

Measure	Time frame
Incidence of caesarean section in labour, recorded from the computerised records prior to hospital discharge	—

Secondary

Measure	Time frame
All outcomes recorded from computerised records prior to hospital discharge: 1. Incidence of caesarean section by primary indication (maternal/fetal) 2. Incidence of operative vaginal delivery 3. Incidence of low Apgar scores (500ml), major obstetric haemorrhage (>1000ml), third and fourth degree perineal tears (OASI), admission to High Dependency Unit (HDU) 5. Prolonged postnatal admission (> 5 days) 6. Number of second-line tests performed, number of FBS procedures and attendances of medical staff to review the CTG	—

Measure

Time frame

All outcomes recorded from computerised records prior to hospital discharge: 1. Incidence of caesarean section by primary indication (maternal/fetal) 2. Incidence of operative vaginal delivery 3. Incidence of low Apgar scores (500ml), major obstetric haemorrhage (>1000ml), third and fourth degree perineal tears (OASI), admission to High Dependency Unit (HDU) 5. Prolonged postnatal admission (> 5 days) 6. Number of second-line tests performed, number of FBS procedures and attendances of medical staff to review the CTG

—

Countries

Ireland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026