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A comparison of physiology-based interpretation of the fetal heart rate patterns during labour at term to guideline-based interpretation in the prediction of neonatal and labour outcomes

Physiology-based versus guideline-based interpretation of intrapartum cardiotocograph in nulliparous women in term labour at baseline and longitudinally in the prediction of early neonatal outcome: a prospective observational study with randomisation of interpretation methods

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN59827903
Enrollment
2500
Registered
2026-01-14
Start date
2025-11-18
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Fetal heart rate patterns during labour at term Pregnancy and Childbirth

Interventions

This is a prospective observational study of Physiology-based interpretation of intrapartum CTG compared to Guidelines-based interpretation in the prediction of early neonatal outcome. Following enrol

Sponsors

University of Ferrara
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Primigravid/Nulliparous women admitted in term labour (defined as uterine contractions frequency of 1 or more in 10 minutes and/or cervical dilatation >/=3cm after 37 completed weeks of gestation) 2. Managed with continuous CTG monitoring 3. Consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Parous women 2. Women with non-cephalic fetal presentation 3. Fetal abnormality 4. Multiple pregnancy 5. Antenatal CTG recording (defined as no uterine contractions and no cervical dilatation) 6. Abnormal CTG recording (without uterine contractions or cervical dilatation >/=3cm)

Countries

Italy

Contacts

Public ContactAustin;Gianluca Ugwumadu;Straface

;

austin.ugwumadu@stgeorges.nhs.uk;gstraface@casacura.it+44 7956174222;+39 3382813207

Outcome results

None listed

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