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The Pregnancy Physiology Pattern Prediction Study (4P Study)

The Pregnancy Physiology Pattern Prediction Study (4P Study): an observational cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN10838017
Enrollment
1000
Registered
2014-12-29
Start date
2014-11-01
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

Vital signs during pregnancy, intrapartum and two weeks post partum Pregnancy and Childbirth

Interventions

Vital signs, including oxygen saturation levels, blood pressure, heart rate, respiration rate and temperature will be recorded onto a tablet and smartphone throughout pregnancy at 4-6 week intervals a

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Over 16 years of age (parental consent to be obtained for participants <18 years old) 2. Pregnant with an intent to deliver in hospital 3. Able to understand written or spoken English or has their own interpreter willing to translate 4. Willing and able to use the home monitoring equipment 5. Within category 1 of the American Society of Anaesthesiologists' classification of physical status at enrolment (normal healthy patient without any clinically important comorbidity and without a clinically significant past/present medical history).

Exclusion criteria

Exclusion criteria: Any known medical condition expected by the recruiting clinician to alter maternal vital signs

Design outcomes

Primary

MeasureTime frame
To create a comprehensive database of physiological values during pregnancy, the intrapartum and postpartum periods for 1000 participants.

Secondary

MeasureTime frame
1. To develop a centile-based early warning score for pregnancy and the postpartum period. 2. To investigate new patterns within vital signs data in pregnancy

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026