N/A
N=584
Transperineal Ultrasound to Assess the Progress of Labour
Placenta Praevia · Vaginismus
Bottom Line
View on ClinicalTrials.gov: NCT02430038 ↗Enrolled (actual)
584
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Caesarean Delivery — 79 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Imperial College London
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caesarean Delivery |
79 | — |
| PRIMARY Acceptability of Intrapartum Ultrasound |
104; 0; 0 | — |
| PRIMARY Feasibility of Ultrasound Labour Parameters |
0; 168; 0 | — |
Summary
This is a prospective observational study of transperineal ultrasound between 24-42 weeks gestation and a prospective longitudinal observational study in all term (37-42 weeks) labouring women.
Eligibility Criteria
Inclusion Criteria
- Gestation 24-42 completed weeks at study entry
- Aged 18-44
- Cephalic
- Singleton pregnancies
- Nulliparous
- Multiparous (excluded for the term predictive model group)
- Multiple pregnancies (excluded for the term predictive model group)
- Established (Active) phase of labour (included for the term predictive model group) o Clinician opinion that patient is in the established phase of labour according to the current NICE guidelines
Exclusion Criteria
- Younger than 18 years.
- Imminent iatrogenic intention to deliver
- Life threatening maternal or fetal compromise needing immediate medical attention and/or delivery
- Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study.
- Miscarriage
- Intra-uterine death
- Previous cervical surgery eg. cone biopsy, cervical cerclage. Note- Single LLETZ is not excluded.
- Non-cephalic presentations
- Multiple pregnancies (for the term predictive model group)
- Multiparous patients (for the term predictive model group)
- Not in established labour (for the term predictive model group)
Data sourced from ClinicalTrials.gov (NCT02430038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.