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The Simulation Training for Operative vaginal Birth – Evaluation (STROBE) study

The Simulation Training for Operative vaginal Birth – Evaluation (STROBE) study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11760611
Enrollment
2400
Registered
2018-04-20
Start date
2018-02-13
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ Midwifery

Interventions

The intervention studied will be the local provision of structured simulation training in operative vaginal birth (the ROBuST course) to trainees in Obstetrics and Gynaecology. The intervention will b

Sponsors

North Bristol NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. The woman had a birth conducted within a study site during the applicable study time period, by any doctor, trained or untrained 2. An operative vaginal birth instrument (forceps or vacuum) was applied to a fetal head 3. The woman had a singleton pregnancy

Exclusion criteria

Exclusion criteria: Excludes an instrumented Caesarean birth

Design outcomes

Primary

MeasureTime frame
Failure to achieve vaginal birth with the primary chosen instrument; Timepoint(s): 01/06/2018

Secondary

MeasureTime frame
1. Use of second instrument to achieve operative vaginal birth (forceps or ventouse) 2. Caesarean section 3. Episiotomy 4. Perineal trauma (1st/2nd/3rd/4th degree tear) 5. Cervical tear requiring suturing 6. General anaesthesia 7. Estimated blood loss (ml) 8. Apgar score at 1, 5 and 10 minutes 9. Umbilical artery pH 10. Shoulder dystocia (Yes/No) 11. Admission to Neonatal Intensive Care Unit (for any reason immediately following birth) 12. Neonatal death within 28 days of birth (for any reason) All outcome measures are routinely assessed and recorded contemporaneously by the obstetrician performing the attempted operative vaginal birth

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026