The Simulation Training for Operative vaginal Birth – Evaluation (STROBE) study
Not Applicable
Completed
- Conditions
- Specialty: Reproductive health and childbirth, Primary sub-specialty: General Obstetrics/ MidwiferyUKCRC code/ Disease: Reproductive Health and Childbirth/ DeliveryPregnancy and Childbirth
- Registration Number
- ISRCTN11760611
- Lead Sponsor
- orth Bristol NHS Trust
- Brief Summary
2019 protocol in https://pubmed.ncbi.nlm.nih.gov/30940102/ (added 23/11/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 2400
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
Excludes an instrumented Caesarean birth
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Failure to achieve vaginal birth with the primary chosen instrument; Timepoint(s): 01/06/2018
- Secondary Outcome Measures
Name Time Method <br> 1. Use of second instrument to achieve operative vaginal birth (forceps or ventouse)<br> 2. Caesarean section<br> 3. Episiotomy<br> 4. Perineal trauma (1st/2nd/3rd/4th degree tear)<br> 5. Cervical tear requiring suturing<br> 6. General anaesthesia<br> 7. Estimated blood loss (ml)<br> 8. Apgar score at 1, 5 and 10 minutes<br> 9. Umbilical artery pH<br> 10. Shoulder dystocia (Yes/No)<br> 11. Admission to Neonatal Intensive Care Unit (for any reason immediately following birth)<br> 12. Neonatal death within 28 days of birth (for any reason)<br><br> All outcome measures are routinely assessed and recorded contemporaneously by the obstetrician performing the attempted operative vaginal birth<br>