Implementing an operative vaginal birth safety bundle

Not Applicable

• Conditions: Operative vaginal birth; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12623000168651
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-17
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 1888

Inclusion Criteria

The study will assess maternal and neonatal outcomes for all women of term gestation with cephalic presentation having an OVB or second stage caesarean section at three Monash health maternity centres. The following cohort of patients will be included:
Inclusion criteria
- Term gestation
- Cephalic presentation
- Spontaneous, induced or augmented labour
- In the second stage undergoing attempted OVB or second stage caesarean section
- Women delivering in the 18 months after completion of the pilot and transition phase, following final bundle implementation (prospective cohort - March 2023 to September 2024) and those delivering in the 18months preceding the pilot (historical control cohort - 1/5/2020 to 31/10/2021).

Exclusion Criteria

Exclusion criteria
- Women less than 37 weeks gestation
- Non-cephalic presentation
- Cervix not fully dilated
- Contraindication to vaginal birth or OVB for any reason
- Multifetal pregnancy
- Women delivery via:
•Normal vaginal birth
•Breech vaginal birth - including forceps for aftercoming head
•Planned elective caesarean section pre-labour
•Caesarean section in the first stage of labour

Study & Design

• Study Type: Observational
• Study Design: Not specified