Pulling forces involved with forceps delivery and its association with maternal injury during birth

Not Applicable

• Conditions: evator ani muscle avulsion during forceps delivery; Pregnancy and Childbirth; Levator ani muscle avulsion during forceps delivery

• Registration Number: ISRCTN18126471
• Lead Sponsor: Safe Obstetrics Systems Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-22
• Last Update Posted: 9 September 2019
• Study Completion: 2020-08-19

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Singleton pregnancy
2. Nulliparae
3. Forceps delivery (Pro-nata forceps)

Exclusion Criteria

1. Twin deliveries
2. Breech deliveries
3. Previous vaginal delivery

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Avulsion of the levator ani muscle. Avulsion will be diagnosed when a defect is observed at the puborectalis insertion using Tomographic Ultrasound Imaging (TUI) at the level of minimal hiatal dimensions and 2.5 and 5mm slices cranially. In doubtful cases, the ‘levator urethra gap’ will be used to rate individual slices as abnormal when the distance from the urethra to the insertion of the puborectalis muscle is more than 25mm.