Prevalence of Obstetric Anal Sphincter Injury With a Reducing Episiotomy Rate

NCT05436171 | Unknown

• 1 other identifier: CRE 2022.259
• Study Type: observational
• Target: 6,700
• Locations: 1 country
• Sites: 1

Brief Summary

Obstetric anal sphincter injury (OASIS) is a serious complication of a vaginal delivery. High proportion of women, 40-59%, suffer from faecal incontinence (FI) after this type of injury.1-3 OASIS and FI have a negative impact on women's quality of life.4 The rate of elective caesarean section at second birth was much higher in women with OASIS at first birth compared with women without the injury (adjusted odds ratio 18.3, 95% CI 16.4-20.4).5 Primiparity has an increased risk of OASIS (odds ratio (OR) 2.39-8.34).6,7 Other factors are macrosomia and instrumental vaginal delivery.6,7 The role of episiotomy on OASIS has also been widely studied but there are controversial results. There were around 500-7000 deliveries at Prince of Wales Hospital annually. Among them, 50-55% was nulliparous women. About 65 -70% of women had normal vaginal delivery and another 5-10% had instrumental delivery. There was a change from 'routine episiotomy' to a more restrictive use of episiotomy in normal vaginal delivery during the last 10 years, with a reduction of rate of episiotomy from 90% to about 50% (from Dept.'s internal audit). The objective of this study is to evaluate the prevalence of OASIS in the era of a reduction of episiotomy.

Conditions

Anal Sphincter Injury

Keywords

Anal sphincter injury; Episiotomy; Prevalence; OASIS

Outcome Measures

Primary Outcomes (1)

• Prevalence of obstetric anal sphincter injury (third or fourth degree tear) detected clinically immediately after delivery

  Prevalence of obstetric anal sphincter injury (third or fourth degree tear) detected clinically immediately after delivery

  Immediately after delivery

Secondary Outcomes (1)

• The factors associated with OASIS

  Immediately after delivery

Study Arms (1)

All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital

All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital The target sample size will be about 67,000 women who had delivered in our unit from 2011 to 2021. Among them, it is expected that 75-80% had vaginal deliveries, either normal vaginal delivery or instrumental delivery. 53,600 will be recruited in study site.

Other: No intervention

Interventions

No intervention OTHER

No intervention

All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Women who had delivered in our unit from 2011 to 2021
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target sample size will be about 67,000 women who had delivered in our unit from 2011 to 2021. Among them, it is expected that 75-80% had vaginal deliveries, either normal vaginal delivery or instrumental delivery. 53,600 will be recruited in study site.

You may qualify if:

• All deliveries conducted from 2011 to 2021 in Prince of Wales Hospital

You may not qualify if:

• Deliveries with Caesarean Section

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 852, Hong Kong

RECRUITING

Related Publications (22)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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Study Officials

• Yan Yan Lau

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Yan Lau

CONTACT

8525569 9272; yanyanlau@cuhk.edu.hk

Lai Loi Lee

CONTACT

85235052583; loretalee@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: August 11, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)